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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

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

 

For the quarterly period ended: March 31, 2023

 

OR

 

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

 

For the transition period from to

 

Commission file number: 001-35731

 

InspireMD, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware   26-2123838
(State or other jurisdiction of   (I.R.S. Employer
incorporation or organization)   Identification No.)

 

4 Menorat Hamaor St.

Tel Aviv, Israel 6744832

(Address of principal executive offices)

(Zip Code)

 

(888) 776-6204

(Registrant’s telephone number, including area code)

 

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 past 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 during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

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 the definitions 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 ☒

 

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 $0.0001 per share   NSPR   Nasdaq Capital Market

 

The number of shares of the registrant’s common stock, $0.0001 par value, outstanding as of May 14, 2023: 8,356,394

 

 

 

 

 

 

TABLE OF CONTENTS

 

    Page
  PART I  
Item 1. Financial Statements F-1
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations 3
Item 3. Quantitative and Qualitative Disclosures About Market Risk 9
Item 4. Controls and Procedures 10
     
  PART II  
Item 1. Legal Proceedings 11
Item 1A. Risk Factors 11
Item 5. Other Information 11
Item 6. Exhibits 12

 

2

 

 

Item 1. Financial Statements

 

INSPIREMD, INC.

CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

AS OF AND FOR THE QUARTER ENDED MARCH 31, 2023

 

TABLE OF CONTENTS

 

  Page
CONSOLIDATED FINANCIAL STATEMENTS:  
Consolidated Balance Sheets F-2 - F-3
Consolidated Statements of Operations F-4
Consolidated Statements of Changes in Equity F-5
Consolidated Statements of Cash Flows F-7
Notes to the Consolidated Financial Statements F-8 - F-15

 

F-1

 

 

INSPIREMD, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(U.S. dollars in thousands)

 

           
   March 31   December 31 
   2023   2022 
ASSETS          
CURRENT ASSETS:          
Cash and cash equivalents  $4,228   $4,632 
Short-term bank deposits   8,657    13,171 
Accounts receivable:          
Trade, net   1,417    1,034 
Other   310    213 
Prepaid expenses   394    655 
Inventory   1,697    1,621 
TOTAL CURRENT ASSETS   16,703    21,326 
           
NON-CURRENT ASSETS:          
Property, plant and equipment, net   887    917 
Operating lease right of use assets   1,472    1,554 
Fund in respect of employee rights upon retirement   859    856 
TOTAL NON-CURRENT ASSETS   3,218    3,327 
TOTAL ASSETS  $19,921   $24,653 

 

F-2

 

 

INSPIREMD, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(U.S. dollars in thousands other than share and per share data)

 

   March 31   December 31 
   2023   2022 
LIABILITIES AND EQUITY          
           
CURRENT LIABILITIES:          
Accounts payable and accruals:          
Trade   607    659 
Other   3,776    4,411 
TOTAL CURRENT LIABILITIES   4,383    5,070 
           
LONG-TERM LIABILITIES-          
Operating lease liabilities   1,081    1,195 
Liability for employees rights upon retirement   1,031    995 
           
TOTAL LONG-TERM LIABILITIES   2,112    2,190 
           
COMMITMENTS AND CONTINGENT LIABILITIES   -      
TOTAL LIABILITIES   6,495    7,260 
           
EQUITY:          
           
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2023 and December 31, 2022; 8,326,648 and 8,330,918 shares issued and outstanding at March 31, 2023 and December 2022, respectively   1    1 
Preferred C shares, par value $0.0001 per share;
1,172,000 shares authorized at March 31, 2023 and December 31, 2022; 1,718 shares issued and outstanding at March 31, 2023 and December 31 2022, respectively		   -*    -* 
Additional paid-in capital   219,266    218,977 
Accumulated deficit   (205,841)   (201,585)
Total equity   13,426    17,393 
Total liabilities and equity  $19,921   $24,653 

 

*Represents an amount less than $1 thousand

 

The accompanying notes are an integral part of the consolidated financial statements.

 

F-3

 

 

INSPIREMD, INC.

(Unaudited)

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(U.S. dollars in thousands, except per share data)

 

           
   3 Months Ended March 31, 
   2023   2022 
         
REVENUES  $1,239   $1,183 
COST OF REVENUES   866    1,061 
GROSS PROFIT   373    122 
OPERATING EXPENSES:          
Research and development   1,843    1,680 
Selling and marketing   788    746 
General and administrative   2,123    2,182 
Total operating expenses   4,754    4,608 
LOSS FROM OPERATIONS   (4,381)   (4,486)
FINANCIAL INCOME, net   125    5 
NET LOSS  $(4,256)  $(4,481)
NET LOSS PER SHARE - basic and diluted   (0.53)   (0.57)
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted   8,093,340    7,804,245 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

F-4

 

 

INSPIREMD, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(Unaudited)

(U.S. dollars in thousands, except share data)

 

                             
   Common stock   Series C
Convertible
Preferred Stock		   Additional paid-in   Accumulated   Total 
   Shares   Amount   Shares   Amount   capital   deficit   equity 
                             
BALANCE AT January 1, 2022   8,296,256    1    1,718    -*    216,625    (183,094)   33,532 
Net loss                            (4,481)   (4,481)
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 4,563 shares   21,620         -         653         653 
BALANCE AT March 31, 2022   8,317,876    1    1,718    -*    217,278    (187,575)   29,704 

 

*Represents an amount less than $1 thousand

 

The accompanying notes are an integral part of the consolidated financial statements.

 

F-5

 

 

INSPIREMD, INC.

CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY

(Unaudited)

(U.S. dollars in thousands, except share data)

 

   Common stock   Series C
Convertible
Preferred Stock		   Additional paid-in   Accumulated   Total 
   Shares   Amount   Shares   Amount   capital   deficit   equity 
                             
BALANCE AT January 1, 2023   8,330,918    1    1,718    -*    218,977    (201,585)   17,393 
Net loss                            (4,256)   (4,256)
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures of 4,270 shares   (4,270)        -         289         289 
BALANCE AT March 31, 2023   8,326,648    1    1,718    -*    219,266    (205,841)   13,426 

 

*Represents an amount less than $1 thousand

 

The accompanying notes are an integral part of the consolidated financial statements.

 

F-6

 

 

INSPIREMD, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

(U.S. dollars in thousands)

 

           
   Three months ended
March 31		 
   2023   2022 
CASH FLOWS FROM OPERATING ACTIVITIES:          
Net loss  $(4,256)  $(4,481)
Adjustments required to reconcile net loss to net cash used in operating activities:          
Depreciation   55    41 
Change in liability for employees rights upon retirement   36    46 
Other financial expenses   22    7 
Change in right of use asset and leasing liability   (34)   (25)
Share-based compensation expenses   289    653 
Loss on amounts funded in respect of employee rights upon retirement, net   23    18 
Decrease (increase) in interest receivable on short term deposits   14    (17)
Changes in operating asset and liability items:          
Decrease in prepaid expenses   261    231 
Decrease (Increase) in trade receivables   (383)   111 
Decrease (Increase) in other receivables   (97)   74 
Increase in inventory   (76)   (143)
Increase (Decrease) in trade payables   (52)   7 
Decrease in other payables   (633)   (656)
Net cash used in operating activities   (4,831)   (4,134)
CASH FLOWS FROM INVESTING ACTIVITIES:          
Purchase of property, plant and equipment   (25)   (37)
Investment in short-term bank deposits   (2,500)   (6,000)
Withdrawal from short-term bank deposits   7,000    6,000 
Amounts funded in respect of employee rights upon retirement   (26)   (28)
Net cash provided by (used in) investing activities   4,449    (65)
CASH FLOWS FROM FINANCING ACTIVITIES:          
Net cash provided by (used in) financing activities   -    - 
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS   (22)   (7)
DECREASE IN CASH AND CASH EQUIVALENTS   (404)   (4,206)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD   4,632    12,004 
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD  $4,228   $7,798 

 

The accompanying notes are an integral part of the consolidated financial statements.

 

F-7

 

 

INSPIREMD, INC.

UNAUDITED NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

 

NOTE 1 - DESCRIPTION OF BUSINESS

 

  a. General
     
    InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.
     
    The Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat carotid artery disease.
     
    The Company’s MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery. MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent. MGuard Prime EPS received CE mark approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection. Over the past years, there has been a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients. As a result of declining sales of the MGuard Prime EPS, which the Company believes is largely driven by the predominant industry preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of 2022, the Company ceased sales of the Company’s MGuard Prime EPS following a phase out period.
     
    The Company markets its products through distributors in international markets, mainly in Europe.
     
  b. Liquidity
     
   

The Company has an accumulated deficit as of March 31, 2023, as well as a history of net losses and negative operating cash flows in recent years. The Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with the Company’s current cash position, the Company has sufficient resources to fund operations until the end of September 2023. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.

 

Management’s plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and raising capital, it may need to reduce activities, curtail or cease operations.

 

On May 12, 2023, the Company entered into a securities purchase agreement for the issuance and sale of Company securities in a private placement. Aggregate gross proceeds to the Company in respect of the private placement is expected to be approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company and before exercising any warrants. The offering is expected to close on or about May 15, 2023, subject to the satisfaction of customary closing conditions.

 

F-8

 

 

  c.

Failure to satisfy regulatory requirements of the new European Medical Device Regulation could prevent the Company from marketing CGuard EPS in countries requiring the CE Mark.

 

For the European Union nations, medical devices must obtain a CE mark before they may be placed on the market. In order to obtain and maintain the CE mark, the Company must Company with EU law on medical devices, which, until May 26, 2021 was governed by the MDD, by presenting comprehensive technical files for the Company’s products demonstrating safety and efficacy of the product to be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified Body. The company has obtained ISO 13485 quality system certification and CGuard EPS that the Company currently distribute into the European Union, displays the required CE mark. In order to maintain certification, the Company is required to pass an annual surveillance audit conducted by Notified Body auditors. The European Union replaced the MDD with the new MDR regulations. The MDR entered into force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic on May 26, 2021 and which changes several aspects of the regulatory framework in the European Union. Manufacturers had the duration of the transition period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark. In the Company’s specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022, and the Company is in the final stages of technical documentation review by the Notified Body auditor to meet the MDR requirements for recertification. In the meantime, on February 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU until August 15, 2023, subject to certain procedural requirements. Subsequently, on March 20, 2023 Regulation (EU) 2023/607 was published allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027. As a result of the foregoing, the Company may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while the Company’s MDR CE recertification is pending.

 

F-9

 

 

  d. Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe
     
   

In February 2022, Russia launched a military invasion into Ukraine. The Company derived approximately 12.1% of total sales in Russia and Belarus in 2022 while during the three months ended March 31, 2023 and March 31,2022, The Company’s sales to Russia and Belarus were 7.9% and 1.5% respectively. The escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s operations, sales, and future growth prospects in that region.

 

As a result of the crisis in Ukraine, the United States and the EU have implemented sanctions against certain Russian individuals and entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region. The Company’s global operations expose the Company to risks that could adversely affect the Company’s business, financial condition, results of operations, cash flows or the market price of the Company’s securities, including the potential for increased tensions between the United States and Russia resulting from the current situation involving Russia and Ukraine, tariffs, economic sanctions and import-export restrictions imposed by either nation, and retaliatory actions by the other nation, as well as the potential negative impact on the Company’s business and sales in Russia, and Belarus. Current geopolitical instability in Russia and Ukraine and related sanctions by the U.S. government against certain companies and individuals may hinder the Company’s ability to conduct business with potential or existing customers and vendors in these countries.

 

The U.S. government has imposed sanctions through several executive orders restricting U.S. companies from conducting business with specified Russian individuals and companies. While the Company believes that the executive orders currently do not preclude the Company from conducting business with the Company’s current customers or vendors in Russia, and Belarus, the sanctions imposed by the U.S. government may be expanded in the future to restrict the Company from engaging with them. If the Company is unable to conduct business with new or existing customers or vendors or pursue business opportunities in Russia, or Belarus, the Company’s business, including revenue, profitability and cash flows, and operations could be adversely affected. The Company cannot provide assurance that current sanctions or potential future changes in sanctions will not have a material impact on the Company’s operations in Russia, and Belarus or on the Company’s financial results.

 

NOTE 2 - BASIS OF PRESENTATION

 

The accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of the Company, the financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2023 and its results of operations, changes in equity and cash flows for the three months ended March 31, 2023 and 2022. These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2023. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of results that could be expected for the entire fiscal year.

 

F-10

 

 

NOTE 3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS

 

    Newly issued accounting pronouncements
     
    Financial Instruments - Credit Losses
     
   

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates (“ASU 2019-10”). The purpose of this amendment is to create a two-tier rollout of major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU 2016-13. Larger public companies had an effective date for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, the Company met the definition of an SRC and adopted the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption. The Company adopted the provisions of this update as of January 1, 2023 with no material impact on its consolidated financial statements.

 

F-11

 

 

NOTE 4 - EQUITY:

 

 

a.

 

As of March 31, 2023, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 2,280 shares of our common stock.

 

As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of 1,793,504 shares of common stock as follows:

 

   Number of
underlying
Common stock		   Weighted
average
exercise price		 
Series E Warrants   198,159   $27.000 
Series F Warrants   433,878   $7.425 
Series G Warrants   1,092,344   $10.230 
Underwriter Warrants   17,966   $7.425 
Other warrants   51,157    225 and above 
Total Warrants   1,793,504   $  

 

As of March 31, 2023, the Company had 155,000,000 authorized shares of capital stock, par value $0.0001 per share, of which 150,000,000 are shares of common stock and 5,000,000 are shares of “blank check” preferred stock.

 

b. During the three months ended March 31, 2023, the Company granted to a consultant options to purchase a total of 50,000 shares of the Company’s common stock. The options have an exercise price of $1.15 per share, which was the fair market value of the Company’s common stock on the date of the grant. 45,000 options are subject to a three-year vesting period (of which 20,000 options are vesting in the first year, 15,000 options are vesting in the second year and 10,000 options are vesting in the third year) and 5,000 options with performance conditions related to marketing activities.

 

In calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0% and expected term of 5.5-6.5 years; expected volatility ranging from 124.58%-125.61%; and risk-free interest rate ranging from 3.65%-3.68%.

 

The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $50,658.

 

F-12

 

 

NOTE 5 – RELATED PARTIES TRANSACTIONS

 

During the three months ended March 31, 2022, a consulting company whose founder and CEO is our board member provided certain marketing services in the amount of $6,276.

 

NOTE 6 - NET LOSS PER SHARE:

 

Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. The calculation of diluted net loss per share excludes potential share issuances of common stock upon the exercise of share options, warrants, and unvested restricted stocks and unvested restricted stock units as the effect is anti-dilutive.

 

 

The total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred Stock excluded from the calculations of diluted loss per share were 2,773,675. This amount includes 342,766 of unvested restricted stock included in the number of issued and outstanding shares as of March 31, 2023.

 

 

The total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred Stock excluded from the calculations of diluted loss per share were 2,903,634. This amount includes 547,383 of unvested restricted stock included in the number of issued and outstanding shares as of March 31, 2022.

 

NOTE 7 - FINANCIAL INSTRUMENTS:

 

a.Fair value of financial instruments

 

The carrying amounts of financial instruments included in working capital approximate their fair value due to the relatively short-term maturities of such instruments.

 

b.As of March 31, 2023, and December 31, 2022, allowance for expected credit loss was immaterial.

 

NOTE 8 - INVENTORY:

 

           
   March 31,   December 31, 
   2023   2022 
   ($ in thousands) 
Finished goods  $138   $179 
Work in process   690    510 
Raw materials and supplies   869    932 
Total inventory  $1,697   $1,621 

 

F-13
 

 

NOTE 9 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER:

 

           
   March 31,   December 31, 
   2023   2022 
   ($ in thousands) 
Employees and employee institutions   970    1,853 
Accrued vacation and recreation pay   240    197 
Accrued expenses   933    554 
Clinical trial accrual   1,046    1,258 
Current Operating lease liabilities   417    419 
Other   170    130 
Accounts payable and accruals-other  $3,776   $4,411 

 

NOTE 10 - DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES:

 

Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:

 

   Three months ended
March 31		 
   2023   2022 
   ($ in thousands) 
Italy  $267   $243 
Germany   214    249 
Other   758    691 
   $1,239   $1,183 

 

By product:

 

   Three months ended
March 31		 
   2023   2022 
   ($ in thousands) 
CGuard  $1,239   $1,161 
MGuard   -    22 
   $1,239   $1,183 

 

By principal customers:

 

   Three months ended
March 31		 
   2023   2022 
Customer A   17%   21%
Customer B   13%   11%

 

All tangible long lived assets are located in Israel.

