10-K 1 2018123110kannualreport.htm ANNUAL REPORT 12-31-2018 Annual Report 12-31-2018

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-K

 

(Mark One)

 

 ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934

 

For the fiscal year ended December 31, 2018

 

 TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES 
 EXCHANGE ACT OF 1934

 

Commission file number 000-52534

 

 

 

PARALLAX HEALTH SCIENCES, INC.

 

(Exact name of registrant as specified in its charter)

 

Nevada

46-4733512

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

 

 

1327 Ocean Avenue, Suite B, Santa Monica, CA

90401

(Address of principal executive offices)

(Zip Code)

 

 

Registrant's telephone number, including area code:

(310) 899-4442

 

Copy of all Communications to:

Peter Hogan, Esq.

Buchalter

1000 Wilshire Blvd., Suite 1500

Los Angeles, CA 90017

(213) 891-0700

 

 

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 the Securities Act.

Yes No

 

 

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.

Yes No

 

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the last 90 days.

Yes No

 

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registration statement was required to submit such files).

Yes No

 

 

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K.

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer, “ “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

 

Large accelerated filer

 

Accelerated filer

Non-accelerated filer

 

Smaller reporting company

 

 

 

Emerging growth company

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes ☐ No ☑

 

The aggregate market value of Common Stock held by non-affiliates of the Registrant as of June 30, 2018 was $8,253,020, based on a closing price of $0.1524 for the Common Stock on June 30, 2018, the last business day of the Registrant’s most recently completed second fiscal quarter. For purposes of this computation, all executive officers and directors have been deemed to be affiliates. Such determination should not be deemed to be an admission that such executive officers and directors are, in fact, affiliates of the Registrant.

 

Indicate the number of shares outstanding of each of the registrant’s

classes of common stock as of the latest practicable date.

 

165,033,141 common shares issued and outstanding as of March 29, 2019




 

TABLE OF CONTENTS

 

 

 

ITEM 1.

BUSINESS

1

 

 

 

ITEM 1A.

RISK FACTORS

28

 

 

 

ITEM 2.

PROPERTIES

29

 

 

 

ITEM 3.

LEGAL PROCEEDINGS

29

 

 

 

ITEM 4.

MINE SAFETY STANDARDS

31

 

 

 

ITEM 5.

MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS

32

 

 

 

ITEM 6.

SELECTED FINANCIAL DATA

35

 

 

 

ITEM 7.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

35

 

 

 

ITEM 7A.

QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKS

45

 

 

 

ITEM 8.

FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

45

 

 

 

ITEM 9.

CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE

45

 

 

 

ITEM 9A.

CONTROLS AND PROCEDURES

45

 

 

 

ITEM 9B.

OTHER INFORMATION

46

 

 

 

ITEM 10.

DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE

47

 

 

 

ITEM 11.

EXECUTIVE COMPENSATION

50

 

 

 

ITEM 12.

SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS

53

 

 

 

ITEM 13.

CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

54

 

 

 

ITEM 14.

PRINCIPAL ACCOUNTANTS FEES AND SERVICES

56

 

 

 

ITEM 15.

EXHIBITS, FINANCIAL STATEMENT SCHEDULES

57

 

 

 




PART I

 

ITEM 1.BUSINESS 

 

Forward-Looking Statements

 

This annual report contains forward-looking statements. These statements relate to future events or the future financial performance of Parallax Health Sciences, Inc. (“Parallax” or the “Company”), and include statements made by the Company regarding insurance reimbursements, state licenses, product development and obtaining FDA clearances. In some cases, forward-looking statements can be identified by terminology such as “may”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors” that may cause the Company’s or its industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results.

 

Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results.

 

In this annual report, unless otherwise specified, all dollar amounts are expressed in United States Dollars and are prepared in accordance with United States Generally Accepted Accounting Principles. All references to “Common Stock” refer to the common shares; and “Preferred Stock” refer to the preferred shares; of the Company’s capital stock.

 

As used in this annual report, the terms “the Company”, “we”, “us”, “our”, and “Parallax” shall mean Parallax Health Sciences, Inc., and its wholly-owned subsidiaries, Parallax Diagnostics, Inc., Parallax Health Management, Inc., and Parallax Behavioral Health, Inc. unless otherwise indicated. The Company’s former wholly-owned subsidiary, RoxSan Pharmacy, Inc., was derecognized effective May 14, 2018. (See “RoxSan Pharmacy” and “Legal Proceedings” sections contained within this annual report.)

 

CORPORATE OVERVIEW

 

Parallax Health Sciences, Inc. is an outcome driven, integrated digital healthcare company delivering scalable connected products, services and actionable data on an interoperable platform.  The Company’s principal mission is to deliver solutions that empower patients, reduce costs and improve the quality of care through patented leading-edge technologies.

 

The Company’s principal executive office is located at 1327 Ocean Avenue, Suite B, Santa Monica, California, 90401. The Company’s telephone number is (310) 899-4442.

 

The Company’s websites are at www.parallaxcare.com, www.parallaxhealthsciences.com, www.parallaxhealthmanagement.com, and www.parallaxdiagnostics.com.

 

Parallax is a fully reporting company with its stock traded on the OTCQB Markets under the symbol “PRLX” (OTCQB.PRLX).

 

CORPORATE HISTORY

 

Formation and Development

 

The Company was incorporated in the State of Nevada on July 6, 2005.  On November 1, 2012, the Company, formerly Endeavor Power Corporation, and its wholly-owned subsidiary, Endeavor Holdings, Inc., a Nevada corporation, entered into an Agreement and Plan of Merger with Parallax Diagnostics, Inc., a Nevada corporation, whereby Parallax Diagnostics became a wholly-owned subsidiary.  On January 9, 2014, the Company changed its name to Parallax Health Sciences, Inc.

 

The Parallax business was founded on the Company’s Point-of-Care diagnostic business, Parallax Diagnostics, Inc., in 2010, when the Company acquired the right, title, and interest, through an exclusive license with Montecito BioSciences, Ltd. (“MBS”), to develop, manufacture and commercialize the Target System, an FDA-cleared 2 desktop point-of-care immunoassay diagnostic testing system. Concurrently, through an Assignment Agreement with MBS, the Company acquired the right, title, and interest to twenty-five (25) FDA-cleared 2 tests in the area of infectious disease, medical conditions, drugs of abuse, cardiac and pregnancy, that are designed to be utilized with the Target System.

 


2FDA 510(k) clearances do not expire. For additional information on FDA clearance and 510(k) requirements, see “FDA Clearances and Approvals” section. 


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On August 31, 2016, the Company entered into an agreement with Qolpom®, Inc., an Arizona corporation in the remote healthcare monitoring and telehealth business (“Qolpom®”) and its shareholders (the “Seller”) to purchase 100% of the issued and outstanding shares of Qolpom®’s common stock and its assets, inventory and intellectual property.  The agreement was fully executed and the transaction was completed on September 20, 2016. The consideration for the acquisition resulted in a fair market value of $290,000, and goodwill of $785,060.  In addition, the agreement included contingent royalties and revenue sharing for future revenues generated from the Qolpom® technology. The Qolpom® name was later changed to Parallax Health Management, Inc. (“PHM”).

 

On March 22, 2017, the Company formed a wholly-owned subsidiary, Parallax Behavioral Health, Inc. (“PBH”), a Delaware corporation, and on April 26, 2017, completed the asset acquisition of 100% of certain intellectual property (“Intellectual Property”) from ProEventa Inc., a Virginia Corporation (“ProEventa”), in accordance with the Intellectual Property Purchase Agreement between the Company, PBH and ProEventa (the “ProEventa Agreement”). ProEventa has an expertise in the development of behavioral health technologies, and is the wholly-owned subsidiary of Grafton Integrated Health Network, Inc., a non-profit Virginia corporation (“Grafton”). Pursuant to the ProEventa Agreement, the initial consideration for the Intellectual Property was paid to ProEventa in the form of a stock purchase agreement to purchase 2,500,000 shares of the Company’s Common Stock for $2,500, resulting in a net cost for the Intellectual Property of $622,500.  In addition, the Agreement included conditional contingent royalties and revenue sharing for future revenues generated from the Intellectual Property.

 

On September 20, 2018, the Company formed Parallax Communications, Inc, a Delaware corporation and wholly-owned subsidiary of Parallax Health Management, Inc.

 

Changes in Management

 

On April 6, 2017, the Company’s board of directors (the “Board”) elected Mr. J. Michael Redmond as Chairman, to serve until the next annual meeting of the shareholders, in accordance with the Company’s bylaws, and/or until his successor is duly appointed, or a resignation is duly tendered.

 

Effective July 6, 2017, the Board caused the departure of Mr. Redmond from his position as President and Chief Executive Officer of the Company and RoxSan Pharmacy, Inc.

 

Effective July 7, 2017, pursuant to a unanimous Board resolution, Mr. Paul R. Arena was appointed as the Company’s President and Chief Executive Officer, and the Board caused Mr. Arena's election to the Board and the Boards of the Company’s wholly-owned subsidiaries, Parallax Health Management, Inc. and Parallax Behavioral Health, Inc.

 

On July 26, 2017, Mr. Jorn Gorlach resigned as a member of the Board.  This resignation did not involve any disagreements with the Company.

 

On June 4, 2018, Mr. Anand Kumar resigned as a member of the Board.  This resignation did not involve any disagreement with the Company.  Mr. Nathaniel T. Bradley, currently serving as Chief Technology Officer, succeeded him, and agreed to serve as a member of the Board until the next annual meeting of the shareholders and/or until his successor is duly appointed.

 

RoxSan Pharmacy

 

In 2013, the Company identified an opportunity to acquire RoxSan Pharmacy, Inc. (“RoxSan”), a California corporation, and began the due diligence process. The Company’s initial interest centered on utilizing the acquisition as a means of accelerating the commercialization of the Company’s Target System and diagnostic platform, as RoxSan had access to a nationwide network of doctors and sales representatives.  During the due diligence process, the Company became aware of numerous opportunities that RoxSan and its markets represented.

 

On March 21, 2013, the Company entered into a Letter of Intent with Shahla Melamed, RoxSan's sole Shareholder, to acquire RoxSan.  Between 2013 and 2015, four (4) amendments were also executed.

 

As part of the acquisition, the Company was required to obtain licensure from the State of California, and on July 31, 2015, the Company received notice that its pharmacy and sterile compounding licenses were issued by the California State Board of Pharmacy. 

 

On August 13, 2015, (the “Closing Date”), pursuant to a resolution of the Board, the Company entered into an Agreement to Purchase and Sell One Hundred Percent of the Issued and Outstanding Shares of RoxSan Pharmacy, Inc. (“RoxSan” or the “Pharmacy”), and its Assets and Inventory (the “Purchase Agreement”).  Pursuant to the Purchase Agreement between Parallax, RoxSan and its sole shareholder, Shahla Melamed (the “Seller” or “Melamed” or “Former Owner”), in exchange for 100% of RoxSan's common stock, and its assets and inventory, Parallax, among other things, issued the Seller a Secured Promissory Note (the “Note”) dated August 13, 2015, in the amount of $20.5 million (the “Acquisition”).  The Note bore interest at a rate of 6% per annum, and matured August 13, 2018 (“Maturity”).  the Company is seeking a reduction in the Purchase Price and related promissory note (See ITEM 3. LEGAL PROCEEDINGS section).  As a result of the Acquisition, effective August 13, 2015, RoxSan became a wholly-owned subsidiary of Parallax. No change in control occurred as a result of the Acquisition.

 

In connection with the Acquisition, the Company entered into an Employment Agreement (the “Employment Agreement”) with the Seller.  Under the Employment Agreement, Melamed agreed to provide exclusive consulting services to RoxSan in the areas of public relations and marketing for a term of four (4) years. On March 4, 2016, the Company terminated the Employment Agreement in accordance with paragraph 3.2 Termination for Cause.  The termination was the result of, among other things, Melamed's breaches in the Agreement, which were substantiated by an investigation conducted by an employment law firm retained by RoxSan.  Under the terms of the Agreement, no financial obligation resulted in the termination.


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Since Parallax’s acquisition of RoxSan, the deleterious actions against the pharmacy by the Former Owner, including, among other things, interference with management and operations, and attempts to damage and/or divert customer and vendor relationships, had a significant adverse impact on the pharmacy. Furthermore, the discovery of the Former Owner’s alleged involvement in suspected insurance fraud caused RoxSan’s contract with its primary IVF drug rebate program to be terminated in August 2016. As a result, RoxSan was no longer eligible to receive incentive rebates for the majority of its IVF drug purchases, which were key to the profitability of the IVF drug sales; and for which without the rebates, RoxSan was unable to provide its customers with competitively priced IVF drugs.  This, among other things, caused a precipitous drop in RoxSan’s IVF revenues, and ultimate exit from the IVF market in mid-2017.  Soon thereafter, in July 2017, RoxSan’s contract with its primary drug supplier was terminated for similar reasons connected to the Former Owner and alleged criminal activities associated with the Melamed family name, despite Parallax’s new ownership and management. After careful consideration, the Company determined that RoxSan was unable to generate enough profits to sustain its pharmacy business, and in December 2017, the pharmacy ceased operations and closed the business location in Beverly Hills, CA; some residual operations were still ongoing during 2018 to wind down the business.  

 

On May 14, 2018, pursuant to unanimous resolutions of the boards of directors of RoxSan Pharmacy, Inc. and Parallax Health Sciences, Inc., RoxSan filed a Chapter 7 petition in the United States Bankruptcy Court for the Central District of California (the “Court”).  Mr. Timothy Yoo was appointed trustee (“Trustee”) on May 15, 2018.  In connection with this filing, RoxSan sought to discharge approximately $5 million of liabilities owed to various parties, and intercompany loans in excess of $1 million owed to Parallax.  The Chapter 7 bankruptcy proceeding by RoxSan Pharmacy, Inc. was fully discharged and the case was closed on March 13, 2019 in U.S. Bankruptcy Court, Central District of California.

 

Due to, among other things, the reduction in RoxSan’s cash flows during 2016 and 2017, RoxSan became delinquent in its payroll tax depository obligations, resulting in a liability owed to federal and state taxing agencies in the aggregate of $1,148,811, which includes $601,148 in taxes withheld from employees (“Trust Fund Taxes”), employer taxes of $183,172, and penalties and interest of $364,491 through December 31, 2018. The liability was included as part of the Chapter 7 bankruptcy petition, and certain portions of the liability may be discharged.  However, in accordance with California bankruptcy laws, federal and state Trust Fund Taxes are not dischargeable.  The Company has retained a tax resolution specialist and is in communications with the taxing agencies in order to resolve RoxSan’s liability.

 

As a result of the loss of financial control of RoxSan, the Company derecognized the subsidiary as of September 30, 2018. The derecognition resulted in a gain of $4,478,268. The Company also extinguished $22,778,281 in debt and accrued interest related to the acquisition of RoxSan.

 

DESCRIPTION OF BUSINESS

 

Overview

 

The Company’s principal focus is on personalized patient care through remote healthcare services, behavioral health systems, and Point-of-Care diagnostic testing.  Parallax’s current family of companies [1] that serve as the foundation for its cross-over business model of operations include:

 

Parallax Diagnostics, Inc. (“Parallax Diagnostics” or “PDI”) acquired a proprietary Point-of-Care diagnostic immunoassay testing platform and 25 test cartridges for the areas of infectious diseases, cardiac markers, drugs of abuse and various other medical conditions.  

 

Parallax Health Management, Inc. (“PHM”) develops remote patient monitoring (“RPM”) and telehealth market products and services, and commercializes them, including the Fotodigm® proprietary platform which allows for systems integration with a number of third-party services and solutions.  

 

Parallax Behavioral Health, Inc. (“PBH”) acquired the intellectual property known as REBOOT, the acronym for Reliable Evidence-Based Outcomes Optimization Technologies, as well as the Intrinsic Code technology, a software platform specifically designed to improve health treatment outcomes through cloud-based and mobile behavioral technology systems that enable its users and user groups to more effectively achieve goals within a prescribed timeline. 

 

[1]During 2017, Parallax’s operations included RoxSan Pharmacy, Inc.  However, the pharmacy ceased operations in December 2017, and the Company derecognized the subsidiary effective May 2018. (see Corporate History and Legal Proceedings).  

 

Parallax Care

 

The Company envisions a world where healthcare is accessible, reliable and affordable, without compromising quality and economics of the healthcare industry.  Driven by a sincere desire to make people’s lives better and push back on the healthcare industry’s crippling economic outlook, the Parallax Care platform was created; the Company’s design is for “outcomes realized through intelligent health.”

 

The Parallax Care system facilitates cost-effective remote diagnosis, treatment and monitoring of patients with chronic diseases. Parallax’s integrated products and services provide Point-of-Care (“POC”) patient testing and monitoring, along with information communicated via cloud-based mobile smartphone applications that are agnostic as to operating systems and utilize sophisticated data analytics. Information is retrieved in real-time by physicians and other healthcare professionals and is integrated into electronic health records.  The Company’s digital products and services capitalize on the transformation of healthcare to provide improved compliance, diagnosis, monitoring and support to patients, along with cost savings and efficiencies to healthcare systems.


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Parallax Care encompasses three separate divisions that can operate independently of one another, or integrate services to meet the various needs of the Company’s clientele: Optimized Outcomes, Connected Health and Smart Data.

 

Optimized Outcomes

REBOOT / COMPASS

Behavioral modification

Connected Health

Fotodigm® platform

Remote patient monitoring, telehealth, and POC diagnostic testing

Smart Data

Intrinsic Code technology

Actionable insights to behavior modification

 

Each of the Company’s divisions target a separate vertical market that complement each other and the Company value proposition. In addition, the synergistic operational cross-over affords the Company the ability to use built-in economies of scale across multiple operating platforms.

 

The Company believes that the solutions lay in the empowerment of the patient, the payer and the provider; creating a model of healthcare that aligns all three interests and creates a singular goal of better health outcomes, at reduced cost.  The Parallax Care platform involves these areas of focus:

 

Behavioral Modification 

 

The Company believes in working to empower the patient to modify their behavior through personal empowerment. The Company has developed and designed a revolutionary technology that will aid in the challenges of behavior modification, and improve adherence to medical regimens, which can lead to lower costs and better health.

 

REBOOT, the Company’s patented cloud-based behavioral software technology, along with COMPASS, the Company’s mobile application that incorporates REBOOT with unique mobile phone features, and WIZARD, which supports scalability of the REBOOT/COMPASS platform, was developed by behavioral specialists at Grafton Integrated Health Network, a multistate behavioral healthcare organization with over 60 years of clinical experience and data in behavioral health.

 

Connected Health 

 

Continually increasing healthcare costs, difficulty accessing care, and a greater need for convenience, are driving consumers to demand more value out of their healthcare dollar and seek care that meets their needs and preferences. The market is responding to this growing demand, and non-traditional care models are rapidly expanding, such as:

Traditional providers (e.g., office-based primary care physicians (PCPs) and specialists, hospitals) are partnering with non-traditional care providers to expand reach.  

New parties, such as consumer product and technology companies, are entering this billion-dollar market. 

Non-traditional care models have the opportunity to complement traditional care models to help improve access and affordability, and to deliver a more personalized healthcare experience. 

 

To meet these changing demands, the Company has developed Fotodigm®, the Company’s proprietary connected health platform that provides remote patient monitoring, telehealth, POC diagnostics and health education products and services on a single platform.  Currently in its beta stage, Fotodigm® has the capability for systems integration of an unlimited number of third-party services and solutions. The Company is continuing the Fotodigm® beta stage to test economic models and delivery modalities in preparation for large-scale deployment of the Fotodigm® platform.  The Fotodigm® platform is based on the following:

 

Telehealth/Remote Patient Monitoring 

Improves digital connectivity among consumers, providers, health plans, and life sciences companies.  

Facilitates self-managed care, with the help of technology-enabled solutions. 

Provides a secure environment that protects consumer privacy. 

Delivers care outside the traditional clinical setting, potentially providing better access to care at a lower cost.  

Assists chronic disease management and improves population health outcomes.  

Empowers patients by providing a cost-effective tool that connects them with their doctors.  

Empowers doctors with improved patient scheduling flexibility and timely communications.  

Provides hospitals with a tool to address the problem and economic hardship caused by readmissions. 

Provides a virtual management tool for chronic disease management. 

 

Target System  

 

Allows doctors to test patients in their office.  

Requires only a one-time learning process to perform all tests.  

Delivers test results in 12 minutes or less.  

Provides patients with important information at the time of testing.  

Costs less than outside lab-based tests, allowing for a reduction in payer costs and patient co-pays.  

Allows doctors to earn additional revenue that they cannot participate in with outside labs and testing not performed in their offices. 

Patients can test from their homes and transmit data to doctors. 


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The Parallax Business Model

 

In the past 60 years, healthcare has transitioned from a direct relationship between doctor and patient, to one that has patients separated from their doctors by the introduction of a huge number of stakeholders, ranging from health insurers, employers, pharmacy benefit managers, imaging, diagnostic testing, lawyers, specialists and a plethora of others.  The patient and healthcare provider both want the same thing: information, quality of service, transparency, value for their hard-earned dollars, and more time in their day.

 

The Company has developed, acquired and licensed multiple proprietary and exclusive platforms that provide services and products, across the healthcare continuum.  These platforms are designed to allow for multiple points of reciprocal consideration, through innovative business models, that provide patients with increased quality of services and products, at reduced cost of time and money.  They also provide healthcare providers with increased access to their patients, the ability to deliver better and more efficient service and increase their income from the services they supply.  The Company believes the Parallax Care system will deliver solutions to problems of health and economics, while providing essential actionable data to pharmaceutical firms, payers and healthcare providers, through our:

 

Patented behavioral machine learning technology; 

Patented POC diagnostic testing technology; 

Patent-pending interoperable connected health platform targeting two of healthcare’s biggest problems that, combined, address markets that represent over $1 trillion in costs 3:   

Medical nonadherence  

Chronic disease management; and 

Smart Data delivered through enhanced patient/disease stratification, in combination with dynamic behavioral data, relating to adherence to pharmacologic and medical therapy regimens designed to: 

help patient outcomes  

reduce the cost of care associated with nonadherence 

deliver actionable data. 

 

Cognitive AI

 

The Company is working with partners that have developed a cognitive artificial intelligence, (“Cognitive AI”) agent architecture with the interaction of emotion, motivation and cognition of situated agents, mainly based on the Psi theory of Dietrich Dörner. The Psi theory addresses emotion, perception, representation and bounded rationality, but being formulated within psychology, has had relatively little impact on the discussion of agents within computer science. Cognitive AI is a formulation of the original theory in a more abstract and formal way, at the same time enhancing it with additional concepts for memory, building of ontological categories and attention.

 

Big Data Opportunity

 

The Company’s real-time data generated from patient-users can be stripped to protect the specific patient-user identity and exchanged for historical data with Center for Disease Control, (“CDC”), National Institute of Health, (“NIH”), various universities and others to provide valuable empirical health related information to the Company’s patient-users using Cognitive AI provided by the Company’s partners and coordinated through various electronic health record organizations for which the Company is agnostic.  This empirical data when it becomes available on the Company’s outcomes optimization based platform will become a valuable tool for determining predictive and supportive diagnostics to its patient-users.

 

The Company’s endeavors to change the healthcare industry are strengthened by providing solutions to real problems facing healthcare stakeholders today. The Company’s products and services have been developed, and are continuing to be developed, to address these issues now. The Company’s models include revenue from, and are compatible with, both the traditional reimbursement through payers, and the new performance-based compensation and financial incentive for the adoption of healthy, preventative behavior.

 

The Cross-Over and Cross-Pollination Model

 

The Company’s business model is built on identifying opportunities represented by one market vertical that provides for a separate vertical to utilize one or more of the Company’s core operations. Although the multiple operations of Parallax Care are focused in separate vertical markets, the Company has designed its business model to allow for cross-pollination and reciprocal transfer of value at multiple points in their respective economic food chains.

 

As an example of the Company’s cross-over and cross-pollination model, each of the Company’s divisions can support each other:

 

The Optimized Outcomes division can provide a range of after-care products and services. 

The Connected Health division can offer telehealth and remote patient monitoring, and POC testing and diagnostics services directly to the doctors and patients. 

The Smart Data division can offer the Company’s software and Intrinsic Code technology systems to the Parallax clientele. 


3 https://www.milkeninstitute.org/publications/view/910  


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The Company believes that the current healthcare system is built on unsustainable models and significant challenges for all the stakeholders in the healthcare system. The Company also believes that it can deliver solutions which fill a void in the current market for high quality, high efficacy products and services delivered at reasonable and rational prices. The Company’s business strategy is to expand through organic growth, selective synergistic acquisition, and develop, license and/or acquire, quality products and or services that complement the Parallax Care systems.

 

Products and Services

 

Parallax believes that its products and services can provide solutions that mitigate rising costs, reduce waste in spending through transparency, reduce the amount of unnecessary services, and increase the health and wellness of patients before they are sick.  

 

Remote healthcare products include patent pending software and mobile apps (to be available for iPhone on Apple App Play Store and Android on Google Play)  and other services, as well as electronic kits and devices from third-party licensed platforms that are designated towards a patient’s primary health concern (i.e. diabetes, blood pressure, cardiovascular, general monitoring, etc.), and offer both audio and video options that interface with the patient’s healthcare providers.  Prescription medication dosage monitoring is also available.

