SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 1, 2020
NanoVibronix, Inc.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation)
| 001-36445 | 01-0801232 | |
| (Commission File Number) | (IRS Employer Identification No.) |
525 Executive Blvd., Elmsford, NY 10523
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code: (914) 233-3004
Not Applicable
(Former name or former address, if changed since last report)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ☐ | Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ☐ | Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).
Emerging growth company þ
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. ☐
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
| Common Stock, par value $0.001 per share | NAOV | Nasdaq Capital Market |
Item 8.01 Other Events.
On April 1, 2020, NanoVibronix, Inc. (the “Company”) issued a press release (the “April 1 Press Release”) announcing that the U.S. Centers for Medicare and Medicaid Services has approved the Company’s PainShield™ for reimbursement for Medicare beneficiaries on a national basis effective January 2020.
On April 2, 2020, the Company issued a press release (the “April 2 Press Release”) announcing that it signed a license agreement with Sanuwave Health, Inc. for the manufacture and delivery of the Company’s WoundShield technology.
The April 1 Press Release and the April 2 Press Release are filed as Exhibit 99.1 and Exhibit 99.2, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
| Exhibit Number | Description | |
| 99.1 | Press Release, dated April 1, 2020. | |
| 99.2 | Press Release, dated April 2, 2020. |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| NANOVIBRONIX, INC. | ||
| Date: April 7, 2020 | By: | /s/ Brian Murphy |
| Name: Brian Murphy | ||
| Title: Chief Executive Officer | ||
Exhibit 99.1
NanoVibronix Receives Reimbursement Approval from U.S. Centers for Medicare & Medicaid Services (CMS) for PainShield™
Enables Providers to Prescribe PainShield to Help Individuals Manage Pain at Home, Avoiding Unnecessary Doctor Visits and Hospitalization During COVID-Related Stay-At-Home Proclamations
ELMSFORD, N.Y., April 1, 2020 (GLOBE NEWSWIRE) -- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the PainShield® Surface Acoustic Wave (SAW) Portable Ultra Sonic therapeutic device, today announced that the U.S. Centers for Medicare and Medicaid Services (CMS) has approved its PainShield™ for reimbursement for Medicare beneficiaries on a national basis effective January 2020.
“PainShield provides an effective alternative to pharmaceuticals for pain management and can be used in a variety of settings including the safety of a patient’s home, which has become increasingly important in light of the coronavirus (COVID-19) pandemic,” said Brian Murphy, CEO of NanoVibronix. “Receiving CMS approval increases the number of providers who may prescribe PainShield as a means for patients, particularly Medicare beneficiaries who may be at a higher risk of infection, to manage their pain while maintaining safe distances and reducing contact in clinical settings. Obtaining this approval strengthens our opportunities to secure private label partners in the United States”.
The company was notified on March 30, 2020 that its Medicare Enrollment Application was approved, and it is now an approved Medicare Supplier for DME through the National Supplier Clearinghouse, Palmetto-GBA as well as Noridian Administrative Services, LLC, the two Medicare Administrative Contractors that handle DME reimbursement nationwide.
PainShield is now available for Medicare reimbursement on a national level under new HCPCS (Healthcare Common Procedure Coding System) code K1004.
PainShield is an ultrasound device, consisting of a reusable driver unit and a disposable patch, which contains a proprietary therapeutic transducer. PainShield delivers a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area, while keeping the level of ultrasound energy at a safe and consistent level. Its range of applications includes acute and chronic pain resolution through its many mechanisms of action. PainShield can be used by patients at home or work or in a clinical setting and can be used even while the patient is sleeping. Patient benefits include ease of application and use, faster recovery time, high compliance, and increased safety and efficacy over existing devices that rely on higher-frequency ultrasound.
About NanoVibronix
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, which is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave (SAW) technology. This technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including the disruption of biofilms and bacteria colonization, as well as providing pain relief. The devices can be administered at home without the assistance of medical professionals. The Company’s primary products include PainShield®, UroShield™ and WoundShield™. Additional information about the Company is available at: www.nanovibronix.com.
Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) the geographic, social and economic impact of COVID-19 on the Company’s ability to conduct its business and raise capital in the future when needed, (ii) market acceptance of our existing and new products or lengthy product delays in key markets; (iii) negative or unreliable clinical trial results (iv) an inability to secure regulatory approvals for the sale of our products, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital may not be available, or may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Nanovibronix Inc
bmurphy@nanovibronix.com
(630) 338-5022
Or:
Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com
(646) 536-7331
SOURCE: NanoVibronix, Inc.