 

F-14
 

 

NOTE 11 – SUBSEQUENT EVENTS

 

On May 12, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which the Company agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares (the “Private Placement Shares”) of the Company’s common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants.

 

The Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in full. The Warrants will be immediately exercisable upon issuance at an exercise price of $1.3827 per share, subject to adjustment as set forth therein. The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the Series H Warrants, 20 trading days following the Company’s public release of primary and secondary end points related to one year follow up study results from the Company’s C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading days following the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”) for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in the United States begins. The Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the warrants.

 

In connection with the Purchase Agreement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Registration Rights Agreement, the Company is required to file a resale registration statement (the “Registration Statement”) with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”), and to have such Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. The Company will be obligated to pay certain liquidated damages if the Company fails to file the Registration Statement when required, fails to cause the Registration Statement to be declared effective by the SEC when required, of if the Company fails to maintain the effectiveness of the Registration Statement.

 

Aggregate gross proceeds to the Company in respect of the Private Placement Offering are expected to be approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company which are expected to amount to approximately $4.6 million. If the Warrants are exercised in cash in full this would result in an additional $71.4 million of proceeds. The Private Placement Offering is expected to close on or about May 15, 2023, subject to satisfaction of customary closing conditions.

 

F-15
 

 

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the accompanying condensed consolidated financial statements and related notes included elsewhere in this Quarterly Report on Form 10-Q.

 

Unless the context requires otherwise, references in this Form 10-Q to the “Company,” “InspireMD,” “we,” “our” and “us” refer to InspireMD, Inc., a Delaware corporation, and its subsidiaries.

 

Forward-Looking Statements

 

This Quarterly Report on Form 10-Q contains “forward-looking statements,” which include information relating to future events, future financial performance, strategies, expectations, competitive environment and regulation, including revenue growth. Words such as “may,” “will,” “should,” “could,” “would,” “predicts,” “potential,” “continue,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” and similar expressions, as well as statements in future tense, identify forward-looking statements. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Forward-looking statements are based on information we have when those statements are made or our management’s good faith belief as of that time with respect to future events and are subject to risks and uncertainties that could cause actual performance or results to differ materially from those expressed in or suggested by the forward-looking statements. Important factors that could cause such differences include, but are not limited to:

 

  ● our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern;
     
  ● our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests;
     
  ● an inability to secure and maintain regulatory approvals for the sale of our products;
     
  ● negative clinical trial results or lengthy product delays in key markets;
     
  ● our ability to maintain compliance with the Nasdaq Capital Market listing standards;
     
  ● our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products;
     
  ● our ability to adequately protect our intellectual property rights;
     
  ● our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards;
     
  ● the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products;
     
  ● intense competition in our industry, with competitors having greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do;
     
  ● entry of new competitors and products and potential technological obsolescence of our products;
     
  ● inability to carry out research, development and commercialization plans;

 

3
 

 

  ● loss of a key customer or supplier;
     
  ● technical problems with our research and products and potential product liability claims;
     
  ● product malfunctions;
     
  ● price increases for supplies and components;
     
  ● adverse economic conditions;
     
  ● insufficient or inadequate reimbursement by governmental and other third-party payers for our products;
     
  ● adverse federal, state and local government regulation in the United States, Europe, Israel and other foreign jurisdictions;
     
  ● 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 volatility in certain jurisdictions;
     
  ● the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and
     
  ● current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk.

 

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in our forward-looking statements. For a discussion of these and other risks that relate to our business and investing in our common stock, you should carefully review the risks and uncertainties described in this Quarterly Report on Form 10-Q, and those described from time to time in our future reports filed with the Securities and Exchange Commission. The forward-looking statements contained in this Quarterly Report on Form 10-Q are expressly qualified in their entirety by this cautionary statement. We do not undertake any obligation to publicly update any forward-looking statement to reflect events or circumstances after the date on which any such statement is made or to reflect the occurrence of unanticipated events.

 

Overview

 

We are a medical device company focusing on the development and commercialization of our proprietary MicroNet™ stent platform for the treatment of carotid artery disease and other vascular disease. A stent is an expandable “scaffold-like” device, usually constructed of a metallic material, that is inserted into the lumen of the artery to create patency and revascularization of blood flow. MicroNet, a micron mesh sleeve, is attached over a stent to provide embolic protection both during and after stenting procedures.

 

4
 

 

Our CGuard™ carotid embolic prevention system (“CGuard EPS™”) combines MicroNet and a unique self-expandable nitinol stent in a single device for use in carotid artery revascularization. Our CGuard EPS originally received CE mark approval under Medical Device Directive 93/42/EEC (“MDD”) in the European Union (“EU”) in March 2013 and was fully launched in Europe in September 2015. Subsequently, we launched CGuard EPS in over 30 countries and on February 3, 2021, we executed a distribution agreement with Chinese partners for the purpose of expanding our presence in the Asian markets. Currently, we are seeking strategic partners for a potential launch of CGuard EPS in Japan and other Asian countries.

 

Our CE mark for CGuard EPS under the MDD expired on November 12, 2022 and we are in the final stages of technical documentation review by the Notified Body auditor to meet the Medical Device Regulation (“MDR”) (MDR 2017/745) requirements (which replaced the MDD) for recertification. In the meantime, on February 14, 2023, we received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing us to continue marketing CGuard EPS in the EU until August 15, 2023 subject to certain procedural requirements. Subsequently, on March 20, 2023, Regulation (EU) 2023/607 was published allowing us to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027. As a result of the foregoing, we may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while our MDR CE recertification is pending. We continue to expedite the review process for recertification under the MDR.

 

On September 8, 2020, we received approval from the U.S. Food and Drug Administration (“FDA”) of our Investigation Device Exemption (“IDE”), thereby allowing us to proceed with a pivotal study of our CGuard™ Carotid Stent System, C-Guardians, for prevention of stroke in patients in the United States. C-Guardians is a prospective, multicenter, single-arm, pivotal study to evaluate the safety and efficacy of the CGuard™ Carotid Sten System when used to treat symptomatic and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting. The trial was designed to enroll approximately 315 subjects in a maximum of 40 study sites located in the United States and Europe. Study sites in Europe may contribute a maximum of approximately 50% of the total enrollees. The primary endpoint of the study will be the composite of incidence of death (all-cause mortality), all stroke, and myocardial infarction (DSMI) through 30-days post-index procedure, based on the clinical events committee (CEC) adjudication and ipsilateral stroke from 31-365 day follow-up, based on Clinical Events Committee (CEC) adjudication. The composite index will be compared to a performance goal based on the observed rate of the two components of the primary endpoint from previous pivotal stent trials which are considered industry standard. The performance goal will be considered met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is < 11.6% and the p-value is less than 0.025.

 

On July 23, 2021, we announced the initiation of enrollment and successful completion of the first cases of our C-Guardian trial of CGuard EPS. There are 315 patients who are expected to be enrolled in the trial and receive CGuard EPS in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting. We are currently continuing with the enrolment phase at approximately 20 trial sites and expect it to be completed approximately at the end of the second quarter of 2023.

 

Additionally, we intend to continue to invest in current and future potential new indications, products and manufacturing enhancements for CGuard EPS that are expected to reduce cost of goods and/or provide the best-in-class performing delivery systems, such as CGuard Prime™for transfemoral access. In furtherance of our strategy that focuses on establishing CGuard EPS as a viable alternative to vascular surgery, we are developing a new transcarotid artery revascularization (TCAR) delivery system, SwitchGuard™, for transcarotid access and neuro protection. In addition, we intend to explore new indications for CGuard EPS to leverage the advantages of stent design and mesh protection, well suited in labels such as acute stroke with tandem lesions.

 

We consider our current addressable market for our CGuard EPS to be individuals with diagnosed, symptomatic high-grade carotid artery stenosis (HGCS, ≥70% occlusion) for whom intervention is preferable to medical (drug) therapy. This group includes not only carotid artery stenting patients but also individuals undergoing carotid endarterectomy, as the two approaches compete for the same patient population. Assuming full penetration of the intervention caseload by CGuard EPS, we estimate that the addressable market for CGuard EPS will be approximately $1.3 billion in 2023 (source: Health Research International Personal Medical Systems, Inc. September 13, 2021 Results of Update Report on Global Carotid Stenting Procedures and Markets by Major Geography and Addressable Markets and internal estimates). According to this same report, and internal estimates, assuming full penetration of the caseload for all individuals diagnosed with high-grade carotid artery stenosis, we estimate that the total available market for CGuard EPS in 2022 will be approximately $9.3 billion. Our mission is to offer a comprehensive set of delivery solutions (TCAR and Transfemoral) in order to deliver best in class results through patient outcomes by way of stent performance with CGuard EPS.

 

We were organized in the State of Delaware on February 29, 2008.

 

5
 

 

Recent Developments

 

Private Placement

 

On May 12, 2023, we entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which we agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares (the “Private Placement Shares”) of our common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants.

 

The Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in full. The Warrants will be immediately exercisable upon issuance at an exercise price of $1.3827 per share, subject to adjustment as set forth therein. The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the Series H Warrants, 20 trading days following the Company’s public release of primary and secondary end points related to one year follow up study results from the Company’s C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading days following the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”) for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in the United States begins. The Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the warrants.

 

In connection with the Purchase Agreement, we entered into a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Registration Rights Agreement, we are required to file a resale registration statement (the “Registration Statement”) with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”), and to have such Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. We will be obligated to pay certain liquidated damages if we fail to file the Registration Statement when required, fails to cause the Registration Statement to be declared effective by the SEC when required, of if we fail to maintain the effectiveness of the Registration Statement.

 

Aggregate gross proceeds to us in respect of the Private Placement Offering are expected to be approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses. If the Warrants are exercised in cash in full this would result in an additional $71.4 million of proceeds.

 

We agreed to pay LifeSci Capital LLC, a placement fee equal to 5.6% of the aggregate gross proceeds from the closing of the Private Placement Offering and a non-accountable expense allowance of $25,000. In addition, we have agreed to pay Piper Sandler & Co. a financial advisory fee of $1.5 million and AGP/Alliance Global Partners a financial advisory fee of $250,000.

The Private Placement Offering is expected to close on or about May 15, 2023, subject to satisfaction of customary closing conditions.

 

6
 

 

Critical Accounting Policies

 

A critical accounting policy is one that is both important to the portrayal of our financial condition and results of operation and requires management’s most difficult, subjective or complex judgments, often as a result of the need to make estimates about the effect of matters that are inherently uncertain. Our critical accounting policies are more fully described in both (i) “Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations” and (ii) Note 2 of the Notes to the Consolidated Financial Statements included in the Annual Report on Form 10-K for the year ended December 31, 2022. There have not been any material changes to such critical accounting policies since December 31, 2022.

 

The currency of the primary economic environment in which our operations are conducted is the U.S. dollar (“$” or “dollar”).

 

Contingencies

 

We and our subsidiaries are involved in legal proceedings that arise from time to time in the ordinary course of business. We record accruals for these types of contingencies to the extent that we conclude the occurrence of such contingencies is probable and that the related liabilities are estimable. When accruing these costs, we recognize an accrual in the amount within a range of loss that is the best estimate within the range. When no amount within the range is a better estimate than any other amount, we accrue for the minimum amount within the range. Legal costs are expensed as incurred.

 

Results of Operations

 

Three months ended March 31, 2023, compared to the three months ended March 31, 2022

 

Revenues. For the three months ended March 31, 2023, revenue increased by $56,000, or 4.7%, to $1,239,000, from $1,183,000 during the three months ended March 31, 2022. This increase was predominantly driven by a 6.7% increase in sales of CGuard EPS from $1,161,000 during the three months ended March 31, 2022, to $1,239,000 during the three months ended March 31, 2023. During the second half of the quarter, our CE mark was reinstated under the MDD directive allowing us to resume sales and shipments to the EU countries and we spent the remainder of the quarter shipping product in order to reduce the backlog of orders that accumulated over the past few months. We believe the quarter over quarter increase in revenue is not representative of the real market demand for CGuard EPS, due to our inability to ship product for the first half of the quarter. We continue to expedite the review process for recertification under the MDR.

 

With respect to geographical regions, the increase in revenue was primarily attributable to a $177,000 increase in Europe, for reasons mentioned in the paragraph above, and a $13,000 increase from the Middle East. This increase was offset by a $87,000 decrease in Latin America and $52,000 decrease in revenue from other regions such as Australia and Asia due to the timing of shipments to our distributers.

 

Gross Profit. For the three months ended March 31, 2023, gross profit (revenue less cost of revenues) increased by $251,000, or 205.6%, to $373,000, from $122,000 during the three months ended March 31, 2022. This increase in gross profit resulted from a decrease in write-offs of $184,000 and a $71,000 increase in revenues (as mentioned above), less the associated related material and labor. Gross margin (gross profits as a percentage of revenue) increased to 30.1% during the three months ended March 31, 2023 from 10.3% during the three months ended March 31, 2022, driven by the factors mentioned above.

 

7
 

 

Research and Development Expenses. For the three months ended March 31, 2023, research and development expenses increased by $163,000, or 9.7%, to $1,843,000, from $1,680,000 during the three months ended March 31, 2022. This increase resulted primarily from an increase of $170,000 in expenses related to the CGuard Prime regulatory and approval process and an increase of $88,000 in miscellaneous expenses offset, in part, by a decrease of $95,000 in expenses related to the C-Guardians FDA study.

 

Selling and Marketing Expenses. For the three months ended March 31, 2023, selling and marketing expenses increased by $42,000, or 5.6%, to $788,000, from $746,000 during the three months ended March 31, 2022. This increase resulted primarily from an increase in compensation expenses of $49,000 offset, in part, by a decrease of $7,000 in miscellaneous expenses.

 

General and Administrative Expenses. For the three months ended March 31, 2023, general and administrative expenses decreased by $59,000, or 2.7%, to $2,123,000, from $2,182,000 during the three months ended March 31, 2022. This decrease resulted primarily from a decrease in share-based compensation-related expenses of $310,000 as no new grants were made from the fourth quarter of 2021 through March 31, 2023 offset, in part, by an increase in regulatory expenses of $171,000 related to MDR registration process and an increase of $80,000 in miscellaneous expenses.

 

Financial Income. For the three months ended March 31, 2023, financial income increased by $120,000, to $125,000, from $5,000 during the three months ended March 31, 2022. The increase in financial income primarily resulted from a $88,000 increase in interest income from short-term bank deposits.

 

Tax Expenses. For the three months ended March 31, 2023, there was no change in our tax expenses as compared to the three months ended March 31, 2022.

 

Net Loss. Our net loss decreased by $225,000, or 5.0%, to $4,256,000, for the three months ended March 31, 2023, from $4,481,000 during the three months ended March 31, 2022. The decrease in net loss resulted primarily from an increase of $251,000 in gross profit and an increase of $120,000 in financial income partially offset by an increase of $146,000 in operating expenses.

 

Liquidity and Capital Resources

 

We had an accumulated deficit as of March 31, 2023 of $206 million, as well as a net loss of $4,256,000 and negative operating cash flows. We expect to continue incurring losses and negative cash flows from operations until our product, CGuard EPS, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with our current cash position, we believe we have sufficient resources to fund operations until the end of September 2023. Therefore, there is substantial doubt about our ability to continue as a going concern.

 

Our plans include continued commercialization of our products and raising capital through sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances, however, that we will be successful in obtaining the level of financing needed for our operations. If we are unsuccessful in commercializing our products or raising capital, we may need to reduce activities, curtail or cease operations.

 

On May 12, 2023, we entered into a securities purchase agreement for the issuance and sale of our securities in a private placement. Aggregate gross proceeds to us in respect of the private placement is expected to be approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable us and before exercising any warrants. The offering is expected to close on or about May 15, 2023, subject to the satisfaction of customary closing conditions.

 

Three months ended March 31, 2023 compared to the three months ended March 31, 2022

 

General. At March 31, 2023, we had cash and cash equivalents of $4,228,000 and short-term bank deposits of $8,657,000 as compared to $4,632,000 and short-term bank deposits of $13,171,000 as of December 31, 2022. We have historically met our cash needs through a combination of issuing new shares, borrowing activities and product sales. Our cash requirements are generally for research and development, marketing and sales activities, finance and administrative costs, capital expenditures and general working capital.

 

8
 

 

For the three months ended March 31, 2023, net cash used in our operating activities increased by $697,000, or 16.9%, to $4,831,000, from $4,134,000 during the same period in 2022. The primary reason for the increase in cash used in our operating activities was an increase of $449,000 in compensation costs paid during the three months ended March 31, 2023 from $2,679,000 in the three months ended March 31, 2022 to $3,128,000 during the same period in 2023 and a decrease of $366,000 in payments received from customers, to $925,000 during the three months ended March 31, 2023 from $1,291,000 during the same period in 2022 ,offset in part by a decrease of $118,000 in payments for third party related expenses and for professional services

 

Cash provided in our investing activities was $4,449,000 during the three months ended March 31, 2023, compared to cash used of $65,000 during the three months ended March 31, 2022. The primary reasons for the increase in cash provided by our investing activities is a withdrawal of short-term deposits, net of investments of $4,500,000 of short-term deposits, offset by a decrease of $12,000 in payments made for purchase of property, plant and equipment to $25,000 during the three months ended March 31, 2023.