 

Behavioral health products include the proprietary behavioral health technology, REBOOT, which powers decision support that can also be delivered securely to any internet connected device.  The software can be used by an individual or an organization of any size, with the potential to transform the cost of treating and managing chronic illnesses such as pulmonary-COPD-asthma, diabetes, and cardiovascular disease by effecting the modification of behavior in patients being treated for these chronic diseases.

 

Diagnostics products include the Target System, the Company’s proprietary POC diagnostic immunoassay testing platform and test cartridges for the areas of infectious diseases, cardiac markers, drugs of abuse and various other medical conditions. The Target System will allow doctors to test patients in their office, with test results delivered in 10 minutes or less.  This allows patients to be provided with important information at the time of testing. The costs of the Target System are less than outside lab-based tests, benefiting both payers and patients.  In addition, doctors will be able to generate additional revenue that would normally be paid to an outside laboratory, and patients can even perform test from their homes, with results transmitted directly to their doctor.

 

Through the development and design of the Fotodigm® platform, the Company’s telehealth, RPM and POC products and services are interoperable and interchangeable with any FDA cleared/approved medical device, providing ease of use and connectivity between patient and doctor.  The advancement in the Company’s technology is strengthened by the ability to scale its products to meet the demands of both individuals and large groups alike.

 

Targeted Problems

 

Medication Nonadherence

 

Medication nonadherence is a priority public health consideration, affecting health outcomes and overall healthcare costs on a worldwide basis. Increasing adherence to medical regimens leads to better health outcomes in chronic disease and reduces the overall costs to the patient, payer and all of the stakeholders across the healthcare continuum.

 

Nonadherence to medication regimen in chronic disease management is the cause of 4:

 

$300 billion in avoidable costs to the U.S. healthcare system annually; 

125,000 premature deaths in the U.S. annually. 

 

Research from the World Health Organization 5 has shown that better adherence to antihypertensive treatment could prevent 89,000 deaths each year in the U.S., with a projected savings of $106 billion a year.

 

Chronic Disease Management

 

Chronic diseases are on the rise in the U.S., leaving healthcare payers with the challenge of covering care for patients with these expensive, long-term conditions.  Healthcare spending reached a total of $3.2 trillion in 2015, based upon estimates from the Center for Medicare Services (“CMS”).  Spending is expected to grow at an average of 5.5% through 2025, with chronic disease treatment comprising a major portion of that spending.

 

Based on the latest data from the Center for Disease Control (“CDC”), the top 8 most expensive chronic diseases for healthcare payers to treat are:

 

Cardiovascular Disease 

Cardiovascular disease (“CVD”) in the U.S. total $317 billion per year, split between $193.7 billion in direct medical costs and $123.5 billion in lost productivity. An adult in the U.S dies from CVD related health conditions every 40 seconds, with CVD deaths accounting for 31% of all U.S. deaths each year.


4 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3234383/#B8 

5 https://www.who.int/chp/knowledge/publications/adherence_report/en/ 


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Smoking-Related Health Issues 

The estimated costs for smoking-related health issues in the U.S. total over $300 billion per year, split between direct healthcare expenses of $170 billion and indirect costs of roughly $156 billion.

 

Alcohol-Related Health Issues 

In 2010, excessive alcohol use cost the U.S. economy $249 billion, or roughly $2.05 per drink. Alcohol-related deaths totaled 88,000 people per year, and shortened the lives of working adults by an average of 30 years.

 

Diabetes 

As one of the most prevalent chronic conditions in healthcare, diabetes care costs reached $245 billion in 2016. Seventy-one percent of diabetes treatment costs ($176 billion) were related to direct healthcare expenses. That equates to 20 percent of U.S. healthcare spending.

 

Cancer 

According to the latest estimates from the CDC and the National Cancer Institute, cancer care costs are roughly $171 billion a year due to healthcare inflation over previous decades.

 

Obesity 

The United States spends $147 billion on healthcare related to obesity, and roughly $117 billion on costs related to inadequate physical activity. In 2006, healthcare costs for obese patients were $1,429 higher than patients at a normal weight. Obesity is implicated in the development or worsening of many other chronic conditions, including diabetes and cardiovascular disease.

 

Arthritis 

The total cost of arthritis in the U.S. was an estimated $128 billion, split between $81 billion in direct medical expenses and $47 billion in related losses of productivity and care management.  Arthritis affects 23 percent of adults in the U.S., or 54 million people, and is expected to rise to 78 million cases by 2040. Arthritis also occurs with other chronic conditions, as many patients are unsure on how to manage their own symptoms.

 

Strokes 

On its own, strokes in the U.S. create medical expenses of $33 billion annually and accounts for 1 out of 20 deaths in the country, or an estimated 130,000 deaths per year.

 

These nonadherence and chronic disease numbers are daunting in the best of conditions, but the reality is that the sheer volume of U.S. citizens reaching the age of 60 will impact the cost trajectory. The projected financial impact is not sustainable under the current healthcare system.

 

Management

 

Parallax is led by experienced veterans with backgrounds from the healthcare, medical devices, drug development, technology, FDA regulatory, medical insurance billing and patient management, finance and management of early stage and high growth companies. The Company’s disciplined and organized approach is balanced by its optimism for the future, and the opportunities present in the current healthcare market. The Parallax team is grounded in a belief that success in business is built on a combination of research, planning and execution.

 

At Parallax, management continually strives to identify solutions to the challenges facing the current healthcare system.  The Company and its management team of professionals are committed to delivering the highest quality products and services to patients, payers, healthcare insurers and stakeholders that are accessible and reasonable, and are built upon sound business models and economics that are designed to provide for sustainable growth and increased value to the Company’s shareholders.

 

TARGET SYSTEM and DIAGNOSTIC TESTING PLATFORM

 

Overview

 

Parallax continues its focus on Point-of-Care diagnostics, with an emphasis on its Target System testing platform and novel applications that detect and/or monitor infectious diseases, cardiac markers and drug of abuse assays.  The Company holds exclusive licenses, in perpetuity, to a line of proprietary, patented and/or patent-pending, FDA-cleared, Point-of-Care diagnostic tests to be utilized with its single platform diagnostic testing Target System.  Parallax, with its products and products in development, offers the potential to transform the diagnostic landscape by transitioning critical tests from the centralized lab directly to the hands of the physician or clinicians.  

 

The Company continues to pursue viable opportunities for the commercialization of its product.  Additionally, the Company has sought to identify strategies that would make its proposition more valuable and competitive.  The Company has made the strategic decision to keep the POC diagnostics product line off the market, and has spent the last few years prosecuting its patents. The Company has been issued patents on core technology of its technology for its Target System.  In 2014, 2015 and 2017, the Company and its license partner, Montecito BioSciences, Ltd. (“MBS”), received patents on its mobile testing platform in conjunction with its Target System cartridges in the United States, China, Hong Kong, Macao, and India. To this end, the Company has pursued patents around its foundational technology and the SPARKS Mobile diagnostic reader. The Company also has a technology that was previously cleared by the FDA technology that is being used as a platform for a test that will detect CD4 and CD8 cells which in turn determine a patient’s immune status.


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Target System Product Strategy

 

In recent years, there has been a continuing shift from the use of laboratory-based analyzers to point-of-care (“POC”) tests that can be performed in a matter of minutes. Unlike the centralized clinical laboratory segment of the diagnostic market, which is mature and highly competitive, the POC market is still in its relatively early stages. According to the recent worldwide research reports, however, such as the 2010 Worldwide IVD Market, by the research firm Kalorama Information, the growth rate of the POC market continues to rise. Although certain simple, single analyte diagnostic tests have been developed, such tests have remained incapable of precise and highly sensitive quantitative measurements. As a result, medical tests that require precise quantitation of the target analyte have remained the domain of immunoassay analyzers in the centralized laboratory.

 

Point-of-Care diagnostic kits typically consist of test strips that the healthcare provider applies a patient’s sample to and then reads the strip either visually or with an instrument in order to determine a result.  They are simple to use, fast, disposable and reliable within an acceptable range. More sensitive analytes or tests requiring quantitative analysis and definitive antibody screening needed in most situations, must be sent out to a diagnostic lab, and hours or days later results arrive. These tests are comparatively complex, expensive, and time consuming; only centralized diagnostic facilities can manage sample handling and the cost of instruments and reagents.  A POC instrument that has the advantage of a test strip device in terms of ease of use and rapid results along with enzyme-linked immunosorbent assay (ELISA)-like capabilities for major diseases would circumscribe diagnosis routinely within the course of a patient visit. This could disrupt the current model.  The Company is planning to develop just such a device that it intends to sell to doctors and healthcare providers.

 

The commercial success of the current generation of small, simple to use diagnostic devices which provide rapid results in POC applications has been limited by their inability to provide precise, highly sensitive, quantitative measurement. Despite these limitations, the rapid increase in discovery of individual markers of disease processes, coupled with the advancements in rapid detection technologies, has made these tools available to medical professionals on a wide scale and POC diagnostics are quickly becoming a high growth industry.

 

The Target System (the VT-1000 Desktop Analyzer, the Target Antigen Detection Cartridge and associated reagents) technology addresses these limitations by applying sophisticated immunochemical and optical methods to detect and quantify analytes present in various human specimens, including blood, urine, and feces. Data indicates that sensitivity will be comparable to expensive and complicated laboratory-based analyzers. The Company believes that there is market potential for advanced POC diagnostic products that provide quick and accurate diagnosis during a patient visit, shortening the decision time to medical intervention and minimizing the need for additional patient follow-up, thereby reducing overall healthcare delivery costs.

 

The Company also believes that there is growth opportunity for the exploitation of its Target System platform in developing nations and regions such as Africa, India, South America, Eastern Europe, Russia and Asia as well as developed markets of North America and Western Europe. One of the first initiatives to be developed for this market will combine the Company’s SPARKS Mobile (a portable hand-held diagnostic analyzer based on the VT-1000 Desktop Analyzer), currently in development, with a test for the monitoring of AIDS/TB patients through the use of a proprietary rapid point-of-care immunoassay CD4-CD8 test called PROMISE CD4, also in development.

 

The Diagnostics Products

 

The Company’s assets include a FDA-cleared VT-1000 Desktop Analyzer and more than two dozen FDA 510(k) cleared diagnostic tests.  The Desktop Analyzer and immunoassay system incorporates a flow-through rapid antigen test platform configuration that has the ability to produce high-performance quantitative blood test results with the ease of rapid qualitative diagnostic strips.  The Company has patents and patent applications related to its current and future products, as well as methods for future test development. The Target VT-1000 Desktop Analyzer is ideally suited for rapid development and commercialization of all new tests that may be introduced.

 

VT-1000 Desktop Analyzer: Quantitative and Qualitative Immunoassay

 

The Company’sVT-1000 Desktop Analyzer is FDA-cleared and is capable of rapidly detecting qualitative and quantitative data for its FDA-cleared Target Platform tests.  The VT-1000 Desktop Analyzer is used for all Target Platform Tests, allowing for clinical personnel to be trained once and also gives consistent results for either qualitative or quantitative testing. The Company plans to develop the SPARKS Mobile, a hand-held analyzer unit, similar in size to a mobile phone/PDA, which will be based on the VT-1000 Desktop Analyzer (see Products in Development).

 

Target Antigen Detection System (“TADS”)

 

The Target Antigen Detection System consists of a unique disposable cartridge with reagents capable of testing multiple test markers, combined with the VT-1000 Desktop Analyzer. The TADS requires a small amount of sample and provides results in minutes.  The simplicity of the fully loaded disposable test cartridge and subsequent ease-of-use of the instrument helps to alleviate the technical burden on medical staff and makes patient diagnosis more efficient.

 

The Company’s Target Antigen Detection System is a departure from the standard devices typical to the rapid testing markets and can allow for physicians to share in revenues. The device is part of the manufacturer’s qualitative and quantitative “Target System Diagnostics Platform,” which offers an array of improved modifications and features to the traditional qualitative and semi-quantitative flow-through immunoassay test. With its platform uniformity, vacuum pump, absorption layer for sample overflow, and complete compatibility with single and multi-light source reflectometer technology, the TADS cartridge is a unique collection of tests for qualitative and quantitative detection diseases and of conditions. The TADS cartridge utilizes a vacuum technology to deposit specimen samples uniformly on test membranes.  The Vacuum Control Flow Device provides a vacuum pump action, which reduces test time and ensures maximum contact with the membrane antibodies.  This collection device allows for numerous tests to be incorporated. The vacuum specimen filtration and excess specimen absorption is built right in.


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Additional Products Planned for Development

 

The Target System provides the platform for the development of a series of quantitative tests for important diagnostic applications that can provide results at a patient's bedside, in a doctor's office, in the emergency room, in a clinic, in an ambulance, on the battlefield, on-site agri-business locations, rural and economically disadvantaged areas.  The Target System expects to meet the POC diagnostic market criteria as follows:

 

Rapid turnaround time 

Direct application of a non-critical volume or placement of sample directly into instrument 

Disposable device or minimal maintenance required 

Minimal technical expertise required 

Positive identification and specimen tracking strategy that eliminates specimen identification errors 

Simple strategy for calibration and QC 

Transferability of data to the LIS or HIS 

Agreement of result with accepted “Gold Standard” tests 

Affordable cost 

 

The Company’s testing system is not limited to HIV or AIDS diagnostics. The test format has been applied in the past to viral and bacterial infections (e.g., Rubella, Rotavirus, Strep. A) and can be adapted towards other epidemics. Diseases like malaria, cholera, hepatitis, yellow fever, or West Nile virus and other viral diseases present increasing health threats to large populations in the world, with major existing problems at the stage of proper diagnosis.  The Company believes that it can adapt the VT-1000 Desktop Analyzer and SPARKS Mobile to the rapid, simple POC diagnosis of almost all of these diseases without the requirement of additional equipment. Further, the Company believes that the combination of a mobile, hand-held testing device with a large number of different tests provided by a family of cartridges will improve the ability of current healthcare and disease diagnostics in a vast majority of today’s underserved regions. In addition, the Target System Platform also allows for the monitoring of environmental components influencing the health of populations, such as the presence of toxins in soil and drinking water and contamination of food supply.

 

The Target System Hand-Held Analyzer: SPARKS Mobile

 

The SPARKS Mobile is the Company’s next-generation analyzer.  Utilizing re-engineered technology of the VT-1000 Desktop Analyzer, the SPARKS Mobile is a handheld device that will include a small, rapid testing format, in conjunction with a data acquisition and test reading, with connectivity and features similar to a smartphone device.

 

Whether searching for markers in the blood stream, or diagnosing a pathogen in urine, the Company’s SPARKS Mobile will be a portable tool for rapid diagnostics. The SPARKS Mobile will also provide an improvement in POC diagnostics and applications in countries with limited healthcare infrastructures and geographic limitations, both of which are of paramount importance in the combat against infectious diseases and in the fight against proliferation of endemic and pandemic diseases.  This innovative SPARKS Mobile will allow for a fast (minutes instead of hours or days) performance of tests at the point of care and will only require a test cartridge and a small number of ready-to-use solutions in preformatted quantities.  Moreover, the SPARKS Mobile will include the ability to store patient information, test data, and QC data, and transmit data through wireless connections.

 

The SPARKS Mobile design goals will plan to:

 

achieve a portable monitoring system, which is compatible with proven and reliable ELISA-based target system technology. 

expand readout capabilities to provide a mobile testing and monitoring platform. 

increase the economy of scale and scope of the diagnostics and monitoring platform by the development of additional utility of the device without redundant infrastructure investments (additional data acquisition of patients, additional tests for other, predominant diseases). 

 

The basic design of the SPARKS Mobile Analyzer is based on the same 510(k) cleared technology employed in the Company’s VT-1000 Desktop Analyzer and is compatible with existing test cartridges. However, a number of innovative features will be integrated into the design to meet customer and patient needs:

 

High Infrared Light Spectrum;  

Easy Field Upgrades; 

No Change of Equipment;  

Printer Hook-up Capability;  

Low Entry Cost for New Test Development and Analysis;  

Safety, Security and Accuracy by design; and 

Desk to Docking Station: Smart Phone Capability 


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Market Opportunities

 

In recent years, there has been a continuing shift from the use of laboratory-based analyzers to more technologically advanced Point-of-Care tests that can be performed in a matter of minutes. Unlike the centralized clinical laboratory segment, which is mature and highly competitive, the Point-of-Care market is still a relatively early stage market. Although certain simple single analyte diagnostic tests have been developed, such tests have remained incapable of precise and highly sensitive quantitative measurements. As a result, medical tests that require precise quantitation of the target analyte have remained the domain of immunoassay analyzers.

 

Diagnostic tests performed outside the central laboratory or decentralized testing is generally known as Point-of-Care. Over the years, the increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of medical environments including the workplace, home, disaster care and most recently, convenience clinics. Moreover, POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years. As more diagnostic manufacturers pursue CLIA 6 waiver status for their POC devices and CE Mark 7 for POC or self-use. At the same time, more decentralized test venues invest in non-waived rapid tests and instruments. POC testing appears to be headed for an even bigger role in diagnosis and monitoring patient care.

 

The Global In-Vitro Diagnostics (“IVD”) market is expected to exceed $92 billion by 2025, up from $64 billion in 2017 8, and is expected to continue at a 4.8% compounded annual growth rate over the next eight years. Self-testing is the biggest trend fueling the growth, and the recent advancements in IVD technology has a large influence over the product type segment, which is poised to grow at a compounded annual growth rate of 6.1% from 2018 to 2025 9.  The growth is being driven by devices aimed at making acute care more efficient. There is a concerted effort to reduce time spent in expensive intensive care units and in the hospital in general. More tests and technologies have been adapted to serve the needs of physician offices and home testing.

 

Key Drivers

 

The two factors that are significant to the rapid growth of POC testing are technology advancements and healthcare economics. The development of new and improved technologies has resulted in the ability to make evidence-based medical decisions that improve patient outcomes and reduce patient acuity, criticality, morbidity and mortality.  Quicker diagnosis of infectious agents can also permit the earlier prescription of appropriate medications, thereby potentially shortening the duration of illness.  Additionally, the economic climate is driving significant changes in the manner in which patients will be tested and how results are delivered. Recent revisions to government regulations, together with growing patient and insurer pressures on hospitals and physicians have increased incentives to reduce overall patient healthcare costs while providing a higher level of care to a greater number of patients. One cost-cutting measure is to reduce the high cost of diagnostic testing carried out in central laboratory sites.

 

Limitations

 

Each of the screening devices described above have limitations in their utility and range of application. Many screening devices have been adopted from their use in clinical laboratories and, when applied to POC application, required special handling of the specimen samples (blood, urine, and feces) and decreased sensitivity and/or specificity.

 

Competitive Landscape

 

There are approximately 40 to 50 companies in the Point-of Care diagnostic industry in the U.S. and approximately another 100 outside the U.S. 10. The POC space can be broken down into various sub-sets such as molecular biologist developing reagents, and markers to diagnostic equipment and test development companies, as well as companies who do neither and focus on marketing tests, equipment and assays.  Most notably in the POC space are the large pharmaceutical companies such as Bayer, Roche, Abbott Labs, ThermoFisher and others.  Parallax’s specific competitive landscape is tied to its patented process involving the SPARKS Mobile Analyzer and Target System platform In-Vitro Tests.  There are a number of companies developing mobile devices to perform a host of health industry-related services and the Company believes that more companies will enter the mobile diagnostic space in the next few years.  The industry has yet to develop a standardized Point-of-Care immunoassay platform for any device to be integrated into.  The Company’s SPARKS Mobile Analyzer is designed to deliver a device that adds immediate value to health providers, patients and health insurance companies.  The Company’s primary goal is to create a mobile platform that can integrate and utilize the flow-through process of its Target System platform, and offer the healthcare provider a system that is fully interoperable and ubiquitous with a potentially large number of in vitro tests.  There are other test platforms in the space, but the Company has filed a patent application on the process of its SPARKS Mobile Analyzer and TADS test cartridge.  There can be no assurance that the Company’s POC devices will prove to be competitive with the other POC devices under development.

 


6Clinical Laboratory Improvement Amendments (CLIA) of 1988 are United States federal regulatory standards that apply to all clinical laboratory testing performed on humans in the United States, except clinical trials and basic research. 

7The letters "CE" are the abbreviation of French phrase "Conformité Européene" which literally means "European Conformity" CE Marking indicates that your medical device complies with the applicable EU regulations and enables the commercialization of your products in 32 European countries. 

8https://www.marketresearchengine.com/reportdetails/global-in-vitro-diagnostics-ivd-market 

9https://www.alliedmarketresearch.com/ivd-in-vitro-diagnostics-market 

10https://www.kaloramainformation.com 


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Until the Company secures a minimum of one million dollars ($1,000,000) of additional capital to operate for the next twelve months it will remain highly vulnerable to competition.  The Company anticipates the need for a minimum of an additional two million dollars ($2,000,000) of investment capital for it to achieve its goals of developing a commercially viable rapid POC CD4-CD8 immune status test and the SPARKS Mobile Analyzer version of the VT-1000 Desktop Analyzer. The Company intends to explore licensing partners for manufacturing and distribution. Should adequate funds be available from future funding resources, the Company may use a small portion of the budgeted proceeds for Research and Development to fund the remaining development of the SPARKS Mobile device.  However, the Parallax Care and Outcomes Platform is the Company’s near term focus.  There can be no assurance that such amount will prove adequate to develop the Company’s products. Furthermore, the Company’s competition has significantly greater resources that they can deploy and time to head off competition.

 

In Vitro Diagnostic Sales Leaders

 

A 2017 report from Kalorama Information ranked the top 10 companies in the In Vitro Diagnostics market, based upon estimated 2017 revenues from clinical diagnostic test instruments, reagents and supplies, as follows:

 

1.Roche Diagnostics, Switzerland www.roche.com  

2.Abbott Diagnostics, Abbott Park, IL www.abbott.com  

3.Siemens Medical Solutions Diagnostics, Deerfield, IL www.diagnostics.siemens.com  

4.Danaher Corporation, Washington, DC, www.danaher.com 

5.Thermo Fisher Scientific, Waltham, MA www.thermofisher.com 

6.Sysmex America, Inc. Lincolnshire, IL, www.sysmex.com 

7.bioMérieux SA, Marcy l’Etoile, France www.biomerieux.com  

8.Ortho Clinical Diagnostics, a division of Johnson & Johnson, Raritan, NJ www.jnj.com  

9.Bio-Rad Laboratories Inc., Hercules, CA www.bio-rad.com  

10.Beckman Coulter Inc., Fullerton, CA www.beckmancoulter.com  

 

Barriers to Use

 

The main barriers and constraints to the use of POC rapid diagnostic tests can be put into four main categories:  

 

Acceptability:Rapid tests need to be acceptable to policymakers, clinicians, and patients, and the medical community. In the POC rapid test market, tests need to have sufficient sensitivity and specificity and need to have an adequate predictive value. Ease of use is critical for POC use by clinicians. Culturally appropriate specimens and credible results are important if rapid tests are to be accepted by patients. 

 

Affordability:Many rapid diagnostic tests are more expensive than the tests or syndromic algorithms they are intended to replace. Decreasing per-test costs, carefully designing diagnostic algorithms, and educating end users about the cost-savings of POC testing, are important means of maximizing rapid test affordability. 

 

Availability:Rapid diagnostic tests are not always available in developing countries. Most tests have limited shelf lives, and many countries have weak public and private sector procurement and distribution systems. The consistency and quality of imported tests can also be issues. To address these constraints, local government regulations, quality assurance, shelf life testing, and distribution systems all need to be assessed and improved. The Company intends to initially control all of the manufacturing of the Target System Desktop and SPARKS Mobile analyzers and test cartridges in conjunction with Montecito. 

 

Reimbursement:The ability to gain scale in reimbursement across a wide number of tests is still a challenge for POC diagnostic companies such as Parallax.  

 

Intellectual Property (Diagnostics)

 

The Company’s products include a FDA-cleared VT-1000 Desktop Analyzer and more than two dozen FDA-cleared tests.  The Company acquired the exclusive rights in perpetuity to a number of pending United States Patent and Trademark Office (“USPTO”) patent applications on the Company’s products in the area of infectious diseases, as well as methods for future test development, through a License Agreement with Montecito BioSciences, Ltd.  The Company intends to seek intellectual property protection for all supporting products such as novel biomarker candidates, antibodies, proteins, and diagnostic tests surrounding its core indication areas, in order to create a barrier to entry for competitors.

 

Expired Patents-Target System

 

The Target System and certain of its related components were previously issued patents by the USPTO.  The following previously-issued patents have expired:  

 

Patent #

Description

Date Filed in US

Date Expired

US4,748,042

Target Ringing & Spotting Machine (method and Apparatus for Imprinting membrane with pattern of antibody)

May 31, 1988

May 31, 2008

US4,797,260

Target Cassette (Antibody testing system)

January 10, 1989

January 10, 2009

US5,137,691

Target Cassette with Removable Air Gap (Antibody testing system with removable air gap)

August 11, 1992

August 11, 2012


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The Company has retained a team of professionals in the field of patent protection and is continuously seeking out new opportunities for its products and products in development.