Exhibit 99.2
NanoVibronix Announces License Agreement
for WoundShield Product
ELMSFORD, N.Y., April 2, 2020 (PR NEWSWIRE) -- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield®, and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that it signed a license agreement with Sanuwave Health, Inc. for the manufacture and delivery of its WoundShield technology.
Under the terms of the agreement, NanoVibronix will receive 100,000 warrants of Sanuwave stock, a $250,000 milestone payment based on FDA approval, and 10% royalty on Sanuwave’s gross revenues from sales or rentals of WoundShield. In return, Sanuwave has received the worldwide, exclusive rights to the company’s WoundShield product and technology. In addition, Sanuwave will bear the costs and clinical validation responsibilities associated with obtaining approval for WoundShield from the U.S. Food and Drug Administration and other regulatory agencies around the world.
“Licensing our WoundShield technology with a leader in wound care devices provides a pathway for worldwide distribution and a growing royalty revenue stream on future sales,” said Brian Murphy, CEO of NanoVibronix. “This agreement is consistent with our strategy of partnering with category leaders with significant sales resources in our key technology markets with UroShield, PainShield and now WoundShield.”
WoundShield is an advanced therapeutic ultrasound system that is intended to accelerate wound healing by increasing blood flow and oxygenation of tissue. The system includes a portable, battery-powered electronic unit that delivers localized energy via an actuator that is applied adjacent to the wound creating a therapeutic effect without interfering with the wound dressing. WoundShield may be integrated with Negative Pressure Wound Therapy to provide a synergetic wound healing effect by angiogenesis and tissue regeneration resulting from a further increase in fibroblast migration
“We are excited to license WoundShield as many of our existing Key Opinion Leaders (KOL’s) have mentioned how synergistic such a product would be to compliment dermaPACE system,” commented Kevin A. Richardson II CEO and Chairman of Sanuwave. “Sanuwave has an established international distribution network which we will initially leverage to grow and establish WoundShield and we plan to begin clinical work in the U.S. in the third quarter of 2020. We are glad to be collaborating with other innovative companies we have known for many years.”
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the assistance of medical professionals. The Company’s primary products include PainShield®, UroShield® and WoundShield®, all of which are portable devices suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: www.nanovibronix.com.
About Sanuwave Health, Inc.
Sanuwave Health, Inc. (OTCQB:SNWV) is a shockwave technology company initially focused on development and commercialization noninvasive, biological response-activating devices for repair and regeneration of skin, musculoskeletal tissues, and vascular structures. Sanuwave’s proprietary technology portfolio includes regenerative medicine products and product candidates for activation of biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvements, which helps restore the body’s normal healing processes and regeneration. Sanuwave applies its patented PACE® technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, has been cleared for the treatment of diabetic foot ulcers by the U.S. FDA, CE Marked throughout Europe, and has device license approval for treatment of skin and subcutaneous soft tissues in Canada, South Korea, Australia, and New Zealand. Sanuwave researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron®, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. New licensing and/or partnership opportunities may also exist for various non-medical uses of Sanuwave’s shockwave technology, particularly in the energy, agricultural, and industrial markets. Additional information about Sanuwave is available at: www.SANUWAVE.com.
Forward-looking Statements
This press release
contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,”
“will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,”
“estimates,” “aims,” “believes,” “hopes,” “potential” or similar words.
Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various
known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified;
consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks
and uncertainties include, without limitation, risks and uncertainties associated with: (i) market acceptance of our existing and
new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results; (iii) inability to secure
regulatory approvals for the sale of our products,; (iv) intense competition in the medical device
industry from much larger, multinational companies,; (v) product liability claims; (vi) product malfunctions;
(vii) our limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements
by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual
property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or
in foreign jurisdictions; (xi) our reliance on single suppliers for certain product components, (xii) the need to raise additional
capital to meet our future business requirements and obligations, given the fact that such capital may not be available, or may
be costly, dilutive or difficult to obtain; and (xiii) our conducting business in foreign jurisdictions exposing us to additional
challenges, such as, e.g., foreign currency exchange rate fluctuations, logistical and communications challenges, the burden and
cost of compliance with foreign laws, and political and/or economic instabilities in specific jurisdictions. More detailed information
about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s
filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly
Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site
at: http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result
of new information, future events, or otherwise.
Investor Contacts:
Nanovibronix Inc
bmurphy@nanovibronix.com
(630) 338-5022
Or:
Brett Maas, Managing Principal, Hayden IR, LLC
brett@haydenir.com
(646) 536-7331
SOURCE: NanoVibronix, Inc.