 

There was no cash provided by financing activities for the three months ended March 31, 2023 and for the three months ended March 31, 2022.

 

As of March 31, 2023, our current assets exceeded our current liabilities by a multiple of 3.8. Current assets decreased by $4,623,000 during the period and current liabilities decreased by $687,000 during the period. As a result, our working capital decreased by $3,936,000 to $12,320,000 as of March 31, 2023.

 

Off Balance Sheet Arrangements

 

We have no off-balance sheet transactions, arrangements, obligations (including contingent obligations) or other relationships with unconsolidated entities or other persons that have, or may have, a material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Factors That May Affect Future Operations

 

We believe that our future operating results will continue to be subject to quarterly variations based upon a wide variety of factors, including the cyclical nature of the ordering patterns of our distributors, timing of regulatory approvals, the implementation of various phases of our clinical trials and manufacturing efficiencies due to the learning curve of utilizing new materials and equipment. Our operating results could also be impacted by a weakening of the Euro and strengthening of the NIS, both against the U.S. dollar. Lastly, other economic conditions we cannot foresee may affect customer demand, such as individual country reimbursement policies pertaining to our products.

Contractual Obligations and Commitments

 

During the three months ended March 31, 2023, there were no material changes to our contractual obligations and commitments.

 

Item 3. Quantitative and Qualitative Disclosures About Market Risk.

 

Not applicable.

 

9
 

 

Item 4. Controls and Procedures

 

Management’s Conclusions Regarding Effectiveness of Disclosure Controls and Procedures

 

As of March 31, 2023, we conducted an evaluation, under the supervision and participation of management including our chief executive officer and chief financial officer, of the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) of the Securities Exchange Act of 1934, as amended). There are inherent limitations to the effectiveness of any system of disclosure controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives.

 

Based upon this evaluation, our chief executive officer and chief financial officer concluded that our disclosure controls and procedures are effective at the reasonable assurance level as of March 31, 2023.

 

Changes in Internal Control over Financial Reporting

 

There were no changes in our internal control over financial reporting during the fiscal quarter ended March 31, 2023, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

10
 

 

PART II - OTHER INFORMATION

 

Item 1. Legal Proceedings

 

From time to time, we may become involved in various lawsuits and legal proceedings, which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in these or other matters may arise from time to time that may harm our business. There are currently no pending material legal proceedings, and we are currently not aware of any legal proceedings or claims against us or our property that we believe will have any significant effect on our business, financial position or operating results.

 

Item 1A. Risk Factors

 

Except for the Risk Factors included in our previous filings made with the SEC and as set forth below, there have been no material changes to our risk factors from those disclosed in “Part I. Item 1A. Risk Factors” in the Form 10-K filed with the SEC on March 30, 2023.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds

 

None.

 

Item 3. Defaults Upon Senior Securities

 

None.

 

Item 4. Mine Safety Disclosures

 

Not applicable.

 

Item 5. Other Information

 

None.

 

11
 

 

Item 6. Exhibits

 

EXHIBIT INDEX

 

Exhibit No.   Description
     
3.1   Amended and Restated Certificate of Incorporation, as amended through March 31, 2015 (incorporated by reference to Exhibit 3.1 to Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 9, 2015)
     
3.2   Amended and Restated Bylaws (incorporated by reference to Exhibit 3.2 to Current Report on Form 8-K filed with the Securities and Exchange Commission on June 29, 2021)
     
3.3   Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on May 25, 2016)
     
3.4   Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on September 29, 2016)
     
3.5   Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 15, 2017)
     
3.6   Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series C Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on November 29, 2017)
     
3.7   Certificate of Amendment to Certificate of Designation of Preferences, Rights and Limitation of Series B Convertible Preferred Stock (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on December 12, 2017)
     
3.8   Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on February 7, 2018)
     
3.9   Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc. (incorporated by reference to Exhibit 3.1 to the Current Report on Form 8-K filed on March 28, 2019)
     
3.10   Certificate of Amendment to Amended and Restated Certificate of Incorporation of InspireMD, Inc., dated April 14, 2021 (incorporated by reference to Exhibit 3.17 to the Quarterly Report on Form 10-Q filed on May 10, 2021)
     
31.1*   Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
31.2*   Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
     
32.1*   Certification of Chief Executive Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
     
32.2*   Certification of Chief Financial Officer pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
     
101.INS*   Inline XBRL Instance Document (the Instance Document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document)
     
101.SCH*   Inline XBRL Taxonomy Extension Schema Document
     
101.CAL*   Inline XBRL Taxonomy Extension Calculation Linkbase Document
     
101.DEF*   Inline XBRL Taxonomy Extension Definition Linkbase Document
     
101.LAB*   Inline XBRL Taxonomy Extension Labels Linkbase Document
     
101.PRE*   Inline XBRL Taxonomy Extension Presentation Linkbase Document
     
     
104*   Cover Page Interactive Data File (formatted in Inline XBRL and contained in Exhibit 101)

 

* Filed herewith.

 

12
 

 

SIGNATURES

 

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 thereunto duly authorized.

 

  INSPIREMD, INC.
     
Date: May 15, 2023 By: /s/ Marvin Slosman
  Name: Marvin Slosman,
  Title:

President and Chief Executive Officer

(Principal Executive Officer)

     
Date: May 15, 2023 By: /s/ Craig Shore
  Name: Craig Shore
  Title:

Chief Financial Officer, Secretary and Treasurer

(Principal Financial and Accounting Officer)

 

13

 

 EX-31.1 2 ex31-1.htm

 

EXHIBIT 31.1

 

CERTIFICATION

 

I, Marvin Slosman, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of InspireMD, Inc.;
     
  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 15, 2023 /s/ Marvin Slosman
  Marvin Slosman
 

Chief Executive Officer

(Principal Executive Officer)

 

 

 

 EX-31.2 3 ex31-2.htm

 

EXHIBIT 31.2

 

CERTIFICATION

 

I, Craig Shore, certify that:

 

  1. I have reviewed this Quarterly Report on Form 10-Q of InspireMD, Inc.;
     
  2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
     
  3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
     
  4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
     
  b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
     
  c. Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
     
  d. Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

  5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

  a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
     
  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: May 15, 2023 /s/ Craig Shore
  Craig Shore
 

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

 

 EX-32.1 4 ex32-1.htm

 

Exhibit 32.1

 

CERTIFICATION

PURSUANT TO

18 U.S.C. SECTION 1350

 

In connection with the Quarterly Report on Form 10-Q of InspireMD, Inc. (the “Company”) for the period ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Marvin Slosman, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, that, to my knowledge:

 

(1) The Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
   
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered in this report.

 

Date: May 15, 2023 By: /s/ Marvin Slosman
  Name: Marvin Slosman
  Title:

Chief Executive Officer

(Principal Executive Officer)

 

 

 

 EX-32.2 5 ex32-2.htm

 

Exhibit 32.2

 

CERTIFICATION

PURSUANT TO

18 U.S.C. SECTION 1350

 

In connection with the Quarterly Report on Form 10-Q of InspireMD, Inc. (the “Company”) for the period ended March 31, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Craig Shore, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, that, to my knowledge:

 

(1) The Report fully complies with the requirements of Section 13(a) or Section 15(d) of the Securities Exchange Act of 1934; and
   
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company as of and for the periods covered in this report.

 

Date: May 15, 2023 By: /s/ Craig Shore
  Name: Craig Shore
  Title:

Chief Financial Officer

(Principal Financial and Accounting Officer)

 

 

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Series C Convertible Preferred Stock [Member] At The Market Offering [Member] Series E Warrants [Member] Series F Warrants [Member] Series G Warrants [Member] Underwriter Warrants [Member] Other Warrants [Member] Weighted average exercise price, description Capital stock par value. Preferred Stock Blank Check [Member] Three Year Vesting Period [Member] First Year Vesting Period [Member] Second Year Vesting Period [Member] Performance Conditions [Member] New Director [Member] Current Operating lease liabilities. Clinical trial accrual current. Information about other countries. Schedule Of Revenues Attributed To Geographic Areas By Product [Table Text Block] CGuard & EPS [Member] MGuard Prime & EPS [Member] Information by name or description of a single external customer. Information by name or description of a single external customer. Share-based compensation related to restricted stock and stock options award, net of forfeitures of shares. Share-based compensation related to restricted stock and stock options award, net of forfeitures of shares, shares. Change In Operating Lease Assets And Liabilities. Loss gains on amounts funded in respect of employee rights upon retirement net. Interest income from short term bank deposits. Amounts with drawn in respect of employee rights upon retirement net. Third Year Vesting Period [Member] Assets, Current Assets, Noncurrent Assets Accounts Payable, Other, Current Liabilities, Current Liabilities, Noncurrent Liabilities Equity, Attributable to Parent Liabilities and Equity Gross Profit Operating Expenses Operating Income (Loss) Shares, Outstanding Other Noncash Income (Expense) ChangeInRightOfUseAssetAndLeasingLiability InterestIncomeFromShorttermBankDeposits Increase (Decrease) in Prepaid Expense Increase (Decrease) in Accounts Receivable Increase (Decrease) in Other Receivables Increase (Decrease) in Inventories Net Cash Provided by (Used in) Operating Activities Payments to Acquire Property, Plant, and Equipment Payments to Acquire Investments AmountsWithdrawnInRespectOfEmployeeRightsUponRetirementNet Net Cash Provided by (Used in) Investing Activities Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents, Period Increase (Decrease), Including Exchange Rate Effect Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents, Including Disposal Group and Discontinued Operations Other Accrued Liabilities, Current EX-101.PRE 10 nspr-20230331_pre.xml XBRL PRESENTATION FILE XML 11 R1.htm IDEA: XBRL DOCUMENT v3.23.1
Cover - shares
 3 Months Ended
Mar. 31, 2023
May 14, 2023
Cover [Abstract]    
Document Type 10-Q  
Amendment Flag false  
Document Quarterly Report true  
Document Transition Report false  
Document Period End Date Mar. 31, 2023  
Document Fiscal Period Focus Q1  
Document Fiscal Year Focus 2023  
Current Fiscal Year End Date --12-31  
Entity File Number 001-35731  
Entity Registrant Name InspireMD, Inc.  
Entity Central Index Key 0001433607  
Entity Tax Identification Number 26-2123838  
Entity Incorporation, State or Country Code DE  
Entity Address, Address Line One 4 Menorat Hamaor St.  
Entity Address, City or Town Tel Aviv  
Entity Address, Country IL  
Entity Address, Postal Zip Code 6744832  
City Area Code (888)  
Local Phone Number 776-6204  
Title of 12(b) Security Common Stock, par value $0.0001 per share  
Trading Symbol NSPR  
Security Exchange Name NASDAQ  
Entity Current Reporting Status Yes  
Entity Interactive Data Current Yes  
Entity Filer Category Non-accelerated Filer  
Entity Small Business true  
Entity Emerging Growth Company false  
Entity Shell Company false  
Entity Common Stock, Shares Outstanding   8,356,394
XML 12 R2.htm IDEA: XBRL DOCUMENT v3.23.1
Condensed Consolidated Balance Sheets (Unaudited) - USD ($)
$ in Thousands
Mar. 31, 2023
Dec. 31, 2022
CURRENT ASSETS:    
Cash and cash equivalents $ 4,228 $ 4,632
Short-term bank deposits 8,657 13,171
Accounts receivable:    
Trade, net 1,417 1,034
Other 310 213
Prepaid expenses 394 655
Inventory 1,697 1,621
TOTAL CURRENT ASSETS 16,703 21,326
NON-CURRENT ASSETS:    
Property, plant and equipment, net 887 917
Operating lease right of use assets 1,472 1,554
Fund in respect of employee rights upon retirement 859 856
TOTAL NON-CURRENT ASSETS 3,218 3,327
TOTAL ASSETS 19,921 24,653
Accounts payable and accruals:    
Trade 607 659
Other 3,776 4,411
TOTAL CURRENT LIABILITIES 4,383 5,070
LONG-TERM LIABILITIES-    
Operating lease liabilities 1,081 1,195
Liability for employees rights upon retirement 1,031 995
TOTAL LONG-TERM LIABILITIES 2,112 2,190
COMMITMENTS AND CONTINGENT LIABILITIES  
TOTAL LIABILITIES 6,495 7,260
EQUITY:    
Common stock, par value $0.0001 per share; 150,000,000 shares authorized at March 31, 2023 and December 31, 2022; 8,326,648 and 8,330,918 shares issued and outstanding at March 31, 2023 and December 2022, respectively 1 1
Preferred C shares, par value $0.0001 per share; 1,172,000 shares authorized at March 31, 2023 and December 31, 2022; 1,718 shares issued and outstanding at March 31, 2023 and December 31 2022, respectively [1]
Additional paid-in capital 219,266 218,977
Accumulated deficit (205,841) (201,585)
Total equity 13,426 17,393
Total liabilities and equity $ 19,921 $ 24,653
[1] Represents an amount less than $1 thousand
XML 13 R3.htm IDEA: XBRL DOCUMENT v3.23.1
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares
Mar. 31, 2023
Dec. 31, 2022
Common stock, par value $ 0.0001 $ 0.0001
Common stock, shares authorized 150,000,000 150,000,000
Common stock, shares issued 8,326,648 8,330,918
Common stock, shares outstanding 8,326,648 8,330,918
Series C Preferred Stock [Member]    
Preferred stock, par value $ 0.0001 $ 0.0001
Preferred stock, shares authorized 1,172,000 1,172,000
Preferred stock, shares issued 1,718 1,718
Preferred stock, shares outstanding 1,718 1,718
XML 14 R4.htm IDEA: XBRL DOCUMENT v3.23.1
Condensed Consolidated Statements of Operations (Unaudited) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2023
Mar. 31, 2022
Income Statement [Abstract]    
REVENUES $ 1,239 $ 1,183
COST OF REVENUES 866 1,061
GROSS PROFIT 373 122
OPERATING EXPENSES:    
Research and development 1,843 1,680
Selling and marketing 788 746
General and administrative 2,123 2,182
Total operating expenses 4,754 4,608
LOSS FROM OPERATIONS (4,381) (4,486)
FINANCIAL INCOME, net 125 5
NET LOSS $ (4,256) $ (4,481)
NET LOSS PER SHARE - basic and diluted $ (0.53) $ (0.57)
WEIGHTED AVERAGE NUMBER OF ORDINARY SHARES USED IN COMPUTING NET LOSS PER SHARE - basic and diluted 8,093,340 7,804,245
XML 15 R5.htm IDEA: XBRL DOCUMENT v3.23.1
Condensed Consolidated Statements of Changes in Equity (Unaudited) - USD ($)
$ in Thousands
Common Stock [Member]
Preferred Stock [Member]
Series C Convertible Preferred Stock [Member]
Additional Paid-in Capital [Member]
Retained Earnings [Member]
Total
Balance at Dec. 31, 2021 $ 1 [1] $ 216,625 $ (183,094) $ 33,532
Balance, shares at Dec. 31, 2021 8,296,256 1,718      
Net loss       (4,481) (4,481)
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures     653   653
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures, shares 21,620      
Balance at Mar. 31, 2022 $ 1 [1] 217,278 (187,575) 29,704
Balance, shares at Mar. 31, 2022 8,317,876 1,718      
Balance at Dec. 31, 2022 $ 1 [2] 218,977 (201,585) 17,393
Balance, shares at Dec. 31, 2022 8,330,918 1,718      
Net loss       (4,256) (4,256)
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures     289   289
Share-based compensation related to restricted stock, restricted stock units and stock options award, net of forfeitures, shares (4,270)      
Balance at Mar. 31, 2023 $ 1 [2] $ 219,266 $ (205,841) $ 13,426
Balance, shares at Mar. 31, 2023 8,326,648 1,718      
[1] Represents an amount less than $1 thousand
[2] Represents an amount less than $1 thousand
XML 16 R6.htm IDEA: XBRL DOCUMENT v3.23.1
Condensed Consolidated Statements of Changes in Equity (Unaudited) (Parenthetical) - shares
 3 Months Ended
Mar. 31, 2023
Mar. 31, 2022
Statement of Stockholders' Equity [Abstract]    
Shares, restricted stock award, forfeited 4,270 4,563
XML 17 R7.htm IDEA: XBRL DOCUMENT v3.23.1
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2023
Mar. 31, 2022
CASH FLOWS FROM OPERATING ACTIVITIES:    
Net loss $ (4,256) $ (4,481)
Adjustments required to reconcile net loss to net cash used in operating activities:    
Depreciation 55 41
Change in liability for employees rights upon retirement 36 46
Other financial expenses 22 7
Change in right of use asset and leasing liability (34) (25)
Share-based compensation expenses 289 653
Loss on amounts funded in respect of employee rights upon retirement, net 23 18
Decrease (increase) in interest receivable on short term deposits 14 (17)
Changes in operating asset and liability items:    
Decrease in prepaid expenses 261 231
Decrease (Increase) in trade receivables (383) 111
Decrease (Increase) in other receivables (97) 74
Increase in inventory (76) (143)
Increase (Decrease) in trade payables (52) 7
Decrease in other payables (633) (656)
Net cash used in operating activities (4,831) (4,134)
CASH FLOWS FROM INVESTING ACTIVITIES:    
Purchase of property, plant and equipment (25) (37)
Investment in short-term bank deposits (2,500) (6,000)
Withdrawal from short-term bank deposits 7,000 6,000
Amounts funded in respect of employee rights upon retirement (26) (28)
Net cash provided by (used in) investing activities 4,449 (65)
CASH FLOWS FROM FINANCING ACTIVITIES:    
Net cash provided by (used in) financing activities
EFFECT OF EXCHANGE RATE CHANGES ON CASH AND CASH EQUIVALENTS (22) (7)
DECREASE IN CASH AND CASH EQUIVALENTS (404) (4,206)
BALANCE OF CASH AND CASH EQUIVALENTS AT BEGINNING OF THE PERIOD 4,632 12,004
BALANCE OF CASH AND CASH EQUIVALENTS AT END OF THE PERIOD $ 4,228 $ 7,798
XML 18 R8.htm IDEA: XBRL DOCUMENT v3.23.1
DESCRIPTION OF BUSINESS
 3 Months Ended
Mar. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
DESCRIPTION OF BUSINESS

NOTE 1 - DESCRIPTION OF BUSINESS

 

  a. General
     
    InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures.
     