 

Key Patented and Patent-Pending Concepts

 

Sample Analysis 

Plurality of Isolated Antibodies to a Plurality of Cognate Antigens 

Identifying Drugs, Targeting Moieties or Diagnostics 

Determining the Immune Status of a Subject  

Flow Through Testing System with Pressure Indicator 

Novel Biomarker Candidates 

Antibodies 

Proteins 

Diagnostic Testing 

 

For additional information on the Company’s patents and patents-pending, see “INTELLECTUAL PROPERTY SUMMARY“ section below.

 

The FDA-Cleared Tests

 

The Company acquired, through an Assignment Agreement, the exclusive rights in perpetuity to the following FDA-cleared tests (the “Tests”):

 

No.

Test/Device Name

510(k) No.

 

No.

Test/Device Name

510(k) No.

1

Rotacube (Rotavirus)

K884017

 

14

Target Hcg

K914303

2

Rubella-Cube TM

K892051

 

15

Target Quantitative Hog One Step

K903937

3

Cmv-Cube TM

K884842

 

16

V-Trend Target Rf Test

K904105

4

Target Quantitative Hcg

K890131

 

17

Blue Dot Test for Pregnancy

K884017

5

Target Strep A (Streptococcus Spp.)

K880460

 

18

Target Cocaine Metabolites-R Test

K910122

6

V-Trend Target Im Test (infect mononucleosis)

K890041

 

19

Target Cocaine Metabolites-V Test

K910123

7

First Sign (Pregnancy, Hcg)

K973208

 

20

Target Cannabinoids-R Test

K910893

8

Target Cardiac Ck-Mb

K890295

 

21

Target Cannabinoids-V Test

K910892

9

Target Cardiac Troponin 1

K972094

 

22

Target Amphetamines / Methamphetamines-R Test

K910739

10

Target C-Reactive Protein Test

K892231

 

23

Target Amphetamines / Methamphetamines-V Test

K910740

11

Target C-Reactive Protein Test

K890423

 

24

Target Opiate-R Test

K890978

12

Target Myoglobin

K963680

 

25

Target Opiate-V Test

K890979

13

Target Aso Test

K910073

 

 

 

 

 

The Company is in the planning process of developing and obtaining FDA clearance for rapid immunoassay tests for the detection of HIV 1 and 2.  There can be no assurance that the Company will be successful in developing such tests or in obtaining the required FDA clearance.

 

For further information on the exclusive rights to the Company’s FDA-cleared Tests, and the complete text of the Assignment Agreement and subsequent Modification, please refer to Exhibits 10.19 and 10.21, respectively, to the Company’s Current Report filed November 15, 2012 on Form 8-K.

 

It is expected that after successful re-introduction of the Target System and the introduction of its novel PROMISE CD4 immune status test, additional tests will be developed and protected by the Company. Generally, the Company and Montecito BioSciences, Ltd. will own improvements to the basic technology platform in exclusivity.

 

Government Regulations

 

The long legal journey toward medical device regulation began with the Pure Food and Drugs Act of 1906.  Medical devices were not included, as no one envisioned how technology would grow increasingly complex, and would ultimately require regulation. The Medical Device Amendments of 1976 gave the FDA authority to ensure the safety and effectiveness of a range of life-saving medical devices, while also protecting the public from fraudulent devices.  The Amendments:

 

defined a medical device, 

established three device classes (I, II, and III), 

identified pathways to market, 

established Advisory Panels, and 

set clinical investigation requirements. 


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Subsequent legislation strengthened the FDA’s regulatory authority.  The following table identifies the legislation and significance for the Major Medical Device:  

 

Legislation

Significance

Safe Medical Devices Act of 1990

Established Quality System requirements 

 

Supported post market surveillance 

 

Allowed FDA discretion for PMAs brought to panel 

FDA Modernization Act of 1997

Supported for early collaboration, expanded Class I and Class II exemptions 

 

Set the “least burdensome provision”* 

 

Supported dispute resolution 

 

Established evaluation of automatic Class III designation (giving the sponsor the opportunity to  

request lower classification due to a minimal risk device, known as “de novo” review) 

 

Mandated free and open participation by all interested persons 

Medical Device User Fee and Modernization Act (MDUFMA) of 2002

Established a fee schedule for most types of device submissions to achieve shorter review times 

 

Requires FDA to include pediatric experts on the panel for a product intended for pediatric use 

FDA Modernization Act of 2007

Reauthorized and expanded MDUFMA 

 

FDA Clearances and Approvals

 

As part of the regulatory infrastructure, the FDA has established almost 1,700 classifications for generic medical devices.  Each one of the generic devices is assigned one of three regulatory Classes, based upon the control level necessary to assure the devices’ safety and effectiveness.  The least burdensome provision allows industry and FDA to consider the least burdensome appropriate means of evaluating a device’s effectiveness when there is a reasonable likelihood of its approval. The intent is to help expedite the availability of new device technologies without compromising scientific integrity in the decision-making process or FDA's ability to protect the public health. This provision does not lower the standard for premarket clearance.  The FDA maintains a database on its website at www.accessdata.fda.gov for many types of applications, including 510(k) records dating back to 1976, and PMA submissions.

 

FDA Classes

 

Device classifications depend on the intended use of the device, its indications for use, and risk posed to the patient and/or user.

 

Class

Risk Level

Type of Controls

Exemptions

Class I

Low

General Controls

Yes

Class II

Moderate

General Controls & Special Controls

Yes

Class III

High

General Controls & Premarket Approval (PMA)

No

 

The FDA requires that medical devices obtain either Premarket Notification Clearance (“PNC” or “510(k)”) or Premarket Approval (“PMA”) prior to commercial distribution, unless an exemption is met.  Whether to submit a 510(k) or a PMA is determined by the applicant.  A 510(k) is normally submitted for a device that can be compared to a similar device already on the market, to illustrate the device’s safety and effectiveness.   A PMA is normally submitted for a device that is completely new to the market or is classified as a Class III device.

 

510(k) Clearance

 

The term “510(k)” refers to Section 510(k) of the Food, Drug and Cosmetic Act, wherein it provides a pathway to clearance for a device that maintains FDA standards, without the lengthy and costly PMA submission process. A 510(k) submission for clearance must demonstrate that the device is at least as safe and effective, that is, substantially equivalent, to an already legally marketed device.  The 510(k) submission must be made at least ninety days in advance of commercial distribution, and if the device meets the requirements, the  FDA orders the device as “cleared.”

 

To further illustrate the 510(k) submission requirement, a 510(k) clearance is required when:

 

introducing a device into commercial distribution (marketing) for the first time; 

there is a significant change in the safety or effectiveness of a legally marketed device; or 

a legally marketed device is being marketed for a new or different intended use. 

 

In contrast, a 510(k) is not required when:

 

unfinished devices or components are sold for further processing or assembly by other parties, excluding the sale of direct replacement parts to end users; 

the device is not being marketed or commercially distributed; 

distributing another party’s domestically manufactured device; 

repackaging or relabeling, if the condition of the device is not significantly changed; 

the device was commercially distributed prior to May 28, 1976, and no significant changes to design, method, component, method of manufacture or intended use have been made; 

acting as an importer of a foreign made medical device; or 

The device falls into a Class I or II exemption classification; or is a Class III device requiring PMA.   

 

To summarize the 510(k) for Parallax’s VT-1000 Target System, the submission was made to the FDA on December 23, 1988, and received 510(k) clearance on January 27, 1989.  In this instance, the clearance process took approximately thirty days.  The VT-1000 will not require any further FDA clearance unless there are significant changes in the safety or effectiveness of the device, or its intended use is changed or appended.  The same is true for the 25 FDA-cleared tests.


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Premarket Approval

 

Premarket Approval (PMA) is the most stringent type of device submission required by the FDA. A PMA application must be submitted to request FDA approval to market a device.  Unlike 510(k) clearance, PMA approval is based upon a determination that there is sufficient valid scientific evidence that the device is safe and effective for its intended use. PMA submissions include extensive research and development, three-phase clinical trials, and a lengthy FDA review process.  

 

To reasonably assure that a device is safe and effective, PMA requires valid scientific evidence that the probable benefits to health from the intended use of a device outweigh the probable risks, and that the device will significantly help a large portion of the target population. Sources of valid scientific evidence may include well controlled investigations, partially controlled studies, historical controls, well documented case histories by qualified experts, and robust human experience.  Independence is an important concept for PMAs, meaning that each PMA should establish the safety and effectiveness of the device under review, and that data about one device cannot be used to support another. 

 

The cost to obtain PMA approval on one novel device can be anywhere from $10 million to $1 billion, and can take an average of 3 to 7 years to bring a device to market. 11 Examples of PMAs include digital mammography, minimally invasive and non-invasive glucose testing devices, implanted defibrillators, and implantable middle ear devices.  

 

Class III De Novo

 

As indicated in the FDA Classes chart above, PMA submissions are required for all Class III devices, regardless of any similarity to a previously marketed product.  Class III devices are those that support or sustain human life, are of substantial important in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.

 

A “de novo” Class III device is one that was originally submitted for 510(k) clearance, but because the device used for comparison in the 510(k) was “not substantially equivalent” (NSE), the device was automatically denied 510(k) clearance, and was reclassified as being a novel Class III medical device requiring PMA approval.  

 

In the event of a de novo designation of a low to moderate risk device, the applicant may submit a request for consideration to be classified as a Class I or Class II device within thirty days of receiving 510(k) NSE determination.  Alternatively, if there is no similar equivalent device for comparison under a 510(k) submission, the applicant may request the FDA to make a risk-based classification of the device as Class I or Class II without ever submitting a 510(k).

 

Devices that are classified through the de novo process can be marketed and used as predicates for future 510(k) submissions, to be utilized as a “substantially equivalent” device, despite the fact that PMA approval was not provided.

 

Post-Approval Studies

 

The FDA can impose requirements at the time of approval of a PMA or HDE, or by regulation afterwards. One requirement may be the need for post-approval studies. The CDRH Post-Approval Studies Program helps ensure that well designed post-approval studies are conducted effectively and efficiently and in the least burdensome manner. Post-approval studies should not be used to evaluate unresolved premarket issues that are important to the initial establishment of device safety and effectiveness.

 

With post-approval studies, FDA can evaluate device performance and potential problems when the device is used more widely than in clinical trials and over a longer period of time. This allows FDA to build in accountability and gather essential post market information, including: 

 

longer-term performance of the device (for example, effects of re-treatments and product changes) 

community performance (clinicians and patients) 

effectiveness of training programs 

sub-group performance 

outcomes of concern – real and potential 

 

Summary Comparison of 510(k) and PMA

 

510(k) Submissions

PMA Submissions

primarily for Class II devices (Class I devices are predominantly exempt) 

primarily for Class III devices 

a Class I or II pre-amendment or legally marketed device (predicate) exists 

a Class I or II pre-amendment or legally marketed device (predicate) does not exist 

third-party review option is available for devices not requiring clinical data 

device is life supporting and/or has potential risk to patient 

documented proof of Substantial Equivalence to a predicate is required 

documented safety and effectiveness data for the device is required 

 


11 https://www.sciencedirect.com/ 


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Manufacturing

 

The Company does not intend to manufacture in house, with the exception of prototype and small batch production of tests for clinical trials and in-house testing.  The Company is required to use manufacturers who operate under Good Manufacturing Practices (“GMP”).  A GMP is a production and testing practice that helps to ensure a quality product. Many countries have legislated that pharmaceutical and medical device companies must follow GMP procedures, and have created their own GMP guidelines that correspond with their legislation. Basic concepts of all of these guidelines remain more or less similar to the ultimate goals of safeguarding the health of the patient as well as producing good quality medicine, medical devices or active pharmaceutical products. In the U.S. a drug may be deemed adulterated if it has passed all of the specifications tests but is found to be manufactured in a condition which violates current good manufacturing practice guidelines. Therefore, complying with GMP is a mandatory aspect in pharmaceutical manufacturing.

 

Although there are a number of them, all guidelines follow a few basic principles:

 

Manufacturing processes are clearly defined and controlled. All critical processes are validated to ensure consistency and compliance with specifications. 

Manufacturing processes are controlled, and any changes to the process are evaluated. Changes that have an impact on the quality of the drug are validated as necessary. 

Instructions and procedures are written in clear and unambiguous language. (Good Documentation Practices) 

Operators are trained to carry out and document procedures. 

Records are made, manually or by instruments, during manufacture that demonstrate that all the steps required by the defined procedures and instructions were in fact taken and that the quantity and quality of the drug was as expected. Deviations are investigated and documented. 

Records of manufacture (including distribution) that enable the complete history of a batch to be traced are retained in a comprehensible and accessible form. 

The distribution of the drugs minimizes any risk to their quality. 

A system is available for recalling any batch of drug from sale or supply. 

Complaints about marketed drugs are examined, the causes of quality defects are investigated, and appropriate measures are taken with respect to the defective drugs and to prevent recurrence. 

GMP guidelines are not prescriptive instructions on how to manufacture products. They are a series of general principles that must be observed during manufacturing. When a company is setting up its quality program and manufacturing process, there may be many ways it can fulfill GMP requirements. It is the Company’s responsibility to determine the most effective and efficient quality process. 

 

Distribution

 

The Company has not yet commenced commercial operations of the Target System, and thus has yet to develop methods of distribution for its diagnostics products beyond the business plan stage.

 

In order to commercially sell the VT-1000 Desktop Analyzer, the Company must have it manufactured under GMP.  The Company can and will provide demonstrations of the VT-1000 Desktop Analyzer capabilities to potential customers.

 

The Company will need to secure additional capitalization before it can acquire additional antibody markers, produce additional Target System cartridges or produce the VT-1000 Desktop Analyzer under GMP.

 

Principal Suppliers

 

The Company has not yet commenced commercial operations of the Target System, and thus has yet to establish principal suppliers of its diagnostics product line.

 

CONNECTED HEALTH and FOTODIGM® PLATFORM

 

Overview

 

Parallax’s primary goal is to deliver good health outcomes for patients through a service that allows healthcare providers of all types to reduce costs, increase revenues and provide a better patient experience and satisfaction. Connected Health and the Fotodigm® platform are a part of the Company’s overall healthcare strategy.  

 

Fotodigm® is a systems integration software platform that provides remote patient monitoring (“RPM”), medication adherence, and an intelligent telemedicine delivery system.  Featuring distinctive data capture and analysis capabilities, the Fotodigm® platform can be promoted directly through hospital and accredited nursing facilities, as well as health and wellness service providers, all seeking to integrate RPM and telehealth services as part of their offerings.

 

Currently in its beta stage, Fotodigm® integrates remote monitoring solutions to improve a patient’s compliance to therapy, pharmaceutical and other treatment regimens prescribed by their physicians.  Through the Fotodigm® platform, alerts and notifications, including visual, audible and vibratory, are sent to patients through email and SMS. In addition, cloud-based recordings are maintained for continuous patient monitoring and telehealth delivery, benefitting both caregivers and patients. FotoDigm® is network agnostic and captures data from any data-generating device, insulin meter, or scale, and works with any analog device, providing easy, flexible data management.

 

Parallax’s Connected Health systems will also offer automated medication dispensing through a patented process, which can reduce the costs and risks associated with noncompliance of medication, therapy and treatment.  This can, in turn, increase the financial yields and service delivery successes for healthcare providers, ultimately improving the quality of life and peace of mind for the patient, the doctors and the care providers overall.


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Biometric Monitoring 12

 

A biometric monitor is a device that measures different aspects of a person’s behavioral or physiological behavior. It basically measures the biological data of a human being.

 

There are different kinds of biometric monitors that can be used, depending on the purpose. There are monitors that measure the temperature of the body; the pulse rate or the heart activity; blood pressure; blood glucose level etc. Below are a few common biometric monitors that are often used in households and hospitals:

 

Thermometers – One of the popular kinds of thermometer is the mercury thermometer which is used to measure the temperature or fever of the body. The mercury expands when heated, and rises up a glass tube, stopping at the corresponding temperature mark. Most thermometers have both Celsius and Fahrenheit readings for the ease of the user. 

 

Blood Pressure Monitors – A blood pressure monitor is a device that measures the blood pressure of an individual based on the readings of two values – the systolic pressure, which is the peak pressure in the arteries, over the diastolic pressure, which is the minimum pressure. Blood pressure should be monitored regularly in patients suffering from hypertension or hypotension, and other related conditions. 

 

Glucose Monitors – Also known as glucometer, glucose monitors measure a person’s blood glucose level. Glucometers are essential to monitor the glucose in the blood of diabetic patients, as an increase in sugar may initiate serious medical conditions. There are two types of glucometers: continuous glucose monitors, which measure the glucose level every few minutes using small sensors; and the fingerstick glucose monitors that uses a sample of blood to read the glucose level. 

 

Pulse Oximeters – Pulse oximeters are used to determine the amount of oxygen in the blood. It is generally used to detect breathing or respiratory problems, and is also used to monitor oxygen saturation in patients under intensive care. There can be three types of pulse oximeters – stand-alone, handheld, or pocket PC –based pulse oximeters. 

 

EKG Machines – Electrocardiogram or EKG machines are devices that measure the activity of the heart. It detects the electronic signals sent by the heart in between heartbeats. It is used to detect abnormal activities of the heart induced by sleep, or stress-related problems. EKG machines can be of two types: continuous, which continuously monitors heart activity; or intermittent which records the activity once in a while, but can be used for weeks or months. 

 

Pedometers– Used mainly for exercise purposes, a pedometer measures the number of steps a person takes while walking to stay fit. By quantifying the number of steps taken, a person can then calculate the amount of calories burned. Many sports item manufacturers are producing pedometers to help motivate fitness enthusiasts. 

 

There are numerous other biometric monitors used for medical or physical training purposes. There are the calorie counters, the body-fat calculators, the cholesterol monitors, fitness monitors – and a number of other devices. Prices of these vary in accordance with the brand, the quality, and the durability of the product.

 

Many cheap monitors do not give correct readings, and can be deadly when monitoring critical patients. Therefore, biometric monitors should be high-quality products that come with a guarantee, rather than inexpensive brand-less ones. Biometric monitors keep a check on health conditions, and a person should never compromise with their health.

 

Remote Patient Care

 

The Fotodigm® platform features a full set of modern communications technologies that provide cloud-based Health Insurance Portability and Accountability Act (“HIPPA”) compliant patient data security. The platform was designed specifically for patients’ ease of use, and provides real-time voice and “video conference” communication directly from any mobile or internet-connected device using biometric data collection. The platform, combined with systems integration services that interface with Electronic Health Records (“EHR”) and Electronic Medical Records (“EMR”) technology platforms, enables “virtual doctor visits,” increasing the conveniences for both patients and their doctors and care providers.  The Fotodigm® platform and its systems integration positioning allows for any physician, clinician, nurse, pharmacist, caregiver, or family member to support the treatment of the chronically ill, both acute and post-acute, in a persistently connected real-time environment, on a larger scale and with greater precision and patient satisfaction.  

 

RPM benefits are equally important in a residential environment. Seniors and chronically ill residents have shown to require less support and/or interventions, have higher group participation rates and improved cognitive capabilities, as well as an overall improved health, a more assured time with family, and longer residencies, which results in greater value-added contributions and greater job satisfaction from staff members.

 

The ability to remotely monitor each resident, from medication compliance and connected sensors, including vital sign, sleep monitoring, and fall detection devices, enables the residential caregiver to provide a significantly enhanced (and commercially desirable) service for optimal health conditions.  With the adoption of a centralized monitoring system, residences will also begin to see a marked reduction in the inter-dependencies that can exist between residents, and an improved state of health for every resident, further reducing the support load on staff members.  

 


12 http://www.ihealthdirectory.com/biometric-monitor/ 


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Medication Monitoring/Compliance/Adherence

 

Nonadherence with medication is a complex and multidimensional healthcare problem. Patients forget to take their medications, creatively alter their medications, engage in unendorsed polypharmacy, mix their medications, and take medications in combinations that may have dire synergistic interaction effects, such as dizziness and confusion.  Estimates of medication nonadherence rates typically range from 20% to 85%, (see figure below) 13. As a result, a substantial number of patients do not benefit optimally from pharmacotherapy and can wind up in emergency situations, hospitalized, or worse.  In fact, hospital readmission generated by medical non-compliance and nonadherence was a $41 billion-dollar problem in the United States in prior years and is growing 14.

 

Med White Med.png 

 

Medication adherence is a cornerstone of significantly improved quality of life, and the Fotodigm® platform is the cornerstone of medication adherence. A unique device specifically designed for seniors and the chronically ill, the Fotodigm® platform offers enormous potential for patients, their families, their caregivers and for those residences that choose to offer superior services and a superior health environment for their clients.

 

The Fotodigm® platform monitors the adherence of treatment and therapy regimens. In addition, with the advent of an intelligent personal medication device with bio-feedback, Fotodigm® allows, perhaps for the very first time, the quantitative and qualitative feedback of real-time data to pharmacists, physicians and clinicians and, based on the individual patient, enables medication titration to achieve optimal medication therapy.

 

Parallax is in the development stage of acquiring, licensing and developing in-house solutions/products for personalized health monitoring of seniors that will capture a host of a patient’s vital information, including temperature, heart rate, perspiration and movement disorders. All of these sensor products can be connected to the Fotodigm® platform so that the bio-feedback information is directly correlated with medication consumption information, providing clinicians, pharmacists and physicians with real-time, comprehensive data and information on patients’ conditions.

 

Product Strategy

 

Parallax’s product strategy is to eliminate obstructions to consumer adoption of remote patient care systems, so patients can stay out of the hospital longer and have a better quality of care and quality of life.

 

Remote patient monitoring systems enable efficient healthcare delivery to patients outside conventional hospital or clinical settings by transmitting real-time patient data for remote clinical review. Correlating vitals with medication history and consumption directly informs healthcare providers as to the real-time status of a patient, at home or in residences. Anomalies can be reported or alerted to those in need through a cloud-based network.  RPM systems incorporate wireless medical devices and computer-based software applications. The evolution of IoT and IoS technologies is clear, and will offer significant business opportunities for patients, residences and the healthcare system in general. RPM is a cost-effective means of keeping patients out of the hospital and have a better quality of care.

 

Product Benefits

 

RPM systems, even within the walls of a single building, can offer countless benefits for the overall healthcare management of clients.  There are countless tangible benefits to medication adherence as well, including significant reductions in hospitalizations, enhanced quality of life, and reductions in the effects of both overmedication and undermedication. Eliminating the distribution and administration of scheduled medications exonerates the residence from the liabilities associated with this task. Human error is all but eliminated. Corporate risks are significantly reduced for this activity and liability insurance premiums may be reduced as well.  Essentially, increasing medication adherence through automation, empowerment and monitoring improves patient outcomes and achieves benefits for all health system stakeholders.

 

Patients:

Better quality of life 

Fewer hospital visits 

Better outcomes 

Reduced travel and health costs 

Increased social interaction with family and friends 

Patient Families:

Better visibility into the quality of life of loved ones 

Fewer hospital visits – fewer interruptions into  

their work days 

Better outcomes 

Reduced travel costs 

Increased peace of mind – reduced stress and concern 

Residential Providers:

Better overall quality of life in the residence 

Reduced risk and liability 

Superior service 

Reduced labor costs 

Increased revenues for enhanced services 

Superior reputation / higher desirability / increased ability to charge for core services 

Healthcare professionals and providers deliver better care more efficiently at lower risk 

Healthcare Industry:

Government, insurance and other payers reduce spending 

Patients who are more adherent with medication regimes use fewer health services 

Pharmaceutical companies increase profitability  

and deliver value beyond the pill 

Pharmacy retailers ensure repeat orders, increased fulfillment and enhance brand loyalty 

Physicians have the ability to become proactive,  

rather than reactive 

Every 1% improvement in medication adherence results in $2 billion in savings to U.S. Healthcare system and a $4 billion revenue increase to pharmaceuticals 15 

Differentiation in the marketplace for early adopters 

 

Market Opportunities

 

The market demand for remote patient care (“RPC”) solutions is at an all-time high and continues to increase due to healthcare insurance reimbursement of the services delivered over RPC systems.  Further, the move from “fee-for-services” to outcomes-based payment structures have brought about the need for doctors and all other healthcare providers to increase the efficiency and to reduce the costs of care delivery to patients.  Clearly, as with the introduction of any new technology, there is a significant market differentiator for early adopters. Residences, assisted living facilities, and long-term care facilities all exist in a competitive environment in which differentiation between them is based upon higher desirability, which amounts to higher profits for those who are able to offer more. Unlike other service businesses, residences have the ability to attract clients requiring services on a long-term basis.  Additional market opportunities exist around hospitals and their management’s needs surrounding the reduction and elimination of patient readmissions.  

 

The global RPM systems market draws immense focus due to strict governmental measures to cut down healthcare expenditure, and reduce hospital stays. Remote patient monitoring serves to minimize hospital readmissions, and reduces the load on physician time, and nursing staff, thus greatly reducing healthcare costs. A rapidly aging population vulnerable to chronic diseases, and a growing desire to live independent lives among the elderly are driving growth in the market. Given the rise in the number of insured patients covered under reforms such as the Affordable Care Act, coupled with stricter reimbursement norms, healthcare providers are under constant pressure to manage wider patient population at lower costs. With the healthcare industry migrating towards an outcome-driven effective healthcare system, remote patient monitoring technology stands optimally positioned for growth.

 

Encouraged by the widespread proliferation of high-speed internet, and related services, the adoption of RPM systems is witnessing strong demand. There is growing interest in IoT-driven healthcare services and wearable medical devices that feature sensors, actuators, and other mobile communication methods through which patient data can be continuously transmitted onto a cloud-based platform. Healthcare providers are increasingly adopting cloud computing technologies, which not only offer cost benefits but also allow healthcare organizations to increase operational efficiency.

 

The global market for remote monitoring systems is projected to reach over $66 billion by 2020, driven by government measures to reduce healthcare spending against a backdrop widening healthcare budget deficit.  As stated by the new market research report on Remote Patient Monitoring Devices, North America represents the largest market worldwide, occupying close to 41% of the total market share, and is expected to grow at an exponential compounded annual growth rate of 21.34% during the forecast period. Asia-Pacific ranks as the fastest growing market with a compounded annual growth rate of 13% over the forecast period. The growth in the region is driven by the increase in per capita healthcare spending and the need for a cost-effective and sustainable healthcare system along with infrastructure capable of addressing the growing healthcare needs of an expanding population. 16

 

Misuse of Opioids and Other Addictive Substances

 

During 2017, there were more than 72,000 overdose deaths in the United States, including 49,068 that involved an opioid, according to a provisional CDC count. More than 130 people died every day from opioid-related drug overdoses in 2016 and 2017, according to the US Department of Health & Human Services (HHS).

 


13 https://www.pillsy.com/articles/medication-adherence-stats 

14 https://cvshealth.com/newsroom 

15 https://medipense.com/en/medication-adherence-compliance/ 

16 https://www.strategyr.com/Remote_Patient_Monitoring_Systems_Market_Report.asp 


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There are many organizations talking about the prevalence of this medical problem; however, those working with the addicted population are segmented and fragmented by a limited or narrow scope of work.  The clinics and treatment centers are restricted by the need for an on-site appointment for testing and counseling, the hospital emergency rooms are only able to treat the critical physical problem that presents from misuse or overdose and have difficulty finding treatment resources that are readily available for referral to treatment, and the patients who do enter treatment encounter many challenges including access to treatment,  frequent appointment schedules making it difficult to maintain employment and lapses in proper chronic disease and pain management.

 

The Company believes that bringing together a number of partners and adding the dimension of population health in-home visits will provide improved, measurable outcomes for the patient and their families.  Regularly scheduled home visits can provide the link between the provider, the healthcare plans and patients.  

 

It is also the Company’s belief that education, early intervention and remote patient monitoring can have a significant, positive impact on reducing the misuse of opioids, alcohol, tobacco and other addictive substances. The Community Health Workers (“CHW”) have been providing health screenings and educational classes for chronic disease management and healthy living for several years, and have been successful in identifying potential health risks and referrals for care. The CHW have become respected and trusted advisors and regarded as a link to the healthcare system.

 

Outcomes Optimization Platform monitoring:

 

Reduction in number of opioid prescriptions issued; 

Number of individuals attending educational sessions; 

Increase in number of patients finding timely access to treatment facility; 

Reduction in number of patient relapses; 

Reduction in hours spent to recovery independence; 

Number of times transportation arranged for appointments;  

Number of enrollments of uninsured patients; 

Referrals to other public benefits and community resources. 

 

The lucrative reimbursement policy introduced by the government agencies promoting the use of telemedicine and virtual health services is driving the market in North America. The U.S. and Canada are the major revenue contributors to the market in North America. Further, the increasing investments in research and development and technological innovations will help major players in the North American region occupy a larger market share over the next few years.

 

Barriers to Entry

 

Despite the significant potential benefits to outcomes and patient satisfaction that may accrue through the leveraging of patient-generated health data (“PGHD”) in clinical care, data ownership remains a barrier to greater use of PGHD in some circumstances. Though the collection and use of PGHD is intuitive to experienced patients, inclusion of such data represents a shift in the way medicine has been practiced. Taking an active role in the collection and management of data about one’s health status increases patient activation, which is strongly related to better health outcomes in multiple conditions.

 

Patients’ and providers’ use of mobile health (“mHealth”) apps provide a framework for assessing the role mHealth can play in medicine and as a source of PGHD. Physicians use social media primarily for personal use (60%), though accessing healthcare news (21%), communicating with peers (18%), marketing the practice (11%), and communicating to patients (4%) are also practiced. Among physicians who choose not to use social media, concerns about patient privacy (52%), lack of time (51%), concerns about liability (42%), the belief that social media has little professional value (40%), and lack of familiarity (23%) are cited most frequently. In 2014, two-thirds of physicians surveyed reported using a mobile app to check medication interactions, diagnose a condition, access EHRs, check results, create clinical notes, and prescribe electronically, and more than a third of U.S. physicians recommended their patients use health apps.17

 

Questions related to provider licensure pose another potential barrier to the routine use of mHealth. When a patient has his or her radiograph read, many current U.S. state laws require that it be read by a physician licensed in the state where the patient is located and had the radiograph. PGHD can raise special issues. For example, if a patient lives in New York and has an mHealth device that continues to monitor certain aspects of his or her health and the patient crosses three states and then travels into the EU, does the patient’s physician need to be licensed in each of the other three states and in the applicable country in the EU when the data is transmitted from that state or country in the EU? Within the United States, most states require that the out-of-state physician receive an unrestricted license in the state in which the initial patient interaction occurred.  Some states issue a telemedicine license to facilitate practice across state lines when the physician holds an unrestricted license in another state.  In the radiograph situation, the imaging physician is reading the radiograph at one point in time and billing for that service. With the monitoring of an individual’s health information continuously, the clinician may be being paid to manage the patient’s condition or his or her overall care.  The special privacy and confidentiality issues can raise important mHealth implications. It is important that vendors and healthcare systems coordinate their efforts to minimize these issues.  


17Petersen C, DeMuro P. Legal and regulatory considerations associated with use of patient-generated health data from social media and mobile health (mHealth) devices. Appl Clin Inf 2015; 6: 16–26 http://dx.doi.org/10.4338/ACI-2014-09-R-0082 


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Competitive Landscape

 

Countless smaller companies around the world are innovating in this sector and are now offering everything from Bluetooth connected toothbrushes and bathroom scales (weight loss or gain is a key indicator of health and disease state) to “wearable’s” that capture everything from body temperature, pulse rates, respiratory rates and blood pressure monitoring to game-changing technologies such as non-invasive blood glucometers that sample blood sugar level several times per second – continuously – without requiring lancets and the drawing of blood samples.

 

Medical clinics, on a global scale, are already adopting technologies that allow them to provide better healthcare to a wider population base.  Insurance companies and HMOs also continue to seek the highest quality healthcare with the highest return on investment by leveraging modern technologies to provide better care to a greater population base at lower cost.

 

There are a large number of companies offering some form of wireless and remote technologies, patient data processing applications and equipment, and electronic medical record data transfer equipment. Competitors supplying advanced patient monitoring and telehealth systems to hospitals are large, established healthcare companies, often working in conjunction with information technology (“IT”) companies on an entire system. The home healthcare and other sectors are much more fragmented and are dominated by privately held companies. In addition, some companies supply innovative products, but only for a small segment of the market; and some companies supply products on a regional basis only.

 

There is a worldwide interest in “connected health” with major companies such as Philips, Nokia, Apple, IBM, Microsoft and Google, all investing heavily in sensors and sensor systems for healthcare, connectivity and RPM. Traditional telecommunications companies like AT&T, Verizon and a host of others are also investing heavily in healthcare systems and in the RPM market.

 

Major players in the global RPM market include Abbott Laboratories, Aerotel Medical Systems, AMD Global Telemedicine, Inc., BIOTRONIK SE & Co. KG, Boston Scientific Corporation, GE Healthcare Ltd., Honeywell Life Care Solutions, Intelesens Ltd., LifeWatch AG, Masimo Corporation, Medtronic Plc, Mindray North America, Nihon Kohden Corporation, Omron Healthcare, Inc., Philips Healthcare, Qualcomm Life, Inc., St. Jude Medical Inc., and Welch Allyn, Incorporated.

 

Intellectual Property (Remote Patient Care)

 

The Company, through Assignment Agreements with La Frontera Community Solutions, Inc., acquired all worldwide rights, title and interest in and to the patent applications for the technology underlying the Fotodigm®  platform and systems.

 

Key Patented and Patent-Pending Concepts

 

Diagnostic Monitoring 

Data Driven Outcomes  

Remote Patient Monitoring  

Remote Patient Biometrics  

Remote Patient Diagnostics  

Remote Medication Monitoring 

Remote Medication Delivery 

Remote Medication Reconciliation   

 

For more information on these patent applications, please see “INTELLECTUAL PROPERTY SUMMARY“ section below.  

 

Government Regulations

 

The FDA regulates certain medical devices and also certain mobile medical apps. On September 25, 2013, it issued a Final Guidance that defines “mobile medical app,” as a mobile app that (1) meets the definition of a “device” in the Federal Food, Drug and Cosmetic Act and (2) is intended to be used as an accessory to a “regulated medical device” or to transform a platform into a “regulated medical device.” The Guidance grouped mobile medical apps into three categories: 1) apps that are actively regulated, (e.g., a mobile medical app that monitors the patient’s blood glucose levels and calculates the amount of insulin needed based on the patient’s condition, age, weight, etc.); 2) apps that are subject to enforcement discretion, (e.g., a mobile medical app that provides a patient an alert as to when to take his or her medications); and 3) those that are not considered devices and thus are not regulated (e.g., a mobile medical app that merely provides general healthcare information available on the internet, not directed to a specific patient).

 

The FDA guidance addresses data security because patients and other users may experience severe consequences should the device lack adequate data protection or be hacked. The guidance does not address the protection of privacy. Rather, privacy is protected by Health Insurance Portability and Accountability Act (“HIPAA”), where applicable. When patients’ health information is in the possession of health providers, health plans, business associates, or other covered entities, it is protected under HIPAA; when it is transmitted among individuals or organizations that are not covered entities under HIPAA, it is not protected. Accordingly, health information transmitted via a mobile device by a covered entity is protected under HIPAA privacy and security rules. However, this same information transmitted via a non-covered entity under HIPAA is not protected. HIPAA also does not cover information on an individual’s mobile device.


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Patient-generated health data (“PGHD”) is merely data of the patient if a patient checks their blood glucose levels with a mobile device. If, however, he or she uses the device to transmit that information to their clinician for the purpose of monitoring that person’s care and the information becomes part of the patient’s electronic health records (“EHR”), the PGHD then falls under HIPAA.

 

The Federal Trade Commission (“FTC”) is not hesitant to file complaints against companies that it believes fail to reasonably protect the security of consumers’ personal data, including medical information. In August 2013, FTC filed a complaint against LabMD, Inc., alleging that the medical testing laboratory exposed the personal medical information of more than 9,000 consumers by placing the information on a peer-to-peer file-sharing network. The filing followed the discovery of the personal information of several hundred consumers who used LabMD’s services in the possession of identity thieves. In this case, as in an earlier case against a medical transcription firm that exposed personal medical information on the public internet, FTC is acting to enforce HIPAA’s security requirements.  

 

The Company makes patient security an utmost priority.  With the Company’s secure HIPAA-compliant cloud-based system, a patient can have confidence that their personal HER, EMR and PGHD is protected with the highest level of technology available.

 

FTC also regulates misleading claims. If in the sale or distribution of a mobile medical app or device one makes claims about what the device can do, FTC can bring an action to make the individual or entity cease and desist from making such claims. In 2013, FTC published a written guidance and a short video for mobile app developers that offer advice on creating apps that protect users’ privacy and comply with truth-in-advertising principles.

 

Principal Suppliers

 

As of December 31, 2018, the principal suppliers of the medical devices utilized with the Fotodigm® platform were:

 

Amazon Web Services, Seattle, WA 

HIPAA-compliant secure server environments for hosting and management of Fotodigm® platform

La Frontera’s Empact Suicide Prevention Center, Tempe, AZ 

Largest CARF (Commission on Accreditation of Rehabilitation Facilities) certified behavioral health suicide prevention call center in United States.

Royal Phillips, Inc. 1070 MX Amsterdam, The Netherlands 

Primary RPM software and hardware supplier; platform built upon Salesforce.com infrastructure providing clinical, monitoring center, and patient management portals for mobile and desktop access.

 

The Company relies upon these suppliers to provide the majority of the delivery of its remote patient monitoring systems and services.  The services are web-based and although the Company relies on these vendors, it can also hold them accountable, receive volume-based pricing, discounts and partnership advantages through the competition of its suppliers. The Company has the ability to change vendors at any time in all service and product lines. Further, the Company is working towards the elimination of its reliance on software and hardware providers related to its in-home RPM offerings and services.

 

PATENTED REBOOT TECHNOLOGY

 

Overview

 

On April 26, 2017, the Company completed the acquisition of 100% of certain intellectual property from ProEventa Inc., a Virginia Corporation (“ProEventa”), in accordance with the Intellectual Property Purchase Agreement between the Company and ProEventa (the “ProEventa Agreement”). ProEventa has an expertise in the development of behavioral health technologies, and is the wholly-owned subsidiary of Grafton Integrated Health Network, Inc., a non-profit Virginia corporation (“Grafton”), Pursuant to the ProEventa Agreement, in exchange for 100% of that certain intellectual property, among other things, consideration to ProEventa included:

 

a stock purchase agreement to purchase 2,500,000 shares of the Company’s Common Stock; and 

a revenue sharing agreement, providing for a cash earn-out to be paid to the ProEventa shareholders of up to $3,000,000, to be derived from certain net revenue generated by the Company, as defined in the agreement; and 

a royalty agreement, providing for a royalty of 3% of the revenues generated from the intellectual property, ending at such time as the Company has paid ProEventa $25,000,000; and 

a limited license to ProEventa for the use of certain of the Intellectual Property’s technology at Grafton Schools. 

 

On April 26, 2017, in conjunction with the ProEventa Agreement, the Company entered into a consulting agreement with James Gaynor, founder of ProEventa, that, among other things, provides for consideration to Mr. Gaynor as follows:

 

a stock purchase agreement to purchase 500,000 shares of the Company’s Common Stock at $0.001 per share; and 

a grant of options to purchase 1,000,000 shares of the Company’s Common Stock at a price of $0.25 per share, vesting annually over a three (3) year period beginning September 1, 2017. 

 

With the completion of this acquisition, the patented technology entitled “Platform for Optimizing Data Driven Outcomes,” is added to the Company’s patent portfolio.  


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Product History

 

For over a decade, Grafton School, Inc. (“Grafton”), a Virginia corporation, perfected a manual system of outcomes developed by Dr. Lisa Marshall and James Gaynor, that re-invented utilizing cloud computing and the internet.  In March 2014, ProEventa, Inc. (a Latin word meaning, “Good Outcomes”), and wholly-owned subsidiary of Grafton, was formed, and began marketing the software based on rights granted by Grafton. REBOOT (“REBOOT”), an acronym for Reliable Evidence-Based Outcomes Optimization Technology, is the behavioral health platform, and was developed to provide goal obtainment through mastery of skills in a customized and fully automated data analysis and intervention model.

 

The technology is supported by applied behavioral analytics and over 25 years of efficacy studies and reduction to practice at Grafton, combined with over $3.75 million-dollar invested to transition the system to a cloud-based platform with mobile applications.

 

Goal Mastery 18

 

In 2004, Grafton Health’s CEO, Jim Gaynor, asked his leadership team to provide the percentage of goals clients at Grafton mastered annually overall and within specific programs and services. While observations and anecdotal reports from Grafton providers and stakeholders indicated clients were showing improvement in their identified goal areas, there was not a system in place to provide an actual goal mastery rate. Out of this request, Grafton’s “Goal Mastery Initiative” was created.

 

The goal mastery process was designed to provide a structured and sustainable system to identify, monitor, and evaluate client progress and to embed data-based decision-making into the transdisciplinary treatment and instruction planning. There are several steps to this process: (1) conducting a thorough assessment of the individual’s strengths and needs, (2) writing goals that are functional, measurable, and specific to the needs, (3) collecting data, typically on a weekly basis, (4) graphing data and comparing them to a Minimum Growth Line, (5) determining level of progress according to a specific standard, and (7) providing a reporting mechanism to identify goal mastery rates at all levels within the organization. When the data trend indicates the goal is not on track for mastery, six primary decision-support factors (Six M’s) are explored to help the transdisciplinary team evaluate the situation and make recommendations for changes to treatment and instruction. After an initial baseline goal mastery rate of 35% when this initiative first started and progressive increases over the year, Grafton has maintained a goal mastery rate at or above 80% for the past several years.

 

The Company has licensed the improved REBOOT technology platform for systems integration into the diagnostics and remote patient care systems.  The next step in the Company’s commitment to data-based decision-making is the introduction of website and mobile technology to support the goal mastery process. The REBOOT technology will be made available to organizations, individual providers, and family members who want to effectively track individuals’ progress and use the Company’s evidence-based process for increasing goal mastery.

 

Ultimately, through the goal mastery process and the deployment of REBOOT, the Company will continue to provide individuals with the support they need to make meaningful and sustainable improvements in their functioning and quality of life.

 

Product Strategy

 

The patented feature set of the REBOOT platform allows it to provide progressive-predictive analytics and goal optimization intelligence on concurrent and compounding goals for an individual or group of people. Its’ utility is broad and has use cases in many vertical growth markets.

 

The product strategy is to enter the market through the healthcare initiative of the Company’s remote patient care and diagnostics divisions. The integration of REBOOT is a key differentiating advantage within the remote patient care market.  The software can be harnessed to assess and prioritize patient goals, provide interventions, track behavioral data and provide meaningful feedback toward goal obtainment, as well as real time decision support with robust progress reporting. The resulting decision and patient support, combined with the remote patient care and diagnostics technologies, make for a technology advantage and a feature set that is designed to take away market share from competitors and capture new client accounts in healthcare field focused on doctors, nursing operations, and hospitals.

 

The technology can be marketed through user licensing or enterprise licensing contracts within the healthcare market, in both platform and supported mobile applications, including the Company’s application known as COMPASS (“COMPASS”).

 

The Company believes that healthcare organizations for the first time will have the opportunity to “scale” their patient adherence programs while having visibility into its effectiveness and bottom-line impact. Individual users will have a goal wizard, virtual coach and rules engine that will help create a path toward wellness. With personalized analysis, decision support and “goal” mastery feedback, the individual will be primed, guided and motivated to adhere to their treatment plan.

 

REBOOT is also applicable to many vertical markets outside healthcare.  The short-term strategy is to monetize the patented technology in healthcare, and license to non-competitive companies within other market verticals. The Company is assessing and prioritizing the licensing prospects.  The management team is also monitoring and identifying patent infringement, and some, already identified, are being assessed for licensing value.


18 Grafton Integrated Health Network® 


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Behavioral Healthcare Industry

 

Per a Behavioral Health Services 2016 Report by Capstone Partners, the demand for behavioral health services will continue to grow due to increased awareness and affordability of mental health and substance abuse treatment options. According to the Substance Abuse and Mental Health Services Administration (“SAMHSA”), expenditures on mental health and substance abuse treatment are estimated to have reached $239 billion in 2014. By comparison, expenditures only totaled $42 billion in 1986 and $121 billion in 2003. More specifically, revenues generated by the substance abuse treatment industry reached an estimated $29.8 billion in 2015, a 3.5% growth over the prior year and 2.9% annual growth rate since 2006. Industry revenues are expected to grow 2.6% annually to reach $33.9 billion by 2020. There are a variety of factors that impact growth of the substance abuse treatment market, including development of new treatments, drug availability and healthcare reform.

 

Industry Drivers

 

Increased Exposure to Drugs and Alcohol

 

In the United States, illicit drug use and alcoholism have grown significantly among all age groups due to increased availability of prescription drugs and medication. This has resulted in an unfortunate trend of increased prescription medication abuse by secondary school and college-aged young adults.

 

Development of New Treatments and Programs

 

Clinical advancements in therapy and medication management have yielded new and better procedures for both psychological and detoxification treatments. Over the past several years, medication-assisted opioid therapy, which allows patients to rid their system of substance dependence through new-aged medication treatments, has led to an increased demand for treatment. Another driver is the future need for clinics to provide youth, elderly and gender-specific programs.

 

Healthcare Reform and Affordability

 

Healthcare in the U.S. has undergone significant changes in recent years that are favorable for the substance abuse treatment industry. Healthcare reform, specifically the Affordable Care Act (“ACA”), the Mental Health Parity and Addiction Equity Act (“MHPAEA”) and the Medicaid Certified Match Substance Abuse Program (“MCMSAP”), has led to more affordable substance abuse treatment.

 

Growth in Private Insurance

 

In the five years following the 2014 health insurance exchange implemented by healthcare reform, the number of people with private health insurance is predicted to significantly increase.

 

Increased Awareness

 

One of the biggest challenges for the industry has been the reluctance of substance abusers and addicts to undergo treatment. Individuals afflicted by substance abuse typically refuse treatment due to the social stigma associated with admitting they have a problem or lack of knowledge about the treatments available. However, recent efforts by health and government agencies have resulted in greater public awareness and acceptance of substance abuse as a disease.

 

Autism Disorder and Treatment Industry

 

Although the specific causes of autism are still not known, one thing is. The rate is increasing, and the market for treatment is growing.

 

Based on new government data, as of 2017, 1 in 45 children in the United States, aged 3-17, have autism. This is up from only 1 in 150 children back in 2000.

 

Research firm, Market Data’s March 2018 report entitled, “The U.S. Autism Treatment Market,” states that market data analysts estimate that there are currently 1.4 million American children with autism. Another 700,000 adults have autism, having “aged out” of children’s programs, and, 81% of autistic children are male.

 

The total annual costs for children with Autism Spectrum Disorder (“ASD”) in the United States in 2017 were estimated to be between $11.5 billion and $60.9 billion - a significant economic burden.

 

Insurance coverage is a problem, but the share of children with access to insurance coverage is expected to increase from the 36% level today. In addition, the number of self-funded private employers covering autism treatment continues to grow.

 

Autism Treatment Options

 

In the past, it was thought that the best way to treat the symptoms of autism was to medicate. Data suggest that approximately 58% of patients with a diagnosis of childhood autism receive some type of pharmaceutical treatment. However, this segment of the market has been shrinking in value as concerns continue over the side effects of commonly used drugs.


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Today, this attitude is changing, as Applied Behavior Analysis (“ABA”) programs have become more widespread and have displayed good outcomes. There are basically three types of ABA program providers: brick and mortar centers, community providers, and in-home therapists.

 

Many autism treatment organizations, and some of the largest competitors, are located in California. This is due to the fact that funding for treatment programs has been in place there since the 1990s, prior to the insurance mandates that were later put into place.

 

Market Opportunities

 

With healthcare costs continuously on the rise, REBOOT is positioned to be unique as an evidenced based, cost-effective approach in improving patient care.  The selection of the healthcare market as the Company’s focal effort is a choice based upon the market size and market demand for outcomes improvement across the market that is both target rich and highly scalable.

 

An estimated one in four adults (about 60 million Americans) experiences mental illness in a given year.19 

About 14 million people live with a serious mental illness.20 

Approximately 20% of youth ages 13 to 18 experience severe mental disorders in a given year. 19 

7% of American adults live with major depression. 20 

An estimated 18% of American adults live with anxiety disorders (e.g., panic disorder, OCD, PTSD). 19 

About 9 million adults have co-occurring mental health and addiction disorders. 19 

20 million Americans suffer from substance abuse. 19 

 

In addition, there is a critical mental health provider shortage creating significant access to care issues:

 

Only 40% of Americans with mental illness report receiving treatment. 19 

One mental health provider exists for every 790 individuals. 21 

Approximately 4,000 Mental Health HPSA (professional shortage areas) exist which is based on a psychiatrist to population ratio of 1:30,000 -- meaning it would take approximately 3,000 additional psychiatrists to eliminate the current mental health HPSA designations. 22 

A report to Congress found that 55 percent of the nation’s 3,100 counties have no practicing psychiatrists, psychologists or social workers. 23 

 

There exists an abundance of opportunities for the Company that are focused on the use of the patented REBOOT technology. The market opportunities currently being pursued for REBOOT include, but are not limited by:

 

Integration within Parallax’s remote patient care platform for goal obtainment and mastery within healthcare operations. 

Integration within Parallax’s COMPASS mobile smartphone applications targeted at and focused on specific user applications including, but not limited to, remote patient care, doctor decision support, patient empowerment, population health, ASD (Autism), chronic disease management and hospital readmissions reduction.  

Development alongside the SPARKS Mobile, Parallax’s patented handheld POC analyzer, featuring immunoassay blood testing and FDA-cleared tests, to enable a complete suite of platform-based offerings for medical practitioners, including individual doctor’s offices, doctor groups, accredited nursing, and hospital operations.  

 

Management is seeking additional opportunities with or in the study of the following markets:

 

Environmental 

Economic 

Healthcare 

Enterprise licensing 

E-learning applications 

Professional sports 

Fitness  

 

Management is also in the process of identifying the comprehensive patent landscape, and determining the best course and greatest value accretion in the prospective markets that will be approached through the patents and intellectual property licensing, including the market values related to patent infringement and outbound licensing opportunities centered around REBOOT as well as the adjacent assets held by Parallax.