    The Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat carotid artery disease.
     
    The Company’s MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery. MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent. MGuard Prime EPS received CE mark approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection. Over the past years, there has been a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients. As a result of declining sales of the MGuard Prime EPS, which the Company believes is largely driven by the predominant industry preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of 2022, the Company ceased sales of the Company’s MGuard Prime EPS following a phase out period.
     
    The Company markets its products through distributors in international markets, mainly in Europe.
     
  b. Liquidity
     
   

The Company has an accumulated deficit as of March 31, 2023, as well as a history of net losses and negative operating cash flows in recent years. The Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with the Company’s current cash position, the Company has sufficient resources to fund operations until the end of September 2023. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.

 

Management’s plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and raising capital, it may need to reduce activities, curtail or cease operations.

 

On May 12, 2023, the Company entered into a securities purchase agreement for the issuance and sale of Company securities in a private placement. Aggregate gross proceeds to the Company in respect of the private placement is expected to be approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company and before exercising any warrants. The offering is expected to close on or about May 15, 2023, subject to the satisfaction of customary closing conditions.

 

 

  c.

Failure to satisfy regulatory requirements of the new European Medical Device Regulation could prevent the Company from marketing CGuard EPS in countries requiring the CE Mark.

 

For the European Union nations, medical devices must obtain a CE mark before they may be placed on the market. In order to obtain and maintain the CE mark, the Company must Company with EU law on medical devices, which, until May 26, 2021 was governed by the MDD, by presenting comprehensive technical files for the Company’s products demonstrating safety and efficacy of the product to be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified Body. The company has obtained ISO 13485 quality system certification and CGuard EPS that the Company currently distribute into the European Union, displays the required CE mark. In order to maintain certification, the Company is required to pass an annual surveillance audit conducted by Notified Body auditors. The European Union replaced the MDD with the new MDR regulations. The MDR entered into force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic on May 26, 2021 and which changes several aspects of the regulatory framework in the European Union. Manufacturers had the duration of the transition period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark. In the Company’s specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022, and the Company is in the final stages of technical documentation review by the Notified Body auditor to meet the MDR requirements for recertification. In the meantime, on February 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU until August 15, 2023, subject to certain procedural requirements. Subsequently, on March 20, 2023 Regulation (EU) 2023/607 was published allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027. As a result of the foregoing, the Company may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while the Company’s MDR CE recertification is pending.

 

 

  d. Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe
     
   

In February 2022, Russia launched a military invasion into Ukraine. The Company derived approximately 12.1% of total sales in Russia and Belarus in 2022 while during the three months ended March 31, 2023 and March 31,2022, The Company’s sales to Russia and Belarus were 7.9% and 1.5% respectively. The escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s operations, sales, and future growth prospects in that region.

 

As a result of the crisis in Ukraine, the United States and the EU have implemented sanctions against certain Russian individuals and entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region. The Company’s global operations expose the Company to risks that could adversely affect the Company’s business, financial condition, results of operations, cash flows or the market price of the Company’s securities, including the potential for increased tensions between the United States and Russia resulting from the current situation involving Russia and Ukraine, tariffs, economic sanctions and import-export restrictions imposed by either nation, and retaliatory actions by the other nation, as well as the potential negative impact on the Company’s business and sales in Russia, and Belarus. Current geopolitical instability in Russia and Ukraine and related sanctions by the U.S. government against certain companies and individuals may hinder the Company’s ability to conduct business with potential or existing customers and vendors in these countries.

 

The U.S. government has imposed sanctions through several executive orders restricting U.S. companies from conducting business with specified Russian individuals and companies. While the Company believes that the executive orders currently do not preclude the Company from conducting business with the Company’s current customers or vendors in Russia, and Belarus, the sanctions imposed by the U.S. government may be expanded in the future to restrict the Company from engaging with them. If the Company is unable to conduct business with new or existing customers or vendors or pursue business opportunities in Russia, or Belarus, the Company’s business, including revenue, profitability and cash flows, and operations could be adversely affected. The Company cannot provide assurance that current sanctions or potential future changes in sanctions will not have a material impact on the Company’s operations in Russia, and Belarus or on the Company’s financial results.

 
XML 19 R9.htm IDEA: XBRL DOCUMENT v3.23.1
BASIS OF PRESENTATION
 3 Months Ended
Mar. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
BASIS OF PRESENTATION

NOTE 2 - BASIS OF PRESENTATION

 

The accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of the Company, the financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2023 and its results of operations, changes in equity and cash flows for the three months ended March 31, 2023 and 2022. These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2023. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of results that could be expected for the entire fiscal year.

 

 
XML 20 R10.htm IDEA: XBRL DOCUMENT v3.23.1
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS
 3 Months Ended
Mar. 31, 2023
Accounting Changes and Error Corrections [Abstract]  
RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS

NOTE 3 - RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS

 

    Newly issued accounting pronouncements
     
    Financial Instruments - Credit Losses
     
   

In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates (“ASU 2019-10”). The purpose of this amendment is to create a two-tier rollout of major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU 2016-13. Larger public companies had an effective date for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, the Company met the definition of an SRC and adopted the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption. The Company adopted the provisions of this update as of January 1, 2023 with no material impact on its consolidated financial statements.

 

 
XML 21 R11.htm IDEA: XBRL DOCUMENT v3.23.1
EQUITY
 3 Months Ended
Mar. 31, 2023
Equity [Abstract]  
EQUITY

NOTE 4 - EQUITY:

 

 

a.

 

As of March 31, 2023, there were 1,718 shares of Series C Preferred Stock outstanding, convertible into an aggregate of 2,280 shares of our common stock.

 

As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of 1,793,504 shares of common stock as follows:

 

   Number of
underlying
Common stock		   Weighted
average
exercise price		 
Series E Warrants   198,159   $27.000 
Series F Warrants   433,878   $7.425 
Series G Warrants   1,092,344   $10.230 
Underwriter Warrants   17,966   $7.425 
Other warrants   51,157    225 and above 
Total Warrants   1,793,504   $  

 

As of March 31, 2023, the Company had 155,000,000 authorized shares of capital stock, par value $0.0001 per share, of which 150,000,000 are shares of common stock and 5,000,000 are shares of “blank check” preferred stock.

 

b. During the three months ended March 31, 2023, the Company granted to a consultant options to purchase a total of 50,000 shares of the Company’s common stock. The options have an exercise price of $1.15 per share, which was the fair market value of the Company’s common stock on the date of the grant. 45,000 options are subject to a three-year vesting period (of which 20,000 options are vesting in the first year, 15,000 options are vesting in the second year and 10,000 options are vesting in the third year) and 5,000 options with performance conditions related to marketing activities.

 

In calculating the fair value of the above options, the Company used the following assumptions: dividend yield of 0% and expected term of 5.5-6.5 years; expected volatility ranging from 124.58%-125.61%; and risk-free interest rate ranging from 3.65%-3.68%.

 

The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $50,658.

 

 
XML 22 R12.htm IDEA: XBRL DOCUMENT v3.23.1
RELATED PARTIES TRANSACTIONS
 3 Months Ended
Mar. 31, 2023
Related Party Transactions [Abstract]  
RELATED PARTIES TRANSACTIONS

NOTE 5 – RELATED PARTIES TRANSACTIONS

 

During the three months ended March 31, 2022, a consulting company whose founder and CEO is our board member provided certain marketing services in the amount of $6,276.

 
XML 23 R13.htm IDEA: XBRL DOCUMENT v3.23.1
NET LOSS PER SHARE
 3 Months Ended
Mar. 31, 2023
Earnings Per Share [Abstract]  
NET LOSS PER SHARE

NOTE 6 - NET LOSS PER SHARE:

 

Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. The calculation of diluted net loss per share excludes potential share issuances of common stock upon the exercise of share options, warrants, and unvested restricted stocks and unvested restricted stock units as the effect is anti-dilutive.

 

 

The total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred Stock excluded from the calculations of diluted loss per share were 2,773,675. This amount includes 342,766 of unvested restricted stock included in the number of issued and outstanding shares as of March 31, 2023.

 

 

The total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred Stock excluded from the calculations of diluted loss per share were 2,903,634. This amount includes 547,383 of unvested restricted stock included in the number of issued and outstanding shares as of March 31, 2022.

 
XML 24 R14.htm IDEA: XBRL DOCUMENT v3.23.1
FINANCIAL INSTRUMENTS
 3 Months Ended
Mar. 31, 2023
Investments, All Other Investments [Abstract]  
FINANCIAL INSTRUMENTS

NOTE 7 - FINANCIAL INSTRUMENTS:

 

a.Fair value of financial instruments

 

The carrying amounts of financial instruments included in working capital approximate their fair value due to the relatively short-term maturities of such instruments.

 

b.As of March 31, 2023, and December 31, 2022, allowance for expected credit loss was immaterial.

 
XML 25 R15.htm IDEA: XBRL DOCUMENT v3.23.1
INVENTORY
 3 Months Ended
Mar. 31, 2023
Inventory Disclosure [Abstract]  
INVENTORY

NOTE 8 - INVENTORY:

 

           
   March 31,   December 31, 
   2023   2022 
   ($ in thousands) 
Finished goods  $138   $179 
Work in process   690    510 
Raw materials and supplies   869    932 
Total inventory  $1,697   $1,621 

 

 
XML 26 R16.htm IDEA: XBRL DOCUMENT v3.23.1
ACCOUNTS PAYABLE AND ACCRUALS - OTHER
 3 Months Ended
Mar. 31, 2023
Payables and Accruals [Abstract]  
ACCOUNTS PAYABLE AND ACCRUALS - OTHER

NOTE 9 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER:

 

           
   March 31,   December 31, 
   2023   2022 
   ($ in thousands) 
Employees and employee institutions   970    1,853 
Accrued vacation and recreation pay   240    197 
Accrued expenses   933    554 
Clinical trial accrual   1,046    1,258 
Current Operating lease liabilities   417    419 
Other   170    130 
Accounts payable and accruals-other  $3,776   $4,411 

 
XML 27 R17.htm IDEA: XBRL DOCUMENT v3.23.1
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES
 3 Months Ended
Mar. 31, 2023
Segment Reporting [Abstract]  
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES

NOTE 10 - DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES:

 

Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:

 

   Three months ended
March 31		 
   2023   2022 
   ($ in thousands) 
Italy  $267   $243 
Germany   214    249 
Other   758    691 
   $1,239   $1,183 

 

By product:

 

   Three months ended
March 31		 
   2023   2022 
   ($ in thousands) 
CGuard  $1,239   $1,161 
MGuard   -    22 
   $1,239   $1,183 

 

By principal customers:

 

   Three months ended
March 31		 
   2023   2022 
Customer A   17%   21%
Customer B   13%   11%

 

All tangible long lived assets are located in Israel.

 

 
XML 28 R18.htm IDEA: XBRL DOCUMENT v3.23.1
SUBSEQUENT EVENTS
 3 Months Ended
Mar. 31, 2023
Subsequent Events [Abstract]  
SUBSEQUENT EVENTS

NOTE 11 – SUBSEQUENT EVENTS

 

On May 12, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which the Company agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of 10,266,270 shares (the “Private Placement Shares”) of the Company’s common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to 15,561,894 shares of common stock and warrants to purchase up to an aggregate of 51,656,328 shares of common stock, consisting of Series H warrants to purchase up to 12,914,086 shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to 12,914,078 shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to 12,914,086 shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to 12,914,086 shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $1.6327 per Private Placement Share and associated Warrants and an offering price of $1.6326 per Pre-Funded Warrant and associated Warrants.

 

The Pre-Funded Warrants will be immediately exercisable at an exercise price of $0.0001 per share and will not expire until exercised in full. The Warrants will be immediately exercisable upon issuance at an exercise price of $1.3827 per share, subject to adjustment as set forth therein. The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the Series H Warrants, 20 trading days following the Company’s public release of primary and secondary end points related to one year follow up study results from the Company’s C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading days following the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”) for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in the United States begins. The Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the warrants.

 

In connection with the Purchase Agreement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Registration Rights Agreement, the Company is required to file a resale registration statement (the “Registration Statement”) with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”), and to have such Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. The Company will be obligated to pay certain liquidated damages if the Company fails to file the Registration Statement when required, fails to cause the Registration Statement to be declared effective by the SEC when required, of if the Company fails to maintain the effectiveness of the Registration Statement.

 

Aggregate gross proceeds to the Company in respect of the Private Placement Offering are expected to be approximately $42.2 million, before deducting fees payable to the placement agent and other offering expenses payable by the Company which are expected to amount to approximately $4.6 million. If the Warrants are exercised in cash in full this would result in an additional $71.4 million of proceeds. The Private Placement Offering is expected to close on or about May 15, 2023, subject to satisfaction of customary closing conditions.
XML 29 R19.htm IDEA: XBRL DOCUMENT v3.23.1
EQUITY (Tables)
 3 Months Ended
Mar. 31, 2023
Equity [Abstract]  
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK

As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of 1,793,504 shares of common stock as follows:

 

   Number of
underlying
Common stock		   Weighted
average
exercise price		 
Series E Warrants   198,159   $27.000 
Series F Warrants   433,878   $7.425 
Series G Warrants   1,092,344   $10.230 
Underwriter Warrants   17,966   $7.425 
Other warrants   51,157    225 and above 
Total Warrants   1,793,504   $  
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INVENTORY (Tables)
 3 Months Ended
Mar. 31, 2023
Inventory Disclosure [Abstract]  
SCHEDULE OF INVENTORY

 

           
   March 31,   December 31, 
   2023   2022 
   ($ in thousands) 
Finished goods  $138   $179 
Work in process   690    510 
Raw materials and supplies   869    932 
Total inventory  $1,697   $1,621 
XML 31 R21.htm IDEA: XBRL DOCUMENT v3.23.1
ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Tables)
 3 Months Ended
Mar. 31, 2023
Payables and Accruals [Abstract]  
SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER

 

           
   March 31,   December 31, 
   2023   2022 
   ($ in thousands) 
Employees and employee institutions   970    1,853 
Accrued vacation and recreation pay   240    197 
Accrued expenses   933    554 
Clinical trial accrual   1,046    1,258 
Current Operating lease liabilities   417    419 
Other   170    130 
Accounts payable and accruals-other  $3,776   $4,411 
XML 32 R22.htm IDEA: XBRL DOCUMENT v3.23.1
DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES (Tables)
 3 Months Ended
Mar. 31, 2023
Segment Reporting [Abstract]  
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS

Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:

 

   Three months ended
March 31		 
   2023   2022 
   ($ in thousands) 
Italy  $267   $243 
Germany   214    249 
Other   758    691 
   $1,239   $1,183 
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT

By product:

 

   Three months ended
March 31		 
   2023   2022 
   ($ in thousands) 
CGuard  $1,239   $1,161 
MGuard   -    22 
   $1,239   $1,183 
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS

By principal customers:

 