19https://www.nami.org/learn-more/mental-health-by-the-numbers  

20http://www.lb7.uscourts.gov/documents/12-cv-1072url2.pdf  

21https://khn.org/news  

22https://www.kff.org  

23https://www.jconline.com/story/news/2014/04/12/dire-shortage-of-psychiatrists-in-greater-lafayette-leaves-patients-waiting-months-for-help/7656745/  


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Autism Market 24

 

The U.S. autism treatment market was estimated to be valued at $1.85 billion as of 2016, growing to $1.87 billion last year. Market data forecasts 3.9% average yearly growth, to $2.23 billion by 2022. This could be conservative, as insurance coverage is improving. In addition, venture capital firms are starting to take notice of investment opportunities in this market.

 

The average ABA center grosses about $821,000, and many are non-profit organizations. Many programs now have waiting lists, and there is a shortage of qualified supervisors.

 

Nine large multi-site ABA program providers operate an estimated 296 brick and mortar centers, and employ thousands of therapists. Together, they account for about $390 million in revenues, representing a 38% market share of ABA programs.

 

Revenues of ABA programs are estimated to generate $1.07 billion in revenues in 2018, outpacing sales of prescription drugs used for autism symptoms.

 

Competitive Landscape

 

Parallax competes with other technology consulting companies, which provides the Company with key technological advantages over the competing companies in the remote patient care and diagnostics markets. Within licensing, Parallax competes with other value-based contracting and technology companies like Oracle, Accenture and IBM, that have taken the same systems integration go-to-market approach.

 

Intellectual Property (Behavioral Health)

 

The Company, through an Intellectual Property Purchase Agreement with ProEventa, Inc., acquired all rights, title and interest in and to the patent entitled “Platform for Data Driven Outcomes.” The patent has been granted in the U.S. under patent #10,061,812, and applications have been filed worldwide. It has been published in the UK under filing GB2526749. A third filing is pending issuance in Australia.  Along with the patents, the Company acquired the technology platform referred to as Reliable Evidenced Based Outcomes Optimization Technologies, or REBOOT, a technology platform specifically designed to improve health treatment outcomes using proprietary applied behavioral analytics technology systems.

 

For more information on these patents and patent applications, please see “INTELLECTUAL PROPERTY SUMMARY” section below.  

 

Government Regulations

 

Mental health and substance abuse services are subject to many federal, state and local regulations regarding licensing, operations, facility ownership, reimbursement rates and procedures. These regulations and strict licensure requirements create high barriers to entry for the industry. Licensing prerequisites typically relate to the provider’s medical qualifications, personnel and equipment, staff-to-patient ratio, adequate records maintenance, rate-setting and compliance with standard building and safety codes. Expansion of substance abuse facilities are also subject to state regulations. The construction of new facilities; expansion of existing facilities; transfer or change of ownership; and the addition of new beds, services or equipment may be subject to state laws that require prior approval by regulatory agencies under Certificate of Need (“CON”) laws. CON laws generally require that a state agency determine the public need for construction or acquisition of facilities/addition of new services.

 

The HIPAA regulations also have a unique impact on the Company, as they impact the management and controls of the data it collects and encounter throughout the Parallax operations.  Also, the state and local governments’ Medicare and Medicaid payments and reimbursements require consistent and diligent management, both in following the advantageous changes in the move towards connected healthcare and greater reimbursements.  There are also regulations and requirements with each approved connected healthcare treatment.  Lastly, there are American Medical Association regulations over U.S. medical practices that affect how the Company’s business is operated, requiring both compliance and alignment with its customers, who require unique reporting and other data and service-related processes as a result of these, and other, regulations. 

 

Principal Suppliers

 

As of December 31, 2018, the principal suppliers for the Behavioral Health platform were:

 

Amazon Web Services, Seattle, WA 

HIPAA-compliant secure server environments for hosting and management of REBOOT and COMPASS.

La Frontera’s Empact Suicide Prevention Center, Tempe, AZ 

Largest CARF-certified behavioral health suicide prevention call center in United States.

 

The Company relies upon these suppliers to provide the majority of the delivery of its behavioral health platform products and services.  The services are web-based and although the Company relies on these vendors, it can also hold them accountable, receive volume-based pricing, discounts and partnership advantages through the competition of its suppliers. The Company has the ability to change vendors at any time in all service and product lines. Further, the Company is working towards the elimination of its reliance on software and hardware providers related to its in-home behavioral health offerings and services.

 


24https://blog.marketresearch.com/autism-treatment-programs-are-growing-a-1.8-billion-market-in-the-u.s  


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INTELLECTUAL PROPERTY SUMMARY

 

The Company retained the services of the Intellectual Property Network (“IPN”) to provide Intellectual Property protection recommendations for all of Parallax’s Intellectual Property, open patent applications and products, both domestically and internationally. IPN is owned and controlled by Paul Arena and Nathan Bradley, who are officers of Parallax. IPN informs the Company and its shareholders of the accurate and current state of the commercial patented coverage and, where possible, identifies the existence of novel and patentable inventions present in the current innovation initiative.  IPN concluded that the Company has a strong patent portfolio protecting its business, and recommended that the Company aggressively proceed with additional patent applications to protect Parallax’s inventions and innovations.  

 

Patents, Patent Applications, Exclusive Licenses and Patent Portfolio Overview

 

I.The Company, through a License Agreements with Montecito BioSciences, Ltd., acquired the worldwide exclusive rights to sub-license, sell, have sold, make, have made, develop, have developed, further develop and modify, or to have further developed or modified, within the field of use set forth in the agreement, the following patents and/or patents pending: 

 

1. Patent 8,920,725 and 9,170,258 - “Portable Apparatus for Improved Sample Analysis” 

 

The present invention is an improved apparatus for sample analysis. The apparatus employs an assay component containing a membrane having one or a plurality of analyte-specific binding agents attached thereto, a means for absorbing liquid, and a piston means for drawing analytes through said membrane into said means for absorbing liquid. The apparatus is configured to be portable and provide a detector for detecting binding of an analyte to an analyte-specific binding agent, a plurality of data acquisition components, and a computer for integrating, analyzing and storing the detected analyte specific binding and acquired data.

 

This Patent and pending application(s) cover the Company’s SPARKS Mobile hand-held analyzer, which is used in conjunction with the Target System test cartridges. The hand-held Target Analyzer device is capable of housing and analyzing two assay cassettes, and optionally features wired or wireless data transfer and multiple data acquisition components including a keypad, a touch-pad, a barcode wand and / or a finger print reader.  On August 23, 2013, the Company was notified that its Chinese Patent Application No. 200780039901.X “Portable Apparatus for Improved Sample Analysis” had been granted by the States’ Intellectual Property Office of the Peoples Republic of China. Patents were also issued in Hong Kong and Macao.  The Company filed in India under a New Indian Patent Application based on the PCT Application No. PCT/US2007/082499 The case is currently pending.

 

Following is the family of cases under Patent 8,920,725 and 9,170,258:

 

ApplicationCountryDate FiledStatusDate GrantedPatent Number 

1.60/863,241United States10/27/2006ProvisionalN/AN/A - continued under 1a 

1a.11/924,033 [1]United States10/25/2007AbandonedN/AN/A - continued under 1b 

1b.13/248,307United States09/29/2011Granted12/30/20148,920,725 B2 

1c.14/553,011United States11/25/2014Granted10/27/20159,170,258 B2 

1d.CN101558302China10/25/2007Granted08/23/2013CN200780039901.X 

1e.HK2010010103654Hong Kong10/25/2007Granted03/28/2014HK1137813 

1f.MO J/001298Macau10/25/2007Pending 

1g.IN785/MUMNP/2009India10/25/2007Pending 

 

[1]Patent Application US11/924,033 is being prosecuted worldwide.  The now abandoned EPO Application No. 07854420.2 was filed in the following designee countries: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Monaco, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Liechtenstein, Turkey and the United Kingdom.   

 

2. Application 14/492,641 - “Method for Determining the Immune Status of a Subject” 

 

The present invention, whose application has been abandoned, is a method for using levels of soluble Clusters of Differentiation (CD) proteins, or cell surface-localized CD proteins extracted from T lymphocytes for determining the immune status of a subject. The present invention also a kit containing a CD protein extraction means and at least one antibody which specifically binds a CD protein for use in carrying out the method of the invention. This family of cases covers a technique and kit for assessing immune status, e.g., in HIV patients, based upon the amount of soluble or surface-localized CD3-CD4, and / or CD8 protein present in a patient sample. This method and kit are an alternative to conventional cell sorting technologies and is owned by Montecito BioSciences, Ltd.

 

ApplicationCountryDate FiledStatusDate GrantedPatent Number 

2.60/845,395United States09/18/2006ProvisionalN/AN/A - continued under 2a 

2a.11/856,925United States09/18/2007AbandonedN/AN/A - continued under 2b 


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3. Application 12/769,036 - “Method of Identifying Drugs, Targeting Moieties or Diagnostics” 

 

The present invention relates to a method for identifying a binding agent or epitope for use in drug design, drug targeting or diagnostics. The method employs contacting and sorting binding agents and cognate epitopes from collections thereof, characterizing the binding agent and cognate epitope, detecting the level or location of the epitope in a sample using the binding agent, and correlating the level or location of the epitope in the sample with the presence or stage of a disease or condition to identify novel drugs, targeting moieties, or diagnostic agents. This family of cases covers a technique for obtaining a population of antibodies that specifically binds to a corresponding population of antigens, without any a priori information about either population. The antigens identified by the method are subsequently characterized and correlated with the presence or stage of a disease or condition there by serving as a target for drug design, drug targeting or diagnostics.

 

ApplicationCountryDate FiledStatusDate GrantedPatent Number 

3.60/608,342United States09/09/2004ProvisionalN/AN/A - continued under 3a 

3a.11/221,038United States09/07/2005AbandonedN/AN/A - continued under 3b 

3b12/769,036United States04/28/2010Pending 

 

4. Patent 9,573,990 - “Method of Producing a Plurality of Isolated Antibodies to a Plurality of Cognate Antigens” 

 

The present invention relates to a method for producing high affinity antibodies that are antigen-specific. The method involves binding a plurality of antibody-producing B-cells from a mammal to a plurality of cognate antigens; sorting the bound antibody-producing B-cell and cognate antigen; amplifying nucleic acid sequences encoding each antibody, or fragment thereof, from the B-cells; and expressing each antibody in a protein expression system. Antibodies produced in this manner are useful in diagnostic and therapeutic applications. This family of cases covers a technique for obtaining a population of antibodies produced by B-cells, without any a priori information about the population of antibodies, and use of the same in an array for profiling antigen expression.

 

ApplicationCountryDate FiledStatusDate GrantedPatent Number 

4.60/608,526United States09/09/2004ProvisionalN/AN/A - continued under 4a 

4a.11/221,252United States09/07/2005AbandonedN/AN/A - continued under 4b 

4b13/253,366United States10/05/2011Granted02/21/20179,573,990 

 

5. Application 14/786,282 – “Flow Through Testing System with Pressure Indicator” 

 

This family of cases covers an improved assay cassette with pressure-sensitive microcapsules for ensuring that a sufficient reduction in pressure is achieved there by maximizing contact between the sample and analytic compound. A device for performing immunoassays on analytes. The device includes an immunosorbent membrane, an absorbent material, a piston component located below said absorbent material to draw analytes in a sample through the immunosorbent membrane into the absorbent material, and discrete groups of pressure-sensitive microcapsules located on the immunosorbent membrane.

 

ApplicationCountryDate FiledStatusDate GrantedPatent Number 

5.61/814,916United States04/23/2013ProvisionalN/AN/A - continued under 5a 

5a.14/786,272United States04/23/2014Pending 

5b.PCT14/35073United States10/22/2015Pending 

 

Summary of Open Applications available for continuation filings (from above):

 

2b. US14/492,641 - “Method for Determining the Immune Status of a Subject” 

3b. US12/769,036 - “Method of Identifying Drugs, Targeting Moieties or Diagnostics” 

5a. US14/786,272 – “Flow Through Testing System with Pressure Indicator” 

 

For further information on the exclusive license of the Patents and Patent Applications above, and the complete text of the License Agreement and subsequent Modification, please refer to Exhibits 10.20 and 10.22, respectively, to the Company’s Current Report filed November 15, 2012 on Form 8-K.

 

II.The Company, through an Assignment Agreements with La Frontera Community Solutions, Inc., acquired all worldwide rights, title and interest in and to the following patent applications and the invention in its entirety: 

 

1.Application 14/979,889 – “Remote User Monitoring System”  

 

A system and method for monitoring a status of a user. One or more biometrics associated with a user in a residence where the user resides are sensed. A status of the user is determined in response to sensing the one or more biometrics. One or more questions about the status to the user are communicated. One or more answers to the one or more questions communicated to the user are received. The status is communicated to an administrator of the residence. The status is communicated in response to one or more of the answers.

 

ApplicationCountryDate FiledStatusDate GrantedPatent Number 

1.14/979,889United States12/28/2015Pending 

 

2.Application 14/979,742 – “Remote Medication Delivery Systems” 

 

A system and method for medication delivery. Information is received indicating a user is scheduled to receive medication. A route between a dispensary storing the medication and a location of the user is determined. The medication is sent in a container from the dispensary to the location utilizing the route.

 

ApplicationCountryDate FiledStatusDate GrantedPatent Number 

2.14/979,742United States06/29/2017Pending 

 

For further information on the exclusive license of the Patent Applications above, and the complete text of the Intellectual Property Purchase Agreement, please refer to Exhibit 10.33 to the Company’s Current Report filed September 26, 2016 on Form 8-K.


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III.The Company, through a License Agreements with ProEventa, Inc., acquired all rights, title and interest in and to the following patent applications and the invention in its entirety: 

 

1.Application 14/212,429 – “Platform for Optimizing Data Driven Outcomes” 

 

A computer-based method for tracking outcome specific data specifically for optimizing, managing, and tracking data driven outcomes. Process utilizes a multi-dimensional platform to facilitate data-driven outcomes processes through assessment, goal development, data tracking, graphing, and re-evaluation. The process allows for optimization of best practices, successful actions, and success-based plan execution, which is identified through automatic data-mining and analysis as well as user specified parameters, algorithms, and analytics.  The process can be utilized by a client, patient, student, service provider, program, product, service, device, organization, business, department, or so forth.  The tool can be utilized across various industries for client behavior management, educational instruction, school improvement activities, program evaluation, organizational key performance indicators, financial management, weight management, tracking insurance claims, or so forth. Also published as WO2014144749A1 Platform for optimizing data driven outcomes. Also published as GB2526749 Platform for optimizing data driven outcomes.  

 

This patent application covers the intellectual property known as “REBOOT”, which stands for “Reliable Evidence Based Outcomes Optimization Technologies,” a structured, scalable and sustainable software system used to identify, monitor, and evaluate a single user or an entire organization's progress towards mastery of any achievable task, objective or goal.

 

ApplicationCountryDate FiledStatusDate GrantedPatent Number 

1.61/791,218United States03/15/2013ProvisionalN/AN/A - continued under 1a 

1a.14/212,429United States03/14/2014Pending 

1b.2014144749A1Worldwide09/18/2014Pending 

 

For further information on the exclusive license of the Patent Application above, and the complete text of the Intellectual Property Purchase Agreement, please refer to Exhibit 10.33 to the Company’s Current Report filed May 4, 2017 on Form 8-K.


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There can be no assurance that the Company will be granted patents for any of the patent applications it has filed with the USPTO or other patent organization worldwide.

 

Expired Patents

 

The Target System and certain of its related components were previously issued patents by the USPTO.  The following previously-issued patents have expired:  

 

Patent #

Description

Date Filed in US

Date Expired

US4,748,042

Target ringing and spotting machine (method and apparatus for imprinting membrane with pattern of antibody)

May 31, 1988

May 31, 2008

US4,797,260

Target cassette (antibody testing system)

January 10, 1989

January 10, 2009

US5,137,691

Target cassette with removable air gap (antibody testing system with removable air gap)

August 11, 1992

August 11, 2012

 

Trademarks

 

The Company will also utilize trademark applications to protect its Intellectual Property that may not be suitable for patent protection. Unlike patent applications, which in many cases must be filed in advance of a particular date, there is no specific date by which a trademark application must be filed. Instead, the time constraint is in a different direction. In the United States, an ordinary so-called “use” trademark application can only be filed after the goods or services have been in interstate commerce.

 

Facilities

 

The Company’s principal executive office is located at 1327 Ocean Avenue, Suite B, Santa Monica, California, 90401, with operations during 2017 at 465 N. Roxbury Drive, Beverly Hills, CA 90210. The Company’s Beverly Hills location was closed in December 2017. The Company’s telephone number is (310) 899-4442 (phone) and (888) 899-3966 (fax).

 

For additional information on the leased properties in Beverly Hills, CA, see “ITEM 2. PROPERTIES“ section contained within this annual report.

 

Employees

 

As of December 31, 2018, the Company had 6 employees, exclusive of its directors and executive officers.

 

The Company currently has 6 employees, exclusive of its directors and executive officers.

 

Research and Development

 

The Company incurred $74,000 and $0 in expenditures during 2018 and 2017, respectively, relating to the research and development of its proprietary medical technology, including costs for patent consultants and filings, and costs incurred to develop new products.

 

Reports to Security Holders

 

The Company is not required to deliver an annual report to its stockholders, but will voluntarily send an annual report, together with its annual audited financial statements upon request. The Company is required to file annual, quarterly and current reports, proxy statements, and other information with the Securities and Exchange Commission. The Company’s Securities and Exchange Commission filings are available to the public over the internet at the SEC's website at www.sec.gov.

 

The public may read and copy any of the Company’s materials filed with the SEC at the SEC's Public Reference Room at 100 F Street, NE, Washington DC 20549. The public may obtain information on the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. The Company is an electronic filer. The SEC maintains an internet site that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC. The internet address of the site is www.sec.gov.

 

ITEM 1A. RISK FACTORS 

 

The Company is a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and is not required to provide the information under this item.

 

ITEM 1B. UNRESOLVED STAFF COMMENTS 

 

None.


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ITEM 2. PROPERTIES 

 

The Company’s principal executive offices are located at 1327 Ocean Avenue, Suite B, Santa Monica, CA 90401.  The pharmacy operations located at 465 N. Roxbury Drive, Beverly Hills, CA 90210 ceased operations in December 2017, and the space was vacated in January 2018.  As of December 31, 2018, the Company sub-leases the Santa Monica space for approximately $5,600 a month.  This space is sufficient to meet its needs at December 31, 2018.  However, once the Company expands its business to a significant degree, it will require additional space. The Company does not currently own any real estate.

 

Dispute with Landlord-Beverly Hills, CA

 

Upon the completion of the acquisition of RoxSan Pharmacy, Inc., in August 2015, the Company became aware that the former owner, Shahla Melamed (“Melamed”), among other things, failed to properly notify the landlord or the Roxbury Drive property owners (the “Lessors”) of the change in ownership of the pharmacy, as required in the lease agreements.  Subsequently, in an effort to unwind the  acquisition of the pharmacy, Melamed attempted to undermine the Company’s efforts to obtain any lease assignment or new lease from the Lessors.  As a result, no lease assignments or lease agreements were made as of December 31, 2017, and the Company vacated the space in January 2018.

 

ITEM 3. LEGAL PROCEEDINGS 

 

From time to time, the Company may be involved in litigation relating to claims arising out of its operations in the normal course of business.  The Company knows of no material, existing or pending legal proceedings against it, nor are the Company involved as a plaintiff in any material proceeding or pending litigation, beyond those defined below.  There are no proceedings in which any of the Company’s directors, officers or affiliates, or any registered or beneficial shareholder, is an adverse party or has a material interest that is adverse to the Company’s interests.

 

Dispute with Former Owner of RoxSan

 

In October 2015, shortly following the Company’s acquisition of RoxSan, Shahla Melamed (“Melamed”), initiated two (2) legal actions against the Company in the Superior Court of the State of California, County of Los Angeles, West District, Shahla Melamed v. Parallax Health Sciences, Inc., action numbers SC 124873 and SC 125702.  

 

In the matter, action No. SC 124873, Melamed sought rescission of the August 13, 2015, Purchase Agreement. During the proceedings, Melamed also contended that the Company owed Melamed monies for, among other things, expenses paid by Melamed on behalf of Parallax.  As a result, the Court split the action into two separate rulings: (1) Rescission Phase and (2) Accounting Phase.

 

Action No. SC 124873-Rescission Phase: 

 

In the Matter, action no. SC 124873, rescission was sought by Melamed on the basis that, allegedly, in order to acquire the Pharmacy, the Company and its principals had allegedly defrauded Melamed, there had allegedly been a complete failure of consideration, and a unilateral mistake was allegedly made on the part of Melamed.  Subsequently filed pleadings by the Company and RoxSan in action no. SC 124873 allege, among other things, that Melamed misrepresented the true earnings and source of income for the pharmacy business and had engaged in a fraudulent and illegal scheme to ship medications to states where her pharmacy was not licensed prior to the sale of the Pharmacy.

 

Final Ruling:  On March 17, 2017, the Court ruled in favor of Parallax, and issued that Melamed is not entitled to rescission of the Purchase Agreement.  The ruling of the Court stated that no fraud on the part of the Company or its principals had been demonstrated.  The Court further ruled that there had been no failure of consideration, and that Melamed’s entry into the Agreement was not a result of a unilateral mistake on the part of Melamed.  The Minutes of the Ruling were entered by the County Clerk on March 17, 2017.

 

Action No. SC 124873-Accounting Phase: 

 

In the Matter, action No. SC 124873, Melamed contended that the Company owed Melamed monies for, among other things, expenses paid by Melamed post-Closing.  An accounting was presented by Melamed’s expert, BDO Seidman (“BDO”), alleging that the Company owed Melamed in excess of $500,000.  The Company disputed this vigorously and prepared a 400+ page analysis (the “Analysis Report”) of the BDO reconciliation report.  The Analysis Report identified errors in the BDO report in excess of $900,000 and found that Melamed owed the Company over $400,000.  Melamed argued the findings in the Analysis Report. Consequently, due to the complexities of the accountings, the Court ordered a third-party adjudicator with an accounting background to review both the BDO report and the Company’s Analysis Report.

 

Draft Ruling: On July 24, 2017, in the Matter, action No. SC124873, the Company was notified that the results of the reconciliation review performed by third-party adjudicator were in favor of the Company in the amount of $412,948.  Melamed objected to the adjudicator’s findings, and a final hearing was held in January 2019.  A final judgment is pending for the Court’s decision on the exact monies owed by Melamed to Parallax.


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Action No. SC125702: 

 

In the Matter, action No. SC125702, Melamed alleges that the Company is in default under the terms of the Purchase Agreement and Secured Note, and the Company’s termination of Melamed’s employment agreement.  The Company firmly believes that it had adequate grounds to justify the termination of the employment, that it acted within its rights, and shall prevail in these proceedings.  A trial date is pending.  In January 2019, Melamed requested mediation and is seeking settlement.

 

Action No. SC 124898:  

 

The Company has initiated legal action against Melamed and filed a complaint, action number SC 124898, in the Superior Court of the State of California, County of Los Angeles, West District, Parallax Health Sciences, Inc., et al. v. Shahla Melamed, et al.  The complaint in that action alleges that Melamed has breached several obligations under the Purchase Agreement, and the Company is seeking to reduce the Secured Note due to undisclosed material changes in the business. A trial date is pending.  In January 2019, Melamed requested mediation and is seeking settlement.

 

As part of the Company’s pleadings to the courts, the Company has presented the following matters:

 

Purchase Price Dispute 

 

Included in the Acquisition Agreement for RoxSan Pharmacy, Inc., and as part of the negotiated purchase price, were representations and warranties made by the former owner involving certain primary revenue streams and related contracts.  Shortly after the closing, however, management discovered that these representations were substantially inaccurate and/or completely false.  These inaccuracies, and the improper disclosures and/or omissions made by the former owner during negotiations, would have significantly affected the purchase price and related note payable.  As a result, among other things, management has initiated legal action against the former owner to seek a reduction in the purchase price.  

 

Included in the false representations made by the former owner were prescription revenues in excess of $8 million (and $16 million prior to the change in ownership) related to workers compensation claims that the former owner warranted as collectible.  The insurance claims related to these prescriptions, which originated from and were provided to the pharmacy by the former owner's direct family members, were investigated by a third-party expert retained by Parallax, and the claims were substantially identified as fraudulent.  The former owner's family member has been indicted by the Department of Justice for among other things, insurance fraud.

 

In addition, management engaged a third-party to perform a valuation of the Pharmacy, utilizing revised inputs that more accurately reflected the Pharmacy's revenue streams as of the date of Acquisition.  The valuation performed resulted in a fair market value of $4.7 to $5.2 million. After careful consideration, and based upon these significant differences, management has determined that the purchase price and related promissory note of $20.5 million does not fairly represent the fair market value at the date of purchase.  We, therefore, applied a discount to the note of $15.3 million, to reduce the purchase price and related note to its estimated fair market value of $5.2 million, utilizing the higher value on the range as a conservative measure.  The discount was amortized over the term of the promissory note.

 

The valuation performed does not include the effects of any liabilities the former owner omitted or damages caused to the Company as a result of the former owner and her immediate family members connected to the Pharmacy.