   Three months ended
March 31		 
   2023   2022 
Customer A   17%   21%
Customer B   13%   11%
XML 33 R23.htm IDEA: XBRL DOCUMENT v3.23.1
DESCRIPTION OF BUSINESS (Details Narrative)
$ in Millions
May 12, 2023
USD ($)
Securities Purchase Agreement [Member] | Subsequent Event [Member]  
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items]  
Private placement $ 42.2
XML 34 R24.htm IDEA: XBRL DOCUMENT v3.23.1
SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK (Details)
shares in Thousands
 3 Months Ended
Mar. 31, 2023
$ / shares
shares
Class of Stock [Line Items]  
Total Warrants 1,793,504
Series E Warrants [Member]  
Class of Stock [Line Items]  
Total Warrants 198,159
Weighted average exercise price | $ / shares $ 27.000
Series F Warrants [Member]  
Class of Stock [Line Items]  
Total Warrants 433,878
Weighted average exercise price | $ / shares $ 7.425
Series G Warrants [Member]  
Class of Stock [Line Items]  
Total Warrants 1,092,344
Weighted average exercise price | $ / shares $ 10.230
Underwriter Warrants [Member]  
Class of Stock [Line Items]  
Total Warrants 17,966
Weighted average exercise price | $ / shares $ 7.425
Other Warrants [Member]  
Class of Stock [Line Items]  
Total Warrants 51,157
Weighted average exercise price, description 225 and above
XML 35 R25.htm IDEA: XBRL DOCUMENT v3.23.1
EQUITY (Details Narrative) - USD ($)
 3 Months Ended
Mar. 31, 2023
Dec. 31, 2022
Class of Stock [Line Items]    
Common stock, shares outstanding 8,326,648 8,330,918
Capital stock shares authorized 155,000,000  
Capital stock par value $ 0.0001  
Common stock shares authorized 150,000,000 150,000,000
Stock option description 45,000 options are subject to a three-year vesting period (of which 20,000 options are vesting in the first year, 15,000 options are vesting in the second year and 10,000 options are vesting in the third year) and 5,000 options with performance conditions related to marketing activities.  
Expected dividend rate 0.00%  
Expected volatility, minimum 124.58%  
Expected volatility, maximum 125.61%  
Risk-free interest rate, minimum 3.65%  
Risk-free interest rate, maximum 3.68%  
Minimum [Member]    
Class of Stock [Line Items]    
Expected term 5 years 6 months  
Maximum [Member]    
Class of Stock [Line Items]    
Expected term 6 years 6 months  
Three Year Vesting Period [Member]    
Class of Stock [Line Items]    
Stock option grants in period 45,000  
First Year Vesting Period [Member]    
Class of Stock [Line Items]    
Stock option grants in period 20,000  
Second Year Vesting Period [Member]    
Class of Stock [Line Items]    
Stock option grants in period 15,000  
Third Year Vesting Period [Member]    
Class of Stock [Line Items]    
Stock option grants in period 10,000  
Performance Conditions [Member]    
Class of Stock [Line Items]    
Stock option grants in period 5,000  
Share-Based Payment Arrangement, Option [Member]    
Class of Stock [Line Items]    
Stock option grants in period 50,000  
Stock option exercise price $ 1.15  
Vesting period 3 years  
Fair value stock option price $ 50,658  
Preferred Stock Blank Check [Member]    
Class of Stock [Line Items]    
Preferred stock shares authorized 5,000,000  
At The Market Offering [Member] | Warrant [Member]    
Class of Stock [Line Items]    
Purchase of warrants 1,793,504  
Series C Convertible Preferred Stock [Member]    
Class of Stock [Line Items]    
Common stock, shares outstanding 1,718  
Conversion of Series C Convertible Preferred Stock to common shares, shares 2,280  
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RELATED PARTIES TRANSACTIONS (Details Narrative)
 3 Months Ended
Mar. 31, 2022
USD ($)
New Director [Member]  
Deferred Compensation Arrangement with Individual, Excluding Share-Based Payments and Postretirement Benefits [Line Items]  
Marketing services expense $ 6,276
XML 37 R27.htm IDEA: XBRL DOCUMENT v3.23.1
NET LOSS PER SHARE (Details Narrative) - shares
 3 Months Ended
Mar. 31, 2023
Mar. 31, 2022
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Diluted loss per share 2,773,675 2,903,634
Restricted Stock [Member]    
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items]    
Diluted loss per share 342,766 547,383
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SCHEDULE OF INVENTORY (Details) - USD ($)
$ in Thousands
Mar. 31, 2023
Dec. 31, 2022
Inventory Disclosure [Abstract]    
Finished goods $ 138 $ 179
Work in process 690 510
Raw materials and supplies 869 932
Total inventory $ 1,697 $ 1,621
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SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER (Details) - USD ($)
$ in Thousands
Mar. 31, 2023
Dec. 31, 2022
Payables and Accruals [Abstract]    
Employees and employee institutions $ 970 $ 1,853
Accrued vacation and recreation pay 240 197
Accrued expenses 933 554
Clinical trial accrual 1,046 1,258
Current Operating lease liabilities 417 419
Other 170 130
Accounts payable and accruals-other $ 3,776 $ 4,411
XML 40 R30.htm IDEA: XBRL DOCUMENT v3.23.1
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS (Details) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2023
Mar. 31, 2022
Revenues from External Customers and Long-Lived Assets [Line Items]    
Revenues $ 1,239 $ 1,183
ITALY    
Revenues from External Customers and Long-Lived Assets [Line Items]    
Revenues 267 243
GERMANY    
Revenues from External Customers and Long-Lived Assets [Line Items]    
Revenues 214 249
Other Countries [Member]    
Revenues from External Customers and Long-Lived Assets [Line Items]    
Revenues $ 758 $ 691
XML 41 R31.htm IDEA: XBRL DOCUMENT v3.23.1
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT (Details) - USD ($)
$ in Thousands
 3 Months Ended
Mar. 31, 2023
Mar. 31, 2022
Revenue from External Customer [Line Items]    
Revenue $ 1,239 $ 1,183
CGuard EPS [Member]    
Revenue from External Customer [Line Items]    
Revenue 1,239 1,161
MGuard Prime EPS [Member]    
Revenue from External Customer [Line Items]    
Revenue $ 22
XML 42 R32.htm IDEA: XBRL DOCUMENT v3.23.1
SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS (Details) - Sales [Member] - Customer Concentration Risk [Member]
 3 Months Ended
Mar. 31, 2023
Mar. 31, 2022
Customer A [Member]    
Revenue, Major Customer [Line Items]    
Percentage of revenues per major customer 17.00% 21.00%
Customer B [Member]    
Revenue, Major Customer [Line Items]    
Percentage of revenues per major customer 13.00% 11.00%
XML 43 R33.htm IDEA: XBRL DOCUMENT v3.23.1
SUBSEQUENT EVENTS (Details Narrative) - Subsequent Event [Member]
$ / shares in Units, $ in Millions
May 12, 2023
USD ($)
$ / shares
shares
Subsequent Event [Line Items]  
Warrant exercise price | $ / shares $ 1.3827
Securities Purchase Agreement [Member]  
Subsequent Event [Line Items]  
Private placement | $ $ 42.2
Offering expenses | $ 4.6
Warrant exercises | $ $ 71.4
Warrant [Member]  
Subsequent Event [Line Items]  
Offering price | $ / shares $ 1.6326
Warrant exercise price | $ / shares $ 0.0001
Private Placement [Member]  
Subsequent Event [Line Items]  
Number of stock issued 10,266,270
Private Placement [Member] | Warrant [Member]  
Subsequent Event [Line Items]  
Number of warrants or rights outstanding 15,561,894
Offering price | $ / shares $ 1.6327
Private Placement [Member] | Common Stock [Member]  
Subsequent Event [Line Items]  
Number of warrants or rights outstanding 51,656,328
Private Placement [Member] | Series H Warrants [Member]  
Subsequent Event [Line Items]  
Number of warrants or rights outstanding 12,914,086
Private Placement [Member] | Series I Warrants [Member]  
Subsequent Event [Line Items]  
Number of warrants or rights outstanding 12,914,078
Private Placement [Member] | Series J Warrants [Member]  
Subsequent Event [Line Items]  
Number of warrants or rights outstanding 12,914,086
Private Placement [Member] | Series K Warrants [Member]  
Subsequent Event [Line Items]  
Number of warrants or rights outstanding 12,914,086
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DE 26-2123838 4 Menorat Hamaor St. Tel Aviv IL 6744832 (888) 776-6204 Yes Yes Non-accelerated Filer true false false Common Stock, par value $0.0001 per share NSPR NASDAQ 8356394 4228000 4632000 8657000 13171000 1417000 1034000 310000 213000 394000 655000 1697000 1621000 16703000 21326000 887000 917000 1472000 1554000 859000 856000 3218000 3327000 19921000 24653000 607000 659000 3776000 4411000 4383000 5070000 1081000 1195000 1031000 995000 2112000 2190000 6495000 7260000 0.0001 0.0001 150000000 150000000 8326648 8326648 8330918 8330918 1000 1000 0.0001 0.0001 1172000 1172000 1718 1718 1718 1718 219266000 218977000 -205841000 -201585000 13426000 17393000 19921000 24653000 1239000 1183000 866000 1061000 373000 122000 1843000 1680000 788000 746000 2123000 2182000 4754000 4608000 -4381000 -4486000 125000 5000 -4256000 -4481000 -0.53 -0.57 8093340 7804245 8296256 1000 1718 216625000 -183094000 33532000 -4481000 -4481000 4563 21620 653000 653000 8317876 1000 1718 217278000 -187575000 29704000 8330918 1000 1718 218977000 -201585000 17393000 8330918 1000 1718 218977000 -201585000 17393000 -4256000 -4256000 4270 -4270 289000 289000 -4270 289000 289000 8326648 1000 1718 219266000 -205841000 13426000 8326648 1000 1718 219266000 -205841000 13426000 -4256000 -4481000 55000 41000 36000 46000 -22000 -7000 34000 25000 289000 653000 23000 18000 -14000 17000 -261000 -231000 383000 -111000 97000 -74000 76000 143000 -52000 7000 -633000 -656000 -4831000 -4134000 25000 37000 2500000 6000000 7000000 6000000 26000 28000 4449000 -65000 -22000 -7000 -404000 -4206000 4632000 12004000 4228000 7798000 <p id="xdx_801_eus-gaap--NatureOfOperations_zboRiqJQ4Eg3" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 1 - <span id="xdx_821_zqmIFncsj8fa">DESCRIPTION OF BUSINESS</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>a.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>General</b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">InspireMD, Inc., a Delaware corporation (the “Company”), together with its subsidiaries, is a medical device company focusing on the development and commercialization of its proprietary MicroNet™ stent platform technology for the treatment of complex vascular and coronary disease. MicroNet, a micron mesh sleeve, is wrapped over a stent to provide embolic protection in stenting procedures. </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s carotid product (CGuard™ EPS) combines MicroNet and a self-expandable nitinol stent in a single device to treat carotid artery disease.</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company’s MGuard™ Prime™ embolic protection system (“MGuard Prime EPS”) was marketed for use in patients with acute coronary syndromes, notably acute myocardial infarction (heart attack) and saphenous vein graft coronary interventions, or bypass surgery. MGuard Prime EPS combines MicroNet with a bare-metal cobalt-chromium based stent. MGuard Prime EPS received CE mark approval in the European Union in October 2010 for improving luminal diameter and providing embolic protection. Over the past years, there has been a shift in industry preferences away from bare-metal stents, such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients. As a result of declining sales of the MGuard Prime EPS, which the Company believes is largely driven by the predominant industry preferences favoring drug-eluting, or drug-coated, stents, during the second quarter of 2022, the Company ceased sales of the Company’s MGuard Prime EPS following a phase out period.</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company markets its products through distributors in international markets, mainly in Europe.</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>b.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Liquidity</b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Company has an accumulated deficit as of March 31, 2023, as well as a history of net losses and negative operating cash flows in recent years. The Company expects to continue incurring losses and negative cash flows from operations until its product, CGuard™ EPS, reaches commercial profitability. As a result of these expected losses and negative cash flows from operations, along with the Company’s current cash position, the Company has sufficient resources to fund operations until the end of September 2023. Therefore, there is substantial doubt about the Company’s ability to continue as a going concern. These financial statements have been prepared assuming that the Company will continue as a going concern and do not include any adjustments that might result from the outcome of this uncertainty.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Management’s plans include the continued commercialization of the Company’s product and raising capital through the sale of additional equity securities, debt or capital inflows from strategic partnerships. There are no assurances however, that the Company will be successful in obtaining the level of financing needed for its operations. If the Company is unsuccessful in commercializing its products and raising capital, it may need to reduce activities, curtail or cease operations.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify">On May 12, 2023, the Company entered into a securities purchase agreement for the issuance and sale of Company securities in a private placement. <span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aggregate gross proceeds to the Company in respect of the private placement is expected to be approximately $<span id="xdx_90E_eus-gaap--ProceedsFromIssuanceOfPrivatePlacement_pn5n6_c20230511__20230512__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_zaQThNHS6KN7" title="Private placement">42.2</span> million, before deducting fees payable to the placement agent and other offering expenses payable by the Company and before exercising any warrants. The offering is expected to close on or about May 15, 2023, subject to the satisfaction of customary closing conditions. </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>c.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Failure to satisfy regulatory requirements of the new European Medical Device Regulation could prevent the Company from marketing CGuard EPS in countries requiring the CE Mark.</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">For the European Union nations, medical devices must obtain a CE mark before they may be placed on the market. In order to obtain and maintain the CE mark, the Company must Company with EU law on medical devices, which, until May 26, 2021 was governed by the MDD, by presenting comprehensive technical files for the Company’s products demonstrating safety and efficacy of the product to be placed on the market and passing initial and annual quality management system audit as per ISO 13485 standard by a European Notified Body. The company has obtained ISO 13485 quality system certification and CGuard EPS that the Company currently distribute into the European Union, displays the required CE mark. In order to maintain certification, the Company is required to pass an annual surveillance audit conducted by Notified Body auditors. The European Union replaced the MDD with the new MDR regulations. The MDR entered into force after a transitional period of three years and a one year extension of that transition period due to the COVID-19 pandemic on May 26, 2021 and which changes several aspects of the regulatory framework in the European Union. Manufacturers had the duration of the transition period to update their technical documentation and processes to meet the new requirements in order to obtain a CE Mark. In the Company’s specific case, the Company’s CE mark for CGuard EPS under the MDD expired on November 12, 2022, and the Company is in the final stages of technical documentation review by the Notified Body auditor to meet the MDR requirements for recertification. In the meantime, on February 14, 2023, the Company received a derogation per Article 97 paragraph 1 of Regulation 2017/745 from the Agency for Medicines and Health Products (FAMHP) allowing the Company to continue marketing CGuard EPS in the EU until August 15, 2023, subject to certain procedural requirements. Subsequently, on March 20, 2023 Regulation (EU) 2023/607 was published allowing the Company to continue marketing CGuard EPS in EU countries under the MDD directive until December 31, 2027. As a result of the foregoing, the Company may market and sell CGuard EPS in the EU and certain other jurisdictions subject to certain procedural requirements while the Company’s MDR CE recertification is pending.</span></p></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="width: 0.5in"> </td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>d.</b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Risks Related to the Geopolitical and Military Tensions Between Russia and Ukraine in Europe</b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td> </td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td> </td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In February 2022, Russia launched a military invasion into Ukraine. The Company derived approximately 12.1% of total sales in Russia and Belarus in 2022 while during the three months ended March 31, 2023 and March 31,2022, The Company’s sales to Russia and Belarus were 7.9% and 1.5% respectively. The escalation of geopolitical instability in Russia and Ukraine as well as currency fluctuations in the Russian Ruble could negatively impact the Company’s operations, sales, and future growth prospects in that region.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As a result of the crisis in Ukraine, the United States and the EU have implemented sanctions against certain Russian individuals and entities and have made it more difficult for the Company to collect on outstanding accounts receivable from customers in this region. The Company’s global operations expose the Company to risks that could adversely affect the Company’s business, financial condition, results of operations, cash flows or the market price of the Company’s securities, including the potential for increased tensions between the United States and Russia resulting from the current situation involving Russia and Ukraine, tariffs, economic sanctions and import-export restrictions imposed by either nation, and retaliatory actions by the other nation, as well as the potential negative impact on the Company’s business and sales in Russia, and Belarus. Current geopolitical instability in Russia and Ukraine and related sanctions by the U.S. government against certain companies and individuals may hinder the Company’s ability to conduct business with potential or existing customers and vendors in these countries.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The U.S. government has imposed sanctions through several executive orders restricting U.S. companies from conducting business with specified Russian individuals and companies. While the Company believes that the executive orders currently do not preclude the Company from conducting business with the Company’s current customers or vendors in Russia, and Belarus, the sanctions imposed by the U.S. government may be expanded in the future to restrict the Company from engaging with them. If the Company is unable to conduct business with new or existing customers or vendors or pursue business opportunities in Russia, or Belarus, the Company’s business, including revenue, profitability and cash flows, and operations could be adversely affected. The Company cannot provide assurance that current sanctions or potential future changes in sanctions will not have a material impact on the Company’s operations in Russia, and Belarus or on the Company’s financial results.</span></p></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> 42200000 <p id="xdx_808_eus-gaap--BasisOfAccounting_z2OTnFICU8t5" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 2 - <span id="xdx_829_zBapmg9ZwAr2">BASIS OF PRESENTATION</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify; text-indent: -12pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The accompanying unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements. In the opinion of the Company, the financial statements reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of its financial position as of March 31, 2023 and its results of operations, changes in equity and cash flows for the three months ended March 31, 2023 and 2022. These consolidated financial statements and notes thereto are unaudited and should be read in conjunction with the Company’s audited financial statements for the year ended December 31, 2022, as found in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission on March 30, 2023. The results of operations for the three months ended March 31, 2023 are not necessarily indicative of results that could be expected for the entire fiscal year.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.75in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_805_eus-gaap--NewAccountingPronouncementsAndChangesInAccountingPrinciplesTextBlock_zVyTYu0ktqgk" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 3 - <span id="xdx_822_z4UNDCV48sL9">RECENTLY ADOPTED AND ISSUED ACCOUNTING PRONOUNCEMENTS</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: center"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Newly issued accounting pronouncements</b></span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Financial Instruments - Credit Losses</span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td></tr> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326)-Measurement of Credit Losses on Financial Instruments. This guidance replaces the current incurred loss impairment methodology. Under the new guidance, on initial recognition and at each reporting period, an entity is required to recognize an allowance that reflects its current estimate of credit losses expected to be incurred over the life of the financial instrument based on historical experience, current conditions and reasonable and supportable forecasts. In November 2019, the FASB issued ASU No. 2019-10, Financial Instruments - Credit Losses (Topic 326), Derivatives and Hedging (Topic 815), and Leases (Topic 842): Effective Dates (“ASU 2019-10”). The purpose of this amendment is to create a two-tier rollout of major updates, staggering the effective dates between larger public companies and all other entities. This granted certain classes of companies, including Smaller Reporting Companies (“SRCs”), additional time to implement major FASB standards, including ASU 2016-13. Larger public companies had an effective date for fiscal years beginning after December 15, 2019, including interim periods within those fiscal years. All other entities are permitted to defer adoption of ASU 2016-13, and its related amendments, until the earlier of fiscal periods beginning after December 15, 2022. Under the current SEC definitions, the Company met the definition of an SRC and adopted the deferral period for ASU 2016-13. The guidance requires a modified retrospective transition approach through a cumulative-effect adjustment to retained earnings as of the beginning of the period of adoption. The Company adopted the provisions of this update as of January 1, 2023 with no material impact on its consolidated financial statements.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/></p></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p id="xdx_800_eus-gaap--StockholdersEquityNoteDisclosureTextBlock_z5OEw14c8Wf" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 4 - <span id="xdx_82E_zq7pA3Vp3k89">EQUITY</span>:</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; border-collapse: collapse"> <tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>a.</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p></td> <td style="font: 10pt Times New Roman, Times, Serif"><p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of March 31, 2023, there were <span id="xdx_909_eus-gaap--CommonStockSharesOutstanding_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zOCkDNc8vyS9" title="Common stock, shares outstanding">1,718</span> shares of Series C Preferred Stock outstanding, convertible into an aggregate of <span id="xdx_902_eus-gaap--StockIssuedDuringPeriodSharesConversionOfConvertibleSecurities_pid_c20230101__20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesCConvertiblePreferredStockMember_zqW2rVBqB969" title="Conversion of Series C Convertible Preferred Stock to common shares, shares">2,280</span> shares of our common stock.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"/></td></tr> </table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_89B_eus-gaap--ScheduleOfStockholdersEquityNoteWarrantsOrRightsTextBlock_zjTIvld6SO07" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of <span class="xdx_phnt_RGlzY2xvc3VyZSAtIEVRVUlUWSAoRGV0YWlscyBOYXJyYXRpdmUpAA__" id="xdx_90C_eus-gaap--ClassOfWarrantOrRightOutstanding_iI_pid_c20230331__us-gaap--SubsidiarySaleOfStockAxis__custom--AtTheMarketOfferingMember__us-gaap--StatementEquityComponentsAxis__us-gaap--WarrantMember_zjOXILoj9Xt8" title="Purchase of warrants">1,793,504</span> shares of common stock as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B4_ztPpoKG2354e" style="display: none">SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 75%; margin-left: 0.75in"> <tr style="vertical-align: bottom"> <td> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center">Number of<br/> underlying<br/> Common stock</td><td style="padding-bottom: 1.5pt"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center">Weighted <br/> average <br/> exercise price</td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: justify">Series E Warrants</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_98C_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesEWarrantsMember_zcQly19jZ08j" style="width: 16%; text-align: right" title="Total Warrants">198,159</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_987_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesEWarrantsMember_z96nedqX74Il" style="width: 16%; text-align: right" title="Weighted average exercise price">27.000</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Series F Warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_985_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesFWarrantsMember_zb6fLueGS4x8" style="text-align: right" title="Total Warrants">433,878</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_98F_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesFWarrantsMember_zWp9STpQZhI9" style="text-align: right" title="Weighted average exercise price">7.425</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Series G Warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_980_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesGWarrantsMember_zhW8GYdc4YG7" style="text-align: right" title="Total Warrants">1,092,344</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_988_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesGWarrantsMember_z82zjG8wXQme" style="text-align: right" title="Weighted average exercise price">10.230</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Underwriter Warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_984_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--UnderwriterWarrantsMember_z416mbrybjsg" style="text-align: right" title="Total Warrants">17,966</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_989_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--UnderwriterWarrantsMember_zdQ9rohnytj7" style="text-align: right" title="Weighted average exercise price">7.425</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Other warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98C_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--OtherWarrantsMember_zDWbYZOGqIw7" style="text-align: right" title="Total Warrants">51,157</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98C_ecustom--ClassOfWarrantsWeightedAverageExercisePriceDescription_c20230101__20230331__us-gaap--StatementClassOfStockAxis__custom--OtherWarrantsMember_zMGxYZZHahhc" style="text-align: right" title="Weighted average exercise price, description"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">225 and above</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Total Warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98E_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331_zgaRfM37Z3y9" style="text-align: right" title="Total Warrants">1,793,504</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td><td style="text-align: left"> </td></tr> </table> <p id="xdx_8A8_z9iSfOTLVgP5" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.75in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of March 31, 2023, the Company had <span id="xdx_904_eus-gaap--CapitalUnitsAuthorized_iI_c20230331_zIf0kphVOUGd" title="Capital stock shares authorized">155,000,000</span> authorized shares of capital stock, par value $<span id="xdx_901_ecustom--CapitalStockParOrStatedValuePerShare_iI_c20230331_zbRlFfgHSfD2" title="Capital stock par value">0.0001</span> per share, of which <span id="xdx_905_eus-gaap--CommonStockSharesAuthorized_iI_c20230331_zhC1TzSPeepa" title="Common stock shares authorized">150,000,000</span> are shares of common stock and <span id="xdx_90E_eus-gaap--PreferredStockSharesAuthorized_iI_c20230331__us-gaap--StatementEquityComponentsAxis__custom--PreferredStockBlankCheckMember_zRlJ392rckNe" title="Preferred stock shares authorized">5,000,000</span> are shares of “blank check” preferred stock.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>b. </b>During the three months ended March 31, 2023, the Company granted to a consultant options to purchase a total of <span id="xdx_90E_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_pid_c20230101__20230331__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zba6tRfrCwk5" title="Stock option grants in period">50,000</span> shares of the Company’s common stock. The options have an exercise price of $<span id="xdx_906_eus-gaap--ShareBasedCompensationArrangementsByShareBasedPaymentAwardOptionsGrantsInPeriodWeightedAverageExercisePrice_pid_c20230101__20230331__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zXbapNx5EwG8" title="Stock option exercise price">1.15</span> per share, which was the fair market value of the Company’s common stock on the date of the grant. <span id="xdx_90A_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardDescription_c20230101__20230331_zVhTqHYwA0L3" title="Stock option description"><span id="xdx_909_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20230101__20230331__us-gaap--VestingAxis__custom--ThreeYearVestingPeriodMember_zScw4DsT4AQa" title="Employees stock option grant">45,000</span> options are subject to a <span id="xdx_902_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardAwardVestingPeriod1_dxL_c20230101__20230331__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_z6cqkMbtKX8c" title="Vesting period::XDX::P3Y"><span style="-sec-ix-hidden: xdx2ixbrl0482">three</span></span>-year vesting period (of which <span id="xdx_90E_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20230101__20230331__us-gaap--VestingAxis__custom--FirstYearVestingPeriodMember_zE0KceTt6lB8" title="Stock option grants in period">20,000</span> options are vesting in the first year, <span id="xdx_905_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20230101__20230331__us-gaap--VestingAxis__custom--SecondYearVestingPeriodMember_zUMy9bEiWEzi" title="Stock option grants in period">15,000</span> options are vesting in the second year and <span id="xdx_907_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_c20230101__20230331__us-gaap--VestingAxis__custom--ThirdYearVestingPeriodMember_zEWT1VBHxne5" title="Stock option grants in period">10,000</span> options are vesting in the third year) and <span id="xdx_90D_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardOptionsGrantsInPeriod_pid_c20230101__20230331__us-gaap--VestingAxis__custom--PerformanceConditionsMember_zomC5y3GJf32" title="Stock option grants in period">5,000</span> options with performance conditions related to marketing activities.</span></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In calculating the fair value of the above options, the Company used the following assumptions: dividend yield of <span id="xdx_905_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedDividendRate_dp_uPure_c20230101__20230331_zMAP7oDuEKAf" title="Expected dividend rate">0</span>% and expected term of <span id="xdx_90B_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtYp_c20230101__20230331__srt--RangeAxis__srt--MinimumMember_zqPg48mJnmRi" title="Expected term">5.5</span>-<span id="xdx_90C_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardFairValueAssumptionsExpectedTerm1_dtY_c20230101__20230331__srt--RangeAxis__srt--MaximumMember_zBO5Uf5P8hB2" title="Expected term">6.5</span> years; expected volatility ranging from <span id="xdx_903_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMinimum_pid_dp_uPure_c20230101__20230331_z7nlomKiucqb" title="Expected volatility, minimum">124.58</span>%-<span id="xdx_909_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsExpectedVolatilityRateMaximum_pid_dp_uPure_c20230101__20230331_zCFBV3eNCGz7" title="Expected volatility, maximum">125.61</span>%; and risk-free interest rate ranging from <span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMinimum_pid_dp_uPure_c20230101__20230331_zxFU9aPM8EXf" title="Risk-free interest rate, minimum">3.65</span>%-<span id="xdx_90F_eus-gaap--ShareBasedCompensationArrangementByShareBasedPaymentAwardFairValueAssumptionsRiskFreeInterestRateMaximum_pid_dp_uPure_c20230101__20230331_zeJuctujjTw3" title="Risk-free interest rate, maximum">3.68</span>%.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; text-align: justify; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The fair value of the above options, using the Black-Scholes option-pricing model, was approximately $<span id="xdx_90A_eus-gaap--SharebasedCompensationArrangementBySharebasedPaymentAwardOptionsVestedInPeriodFairValue1_pp0d_c20230101__20230331__us-gaap--AwardTypeAxis__us-gaap--EmployeeStockOptionMember_zo0RY4E2WvPf" title="Fair value stock option price">50,658</span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> 1718 2280 <p id="xdx_89B_eus-gaap--ScheduleOfStockholdersEquityNoteWarrantsOrRightsTextBlock_zjTIvld6SO07" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of March 31, 2023, the Company has outstanding warrants to purchase an aggregate of <span class="xdx_phnt_RGlzY2xvc3VyZSAtIEVRVUlUWSAoRGV0YWlscyBOYXJyYXRpdmUpAA__" id="xdx_90C_eus-gaap--ClassOfWarrantOrRightOutstanding_iI_pid_c20230331__us-gaap--SubsidiarySaleOfStockAxis__custom--AtTheMarketOfferingMember__us-gaap--StatementEquityComponentsAxis__us-gaap--WarrantMember_zjOXILoj9Xt8" title="Purchase of warrants">1,793,504</span> shares of common stock as follows:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B4_ztPpoKG2354e" style="display: none">SCHEDULE OF ISSUANCE OF WARRANTS TO PURCHASE COMMON STOCK</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 75%; margin-left: 0.75in"> <tr style="vertical-align: bottom"> <td> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center">Number of<br/> underlying<br/> Common stock</td><td style="padding-bottom: 1.5pt"> </td><td style="padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; text-align: center">Weighted <br/> average <br/> exercise price</td><td style="padding-bottom: 1.5pt"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: justify">Series E Warrants</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_98C_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesEWarrantsMember_zcQly19jZ08j" style="width: 16%; text-align: right" title="Total Warrants">198,159</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_987_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesEWarrantsMember_z96nedqX74Il" style="width: 16%; text-align: right" title="Weighted average exercise price">27.000</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Series F Warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_985_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesFWarrantsMember_zb6fLueGS4x8" style="text-align: right" title="Total Warrants">433,878</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_98F_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesFWarrantsMember_zWp9STpQZhI9" style="text-align: right" title="Weighted average exercise price">7.425</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Series G Warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_980_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesGWarrantsMember_zhW8GYdc4YG7" style="text-align: right" title="Total Warrants">1,092,344</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_988_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--SeriesGWarrantsMember_z82zjG8wXQme" style="text-align: right" title="Weighted average exercise price">10.230</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Underwriter Warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_984_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--UnderwriterWarrantsMember_z416mbrybjsg" style="text-align: right" title="Total Warrants">17,966</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td id="xdx_989_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_pid_c20230331__us-gaap--StatementClassOfStockAxis__custom--UnderwriterWarrantsMember_zdQ9rohnytj7" style="text-align: right" title="Weighted average exercise price">7.425</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: justify">Other warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98C_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331__us-gaap--StatementClassOfStockAxis__custom--OtherWarrantsMember_zDWbYZOGqIw7" style="text-align: right" title="Total Warrants">51,157</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_98C_ecustom--ClassOfWarrantsWeightedAverageExercisePriceDescription_c20230101__20230331__us-gaap--StatementClassOfStockAxis__custom--OtherWarrantsMember_zMGxYZZHahhc" style="text-align: right" title="Weighted average exercise price, description"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">225 and above</span></td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: justify">Total Warrants</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98E_eus-gaap--ClassOfWarrantOrRightNumberOfSecuritiesCalledByWarrantsOrRights_iI_c20230331_zgaRfM37Z3y9" style="text-align: right" title="Total Warrants">1,793,504</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left">$</td><td style="text-align: right"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></td><td style="text-align: left"> </td></tr> </table> 1793504 198159000 27.000 433878000 7.425 1092344000 10.230 17966000 7.425 51157000 225 and above 1793504000 155000000 0.0001 150000000 5000000 50000 1.15 45,000 options are subject to a three-year vesting period (of which 20,000 options are vesting in the first year, 15,000 options are vesting in the second year and 10,000 options are vesting in the third year) and 5,000 options with performance conditions related to marketing activities. 45000 20000 15000 10000 5000 0 P5Y6M P6Y6M 1.2458 1.2561 0.0365 0.0368 50658 <p id="xdx_800_eus-gaap--RelatedPartyTransactionsDisclosureTextBlock_zNBA728lwYHb" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 5 – <span id="xdx_821_ziJZm6GOk01c">RELATED PARTIES TRANSACTIONS</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">During the three months ended March 31, 2022, a consulting company whose founder and CEO is our board member provided certain marketing services in the amount of $<span id="xdx_905_eus-gaap--CostsAndExpensesRelatedParty_pp0p0_c20220101__20220331__srt--TitleOfIndividualAxis__custom--NewDirectorMember_z7PlMMZ2Npbj" title="Marketing services expense">6,276</span>.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> 6276 <p id="xdx_808_eus-gaap--EarningsPerShareTextBlock_zNVd3W0gFIdl" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 6 - <span id="xdx_821_zfHQ0WOQKhTe">NET LOSS PER SHARE</span>:</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.6in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. The calculation of diluted net loss per share excludes potential share issuances of common stock upon the exercise of share options, warrants, and unvested restricted stocks and unvested restricted stock units as the effect is anti-dilutive.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.55in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.55in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred Stock excluded from the calculations of diluted loss per share were <span id="xdx_90F_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pid_c20230101__20230331_zqAGmsFumCUi" title="Diluted loss per share">2,773,675</span>. This amount includes <span id="xdx_909_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pid_c20230101__20230331__us-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--RestrictedStockMember_zxWgY1C3S0g6" title="Diluted loss per share">342,766</span> of unvested restricted stock included in the number of issued and outstanding shares as of March 31, 2023.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.55in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.55in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.5in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The total number of shares of common stock related to outstanding options, warrants, restricted stock, restricted stock units, Series C Preferred Stock excluded from the calculations of diluted loss per share were <span id="xdx_904_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pid_c20220101__20220331_zXZc9905qPAa" title="Diluted loss per share">2,903,634</span>. This amount includes <span id="xdx_906_eus-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareAmount_pid_c20220101__20220331__us-gaap--AntidilutiveSecuritiesExcludedFromComputationOfEarningsPerShareByAntidilutiveSecuritiesAxis__us-gaap--RestrictedStockMember_zHGVsmvueFbh" title="Diluted loss per share">547,383</span> of unvested restricted stock included in the number of issued and outstanding shares as of March 31, 2022.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.55in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> 2773675 342766 2903634 547383 <p id="xdx_803_eus-gaap--FinancialInstrumentsDisclosureTextBlock_zKHQ1QoAmomk" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 7 - <span id="xdx_822_zZ7ExUBxTALb">FINANCIAL INSTRUMENTS</span>:</b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"/><td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>a.</b></span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>Fair value of financial instruments</b></span></td></tr></table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 49.65pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.75in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The carrying amounts of financial instruments included in working capital approximate their fair value due to the relatively short-term maturities of such instruments.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 48.55pt; text-align: justify; text-indent: 1.1pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; width: 100%; margin-top: 0; margin-bottom: 0"><tr style="font: 10pt Times New Roman, Times, Serif; vertical-align: top"> <td style="font: 10pt Times New Roman, Times, Serif; width: 0.5in"/><td style="font: 10pt Times New Roman, Times, Serif; width: 0.25in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>b.</b></span></td><td style="font: 10pt Times New Roman, Times, Serif; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">As of March 31, 2023, and December 31, 2022, allowance for expected credit loss was immaterial.</span></td></tr></table> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_805_eus-gaap--InventoryDisclosureTextBlock_zgNKJcLGfwg8" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 8 - <span id="xdx_821_zqIxBpFjZQ4l">INVENTORY</span>:</b></span></p> <p id="xdx_89C_eus-gaap--ScheduleOfInventoryCurrentTableTextBlock_zqQ3U7gtg8ni" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B8_znBjheW6Vqx2" style="display: none">SCHEDULE OF INVENTORY</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.5in"> <tr style="display: none; vertical-align: bottom; background-color: White"> <td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_499_20230331_z3U8IwEeYDz7" style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_49F_20221231_zIELU1AMLo31" style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold"> </td> <td colspan="2" style="font-weight: bold; text-align: center">March 31,</td><td style="font-weight: bold"> </td><td style="font-weight: bold"> </td> <td colspan="2" style="font-weight: bold; text-align: center">December 31,</td><td style="font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">($ in thousands)</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_400_eus-gaap--InventoryFinishedGoods_iI_pn3n3_maINzzJA_z8ZEDgP1g1S2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Finished goods</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">138</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">179</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_404_eus-gaap--InventoryWorkInProcess_iI_pn3n3_maINzzJA_zpBgPMPRRkI8" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Work in process</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">690</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">510</td><td style="text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--InventoryRawMaterialsAndSupplies_iI_pn3n3_maINzzJA_z5e6htS8eaEa" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Raw materials and supplies</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">869</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">932</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--InventoryNet_iTI_pn3n3_mtINzzJA_z8LNmkheCGo3" style="vertical-align: bottom; background-color: White"> <td style="text-align: right; padding-bottom: 2.5pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Total inventory</span></td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">1,697</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">1,621</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8AC_zbwqn1gVWm11" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p id="xdx_89C_eus-gaap--ScheduleOfInventoryCurrentTableTextBlock_zqQ3U7gtg8ni" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8B8_znBjheW6Vqx2" style="display: none">SCHEDULE OF INVENTORY</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.5in"> <tr style="display: none; vertical-align: bottom; background-color: White"> <td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_499_20230331_z3U8IwEeYDz7" style="text-align: right"> </td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_49F_20221231_zIELU1AMLo31" style="text-align: right"> </td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold"> </td> <td colspan="2" style="font-weight: bold; text-align: center">March 31,</td><td style="font-weight: bold"> </td><td style="font-weight: bold"> </td> <td colspan="2" style="font-weight: bold; text-align: center">December 31,</td><td style="font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">($ in thousands)</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_400_eus-gaap--InventoryFinishedGoods_iI_pn3n3_maINzzJA_z8ZEDgP1g1S2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Finished goods</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">138</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td style="width: 16%; text-align: right">179</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_404_eus-gaap--InventoryWorkInProcess_iI_pn3n3_maINzzJA_zpBgPMPRRkI8" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Work in process</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">690</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">510</td><td style="text-align: left"> </td></tr> <tr id="xdx_40B_eus-gaap--InventoryRawMaterialsAndSupplies_iI_pn3n3_maINzzJA_z5e6htS8eaEa" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left; padding-bottom: 1.5pt">Raw materials and supplies</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">869</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">932</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40A_eus-gaap--InventoryNet_iTI_pn3n3_mtINzzJA_z8LNmkheCGo3" style="vertical-align: bottom; background-color: White"> <td style="text-align: right; padding-bottom: 2.5pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Total inventory</span></td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">1,697</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">1,621</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 138000 179000 690000 510000 869000 932000 1697000 1621000 <p id="xdx_809_eus-gaap--AccountsPayableAccruedLiabilitiesAndOtherLiabilitiesDisclosureCurrentTextBlock_zEIlno7QxfEd" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 9 - <span id="xdx_823_zOQmTTcNo23g">ACCOUNTS PAYABLE AND ACCRUALS - OTHER</span>:</b></span></p> <p id="xdx_898_eus-gaap--ScheduleOfAccountsPayableAndAccruedLiabilitiesTableTextBlock_zZUtXRfcwFIe" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8BF_zZfMN9l2AWRh" style="display: none">SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.5in"> <tr style="display: none; vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_49C_20230331_zVICNWI3o3hh" style="border-bottom: Black 1.5pt solid; text-align: right"> </td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_494_20221231_z4xNAcopn3kl" style="border-bottom: Black 1.5pt solid; text-align: right"> </td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold"> </td> <td colspan="2" style="font-weight: bold; text-align: center">March 31,</td><td style="font-weight: bold"> </td><td style="font-weight: bold"> </td> <td colspan="2" style="font-weight: bold; text-align: center">December 31,</td><td style="font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">($ in thousands)</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_406_eus-gaap--AccruedSalariesCurrent_iI_pn3n3_maAPOCziog_zm7athNWqcUf" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Employees and employee institutions</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">970</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">1,853</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40C_eus-gaap--AccruedVacationCurrent_iI_pn3n3_maAPOCziog_z1d4zGZb1vmj" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Accrued vacation and recreation pay</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">240</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">197</td><td style="text-align: left"> </td></tr> <tr id="xdx_406_eus-gaap--AccruedLiabilitiesCurrent_iI_pn3n3_maAPOCziog_zxaahHU6o858" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Accrued expenses</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">933</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">554</td><td style="text-align: left"> </td></tr> <tr id="xdx_405_ecustom--ClinicalTrialAccrualCurrent_iI_pn3n3_maAPOCziog_zqCCr7ZkXFq4" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Clinical trial accrual</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">1,046</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">1,258</td><td style="text-align: left"> </td></tr> <tr id="xdx_40E_ecustom--AccruedOperatingLeaseLiabilitiesCurrent_iI_pn3n3_maAPOCziog_zq1rqWmvGvZ2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Current Operating lease liabilities</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">417</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">419</td><td style="text-align: left"> </td></tr> <tr id="xdx_407_eus-gaap--OtherAccruedLiabilitiesCurrent_iI_pn3n3_maAPOCziog_ztVrBKq8cOSb" style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt">Other</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">170</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">130</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--AccountsPayableOtherCurrent_iTI_pn3n3_mtAPOCziog_zpIx9R6SH7x6" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 2.5pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Accounts payable and accruals-other</span></td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">3,776</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">4,411</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8AF_z1Jvb5EuqnMl" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p id="xdx_898_eus-gaap--ScheduleOfAccountsPayableAndAccruedLiabilitiesTableTextBlock_zZUtXRfcwFIe" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> <span id="xdx_8BF_zZfMN9l2AWRh" style="display: none">SCHEDULE OF ACCOUNTS PAYABLE AND ACCRUALS - OTHER</span></span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.5in"> <tr style="display: none; vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_49C_20230331_zVICNWI3o3hh" style="border-bottom: Black 1.5pt solid; text-align: right"> </td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_494_20221231_z4xNAcopn3kl" style="border-bottom: Black 1.5pt solid; text-align: right"> </td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold"> </td> <td colspan="2" style="font-weight: bold; text-align: center">March 31,</td><td style="font-weight: bold"> </td><td style="font-weight: bold"> </td> <td colspan="2" style="font-weight: bold; text-align: center">December 31,</td><td style="font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td style="text-align: center"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">($ in thousands)</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr id="xdx_406_eus-gaap--AccruedSalariesCurrent_iI_pn3n3_maAPOCziog_zm7athNWqcUf" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Employees and employee institutions</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">970</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td style="width: 16%; text-align: right">1,853</td><td style="width: 1%; text-align: left"> </td></tr> <tr id="xdx_40C_eus-gaap--AccruedVacationCurrent_iI_pn3n3_maAPOCziog_z1d4zGZb1vmj" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Accrued vacation and recreation pay</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">240</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">197</td><td style="text-align: left"> </td></tr> <tr id="xdx_406_eus-gaap--AccruedLiabilitiesCurrent_iI_pn3n3_maAPOCziog_zxaahHU6o858" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Accrued expenses</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">933</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">554</td><td style="text-align: left"> </td></tr> <tr id="xdx_405_ecustom--ClinicalTrialAccrualCurrent_iI_pn3n3_maAPOCziog_zqCCr7ZkXFq4" style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Clinical trial accrual</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">1,046</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">1,258</td><td style="text-align: left"> </td></tr> <tr