 

Control of Funds Dispute / US Postal Interference 

 

For a period of time immediately after the closing of the Acquisition, the Melamed would not relinquish control of the Pharmacy's bank accounts, and collected the Pharmacy's incoming cash revenues, refusing to transfer the funds to the new ownership. Furthermore, when the Company attempted to change the corporate records and signatories on the existing bank accounts, the former owner disputed the changes, resulting in approximately $180,000 in corporate funds being frozen and held for adjudication. During this period, the Company was forced to request that the former owner pay the Pharmacy's operating expenses.  At no time after the Company opened new accounts did the former owner cooperate with the transference or willingly relinquish control of the Pharmacy's operating cash flow or incoming cash revenues.

 

The former owner continued to interfere in the transference of control of the Pharmacy by submitting change of address forms to the US Postal Service, wherein the former owner diverted the Pharmacy mail to her home address.  Once this was discovered and rectified with the post office, the former owner filed another change of address to divert mail to a post office box.  During these periods of time, the former owner received check payments and negotiated the checks by opening up a bank account utilizing a DBA, “Roxsan Pharmacy.”  The Company was able to identify some of the checks the former owner negotiated by directly contacting the payer and receiving copies of the cancelled checks, with the former owner's signature endorsement and account number on the check.

 

On May 14, 2018, pursuant to unanimous resolutions of the boards of directors of RoxSan Pharmacy, Inc. and Parallax Health Sciences, Inc., RoxSan filed a Chapter 7 petition in the United States Bankruptcy Court for the Central District of California (the “Court”).  Mr. Timothy Yoo was appointed trustee (“Trustee”) on May 15, 2018.  In connection with this filing, RoxSan seeks to discharge approximately $5 million of liabilities owed to various parties, and intercompany loans in excess of $1 million owed to Parallax.  The Chapter 7 bankruptcy proceeding by RoxSan Pharmacy, Inc. was fully discharged and the case was closed on March 13, 2019, in U.S. Bankruptcy Court, Central District of California.


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Disputes with Former Executives

 

Action No. CV2017-052804 

 

On March 9, 2017, Mr. Dave Engert filed a lawsuit in Arizona and then later changed the venue to Federal Court in Southern California claiming, among other issues, that monies are owed to him under his Consulting Agreement and that his termination was without cause.  On October 23, 2017, the Company filed a response and counterclaims against Mr. Engert for an amount exceeding $100,000.  The counterclaims include possible fraud and negligence committed by Mr. Engert and Mr. J. Michael Redmond, former successor Chairman of Mr. Engert, director, President and Chief Executive Officer of the Company and former President, Chief Executive Officer, Chairman and director of RoxSan Pharmacy, Inc.

 

On October 8, 2018, the Company reached a settlement with Mr. Engert, subject to the release of the bankruptcy Trustee in the RoxSan matter.  On January 22, 2019, the Trustee filed a “No Assets” report with the bankruptcy Court.  The order was released by the court and the settlement agreement is being concluded.

 

Action No. BC700070 

 

On March 28, 2018, Mr. J. Michael Redmond filed a lawsuit against the Company and RoxSan Pharmacy, Inc. in the United States District Court, Central District of California for an amount exceeding $75,000.  The Company intends to vigorously defend against this action. There are counterclaims that include possible fraud and negligence committed by Mr. Redmond, former successor Chairman of Mr. Engert, director, President and Chief Executive Officer of the Company and former President, Chief Executive Officer, Chairman and director of RoxSan Pharmacy, Inc.

 

All five (5) legal matters are currently pending.

 

ITEM 4.MINE SAFETY STANDARDS  

 

Not applicable.


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PART II

 

ITEM 5.MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS  

 

The Company’s Common Stock is quoted on the OTC Markets under the trading symbol PRLX.QB. The following table sets forth the high and low bid prices for the Company’s Common Stock per quarter as reported by the OTCQB for the last two years. These prices represent quotations between dealers without adjustment for retail mark-up, markdown or commission and may not represent actual transactions.

 

Quarter Ended

High

Low

December 31, 2018

$0.11

$0.08

September 30, 2018

$0.13

$0.13

June 30, 2018

$0.21

$0.15

March 31, 2018

$0.24

$0.16

December 31, 2017

$0.11

$0.10

September 30, 2017

$0.24

$0.22

June 30, 2017

$0.21

$0.21

March 31, 2017

$0.24

$0.20

 

The Company’s Common Stock is subject to rules adopted by the Commission regulating broker dealer practices in connection with transactions in “penny stocks.” Those disclosure rules applicable to “penny stocks” require a broker dealer, prior to a transaction in a “penny stock” not otherwise exempt from the rules, to deliver a standardized list disclosure document prepared by the Securities and Exchange Commission. That disclosure document advises an investor that investment in “penny stocks” can be very risky and that the investor’s salesperson or broker is not an impartial advisor but rather paid to sell the shares. The disclosure contains further warnings for the investor to exercise caution in connection with an investment in “penny stocks,” to independently investigate the security, as well as the salesperson with whom the investor is working and to understand the risky nature of an investment in this security. The broker dealer must also provide the customer with certain other information and must make a special written determination that the “penny stock” is a suitable investment for the purchaser and receive the purchaser’s written agreement to the transaction. Further, the rules require that, following the proposed transaction, the broker provide the customer with monthly account statements containing market information about the prices of the securities.

 

Record Holders

 

The Company’s Common Stock is issued in registered form. Action Stock Transfer Corp., 2469 E. Fort Union Blvd., Suite 214, Salt Lake City, UT 84121 (Telephone 801-274-1088, Facsimile 801-274-1099) is the registrar and transfer agent for the Company’s Common Stock.

 

As of December 31, 2018, pursuant to Action Stock Transfer Corp., the Company’s shareholders' list showed 116 registered shareholders and 143,798,141 shares of Common Stock outstanding. The total shares of Common Stock outstanding does not include 14,315,000 shares to be issued, of which 375,000 are in Common Stock awards and purchases, 6,070,000 are debt conversions, 2,370,000 are in connection with debt settlements, and 5,500,000 which were unvested at December 31, 2018.

 

As of December 31, 2018, an aggregate of 1,013,691 shares of the Company’s Preferred Stock were issued and outstanding and are held by 10 shareholders. All 823,691 shares of Series A Preferred Stock and 40,000 shares of Series B Preferred Stock are convertible into the Company’s Common Stock at a conversion rate of 20 shares of Common Stock for each share of Preferred Stock held. Shares of Series C Preferred Stock are convertible into the Company’s Common Stock at a conversion rate of 41.67 shares of Common Stock for each share of Preferred Stock held.  Shares of Series B and Series C Preferred Stock include 50% warrant coverage (see Warrants).

 

Dividends

 

The Company has never declared or paid dividends on its Common Stock, nor does the Company anticipate paying dividends on its Common Stock in the foreseeable future.  Instead, the Company anticipates that all of its earnings, if any, will be used or the operation and growth of its business.  Further, any credit agreement the Company may expect to enter into may restrict its ability to pay dividends or make distributions to its stockholders.  Any future determination to pay dividends will be at the discretion of the Board and will depend on the financial position, results of operations, cash flows, capital requirements, debt covenants, applicable law and other factors as the Board deems relevant.  

 

Dividends are payable semi-annually on the Company’s Series A Preferred Stock at a rate of 7% per annum, 10% per annum on Series B Preferred Stock, and 8% per annum on Series C Preferred Stock.  Dividends may be paid in kind, at the option of Parallax, to the extent that if the Company is not legally permitted to distribute cash dividends, the Company shall pay dividends in the form of shares of Preferred Stock equal to the amount of the dividend. No dividends have been declared on the Company’s Preferred Stock. Dividends in the amount of $362,252, representing cumulative dividends on Parallax’s Preferred Stock, were in arrears as of December 31, 2018.


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Equity Compensation Plan Information

 

In 2015, the Board adopted and approved the 2015 Incentive Compensation Plan (“the 2015 Plan“), wherein ten million (10,000,000) shares of restricted Common Stock were reserved for issuance. The 2015 Plan was intended to assist the Company in securing and retaining key employees, directors and consultants by allowing them to participate in the Company's ownership and growth through the grant of incentive and non-qualified options. The 2015 Plan is currently administered by the Company's Board. Subject to the provisions of the plan, the Board will determine who shall receive options, the number of shares of Common Stock that may be purchased under the options.

 

In 2016, the Board adopted and approved the 2016 Incentive Compensation Plan (“the 2016 Plan“), wherein ten million (10,000,000) shares of restricted Common Stock were reserved for issuance. The 2016 Plan was intended to assist the Company in securing and retaining key employees, directors and consultants by allowing them to participate in the Company's ownership and growth through the grant of incentive and non-qualified options. The 2016 Plan is currently administered by the Company's Board. Subject to the provisions of the plan, the Board will determine who shall receive options, the number of shares of Common Stock that may be purchased under the options.

 

As of December 31, 2018, the Company has granted options to purchase an aggregate of 18,060,000 shares of its Common Stock, net of options exercised, expired and forfeited. In connection with the options granted, a total of $3,051,306 has been recorded as deferred stock option compensation, of which $1,082,970 was expensed in prior years, and $572,870 was expensed in 2018.  There remains $1,395,466 in deferred stock option compensation to be expensed over the next twenty-one (21) months.

 

Warrants

 

In connection with 823,691 shares of Series A Preferred Stock issued and outstanding as of December 31, 2018, the 15,262,491 underlying warrants have expired.

 

In connection with 40,000 shares of Series B Preferred Stock issued and outstanding as of December 31, 2018, the Company issued warrants to purchase 400,000 shares of Common Stock at an exercise price of $0.75 per share for a period of two (2) years.

 

In connection with 150,000 shares of Series C Preferred Stock issued and outstanding as of December 31, 2018, the Company issued warrants to purchase 3,125,000 shares of Common Stock at an exercise price of $0.25 per share for a period of three (3) years.

 

In connection with certain convertible promissory notes issued in 2018, the Company issued warrants to purchase 25,000 shares of Common Stock at an exercise price of $0.25 per share for a period of three (3) years.

 

In connection with certain consulting agreements entered into in 2018, the Company issued warrants to purchase 450,000 shares of Common Stock at an exercise price of $0.25 per share for a period of three (3) years.

 

In connection with certain related party convertible promissory notes issued in 2018, as amended, the Company issued warrants to purchase 1,688,750 shares of Common Stock at an exercise price of $0.10 per share for a period of three (3) years.

 

In connection with certain convertible promissory notes issued in 2018, as amended, the Company issued warrants to purchase 6,000,000 shares of Common Stock at an exercise price of $0.10 for a period of three (3) years.

 

In connection with a certain consulting agreement entered into in 2018, the Company issued warrants to purchase 300,000 shares of Common Stock at an exercise price of $0.001 for a period of five (5) years.

 

In connection with a certain consulting agreement entered into in 2018, the Company issued warrants to purchase 250,000 shares of Common Stock at an exercise price of $0.25 for a period of three (3) years.

 

In connection with certain convertible debentures issued in 2018, the Company issued warrants to purchase 600,000 shares of Common Stock at an exercise price of $0.15 per share for a period of five (5) years.

 

In connection with a certain consulting agreement entered into in 2018, the Company issued warrants to purchase 75,000 shares of Common Stock at an exercise price of $0.01 for a period of two (2) years.

 

In connection with 10,000 shares of Series B Preferred Stock, the 100,000 underlying warrants expired December 2, 2018.

 

As of December 31, 2018, the Company had 19,668,750 warrants issued and outstanding.  The number of shares of Common Stock underlying the warrants and the exercise price are subject to adjustment upon certain events.

 

Purchase of Equity Securities by the Issuer and Affiliated Purchasers

 

The Company did not purchase any shares of its Common Stock or other securities during the year ended December 31, 2018.


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Recent Sales of Unregistered Securities

 

The following represents all unregistered securities issued by the registrant during the current period, including sales of reacquired securities, as well as new issues, securities issued in exchange for property, services, or other securities, and new securities resulting from the modification of outstanding securities:

 

On January 11, 2018, pursuant to a resolution of the Board, the Company issued 6,000,000 shares of its restricted Common Stock to certain officers and directors.  The shares were purchased at par, or $0.001 per share, for  $6,000, of which $1,000 was cash and $5,000 was stock compensation.

 

On January 19, 2018, in connection with an equity offering, the Company issued 1,000,000 shares of its restricted Common Stock at a price of $0.04 per share, for cash in the amount of $40,000.

 

On January 29, 2018, in connection with a certain consulting agreement, the Company issued 250,000 shares of its restricted Common Stock to the consultant for services to be provided over a twelve (12) month period.  The shares were valued at $67,500, of which 25% vest immediately, and the remainder vest periodically over the term of the agreement.  

 

In February 2018, in connection with certain senior secured promissory notes, the Company issued 440,000 shares of its restricted Common Stock to the note holders as a form of interest.  The shares were valued at $44,000, of which $22,211 was expensed, $21,789 was deferred, to be amortized over the term of the notes, and $43,560 was recorded to paid in capital.

 

On April 5, 2018, in connection with a stock purchase agreement, the Company granted a key employee the right to purchase 1,000,000 shares of its restricted Common Stock at a price of $0.001 per share.  The shares, valued at $200,000, were issued for cash in the amount of $1,000.  As a result, $199,000 was recorded to paid in capital.

 

On April 8, 2018, in connection with certain convertible debt in the amount of $45,000 and accrued interest of $3,114, the Company issued 481,130 shares of its restricted Common Stock at a conversion rate of $0.10 per share.

 

In May 2018, in connection with certain senior secured promissory notes, the Company issued 890,000 shares of its restricted Common Stock to the note holders as a form of interest.  The shares were valued at $89,000, of which $62,583 was expensed, $11,417 was deferred, to be amortized over the term of the notes.

 

On June 30, 2018, in connection with the exercise of certain employee stock options, the Company issued 846,051 shares of its restricted Common Stock at a conversion rate of $0.05 per share.  The shares were issued on a cashless basis, resulting in a net value of $269,325.

 

On July 28, 2018, in connection with certain senior secured promissory notes, the Company issued 150,000 shares of its restricted Common Stock to the note holders as a form of interest.  The shares were valued at $15,000.

 

In August 2018, in connection with certain senior secured promissory notes, the Company issued 440,000 shares of its restricted Common Stock to the note holders as a form of interest.  The shares were valued at $44,000.

 

On August 10, 2018, in connection with the Company’s convertible Series C Preferred Stock (“Series C Shares”) equity offering, an accredited investor was issued 20,000 Series C Shares at a price of $5.00 per share, for cash in the amount of $100,000.  

 

On August 11, 2018, in connection with the Company’s Series C Shares equity offering, an accredited investor was issued 40,000 Series C Shares at a price of $5.00 per share, for cash in the amount of $200,000.  

 

On August 12, 2018, in connection with certain convertible debt in the amount of $10,000 and accrued interest of $1,000, the Company issued 110,000 shares of its restricted Common Stock at a conversion rate of $0.10 per share.  

 

On August 13, 2018, in connection with the exercise of certain employee stock options, the Company issued 1,071,430 shares of its restricted Common Stock at a conversion rate of $0.05 per share.  The shares were issued on a cashless basis, resulting in a net value of $187,500.  

 

On August 20, 2018, in connection with certain convertible debt in the amount of $150,000 and accrued interest of $15,000, the Company issued 1,650,000 shares of its restricted Common Stock at a conversion rate of $0.10 per share.  

 

On August 28, 2018, in connection with certain convertible debt in the amount of $20,000 and accrued interest of $2,000, the Company issued 220,000 shares of its restricted Common Stock at a conversion rate of $0.10 per share.  

 

On September 28, 2018, in connection with certain senior secured promissory notes, the Company issued 150,000 shares of its restricted Common Stock to the note holders as a form of interest.  The shares were valued at $15,000.

 

On September 30, 2018, in connection with certain convertible debt in the amount of $50,000, the Company issued 625,000 shares its restricted Common Stock at a conversion rate of $0.08 per share.  As a result, $49,375 was recorded to paid in capital.

 

On September 30, 2018, in connection with the Company’s Series C Shares equity offering, three officers were issued an aggregate of 90,000 Series C Shares at a price of $5.00 per share, in exchange for debt in the principal sum of $450,000.


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On November 1, 2018, in connection with a certain consulting agreement, the Company issued 600,000 shares of its restricted Common Stock to the consultant for services to be provided over a twelve (12) month period.  The shares were valued at $85,500, and vest monthly over the term of the agreement.  

 

As of December 31, 2018, a total of $3,272,500 in deferred stock compensation was recorded, of which $1,028,498 was expensed in prior years, and $1,095,193 was expensed in 2018.  There remains $1,148,809 in deferred stock compensation as of December 31, 2018, to be expensed over the next thirty (30) months.

 

Exemption From Registration. The shares of Common Stock referenced herein were issued in reliance upon an exemption from registration afforded either under Section 4(2) of the Securities Act for transactions by an issuer not involving a public offering, or Regulation D promulgated thereunder, or Regulation S for offers and sales of securities outside the U.S.

 

ITEM 6.SELECTED FINANCIAL DATA  

 

The Company is a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and is not required to provide the information under this item.

 

ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 

 

Forward-Looking Statements

 

This annual report contains forward-looking statements. These statements relate to future events or the future financial performance of Parallax Health Sciences, Inc. (“Parallax” or the “Company”), and include statements made by the Company regarding pharmaceutical insurance reimbursements, state licenses, product development and obtaining FDA clearances. In some cases, forward-looking statements can be identified by terminology such as “may”, “should”, “expects”, “plans”, “anticipates”, “believes”, “estimates”, “predicts”, “potential” or “continue” or negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors” that may cause the Company’s or its industry’s actual results, levels of activity, performance or achievements expressed or implied by these forward-looking statements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results.

 

Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable law, including the securities laws of the United States, the Company does not intend to update any of the forward-looking statements to conform these statements to actual results.

 

Unless otherwise specified, all dollar amounts are expressed in United States Dollars and are prepared in accordance with United States Generally Accepted Accounting Principles. All references to “Common Stock” refer to the common shares; and “Preferred Stock” refer to the preferred shares; of the Company’s capital stock.

 

You should read the following discussion of the Company’s results of operations and financial condition with the consolidated financial statements and related notes included elsewhere in this annual report. The Company intends for this discussion to provide you with information that will assist you in understanding the Company’s financial statements, the changes in certain key items in those financial statements from year to year, and the primary factors that accounted for those changes.

 

NOTE: The following sections of this report and any further reference made to “the Company”, “we”, “us”, “our” and “Parallax “ shall mean Parallax Health Sciences, Inc., and its wholly-owned subsidiaries, Parallax Diagnostics, Inc., Parallax Health Management, Inc., and Parallax Behavioral Health, Inc., unless otherwise indicated. The Company’s former wholly-owned subsidiary, RoxSan Pharmacy, Inc., was derecognized effective May 14, 2018. (See “RoxSan Pharmacy” and “Legal Proceedings” sections contained within this annual report.)

 

Corporate History

 

The Company was incorporated in the State of Nevada on July 6, 2005.  On November 1, 2012, we, formerly Endeavor Power Corporation, and its wholly-owned subsidiary Endeavor Holdings, Inc., a Nevada corporation, entered into an Agreement and Plan of Merger with Parallax Diagnostics, Inc., a Nevada corporation (“Parallax Diagnostics”), whereby Parallax Diagnostics became a wholly-owned subsidiary.  On January 9, 2014, the Company changed its name to Parallax Health Sciences, Inc. (“Parallax”).  (OTCQB.PRLX)

 

The Parallax business was founded on the Company’s point of care diagnostic business, Parallax Diagnostics, Inc., in 2010, when the Company acquired the right, title, and interest, through an exclusive license with Montecito BioSciences, Ltd. (“MBS”), to develop, manufacture and commercialize the Target System, an immunoassay point-of-care diagnostic testing system. Concurrently, through an Assignment Agreement with MBS, the Company acquired the right, title, and interest to twenty-five (25) FDA-cleared tests in the area of infectious disease, medical conditions, drugs of abuse, cardiac and pregnancy, that are designed to be utilized with the Target System.

 

In August 2015, the Company acquired RoxSan Pharmacy, Inc. (“RoxSan” or the “Pharmacy”).  In December 2017, the Pharmacy ceased operations, and in May 2018, RoxSan filed a Chapter 7 bankruptcy petition.  See “Dispute with Former Owner of RoxSan” below.  


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On August 31, 2016, the Company entered into an agreement with Qolpom®, Inc., an Arizona corporation in the remote healthcare monitoring and telehealth business (“Qolpom®”) and its shareholders (the “Seller”) to purchase 100% of the issued and outstanding shares of Qolpom®’s common stock and its assets, inventory and intellectual property.  The agreement was fully executed on September 20, 2016, and the transaction was completed. The consideration for the acquisition resulted in a fair market value of $290,000, and goodwill of $785,060.  In addition, the agreement included contingent royalties and revenue sharing for future revenues generated from the Qolpom® technology. The Qolpom® name was later changed to Parallax Health Management, Inc. (“PHM”).

 

On March 22, 2017, the Company formed Parallax Behavioral Health, Inc. (“PBH”), a Delaware corporation and wholly-owned subsidiary, and on April 26, 2017, completed the asset acquisition of 100% of certain intellectual property (“Intellectual Property”) from ProEventa Inc., a Virginia Corporation (“ProEventa”), in accordance with the Intellectual Property Purchase Agreement between the Company, PBH and ProEventa (the “ProEventa Agreement”). ProEventa has an expertise in the development of behavioral health technologies, and is the wholly-owned subsidiary of Grafton Integrated Health Network, Inc., a non-profit Virginia corporation (“Grafton”). Pursuant to the ProEventa Agreement, the initial consideration for the Intellectual Property was paid to ProEventa in the form of a stock purchase agreement to purchase 2,500,000 shares of the Company’s Common Stock for $2,500, resulting in a net cost for the Intellectual Property of $622,500.  In addition, the Agreement included conditional contingent royalties and revenue sharing for future revenues generated from the Intellectual Property.

 

On September 20, 2018, the Company formed Parallax Communications, Inc, a Delaware corporation and wholly-owned subsidiary of Parallax Health Management, Inc.

 

Changes in Management

 

On April 6, 2017, the Company’s board of directors (the “Board”) elected Mr. J. Michael Redmond as Chairman, to serve until the next annual meeting of the shareholders, in accordance with the Company’s bylaws, and/or until his successor is duly appointed, or a resignation is duly tendered.

 

Effective July 6, 2017, the Board caused the departure of Mr. Redmond from his position as President and Chief Executive Officer of Parallax and RoxSan Pharmacy, Inc.

 

Effective July 7, 2017, pursuant to a unanimous Board resolution, Mr. Paul R. Arena was appointed as the Company’s President and Chief Executive Officer, and the Board caused Mr. Arena's election to the Board and the board of directors of the Company’s wholly-owned subsidiaries, Parallax Health Management, Inc. and Parallax Behavioral Health, Inc.

 

On July 26, 2017, Mr. Jorn Gorlach resigned as a member of the Board.  This resignation did not involve any disagreements with us.

 

On June 4, 2018, Mr. Anand Kumar resigned as a member of the Board.  This resignation did not involve any disagreement with the Company.  Mr. Nathaniel T. Bradley, currently serving as Chief Technology Officer, succeeded him; and agreed to serve as a member of the Board until the next annual meeting of the shareholders and/or until his successor is duly appointed.

 

Dispute with Former Owner of RoxSan

 

On August 13, 2015, the Company completed the acquisition of RoxSan Pharmacy, Inc. (“RoxSan” or the “Pharmacy”).  Shortly thereafter, the Company's management and the former owner (“Former Owner” or “Melamed”) clashed over control of the RoxSan Pharmacy business operations and bank accounts.

 

Purchase Price Dispute 

Included in the acquisition agreement, and as part of the negotiated purchase price, were representations and warranties made by the Former Owner involving certain primary revenue streams and related contracts.  Shortly after the closing, however, management discovered that these representations were substantially inaccurate and/or completely false.  These inaccuracies, and the improper disclosures and/or omissions made by the Former Owner during negotiations, would have significantly affected the purchase price and related note payable.  As a result, among other things, management has initiated legal action against the Former Owner to seek a reduction in the purchase price.

 

In addition, management engaged a third-party to perform a valuation of the pharmacy, utilizing revised inputs that more accurately reflected the Pharmacy's revenue streams as of the date of acquisition.  The valuation performed resulted in a fair market value of $4.7 to $5.2 million. After careful consideration, and based upon these significant differences, management determined that the purchase price and related promissory note of $20.5 million did not fairly represent the fair market value at the date of purchase.  The Company, therefore, applied a discount to the note of $15.3 million, to reduce the purchase price and related note to its estimated fair market value of $5.2 million, utilizing the higher value on the range of as a conservative measure. The discount was amortized over thirty-six months.

 

The valuation performed does not include the effects of any liabilities the Former Owner omitted or damages caused to the Company as a result of the Former Owner and her immediate family members connected to the Pharmacy.


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Control of Funds Dispute / US Postal Service Interference 

For a period of time immediately after the closing of the acquisition, the Former Owner would not relinquish control of the Pharmacy's bank accounts, and collected the Pharmacy's incoming cash revenues, refusing to transfer the funds to the new ownership. Furthermore, when the Company attempted to change the corporate records and signatories on the existing bank accounts, the Former Owner disputed the changes, resulting in approximately $180,000 in corporate funds being frozen and held for adjudication. During this period, the Company was forced to request that the Former Owner pay the Pharmacy's operating expenses.  At no time after the Company opened new accounts did the Former Owner cooperate with the transference or willingly relinquish control of the Pharmacy's operating cash flow or incoming cash revenues.

 

The Former Owner continued to interfere in the transference of control of the Pharmacy by submitting change of address forms to the US Postal Service, wherein the Former Owner diverted the Pharmacy mail to her home address.  Once this was discovered and rectified with the post office, the Former Owner filed another change of address to divert mail to a post office box.  During these periods of time, the Former Owner received check payments and negotiated the checks by opening up a bank account utilizing a DBA, "Roxsan Pharmacy."  The Company was able to identify some of the checks the Former Owner negotiated by directly contacting the payer and receiving copies of the cancelled checks, with the Former Owner's signature endorsement and account number on the check.

 

As a result, an extensive reconciliation was performed to determine what amounts were collected and paid by the Former Owner, and what amounts were due to the Company.  The reconciliation resulted in over $412,000 owed to the Company from the Former Owner.  The reconciliation and underlying documentation went under judicial review, and on July 24, 2017 the Company was notified that the results of the review were in favor of the Company in the amount of $412,948.  A final judgment is pending for the exact amount of monies owed to the Company from the Former Owner.

 

Faced with Melamed continuing to materially interfere with the Pharmacy’s operations to the detriment of its business, the Company retained the services of an employment law firm to investigate Melamed's actions and provide a report to the Company’s Board (the "Report").  The Company also placed Melamed on a paid leave of absence because of her actions. The Board, after reviewing the findings in the Report, found substantive cause for Melamed's termination, and immediately sent Melamed written notification of the Company's intent to dismiss her for cause.  Under the Employment Agreement, Melamed was provided with a thirty (30) day cure period.  However, the Company received no response of intent to cure from Melamed or her counsel, and no evidence of a cure was provided to the Company.  As a result, the Board authorized Melamed's termination for cause on March 3, 2016, and on March 6, 2016, Melamed was formally terminated in writing.

 

In the course of management’s operation of the RoxSan Pharmacy, and adherence to Financial Accounting Standards Board revenue recognition policies, management became concerned with the absence of the claim processing for over $16 million of pre-Close Workers Compensation prescription revenues, which Melamed represented to the Company prior to Closing as being the vast majority of the high margin compound revenue. In addition to the $16 million in pre-Close claims, the Pharmacy generated over $8 million after the change in ownership, until the CFO alerted management of a serious and dramatic change in the receivables collection timetable, the underpinning cash flow processes, and the potential illegitimacy of the Workers Compensation revenues. Further, the CFO was uncomfortable with recognizing the revenue as it was presented by Melamed's financial records, and, in the absence of any reasonable assurance of collectability of the Workers Compensation revenues, the Company established an allowance for doubtful receivables for the $8 million in post-Close claims for which collectability was highly unlikely.

 

The Company retained the services of a forensic Workers Compensation fraud specialist to determine the legitimacy of the pre-Close Workers Compensation revenues and related insurance claims.  As a result of this forensic review, it was determined that these claims were essentially valueless.  As a result of these findings and undisclosed changes to the cash flow and quality of earnings that represented a majority of the revenue of the Pharmacy, the Company’s Board deemed it necessary to demand a reduction in the terms of the Sale and Purchase Agreement to more accurately reflect the true valuation of RoxSan.  This was met with resistance on the part of the Seller.

 

Shortly thereafter, in October 2015, Melamed, initiated two (2) legal actions against the Company in the Superior Court of the State of California, County of Los Angeles, West District, Shahla Melamed v. Parallax Health Sciences, Inc., action numbers SC 124873 and SC 125702.

 

In the matter, action No. SC 124873, Melamed sought rescission of the August 13, 2015 Purchase Agreement. During the proceedings, Melamed also contended that the Company owed Melamed monies for, among other things, expenses paid by Melamed on behalf of the Company.  As a result, the Court split the action into two separate rulings: (1) Rescission Phase and (2) Accounting Phase.

 

Rescission Phase  -  Final Ruling:  On March 17, 2017, the Court ruled in favor of the Company, and issued that Melamed is not entitled to rescission of the Purchase Agreement.  The ruling of the Court stated that no fraud on the part of the Company or its principals had been demonstrated.  The Court further ruled that there had been no failure of consideration, and that Melamed’s entry into the Agreement was not a result of a unilateral mistake on the part of Melamed.  The Minutes of the Ruling were entered by the County Clerk on March 17, 2017. 

 

Accounting Phase  -  Draft Ruling: On July 24, 2017, in the Matter, action No. SC124873, the Company was notified that the results of the reconciliation review performed by third-party adjudicator were in favor of the Company in the amount of $412,948.  Melamed objected to the adjudicator’s findings, and a final hearing was held in January 2018.  A final judgment is pending for the Court’s decision on the exact monies owed by Melamed to the Company. 


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In the Matter, action No. SC125702, Melamed alleges that the Company is in default under the terms of the Purchase Agreement and Secured Note and the Company’s termination of Melamed’s employment agreement.  The Company firmly believes that it had adequate grounds to justify the termination of the employment, that it acted within its rights, and shall prevail in these proceedings.

 

The Company has initiated legal action against Melamed and filed a complaint, action number SC 124898, in the Superior Court of the State of California, County of Los Angeles, West District, Parallax Health Sciences, Inc., et al. v. Shahla Melamed, et al.  The Complaint in that action alleges that Melamed has breached several obligations under the Purchase Agreement, and the Company is seeking to reduce the Secured Note due to undisclosed material changes in the business.

 

On May 14, 2018, pursuant to unanimous resolutions of the boards of directors of RoxSan Pharmacy, Inc. and Parallax Health Sciences, Inc., RoxSan filed a Chapter 7 petition in the United States Bankruptcy Court for the Central District of California (the “Court”).  Mr. Timothy Yoo was appointed trustee (“Trustee”) on May 15, 2018.  In connection with this filing, RoxSan seeks to discharge approximately $5 million of liabilities owed to various parties, and intercompany loans in excess of $1 million owed to Parallax.  The Chapter 7 bankruptcy proceeding by RoxSan Pharmacy, Inc. was fully discharged and the case was closed on March 13, 2019, in U.S. Bankruptcy Court, Central District of California.

 

Due to, among other things, the reduction in RoxSan’s cash flows during 2016 and 2017, RoxSan became delinquent in its payroll tax depository obligations, resulting in a liability owed to federal and state taxing agencies in the aggregate of $1,148,811, which includes $601,148 in taxes withheld from employees (“Trust Fund Taxes”), employer taxes of $183,172, and penalties and interest of $364,491 through December 31, 2018. The liability was included as part of the Chapter 7 bankruptcy petition, and certain portions of the liability may be discharged.  However, in accordance with California bankruptcy laws, federal and state Trust Fund Taxes are not dischargeable.  The Company has retained a tax resolution specialist and is in communications with the taxing agencies in order to resolve RoxSan’s liability.

 

As a result of the loss of financial control of RoxSan, the Company derecognized the subsidiary as of September 30, 2018. The derecognition resulted in a gain of $4,478,268. The Company also extinguished $22,778,281 in debt and accrued interest related to the acquisition of RoxSan.

 

Disputes with Former Executives

 

On March 9, 2017, Mr. Dave Engert filed a lawsuit in Arizona and then on or about May 5, 2017, Mr. Engert, changed the venue and filed suit against the Company and RoxSan Pharmacy, Inc. in the United States District Court, Central District of California for an amount exceeding $75,000.  The Company filed an answer and counterclaims against Mr. Engert for an amount exceeding $100,000.  The counterclaims included possible fraud and negligence committed by Mr. Engert and Mr. J. Michael Redmond, former successor Chairman of Mr. Engert, director, President and Chief Executive Officer of the Company and former President, Chief Executive Officer, Chairman and director of RoxSan Pharmacy, Inc.  On October 8, 2018, the Company reached a settlement with Mr. Engert (the “Engert Settlement”), subject to the release of the bankruptcy trustee in the RoxSan bankruptcy matter.  On January 22, 2019, the Trustee filed a “No Assets” report with the Court.  The order was released by the court and the settlement agreement is being concluded.

 

On March 28, 2018, Mr. J. Michael Redmond filed a lawsuit against the Company and RoxSan Pharmacy, Inc. in the United States District Court, Central District of California for an amount exceeding $75,000.  The Company intends to vigorously defend against this action. There are counterclaims that include possible fraud and negligence committed by Mr. Redmond, former successor Chairman of Mr. Engert, director, President and Chief Executive Officer of the Company and former President, Chief Executive Officer, Chairman and director of RoxSan Pharmacy, Inc.

 

For additional information on these proceedings, see “ITEM 3. LEGAL PROCEEDINGS“ section contained within this annual report.

 

Extinguishment of Debt

 

As a result of the loss of financial control and derecognition of the subsidiary, RoxSan Pharmacy, Inc., the Company extinguished $22,778,281 in debt and accrued interest related to the acquisition of RoxSan.

 

In addition, management determined that there is no future sacrifice of economic benefit arising from certain debt previously recognized by the Company to transfer assets or provide services in the future.  As a result, certain notes and loans payable in the amount of $95,975, accrued interest in the amount of $56,892, and accounts payable in the amount of $284,714, has been extinguished as of December 31, 2018.


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Description of Business  

 

Parallax Health Sciences, Inc. is an innovative digital healthcare company headquartered in Santa Monica, California. The Company’s principal focus is to build and expand an integrated digital healthcare network with products and services that can provide remote communication, diagnosis, treatment, and monitoring of patients on a single proprietary platform. The Parallax Care system provides scalable connected products, services and actionable data integrated on a single interoperable platform.  The Company’s principal mission is to deliver solutions that empower patients, reduce costs and improve the quality of care through patented leading-edge technologies.

 

The Company has developed, acquired and licensed multiple platforms, proprietary and exclusive, that provide services and products across the healthcare continuum.  These platforms are designed to allow for multiple points of reciprocal consideration through innovative business models that provide patients with increased quality of services and products at reduced cost of time and money.  They also provide healthcare providers with increased access to their patients, the ability to deliver better and more efficient service and increase their income from the services they supply.

 

The Company believes that the Parallax Care products and services can provide solutions that mitigate rising costs, reduce waste in spending and the amount of unnecessary services, and increase the health and wellness of patients.  The Company’s endeavors to change the healthcare industry are strengthened by providing solutions to real problems facing healthcare stakeholders today.  The Company’s products and services have been developed, and are continuing to be developed, to address these issues now.

 

The Parallax Care technology-enabled digital healthcare system is structured with three separate divisions that can operate independently of one another, or integrate services to meet the various needs of the Company’s clientele: Optimized Outcomes, Connected Health and Smart Data.  Each of these divisions target a separate vertical market that are synergistic, compliment, and strengthen each other and the  Company value proposition as a whole.

 

Optimized Outcomes 

 

The Company’s REBOOT technology, an acronym for “Reliable Evidence-Based Outcome Optimization Technology,” is at the heart of the Company’s behavioral technology provides reliable evidence-based outcome optimization through a patented machine learning platform.  REBOOT has been specifically designed to improve health treatment outcomes through internet-based and mobile behavioral technology systems that enable its users and user groups to more effectively achieve goals within a prescribed timeline, with the potential to transform the cost of treating and managing chronic illnesses such as pulmonary-COPD-asthma, diabetes, and cardiovascular disease by effecting the modification of behavior in patients being treated for these chronic diseases.  The REBOOT technology, developed and commercially tested for over 5 years at a cost exceeding $4,000,000, provides reliable evidence-based outcome optimization through a patented machine learning platform delivered through:

 

A cloud-based software system, scalable for use from one patient to over 100 million; 

A mobile application, COMPASS, that is interchangeable from one disease to another, and one patient to another; and 

A stratification tool, WIZARD, which was developed specifically to support scalability of the REBOOT/ COMPASS platform.   

 

REBOOT can be sold as a product line into certain defined verticals, independent of, or in combination with, the Company’s connected healthcare and data platforms, products and services.  The REBOOT technology is currently protected by patents issued in U.S., China, India, and Hong Kong and Macao.

 

Connected Health 

Fotodigm®

Fotodigm® is the Company’s patent-pending, integrated, interoperable, cloud-based platform, that allows for ease of use of the Company’s proprietary products and services and third-party Plug-n-Play interfaces. Designed with increased accessibility and accelerated adoption in mind, Fotodigm® enables patients and doctors to use a singular, integrated, interoperable platform for:

 

Telehealth;  

Remote Patient Monitoring (“RPM”); 

Point-of-Care (“POC”) testing; 

Healthcare education services.  

 

Fotodigm® provides simple, cost-effective, accessible and affordable products and services that deliver industry breakthrough advantages.  The Fotodigm® construct was developed to provide payers, patients and providers with the ability to choose and interchange their services, and be able to interchange where the healthcare practitioner deems it the best course of action.

 

The Target System 

The Target System is the Company’s proprietary diagnostic immunoassay testing platform and test cartridges designed for twenty-five specific FDA-cleared tests in areas of infectious diseases, cardiac markers, drugs of abuse and various other medical conditions. The Target System is comprised of:

 

the VT-1000, an FDA-cleared, clinically and commercially proven bench-top quantitative and qualitative immunoassay testing system specifically designed to reside in the primary care physician office; 

the SPARKS Mobile, a patented (US, China, India, Hong Kong and Macao) mobile testing system that incorporates the VT-1000 feature set with smartphone capabilities (to be completed before commercialization, includes design and build, then certification); 

25 FDA-cleared rapid tests in the areas of: 

Cardiac;  

Infectious diseases;  

Medical conditions;  

Drugs of abuse;  

Pregnancy. 

 

The Target System has the capacity to test hundreds of conditions, and is to be offered to doctors for use at the doctors’ offices and at patients’ homes.

 

Smart Data 

Parallax’s Intrinsic Code is the Company’s unique Smart Data patient data collection and repository system.  Intrinsic Code not only identifies the traditional data from patients, but is also designed to provide actionable insights into the behavioral changes in patients, which has resulted in increased adherence to their medical regimens and pharmacologic therapies.  These insights are extremely valuable to pharmaceutical companies, as medication nonadherence creates false efficacy results of therapies in the manner in which they were designed, tested and provided regulatory approval upon. Payers are deeply concerned with the data on adherence to medical and medication therapy regimens, as it directly affects their financial performance.


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Management

 

Parallax is led by experienced veterans from the healthcare, technology, finance and management fields.  The Company's disciplined and organized approach is balanced by its optimism for the future, and the opportunities present in the current healthcare market. The Parallax team is grounded in a belief that success in business is built on a combination of research, planning and execution.

 

Operating Segments

 

The Company’s current operations include the following business segments for financial statement presentation: Remote Patient Monitoring (RPM), Behavioral Health Services (BHS), and Corporate.

 

Remote Patient Monitoring  

 

Parallax has developed a distinctive technology platform that provides for the complete remote patient care delivery system: the patent-pending Fotodigm® platform, which utilizes proprietary software and technology to bridge clinical behavioral science with technology and logistics for payers, providers and clinical professionals across a variety of wellness and clinical devices, including both fitness and clinical applications. Fotodigm® is a secure and scalable platform for collecting, transmitting and analyzing biometric, pharmaceutical, and health data to healthcare providers, primarily hospitals, accredited nursing operations, and physicians using optical character recognition, otherwise known as “Machine Face Recognition” technology that is licensed from others.

 

The RPM segment generates revenues through fees charged for the license and utilization of its proprietary system that provides software integrations of the Fotodigm® platform.  Additionally, the RPM segment generates incremental revenues through the delivery of acute, post-acute and chronic health patient management software systems that enable Parallax customers to bill for and collect payments from patients and third-party payers for telemonitoring and remote services that they deliver.

 

Behavioral Health Services 

 

In April 2017, the Behavioral Health Services segment commenced with the acquisition of the REBOOT and Intrinsic Code technologies. The BHS segment will generate revenues primarily through licensing and subscription of software and systems. As of December 31, 2018, the BHS segment had not yet begun full operations, generating limited test market sales.

 

Diagnostics/Corporate  

 

The Diagnostics/Corporate Segment supports the costs and operating expenses related to the continued development and exploitation of the Company’s proprietary Target System POS medical diagnostic and monitoring platform and processes.  In addition, the Diagnostics/Corporate Segment provides management and administrative services to support the Company and consists of certain aspects of the Company’s executive management, corporate relations, legal, compliance, human resources, and corporate information technology and finance departments.  

 

The following summary of the Company’s financial condition and results of operations should be read in conjunction with the Company’s audited consolidated financial statements for the years ended December 31, 2018 and 2017, which are included herein. The financial information of Parallax Health Sciences, Inc., and its wholly-owned subsidiaries, Parallax Diagnostics, Inc., Parallax Health Management, Inc., and Parallax Behavioral Health, Inc., is provided below on a consolidated basis, unless otherwise indicated. All significant intercompany accounts and transactions have been eliminated.

 

Balance Sheet

 

As of December 31, 2018, the Company had total assets of $1,364,357 compared with total assets of $1,752,036 at December 31, 2017. The decrease in total assets of $387,679 is attributable to an increase in cash of $79, a decrease in accounts receivable, net of allowance for doubtful accounts, of $3,275, a decrease in current assets held for sale of $51,961, a decrease in intangible assets of $10,000, $120,620 of amortization related to intangible assets, and a decrease in noncurrent assets held for sale of $201,902.

 

As of December 31, 2018, the Company had total liabilities of $7,345,916 compared with total liabilities of $28,930,119 at December 31, 2017. The decrease in total liabilities of $21,584,203 is attributable to a decrease in accounts payable and accrued expenses of $393,210, an increase in short-term debentures of $755,627, an increase in related party short-term debentures of $428,132, a decrease in convertible notes payable of $445,000, an increase in related party payables of $375,153, a decrease in license fees payable of $460,000, an increase in royalties payable of $110,000, an increase in long-term debentures, net of unamortized discount, of $226,050, a decrease in unsecured notes payable of $95,975, a decrease in related party convertible notes payable of $100,000, repayments of secured notes payable of $9,245, a decrease in unamortized discount of $3,145,000, a decrease in long-term secured promissory notes of $20,500,000, and a decrease in liabilities subject to compromise of $4,620,735.


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Results of Operations

 

The year ended December 31, 2018, compared to the year ended December 31, 2017

 

 

For the year ended

 

 

December 31, 2018

 

December 31, 2017

 

Revenue

$

11,739

 

$

94,937

 

Cost of sales

$

20,339

 

$

142,044

 

Gross profit (loss)

$

(8,600

)

$

(47,107

)

General and administrative expenses

$

6,552,693

 

$

3,997,512

 

Operating loss

$

(6,561,293

)

$

(4,044,619

)

Gain on disposal of subsidiary

$

4,478,268

 

$

––

 

Gain on extinguishment of debt

$

23,215,862

 

$

––

 

Discount amortization

$

(2,806,050

)

$

(5,450,000

)

Interest expense, net of income

$

(1,213,069

)

$

(1,016,773

)

Net income (loss) – continuing operations

$

17,113,718

 

$

(10,511,392

)

Net income (loss) – discontinued operations

$

(824,398

)

$

(3,153,553

)

Net income (loss)

$

16,289,320

 

$

(13,664,945

)

 

Revenue

 

Revenue in the amount of $11,739 for the year ended December 31, 2018, consists contract fees and equipment sales related to the Company’s remote health care systems in the amount of $9,939, and subscription fees related to the Company’s behavioral health services in the amount of $1,800.

 

Revenue in the amount of $94,937 for the year ended December 31, 2017, consists of contract fees and equipment sales related to the Company’s remote health care systems in the amount of $93,737, and subscription fees related to the Company’s behavioral health services in the amount of $1,200.

 

The Company’s behavioral health services segment had not yet begun full operations, generating limited test market sales.  The Company has not yet fully launched the medical diagnostics and testing activities of the Company’s Connected Health division.

 

Cost of sales

 

Costs of sales in the amount of $20,339 for the year ended December 31, 2018, consists of equipment and other costs related to the Company’s remote health care systems.

 

Costs of sales in the amount of $142,044 for the year ended December 31, 2017, consists of equipment and other costs related to the Company’s remote health care systems.

 

The Company’s behavioral health services segment had not yet begun full operations, generating limited test market sales.  The Company has not yet fully launched the medical diagnostics and testing activities of the Company’s Connected Health division.

 

General and Administrative Expenses

 

 

For the year ended

 

 

 

 

December 31, 2018

 

December 31, 2017

 

Variances

 

Legal, accounting, and management services

$

2,279,281

 

$

741,553

 

$

1,537,728

 

Stock compensation/stock option amortization

 

3,440,340

 

 

2,473,508

 

 

966,832

 

Salaries, taxes and benefits

 

360,226

 

 

619,574

 

 

(259,348

)

Depreciation and amortization

 

120,620

 

 

83,739

 

 

36,881

 

Rent expense-office

 

73,351

 

 

8,148

 

 

65,203

 

Travel, meals and entertainment

 

50,767

 

 

23,900

 

 

26,867

 

Office supplies and miscellaneous expenses

 

228,108

 

 

47,090

 

 

181,018

 

Total general and administrative expenses

$

6,552,693

 

$

3,997,512

 

$

2,555,181

 


Table of Contents

- 41 -



 

General and administrative expenses in the amount of $6,552,693 for the year ended December 31, 2018, were comprised of $2,279,281 in legal, accounting and management fees, $3,440,340 in stock compensation/stock option amortization, $360,226 in salaries and related taxes and benefits, $120,620 in depreciation and amortization, $73,351 in rent expense, $50,767 in travel, meals and entertainment, and $228,108 of office overhead and other general and administrative expenses.

 

General and administrative expenses in the amount of $3,997,512 for the year ended December 31, 2017, were comprised of $741,553 in legal, accounting and management fees, $2,473,508 in stock compensation/stock option amortization, $619,574 in salaries and related taxes and benefits, $83,739 in depreciation and amortization, $8,148 in rent expense, $23,900 in travel, meals and entertainment, and $47,090 of office overhead and other general and administrative expenses.

 

General and administrative expenses for the year ended December 31, 2018, were $6,552,693 as compared to $3,997,512 for the year ended December 31, 2017, which resulted in an increase in general and administrative expenses for the current year of $2,555,181.

 

Significant changes in general and administrative expenses of $2,555,181 during the year 2018 compared to 2017 were attributable to the following items:

 

an increase in legal, accounting and consulting services of $1,537,728, primarily due to an increase in legal costs of $480,598 resulting from pending litigation and other matters requiring legal counsel; an increase from the establishment of a $250,000 reserve for anticipated future legal costs related to pending litigation; an increase of $112,441 resulting from consultants retained for litigation and valuation purposes in the current year, compared to no such expense in the prior year; a decrease in accounting and audit fees of $164,786 due to a change in auditors in the prior year, resulting in 2016 and 2017 audit fees charged by the newly engaged audit firm in the prior year, compared to only 2018 fees charged in the current year; an increase management consulting fees of $824,225 resulting from changes in management; and an increase in miscellaneous management fees of $35,250; and 

an increase in stock compensation/stock option amortization of $966,832, primarily due to an increase in stock awards, resulting in an increase in stock compensation of $926,944; an increase in deferred compensation for stock awards, resulting in an increase in stock award amortization expense of $42,863; the issuance of additional stock options, resulting in an increase in stock option amortization of $356,122; and fully amortized stock options, resulting in a decrease in stock option amortization of $359,097; and  

a decrease in salaries and fees, and related taxes and benefits of $259,348 primarily due to a decrease in compensation of $18,798, and employee benefits of $73,715, resulting from a decrease in staff; a decrease in payroll tax expense of $131,335 resulting from a reduction in accrued compensation and related payroll taxes; and a decrease in miscellaneous fees for outside services in the amount of $35,500; and 

an increase in depreciation and amortization of $36,881, primarily due to  the acquisition of additional intangible assets in the prior year, resulting in partial year amortization expense in the prior year compared to a full year amortization in the current year; and 

an increase in rent expense for office space of $65,203, due to vacating certain temporary office space and the reallocation of primary office space; and 

an increase in travel, meals and entertainment of $26,867, primarily due to an increase in travel costs of $5,209; a one-time relocation cost incurred in the current year of $20,000, and an increase in meals and entertainment of $1,658; and  

an increase in office supplies and miscellaneous expenses of $181,018, due to an increase in automobile expense of $40,371, computer and internet costs of $9,814, transfer agent fees of $10,935, patent and product development costs of $73,896, storage and moving of $31,343, communication costs of $10,712, and other general office and administrative expenses of $3,947. 

General and administrative expenses for both 2018 and 2017 were incurred for the purpose of advancing the Company closer to its financing and operating goals in the bio-medical and digital healthcare sectors.

 

Net Loss

 

During the year ended December 31, 2018, the Company generated net income from continuing operations of $17,113,718, compared with a net loss from continuing operations of $10,511,392 for the year ended December 31, 2017. The increase in net income of $27,625,110 is attributable to an increase in gross profits of $38,507, an increase in general and administrative expenses of $2,555,181, an increase from the gain on disposal of subsidiary of $4,478,268, an increase from the gain on extinguishment of debt of $23,215,862, a decrease in discount amortization of $2,643,950, and an increase in interest expense of $196,296.