id="xdx_40E_ecustom--AccruedOperatingLeaseLiabilitiesCurrent_iI_pn3n3_maAPOCziog_zq1rqWmvGvZ2" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="text-align: left">Current Operating lease liabilities</td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">417</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td style="text-align: right">419</td><td style="text-align: left"> </td></tr> <tr id="xdx_407_eus-gaap--OtherAccruedLiabilitiesCurrent_iI_pn3n3_maAPOCziog_ztVrBKq8cOSb" style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt">Other</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">170</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td style="border-bottom: Black 1.5pt solid; text-align: right">130</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr id="xdx_40F_eus-gaap--AccountsPayableOtherCurrent_iTI_pn3n3_mtAPOCziog_zpIx9R6SH7x6" style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 2.5pt"><span style="display: none; font-family: Times New Roman, Times, Serif; font-size: 10pt">Accounts payable and accruals-other</span></td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">3,776</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td style="border-bottom: Black 2.5pt double; text-align: right">4,411</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 970000 1853000 240000 197000 933000 554000 1046000 1258000 417000 419000 170000 130000 3776000 4411000 <p id="xdx_80C_eus-gaap--SegmentReportingDisclosureTextBlock_zAnLIPnMomig" style="font: 10pt Times New Roman, Times, Serif; margin-top: 0pt; margin-right: 0pt; margin-bottom: 0pt"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 10 - <span id="xdx_82C_zXkXLZPKuwlj">DISAGGREGATED REVENUE AND ENTITY WIDE DISCLOSURES</span></b>:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 70.9pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_895_eus-gaap--ScheduleOfRevenueFromExternalCustomersAttributedToForeignCountriesByGeographicAreaTextBlock_zESVvc4GZ4Wh" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.75in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span id="xdx_8B3_z3U1gvUzA951" style="display: none">SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.75in"> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Three months ended<br/> March 31</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">($ in thousands)</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%">Italy</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_985_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--StatementGeographicalAxis__country--IT_zmQfhTDqmSb8" style="width: 16%; text-align: right" title="Revenues">267</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_980_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--StatementGeographicalAxis__country--IT_zQf5IM7tiG7a" style="width: 16%; text-align: right" title="Revenues">243</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Germany</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98A_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--StatementGeographicalAxis__country--DE_ztRPeNngm63f" style="text-align: right" title="Revenues">214</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--StatementGeographicalAxis__country--DE_zZyPDkRRU7P8" style="text-align: right" title="Revenues">249</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt">Other</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98E_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--StatementGeographicalAxis__custom--OtherCountriesMember_zzVUx8AdXGK2" style="border-bottom: Black 1.5pt solid; text-align: right" title="Revenues">758</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_983_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--StatementGeographicalAxis__custom--OtherCountriesMember_zvz7BpWCS7Ye" style="border-bottom: Black 1.5pt solid; text-align: right" title="Revenues">691</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 2.5pt"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_98C_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331_ztuHMgFiBhT7" style="border-bottom: Black 2.5pt double; text-align: right" title="Revenues">1,239</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_989_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331_zRfrkRdUn7sl" style="border-bottom: Black 2.5pt double; text-align: right" title="Revenues">1,183</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A5_zyZU0GWVmqdd" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 0.5in; text-align: justify; text-indent: 0.5in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_891_ecustom--ScheduleOfRevenuesAttributedToGeographicAreasByProductTableTextBlock_zqyTn7Uyppy1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">By product:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8BE_zfxyXqCcJbCj" style="display: none">SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.75in"> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Three months ended<br/> March 31</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold"> </td> <td colspan="6" style="font-weight: bold; text-align: center">($ in thousands)</td><td style="font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%">CGuard</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_980_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--ProductOrServiceAxis__custom--CGuardEPSMember_zzYRIHWYTFLb" style="width: 16%; text-align: right" title="Revenue">1,239</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_98D_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--ProductOrServiceAxis__custom--CGuardEPSMember_zp7fjvnGRE2e" style="width: 16%; text-align: right" title="Revenue">1,161</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt">MGuard</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_987_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--ProductOrServiceAxis__custom--MGuardPrimeEPSMember_z2bP2rhMfI76" style="border-bottom: Black 1.5pt solid; text-align: right" title="Revenue"><span style="-sec-ix-hidden: xdx2ixbrl0591">-</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98B_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--ProductOrServiceAxis__custom--MGuardPrimeEPSMember_zcaKallc3LQ7" style="border-bottom: Black 1.5pt solid; text-align: right" title="Revenue">22</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 2.5pt"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_987_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331_zFpgPixK7t2j" style="border-bottom: Black 2.5pt double; text-align: right" title="Revenue">1,239</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_98E_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331_zMEY8vsdPol2" style="border-bottom: Black 2.5pt double; text-align: right" title="Revenue">1,183</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> <p id="xdx_8A8_zryWJh5v5PRa" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p id="xdx_89E_eus-gaap--ScheduleOfRevenueByMajorCustomersByReportingSegmentsTableTextBlock_zBsoCuIluArl" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">By principal customers:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/><span id="xdx_8B8_z8BneZgjG9fi" style="display: none">SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.75in"> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Three months ended<br/> March 31</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Customer A</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_980_eus-gaap--ConcentrationRiskPercentage1_pid_dp_c20230101__20230331__srt--MajorCustomersAxis__custom--CustomerAMember__us-gaap--ConcentrationRiskByBenchmarkAxis__us-gaap--SalesMember__us-gaap--ConcentrationRiskByTypeAxis__us-gaap--CustomerConcentrationRiskMember_z26XgH3jHEq8" style="width: 16%; text-align: right" title="Percentage of revenues per major customer">17</td><td style="width: 1%; text-align: left">%</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_984_eus-gaap--ConcentrationRiskPercentage1_pid_dp_c20220101__20220331__srt--MajorCustomersAxis__custom--CustomerAMember__us-gaap--ConcentrationRiskByBenchmarkAxis__us-gaap--SalesMember__us-gaap--ConcentrationRiskByTypeAxis__us-gaap--CustomerConcentrationRiskMember_zVpVqjqmggPj" style="width: 16%; text-align: right" title="Percentage of revenues per major customer">21</td><td style="width: 1%; text-align: left">%</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Customer B</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98A_eus-gaap--ConcentrationRiskPercentage1_pid_dp_c20230101__20230331__srt--MajorCustomersAxis__custom--CustomerBMember__us-gaap--ConcentrationRiskByBenchmarkAxis__us-gaap--SalesMember__us-gaap--ConcentrationRiskByTypeAxis__us-gaap--CustomerConcentrationRiskMember_zFVbBZ5JWNre" style="text-align: right" title="Percentage of revenues per major customer">13</td><td style="text-align: left">%</td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--ConcentrationRiskPercentage1_pid_dp_c20220101__20220331__srt--MajorCustomersAxis__custom--CustomerBMember__us-gaap--ConcentrationRiskByBenchmarkAxis__us-gaap--SalesMember__us-gaap--ConcentrationRiskByTypeAxis__us-gaap--CustomerConcentrationRiskMember_zLtz7hImbP3f" style="text-align: right" title="Percentage of revenues per major customer">11</td><td style="text-align: left">%</td></tr> </table> <p id="xdx_8AF_zoQ9oCcfv4vh" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 1in; text-indent: -1in"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">All tangible long lived assets are located in Israel.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"> </p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 56.7pt; text-align: justify"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0 0 0 56.7pt; text-align: justify"/> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b/></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p id="xdx_895_eus-gaap--ScheduleOfRevenueFromExternalCustomersAttributedToForeignCountriesByGeographicAreaTextBlock_zESVvc4GZ4Wh" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0pt 0pt 0.75in; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Revenues are attributed to geographic areas based on the location of the customers. The following is a summary of revenues:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span id="xdx_8B3_z3U1gvUzA951" style="display: none">SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.75in"> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Three months ended<br/> March 31</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">($ in thousands)</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%">Italy</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_985_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--StatementGeographicalAxis__country--IT_zmQfhTDqmSb8" style="width: 16%; text-align: right" title="Revenues">267</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_980_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--StatementGeographicalAxis__country--IT_zQf5IM7tiG7a" style="width: 16%; text-align: right" title="Revenues">243</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td>Germany</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98A_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--StatementGeographicalAxis__country--DE_ztRPeNngm63f" style="text-align: right" title="Revenues">214</td><td style="text-align: left"> </td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--StatementGeographicalAxis__country--DE_zZyPDkRRU7P8" style="text-align: right" title="Revenues">249</td><td style="text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 1.5pt">Other</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98E_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--StatementGeographicalAxis__custom--OtherCountriesMember_zzVUx8AdXGK2" style="border-bottom: Black 1.5pt solid; text-align: right" title="Revenues">758</td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_983_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--StatementGeographicalAxis__custom--OtherCountriesMember_zvz7BpWCS7Ye" style="border-bottom: Black 1.5pt solid; text-align: right" title="Revenues">691</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 2.5pt"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_98C_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331_ztuHMgFiBhT7" style="border-bottom: Black 2.5pt double; text-align: right" title="Revenues">1,239</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_989_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331_zRfrkRdUn7sl" style="border-bottom: Black 2.5pt double; text-align: right" title="Revenues">1,183</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 267000 243000 214000 249000 758000 691000 1239000 1183000 <p id="xdx_891_ecustom--ScheduleOfRevenuesAttributedToGeographicAreasByProductTableTextBlock_zqyTn7Uyppy1" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">By product:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><span id="xdx_8BE_zfxyXqCcJbCj" style="display: none">SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRODUCT</span> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.75in"> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Three months ended<br/> March 31</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold"> </td> <td colspan="6" style="font-weight: bold; text-align: center">($ in thousands)</td><td style="font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%">CGuard</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_980_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--ProductOrServiceAxis__custom--CGuardEPSMember_zzYRIHWYTFLb" style="width: 16%; text-align: right" title="Revenue">1,239</td><td style="width: 1%; text-align: left"> </td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left">$</td><td id="xdx_98D_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--ProductOrServiceAxis__custom--CGuardEPSMember_zp7fjvnGRE2e" style="width: 16%; text-align: right" title="Revenue">1,161</td><td style="width: 1%; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="padding-bottom: 1.5pt">MGuard</td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_987_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331__srt--ProductOrServiceAxis__custom--MGuardPrimeEPSMember_z2bP2rhMfI76" style="border-bottom: Black 1.5pt solid; text-align: right" title="Revenue"><span style="-sec-ix-hidden: xdx2ixbrl0591">-</span></td><td style="padding-bottom: 1.5pt; text-align: left"> </td><td style="padding-bottom: 1.5pt"> </td> <td style="border-bottom: Black 1.5pt solid; text-align: left"> </td><td id="xdx_98B_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331__srt--ProductOrServiceAxis__custom--MGuardPrimeEPSMember_zcaKallc3LQ7" style="border-bottom: Black 1.5pt solid; text-align: right" title="Revenue">22</td><td style="padding-bottom: 1.5pt; text-align: left"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="padding-bottom: 2.5pt"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_987_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20230101__20230331_zFpgPixK7t2j" style="border-bottom: Black 2.5pt double; text-align: right" title="Revenue">1,239</td><td style="padding-bottom: 2.5pt; text-align: left"> </td><td style="padding-bottom: 2.5pt"> </td> <td style="border-bottom: Black 2.5pt double; text-align: left">$</td><td id="xdx_98E_eus-gaap--RevenueFromContractWithCustomerExcludingAssessedTax_pn3n3_c20220101__20220331_zMEY8vsdPol2" style="border-bottom: Black 2.5pt double; text-align: right" title="Revenue">1,183</td><td style="padding-bottom: 2.5pt; text-align: left"> </td></tr> </table> 1239000 1161000 22000 1239000 1183000 <p id="xdx_89E_eus-gaap--ScheduleOfRevenueByMajorCustomersByReportingSegmentsTableTextBlock_zBsoCuIluArl" style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">By principal customers:</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0pt 0 0pt 56.7pt; text-align: justify"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"/><span id="xdx_8B8_z8BneZgjG9fi" style="display: none">SCHEDULE OF REVENUES ATTRIBUTED TO GEOGRAPHIC AREAS BY PRINCIPAL CUSTOMERS</span><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <table cellpadding="0" cellspacing="0" style="font: 10pt Times New Roman, Times, Serif; border-collapse: collapse; width: 80%; margin-left: 0.75in"> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="6" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">Three months ended<br/> March 31</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom"> <td> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2023</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td><td style="font-weight: bold; padding-bottom: 1.5pt"> </td> <td colspan="2" style="border-bottom: Black 1.5pt solid; font-weight: bold; text-align: center">2022</td><td style="padding-bottom: 1.5pt; font-weight: bold"> </td></tr> <tr style="vertical-align: bottom; background-color: rgb(204,238,255)"> <td style="width: 60%; text-align: left">Customer A</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_980_eus-gaap--ConcentrationRiskPercentage1_pid_dp_c20230101__20230331__srt--MajorCustomersAxis__custom--CustomerAMember__us-gaap--ConcentrationRiskByBenchmarkAxis__us-gaap--SalesMember__us-gaap--ConcentrationRiskByTypeAxis__us-gaap--CustomerConcentrationRiskMember_z26XgH3jHEq8" style="width: 16%; text-align: right" title="Percentage of revenues per major customer">17</td><td style="width: 1%; text-align: left">%</td><td style="width: 2%"> </td> <td style="width: 1%; text-align: left"> </td><td id="xdx_984_eus-gaap--ConcentrationRiskPercentage1_pid_dp_c20220101__20220331__srt--MajorCustomersAxis__custom--CustomerAMember__us-gaap--ConcentrationRiskByBenchmarkAxis__us-gaap--SalesMember__us-gaap--ConcentrationRiskByTypeAxis__us-gaap--CustomerConcentrationRiskMember_zVpVqjqmggPj" style="width: 16%; text-align: right" title="Percentage of revenues per major customer">21</td><td style="width: 1%; text-align: left">%</td></tr> <tr style="vertical-align: bottom; background-color: White"> <td style="text-align: left">Customer B</td><td> </td> <td style="text-align: left"> </td><td id="xdx_98A_eus-gaap--ConcentrationRiskPercentage1_pid_dp_c20230101__20230331__srt--MajorCustomersAxis__custom--CustomerBMember__us-gaap--ConcentrationRiskByBenchmarkAxis__us-gaap--SalesMember__us-gaap--ConcentrationRiskByTypeAxis__us-gaap--CustomerConcentrationRiskMember_zFVbBZ5JWNre" style="text-align: right" title="Percentage of revenues per major customer">13</td><td style="text-align: left">%</td><td> </td> <td style="text-align: left"> </td><td id="xdx_983_eus-gaap--ConcentrationRiskPercentage1_pid_dp_c20220101__20220331__srt--MajorCustomersAxis__custom--CustomerBMember__us-gaap--ConcentrationRiskByBenchmarkAxis__us-gaap--SalesMember__us-gaap--ConcentrationRiskByTypeAxis__us-gaap--CustomerConcentrationRiskMember_zLtz7hImbP3f" style="text-align: right" title="Percentage of revenues per major customer">11</td><td style="text-align: left">%</td></tr> </table> 0.17 0.21 0.13 0.11 <p id="xdx_805_eus-gaap--SubsequentEventsTextBlock_z0GltG7oLgO6" style="font: 10pt Times New Roman, Times, Serif; margin: 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b>NOTE 11 – <span id="xdx_823_zYXpAcIsQQW8">SUBSEQUENT EVENTS</span></b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"><b> </b></span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">On May 12, 2023, the Company entered into a securities purchase agreement (the “Purchase Agreement”) pursuant to which the Company agreed to sell and issue in a private placement (the “Private Placement Offering) an aggregate of <span id="xdx_905_eus-gaap--StockIssuedDuringPeriodSharesNewIssues_c20230511__20230512__us-gaap--SubsidiarySaleOfStockAxis__us-gaap--PrivatePlacementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_zrAFCY9p6EY" title="Number of stock issued">10,266,270</span> shares (the “Private Placement Shares”) of the Company’s common stock, pre-funded warrants (the “Pre-Funded Warrants”) to purchase up to <span id="xdx_90A_eus-gaap--ClassOfWarrantOrRightOutstanding_iI_c20230512__us-gaap--SubsidiarySaleOfStockAxis__us-gaap--PrivatePlacementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__us-gaap--WarrantMember_zghf6inO9C7h" title="Number of warrants or rights outstanding">15,561,894</span> shares of common stock and warrants to purchase up to an aggregate of <span id="xdx_907_eus-gaap--ClassOfWarrantOrRightOutstanding_iI_c20230512__us-gaap--SubsidiarySaleOfStockAxis__us-gaap--PrivatePlacementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__us-gaap--CommonStockMember_zDaW6aAWLFKk" title="Number of warrants or rights outstanding">51,656,328</span> shares of common stock, consisting of Series H warrants to purchase up to <span id="xdx_90D_eus-gaap--ClassOfWarrantOrRightOutstanding_iI_c20230512__us-gaap--SubsidiarySaleOfStockAxis__us-gaap--PrivatePlacementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__custom--SeriesHWarrantsMember_zA9WGnkTUVVl" title="Number of warrants or rights outstanding">12,914,086</span> shares of common stock (the “Series H Warrants”), Series I warrants to purchase up to <span id="xdx_90D_eus-gaap--ClassOfWarrantOrRightOutstanding_iI_c20230512__us-gaap--SubsidiarySaleOfStockAxis__us-gaap--PrivatePlacementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__custom--SeriesIWarrantsMember_zi8w97TnUEG3" title="Number of warrants or rights outstanding">12,914,078</span> shares of common stock (the “Series I Warrants”), Series J warrants to purchase up to <span id="xdx_903_eus-gaap--ClassOfWarrantOrRightOutstanding_iI_c20230512__us-gaap--SubsidiarySaleOfStockAxis__us-gaap--PrivatePlacementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__custom--SeriesJWarrantsMember_z5tptaMMbkQ1" title="Number of warrants or rights outstanding">12,914,086</span> shares of Common Stock (the “Series J Warrants”) and Series K warrants to purchase up to <span id="xdx_905_eus-gaap--ClassOfWarrantOrRightOutstanding_iI_c20230512__us-gaap--SubsidiarySaleOfStockAxis__us-gaap--PrivatePlacementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__custom--SeriesKWarrantsMember_z2wClsMpOQN" title="Number of warrants or rights outstanding">12,914,086</span> shares of common stock (the “Series K Warrants” and together with the Series H Warrants, Series I Warrants and Series J Warrants, the “Warrants”), at an offering price of $<span id="xdx_904_eus-gaap--SharesIssuedPricePerShare_iI_c20230512__us-gaap--SubsidiarySaleOfStockAxis__us-gaap--PrivatePlacementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__us-gaap--WarrantMember_zjVTWAuQCud3" title="Offering price">1.6327</span> per Private Placement Share and associated Warrants and an offering price of $<span id="xdx_902_eus-gaap--SharesIssuedPricePerShare_iI_c20230512__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__us-gaap--WarrantMember_z4G2gLZaEw52" title="Offering price">1.6326</span> per Pre-Funded Warrant and associated Warrants.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">The Pre-Funded Warrants will be immediately exercisable at an exercise price of $<span id="xdx_905_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_c20230512__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember__us-gaap--StatementEquityComponentsAxis__us-gaap--WarrantMember_zUR9XXEXehc4" title="Warrant exercise price">0.0001</span> per share and will not expire until exercised in full. The Warrants will be immediately exercisable upon issuance at an exercise price of $<span id="xdx_909_eus-gaap--ClassOfWarrantOrRightExercisePriceOfWarrantsOrRights1_iI_c20230512__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_zmNFWhQmKy2k" title="Warrant exercise price">1.3827 </span>per share, subject to adjustment as set forth therein. The Warrants have a term of the earlier of (i) five years from the date of issuance and (ii) (A) in the case of the Series H Warrants, 20 trading days following the Company’s public release of primary and secondary end points related to one year follow up study results from the Company’s C-Guardians pivotal trial, (B) in the case of the Series I Warrants, 20 trading days following the Company’s announcement of receipt of Premarket Approval from the Food and Drug Administration (“FDA”) for the CGuard Prime Carotid Stent System (135 cm), (C) in the case of the Series J Warrants, 20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard and CGuard Prime 80 and (D) in the case on the Series K Warrants, 20 trading days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in the United States begins. The Warrants may be exercised on a cashless basis if there is no effective registration statement registering the shares underlying the warrants.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">In connection with the Purchase Agreement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”). Pursuant to the Registration Rights Agreement, the Company is required to file a resale registration statement (the “Registration Statement”) with the SEC to register for resale the Private Placement Shares and the shares of common stock issuable upon exercise of the Pre-Funded Warrants and Warrants, within 20 days of the signing date of the Purchase Agreement (the “Signing Date”), and to have such Registration Statement declared effective within 45 days after the Signing Date in the event the Registration Statement is not reviewed by the SEC, or 90 days of the Signing Date in the event the Registration Statement is reviewed by the SEC. The Company will be obligated to pay certain liquidated damages if the Company fails to file the Registration Statement when required, fails to cause the Registration Statement to be declared effective by the SEC when required, of if the Company fails to maintain the effectiveness of the Registration Statement.</span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt"> </span></p> <p style="font: 10pt Times New Roman, Times, Serif; margin: 0; text-align: justify; text-indent: 0.5in; background-color: white"><span style="font-family: Times New Roman, Times, Serif; font-size: 10pt">Aggregate gross proceeds to the Company in respect of the Private Placement Offering are expected to be approximately $<span id="xdx_90D_eus-gaap--ProceedsFromIssuanceOfPrivatePlacement_pn5n6_c20230511__20230512__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_zuvnY1t52eC4" title="Private placement">42.2</span> million, before deducting fees payable to the placement agent and other offering expenses payable by the Company which are expected to amount to approximately $<span id="xdx_90F_eus-gaap--StockIssuedDuringPeriodValueNewIssues_pn5n6_c20230511__20230512__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_zZ5lfecX1Yk3" title="Offering expenses">4.6</span> million. If the Warrants are exercised in cash in full this would result in an additional $<span id="xdx_902_eus-gaap--ProceedsFromWarrantExercises_pn5n6_c20230511__20230512__us-gaap--TypeOfArrangementAxis__custom--SecuritiesPurchaseAgreementMember__us-gaap--SubsequentEventTypeAxis__us-gaap--SubsequentEventMember_zZWFzzOnAsxg" title="Warrant exercises">71.4</span> million of proceeds. The Private Placement Offering is expected to close on or about May 15, 2023, subject to satisfaction of customary closing conditions.</span></p> 10266270 15561894 51656328 12914086 12914078 12914086 12914086 1.6327 1.6326 0.0001 1.3827 42200000 4600000 71400000 Represents an amount less than $1 thousand Represents an amount less than $1 thousand Represents an amount less than $1 thousand EXCEL 45 Financial_Report.xlsx IDEA: XBRL DOCUMENT begin 644 Financial_Report.xlsx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