 

Liquidity and Capital Resources

 

Working Capital

 

 

Increase

 

 

December 31, 2018

 

December 31, 2017

 

(Decrease)

 

Current assets

$

262

 

$

55,419

 

$

(55,157

)

Current liabilities

 

5,139,617

 

 

4,418,915

 

 

720,702

 

Working capital (deficit)

$

(5,139,355

)

$

(4,363,496

)

$

(775,859

)


- 42 -



 

As of December 31, 2018, the Company had cash in the amount of $262 compared to $183 as of December 31, 2017.

 

The Company had a working capital deficit of $5,139,355 as of December 31, 2018, compared to a working capital deficit of $4,363,496 at December 31, 2017. The increase in working capital deficit of $775,859 is primarily attributable to an increase in cash of $79; decreases in accounts receivable of $3,275, and current assets held for sale of $51,961; increases in short-term debentures of $755,627, related party short-term debentures of $428,132, and related party payable of $375,153; and decreases in accounts payable and accrued expenses of $393,210 and convertible notes payable of $445,000.

 

Cash Flows

For the year ended

 

Increase

 

 

December 31, 2018

 

December 31, 2017

 

(Decrease)

 

Net cash used by operating activities

$

(1,291,984

)

$

(1,351,195

)

$

59,211

 

Net cash used by investing activities

 

––

 

 

––

 

 

––

 

Net cash provided by financing activities

 

1,332,005

 

 

1,392,500

 

 

(60,495

)

Net cash provided (used) by continuing operations

$

40,021

 

$

41,305

 

$

(1,284

)

Net cash provided (used) by discontinued operations

 

(39,942

)

 

(51,302

)

 

11,090

 

Net increase (decrease) in cash

$

79

 

$

(9,727

)

$

9,806

 

 

During the year ended December 31, 2018, the Company used $1,291,984 of cash flow for operating activities of continuing operations, compared with $1,351,195 for the year ended December 31, 2017. The decrease in cash used by operating activities of $59,211 is primarily attributable to an increase in net income from operations of $28,226,258; increases in depreciation and amortization of $36,881, and stock compensation/stock option amortization of $966,830; decreases in discount amortization of $2,643,950, and allowance for bad debt of $3,764; decreases resulting from the gain on disposal of subsidiary of $4,478,268, and the gain on extinguishment of debt of $23,215,862; an increase in the changes in accounts receivable of $4,271, accounts payable and accrued expenses of $405,514, and related party payables of $1,365,139; and a decrease in the changes in prepaid expenses of $2,690.

 

Cash Flows from Investing Activities

 

During the years ended December 31, 2018 and 2017, the Company used no cash flow for investing activities.

 

Cash Flows from Financing Activities

 

During the year ended December 31, 2018, the Company was provided with $1,332,005 in cash flows from financing activities of continuing operations, compared to $1,392,500 during the year ended December 31, 2017. The decrease in cash flows provided by financing activities of $60,495 is attributable to an increase in repayments of notes payable of $9,245, and an increase in proceeds from convertible notes payable of $84,000, repayment of convertible notes payable of $50,000, proceeds from the issuance of debentures of $225,000, proceeds from the issuance of preferred shares of $150,000, and a decrease in the proceeds from the issuance of Common Stock of $160,250, of which $2,500 was in connection with the acquisition of certain intangible assets.

 

As of December 31, 2018, related parties are due a total of $1,923,952, consisting of $869,859 in accrued compensation owed to officers; $134,861 in cash advances from officers and beneficial owners to the Company for operating expenses; $428,132 in convertible debentures; and $491,100 in related party convertible notes payable.

 

The Company has issued a convertible promissory note to a related party in the aggregate sum of $491,100, representing cash loans and unpaid compensation.  The note bears interest at a rate of 7% per annum, matures December 31, 2023, and contains a repayment provision to convert the debt into restricted shares of the Company’s Common Stock at a conversion rate of $0.10 per share.  During the year ended December 31, 2018, interest in the amount of $20,378 was expensed, of which $798 was paid to the note holders in cash.  As of December 31, 2018, a total of $74,060 in interest remains accrued.

 

The Company converted related party convertible promissory notes in the aggregate principal of $337,750 and related accrued interest of $128,132, into convertible debentures in the aggregate principal of $428,132.  The convertible debentures bear interest at a rate of 10% per annum, mature February 29, 2019, and are convertible into  restricted shares of the Company’s Common Stock at a conversion rate of $0.12 per share.  During the year ended December 31, 2018, interest in on the convertible promissory notes the amount of $102,755 was expensed.  As of December 31, 2018, no accrued interest remains.

 

The Company’s principal sources of funds have been from the Company’s sales of its Preferred and Common Stock, and loans from related parties and third-party lenders.

 

Future Financings

 

The Company has suffered recurring losses from operations. The continuation of the Company’s operations is dependent upon the Company’s attaining and maintaining profitable operations and raising additional capital as needed. The Company anticipates that it will have to raise additional funds through private placements of the Company’s equity securities and/or debt financing to complete its business plan.


Table of Contents

- 43 -



The Company will require additional financing in order to proceed with its plan of operations, including approximately $3,000,000 over the next 12 months to pay for its ongoing expenses. These cash requirements include working capital, general and administrative expenses, the development of the Company’s product line, and the pursuit of acquisitions. These cash requirements are in excess of the Company’s current cash and working capital resources. Accordingly, the Company will require additional financing in order to continue operations and to repay its liabilities. There is no assurance that the financing will be completed as planned or at all. If the Company is unable to secure adequate capital to continue the Company’s planned operations, the Company’s shareholders may lose some or all of their investment and the Company’s business may fail.

 

In August 2018, the Company established a private placement equity offering for the purchase of Series C convertible Preferred Stock (the “Series C Shares”).  The offering provides for, among other thing, the purchase of Series C Shares at a price of $5.00 per share, with a minimum unit of 20,000 shares, or $100,000.  All Series C Shares are convertible into Common Stock at a conversion rate of $0.12 per share, or a ratio of 41.67 shares of Common Stock for each Series C Share held (41.67:1) (“Conversion Ratio”) if converted within one (1) year, or a lesser Conversion Ratio after one year.  The Company issued $750,000 of Series C Preferred to various accredited investors; including three persons who are officers and directors of the Company that converted deferred compensation in the aggregate of $450,000. The issuances also included warrants to purchase Common Stock for a period of 3 years at an exercise price of $0.25 per share, the number of warrants of which is determined at 50% of the prevailing Conversion Ratio. The Series C offering is closed to further investors.

 

In November 2018, the Company converted non-related party convertible promissory notes in the aggregate principal of $600,000, and related accrued interest of $155,627, into convertible debentures (“Debentures”) in the aggregate principal of $755,627. The Debentures bear an interest rate of 10% per annum, mature February 28, 2019, and are convertible into restricted shares of the Company’s Common Stock at a conversion rate of $0.12 per share. During the year ended December 31, 2018, interest on the convertible promissory notes in the amount of $155,627 was expensed.  As of December 31, 2018, no accrued interest remains.

 

In November 2018, the Company also issued $250,000 in debentures at a discount of 10%, for $225,000 cash.  The debentures bear an interest rate of 10% per annum, mature November 14, 2021, and are convertible into restricted shares of the Company’s Common Stock at a conversion rate of $0.12 per share.

 

On or about March 29, 2019, the Company established a private placement equity offering (the “Offering”) for the purchase of 49,000,000 shares, or a maximum of $6,000,000, in Common Stock, plus equal Warrants at an exercise price of $0.25 per share for a term of three (3) years (the Common Stock and the Warrants together, the “Units”).  The Offering provides for, among other thing, the purchase of the Units at a price of $0.125 per share, with a minimum total Offering of $1,250,000, and a minimum investment of 200,000 shares, or $25,000.  Prior to the Offering, the Company sold $500,000 in Units through a Simple Agreement Future Equity (“SAFE”) offering.  The SAFE Units were sold at a 20% discount of the offering Unit price of $0.125, and are not a part of, nor reduce, the $1,250,000 minimum. The initial closing will occur on or before May 15, 2019, on a date chosen by the Company, unless extended by the Company in its discretion.  The Company may sell Units in one or more closings.

 

The Company anticipates continuing to rely on equity sales of its Common Stock and Preferred Stock in order to continue to fund its business operations. Issuances of additional shares will result in dilution to the Company’s existing stockholders. There is no assurance that the Company will achieve any additional sales of its equity securities or arrange for debt or other financing to fund its planned business activities.

 

Personnel

 

As of December 31, 2018, the Company had 6 employees, excluding its directors and executive officers. Currently, the Company has 6 employees, excluding its directors and executive officers.

 

Contractual Obligations

 

The Company is a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and is not required to provide the information under this item.

 

Going Concern

 

The Company has incurred losses since inception resulting in an accumulated deficit of $17,272,260, and further losses are anticipated in the development of its business. The Company’s ability to continue as a going concern is dependent upon its ability to generate profitable operations in the future and/or to obtain the necessary financing to meet its obligations and repay its liabilities arising from normal business operations when they come due, which may not be available at commercially reasonable terms. There can be no assurance that the Company will be able to generate profitable operations and/or continue to raise funds, in which case the Company may be unable to meet its obligations and the Company may cease operations. These factors, among others, raise substantial doubt about the Company’s ability to continue as a going concern.


- 44 -



The  audited consolidated financial statements included with this annual report have been prepared on the going concern basis which assumes that adequate sources of financing will be obtained as required and that the Company’s assets will be realized and liabilities settled in the ordinary course of business. Accordingly, the audited consolidated financial statements do not include any adjustments related to the recoverability of assets and classification of assets and liabilities that might be necessary should the Company be unable to continue as a going concern.

 

Off-Balance Sheet Arrangements

 

The Company has no significant off-balance sheet arrangements that have or are reasonably likely to have a current or future effect on the Company’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources that are material to stockholders.

 

Critical Accounting Policies

 

The discussion and analysis of the Company’s financial condition and results of operations are based upon the Company’s audited consolidated financial statements, which have been prepared in accordance with the accounting principles generally accepted in the United States of America. Preparing financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenue, and expenses. These estimates and assumptions are affected by management’s application of accounting policies. The Company believes that understanding the basis and nature of the estimates and assumptions involved with the following aspects of the Company’s financial statements is critical to an understanding of its consolidated financial statements.

 

Included in the acquisition agreement for RoxSan Pharmacy, Inc., and as part of the negotiated purchase price, were representations and warranties made by the Former Owner involving certain primary revenue streams and related contracts.  Shortly after the closing, however, management discovered that these representations were substantially inaccurate and/or completely false. These inaccuracies, and the improper disclosures and/or omissions made by the Former Owner during negotiations, would have significantly affected the purchase price and related note payable issued under the acquisition agreement. Management engaged a third-party to perform a valuation of the Pharmacy, utilizing revised inputs that more accurately reflected the Pharmacy's revenue streams as of the date of acquisition.  The valuation performed resulted in a fair market value of $4.7 to $5.2 million. After careful consideration, and based upon these significant differences, management determined that the purchase price and related promissory note of $20,500,000 did not fairly represent the fair market value at the date of purchase.  The Company, therefore, applied a discount to the note of $15.3 million, to reduce the purchase price and related note to its estimated fair market value of $5.2 million, utilizing the higher value on the range as a conservative measure.  The discount was amortized over thirty-six (36) months.

 

ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK  

 

The Company is a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and is not required to provide the information under this item.

 

ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA  

 

The Company’s audited consolidated financial statements are stated in United States dollars (US$) and are prepared in accordance with United States Generally Accepted Accounting Principles.

 

The following audited consolidated financial statements are filed as part of this annual report:

 

Report of Independent Registered Public Accounting Firm  

F-1

 

 

Consolidated Balance Sheets as at December 31, 2018 and 2017

F-2

 

 

Consolidated Statements of Operations for the years ended December 31, 2018 and 2017

F-3

 

 

Consolidated Statements of Changes in Stockholders' Deficit for the years ended December 31, 2018 and 2017

F-4

 

 

Consolidated Statements of Cash Flows for the years ended December 31, 2018 and 2017

F-5

 

 

Notes to the Consolidated Financial Statements for the years ended December 31, 2018 and 2017

F-6


Table of Contents

- 45 -



 

FREEDMAN & GOLDBERG

 

CERTIFIED PUBLIC ACCOUNTANTS

 

 

A PROFESSIONAL CORPORATION

 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and

Stockholders of Parallax Health Sciences, Inc.

 

Opinion on the Financial Statements

 

We have audited the accompanying consolidated balance sheets of Parallax Health Sciences, Inc., and subsidiaries (the "Company") as of December 31, 2018 and 2017, and the related statements of operations, stockholders' deficit, and cash flows for each of the years in the two-year period ended December 3 I, 2018, and the related notes (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2018 and 2017, and the results of its operations and its cash flows for each of the years in the two-year period ended December 31, 2018, in conformity with accounting principles generally accepted in the United States of America.

 

Basis for Opinion

 

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

 

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.

 

Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note I to the financial statements, the Company has suffered recurring losses from operations and has a net capital deficiency that raise substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

 

 

 

/s/ Freedman & Goldberg

 

We have served as the Company's auditor since 2016.

 

Farmington Hills, Michigan

 

March 29, 2019

 

31150 Northwestern Highway, Suite 200, Farmington Hills, Michigan 48334  (248) 626-2400  Fax (248) 626-4298

2444 East Hill Road, Grand Blanc, Michigan 48439  (810) 694-0336  Fax (810) 694-9789

Website: freedmangoldberg.com


Table of Contents

- F-1 -



 

PARALLAX HEALTH SCIENCES, INC.

CONSOLIDATED BALANCE SHEETS

 

 

December 31, 2018

 

December 31, 2017

 

ASSETS

 

 

 

 

 

 

Current assets

 

 

 

 

 

 

Cash and cash equivalents

$

262

 

$

183

 

Accounts receivable, net

 

––

 

 

3,275

 

Current assets held for sale

 

––

 

 

51,961

 

Total current assets

 

262

 

 

55,419

 

 

 

 

 

 

 

 

Intangible assets, net

 

579,035

 

 

709,655

 

Goodwill

 

785,060

 

 

785,060

 

Noncurrent assets held for sale

 

––

 

 

201,902

 

 

 

 

 

 

 

 

TOTAL ASSETS

$

1,364,357

 

$

1,752,036

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS' DEFICIT

 

 

 

 

 

 

Current liabilities

 

 

 

 

 

 

Accounts payable and accrued expenses

$

2,655,138

 

$

3,048,348

 

Debentures, convertible

 

755,627

 

 

––

 

Debentures, convertible, related party

 

428,132

 

 

––

 

Notes payable, convertible

 

296,000

 

 

741,000

 

Related party payables

 

1,004,720

 

 

629,567

 

Total current liabilities

 

5,139,617

 

 

4,418,915

 

 

 

 

 

 

 

 

Long-term liabilities

 

 

 

 

 

 

License fee payable

 

430,000

 

 

890,000

 

Royalties payable

 

310,000

 

 

200,000

 

Debentures, convertible, net of unamortized discount

 

226,050

 

 

––

 

Notes and loans payable, unsecured

 

––

 

 

95,975

 

Note payable, convertible

 

720,154

 

 

144,000

 

Notes payable, related party, convertible

 

491,100

 

 

1,167,254

 

Notes payable, secured, net of unamortized discount

 

28,995

 

 

17,393,240

 

Total long-term liabilities

 

2,206,299

 

 

19,890,469

 

 

 

 

 

 

 

 

Liabilities subject to compromise

 

––

 

 

4,620,735

 

Total liabilities

 

7,345,916

 

 

28,930,119

 

 

 

 

 

 

 

 

Stockholders' deficit

 

 

 

 

 

 

Preferred stock, $.001 par, 10,000,000 shares authorized,

 

1,014

 

 

864

 

1,013,691 and 863,691 issued and outstanding

 

 

 

 

 

 

as of December 31, 2018 and 2017, respectively

 

 

 

 

 

 

Common stock, $.001 par, 250,000,000 shares authorized,

 

158,113

 

 

136,754

 

158,113,141 and 136,754,530 issued and outstanding

 

 

 

 

 

 

as of December 31, 2018 and 2017, respectively

 

 

 

 

 

 

Additional paid in capital - preferred

 

1,415,653

 

 

665,803

 

Additional paid in capital - common

 

9,715,921

 

 

5,580,668

 

Subscriptions receivable

 

––

 

 

(592

)

Accumulated deficit

 

(17,272,260

)

 

(33,561,580

)

Total stockholders' deficit

 

(5,981,559

)

 

(27,178,083

)

 

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT

$

1,364,357

 

$

1,752,036

 

 

The accompanying notes are an integral part of these financial statements


Table of Contents

- F-2 -



PARALLAX HEALTH SCIENCES, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

For the year ended

 

 

December 31, 2018

 

December 31, 2017

 

 

 

 

 

 

 

 

Revenue

$

11,739

 

$

94,937

 

Cost of sales

 

20,339

 

 

142,044

 

Gross profit (loss)

 

(8,600

)

 

(47,107

)

 

 

 

 

 

 

 

General and administrative expenses

 

6,552,693

 

 

3,997,512

 

 

 

 

 

 

 

 

Operating loss

 

(6,561,293

)

 

(4,044,619

)

 

 

 

 

 

 

 

Other income (expenses)

 

 

 

 

 

 

Gain on disposal of subsidiary

 

4,478,268

 

 

––

 

Gain on extinguishment of debt

 

23,215,862

 

 

––

 

Discount amortization

 

(2,806,050

)

 

(5,450,000

)

Interest expense, net of  income

 

(1,213,069

)

 

(1,016,773

)

Total other income (expenses)

 

23,675,011

 

 

(6,466,773

)

 

 

 

 

 

 

 

Net income (loss) - continuing operations

 

17,113,718

 

 

(10,511,392

)

 

 

 

 

 

 

 

Net loss - discontinued operations

 

(824,398)

 

 

(3,153,553

)

 

 

 

 

 

 

 

Net income (loss)

$

16,289,320

 

$

(13,664,945

)

 

 

 

 

 

 

 

Net income (loss) per common share - basic

 

 

 

 

 

 

Continuing operations

$

0.115

 

$

(0.087

)

Discontinued operations

$

(0.006

)

$

(0.026

)

 

 

 

 

 

 

 

Net income (loss) per common share - diluted

 

 

 

 

 

 

Continuing operations

$

0.079

 

$

(0.059

)

Discontinued operations

$

(0.004

)

$

(0.018

)

 

 

 

 

 

 

 

Weighted average common shares outstanding - basic

 

148,335,736

 

 

120,493,618

 

Weighted average common shares outstanding - diluted

 

215,576,153

 

 

178,292,040

 

 

 

The accompanying notes are an integral part of these financial statements

 


Table of Contents

- F-3 -



 

PARALLAX HEALTH SCIENCES, INC.

STATEMENT OF STOCKHOLDERS DEFICIT

FROM JANUARY 1, 2017 TO DECEMBER 31, 2018

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

PREFERRED STOCK

 

COMMON STOCK

 

ADDITIONAL PAID IN CAPITAL

 

DEFERRED

 

SUBSCRIPTIONS

 

ACCUMULATED

 

 

 

 

SHARES

 

AMOUNT

 

SHARES

 

AMOUNT

 

PREFERRED

 

COMMON

 

COMPENSATION

 

RECEIVABLE

 

DEFICIT

 

TOTAL

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, January 1, 2017

833,691

 

$

834

 

107,066,774

 

$

107,067

 

$

515,833

 

$

1,933,518

 

$

(232,906

)

$

(1,592

)

$

(19,896,635

)

$

(17,573,881

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of preferred stock for cash

30,000

 

 

30

 

 

 

 

 

 

 

149,970

 

 

 

 

 

 

 

 

 

 

 

 

 

 

150,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for acquisition of intangible assets

 

 

 

 

 

2,500,000

 

 

2,500

 

 

 

 

 

622,500

 

 

 

 

 

 

 

 

 

 

 

625,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for cash

 

 

 

 

 

3,950,000

 

 

3,950

 

 

 

 

 

193,550

 

 

 

 

 

 

 

 

 

 

 

197,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for services

 

 

 

 

 

3,000,000

 

 

3,000

 

 

 

 

 

747,000

 

 

 

 

 

(3,000)

 

 

 

 

 

747,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for debt settlement

 

 

 

 

 

2,100,000

 

 

2,100

 

 

 

 

 

112,900

 

 

 

 

 

 

 

 

 

 

 

115,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conversion of related party debt

 

 

 

 

 

3,906,154

 

 

3,906

 

 

 

 

 

521,827

 

 

 

 

 

 

 

 

 

 

 

525,733

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant of stock options to consultants

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,430,800

 

 

(1,430,800

)

 

 

 

 

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant of stock options to employees

 

 

 

 

 

 

 

 

 

 

 

 

 

 

495,950

 

 

(495,950

)

 

 

 

 

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant of stock awards for services

 

 

 

 

 

13,950,000

 

 

13,950

 

 

 

 

 

2,835,300

 

 

(2,838,500

)

 

(10,250

)

 

 

 

 

500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options-employees

 

 

 

 

 

281,602

 

 

281

 

 

 

 

 

67,303

 

 

 

 

 

 

 

 

 

 

 

67,584

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Forfeiture of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(246,985

)

 

246,985

 

 

 

 

 

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Change in value of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(3,983

)

 

3,983

 

 

 

 

 

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

589,678

 

 

 

 

 

 

 

 

589,678

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of stock awards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,028,498

 

 

 

 

 

 

 

 

1,028,498

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Subscriptions received

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

14,250

 

 

 

 

 

14,250

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(13,664,945

)

 

(13,876,506

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2017

863,691

 

$

864

 

136,754,530

 

$

136,754

 

$

665,803

 

$

8,709,680

 

$

(3,129,012

)

$

(592

)

$

(33,561,580

)

$

(27,178,083

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of preferred stock for cash

60,000

 

 

60

 

 

 

 

 

 

 

299,940

 

 

 

 

 

 

 

 

 

 

 

 

 

 

300,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of preferred stock for related party debt

90,000

 

 

90

 

 

 

 

 

 

 

449,910

 

 

 

 

 

 

 

 

 

 

 

 

 

 

450,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock to directors

 

 

 

 

 

1,000,000

 

 

1,000

 

 

 

 

 

164,000

 

 

 

 

 

 

 

 

 

 

 

165,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock to officers

 

 

 

 

 

5,000,000

 

 

5,000

 

 

 

 

 

820,000

 

 

 

 

 

(5,000)

 

 

 

 

 

820,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for cash

 

 

 

 

 

2,000,000

 

 

2,000

 

 

 

 

 

238,000

 

 

 

 

 

 

 

 

 

 

 

240,000

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Issuance of common stock for debt service

 

 

 

 

 

2,810,000

 

 

2,810

 

 

 

 

 

278,190

 

 

(281,000)

 

 

 

 

 

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Conversion of debt for common stock

 

 

 

 

 

6,881,130

 

 

6,881

 

 

 

 

 

668,733

 

 

 

 

 

 

 

 

 

 

 

675,614

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant of stock options to consultant

 

 

 

 

 

 

 

 

 

 

 

 

 

 

539,200

 

 

(539,200)

 

 

 

 

 

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant of stock options to officers/directors

 

 

 

 

 

 

 

 

 

 

 

 

 

 

294,500

 

 

(294,500)

 

 

 

 

 

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Grant of stock awards for services

 

 

 

 

 

1,750,000

 

 

1,750

 

 

 

 

 

277,360

 

 

(153,000)

 

 

 

 

 

 

 

 

126,110

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options-officers

 

 

 

 

 

1,071,430

 

 

1,071

 

 

 

 

 

186,429

 

 

 

 

 

 

 

 

 

 

 

187,500

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Exercise of stock options-employees

 

 

 

 

 

846,051

 

 

847

 

 

 

 

 

268,479

 

 

 

 

 

 

 

 

 

 

 

269,326

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Forfeiture of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(184,373)

 

 

184,373

 

 

 

 

 

 

 

 

––

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of stock options

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

572,869

 

 

 

 

 

 

 

 

572,869

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Amortization of stock awards

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

1,095,193

 

 

 

 

 

 

 

 

1,095,193

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Subscriptions received

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

5,592

 

 

 

 

 

5,592

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Net income

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

16,289,320

 

 

16,289,320

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance, December 31, 2018

1,013,691

 

$

1,014

 

158,113,141

 

$

158,113

 

$

1,415,653

 

 

12,260,198

 

$

(2,544,277

)

$

––

 

$

(17,272,260

)

$

(5,981,559

)

 

The accompanying notes are an integral part of these financial statements


Table of Contents

- F-4 -



PARALLAX HEALTH SCIENCES, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

 

 

For the year ended

 

 

December 31, 2018

 

December 31, 2017

 

Cash flows from operating activities:

 

 

 

 

 

 

Net income (loss)

$

17,113,718

 

$

(10,511,392

)

Adjustments to reconcile net income (loss) to net cash used by operating activities:

 

 

 

 

 

 

Depreciation and amortization

 

120,620

 

 

83,739

 

Stock compensation/stock option expense

 

3,440,340

 

 

2,473,510

 

Discount amortization

 

2,806,050

 

 

5,450,000

 

Allowance for bad debt

 

236

 

 

4,000

 

Gain on disposal of subsidiary

 

(4,478,268

)

 

––

 

Gain on extinguishment of debt

 

(23,215,862

)

 

––

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

(Increase) decrease in trade and other receivables

 

3,039

 

 

(1,232

)