InspireMD Provides Corporate Update for Shareholders

Tel Aviv, Israel— April 19, 2021 – InspireMD, Inc. (NYSE American: NSPR, NSPR.WS, NSPR.WSB), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today provided an update of recent corporate developments.

 

  • Shareholders approved a 1:15 reverse stock split, reducing the number of outstanding shares from 118 million to 7.9 million shares, which will take effect following the close of trading on April 26, 2021
  • Today, the Company submitted its application to join the Nasdaq Capital Market, which the Company views as more attractive to a broader range of investors than its current listing

 

InspireMD CEO Marvin Slosman commented, “The fundamentals of our business remain sound and consistent and, as previously noted, our execution against our milestones continues to progress well.  Following our previously announced oversubscribed capital raise of $20.7M we are securely positioned to conduct our C-Guardian FDA clinical trial while maintaining sufficient operating capital to meet our commercial expansion and product development goals, while establishing CGuard EPS as the most advanced carotid stent system in the market. Our business model, superior technology platform harnessed by our proprietary MicroNet™ embolic protection system and timing of the growth in carotid stenting have laid the foundation necessary for CGuard EPS to become a market leader in the prevention of stroke caused by carotid artery disease. We believe that moving to the Nasdaq Capital Market is a strategically sound approach that places us in the company of our peers and allows for improved visibility in the market.  InspireMD is fundamentally a stronger company today than ever before, and I am proud of the extraordinary efforts of our expanding team in creating an exciting future for our company.”

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.

InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain of its warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

 

Forward-looking Statements

 This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

 

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

 

 

CORE IR

investor-relations@inspiremd.com

 

 

InspireMD Announces 1-for-15 Reverse Stock Split

 Tel Aviv, Israel— April 14, 2021 – InspireMD, Inc. (NYSE American: NSPR, NSPR.WS, NSPR.WSB), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced a 1-for-15 reverse split of its common stock, effective as of April 26, 2021.  Beginning on April 27, 2021, the Company’s common stock will trade on the NYSE American on a split adjusted basis.

At InspireMD’s special meeting of stockholders on April 14, 2021, the Company’s stockholders authorized the Board of Directors to amend the Amended and Restated Certificate of Incorporation of the Company to effect a reverse stock split at a ratio in the range of 1-for-10 to 1-for-20.

Upon effectiveness, the reverse stock split will cause a reduction in the number of shares of common stock outstanding and issuable upon the conversion of the Company’s outstanding shares of preferred stock and the exercise of its outstanding stock options and warrants in proportion to the ratio of the reverse stock split and will cause a proportionate increase in the conversion and exercise prices of such preferred stock, stock options and warrants. The number of shares of common stock issuable upon exercise or vesting of outstanding stock options and warrants will be rounded up to the nearest whole share. Accordingly, upon effectiveness of the reverse stock split, each outstanding warrant currently trading on the NYSE American under the symbol “NSPR.WS” shall become a warrant to purchase one-twenty six thousand two hundred fiftieth (1/26,250) of one share of common stock at an exercise price of $131,250.00 per full share of common stock, and each outstanding warrant currently trading on the NYSE American under the symbol “NSPR.WSB” shall become a warrant to purchase one-twenty six thousand two hundred fiftieth (1/26,250) of one share of common stock at an exercise price of $52,500.00 per full share of common stock, pursuant to the terms of such warrants. Warrants may only be exercised for a whole number of shares of common stock. Warrants exercised on or prior to April 26, 2021 will be deemed exercised on a pre-adjusted basis.

The Company’s common stock will continue to trade on the NYSE American under the symbol “NSPR.” The new CUSIP number for the common stock following the reverse stock split is 45779A 846.

The number of authorized shares of the Company’s common stock will remain at 150,000,000, while the number of outstanding shares will be reduced from approximately 118.0 million to 7.9 million. No fractional shares will be issued following the reverse stock split.

Registered stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form do not need to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Action Stock Transfer Corp, will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. Action Stock Transfer Corp can be reached at (801) 274-1088.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on February 9, 2021, a copy of which is also available at www.sec.gov or at www.inspiremd.com under the SEC Filings tab located on the Investors page.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.

InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

 

Forward-looking Statements

 This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com

 

CORE IR

investor-relations@inspiremd.com

 

InspireMD CEO Marvin Slosman Issues Letter to Fellow Stockholders Urging Support of the Company’s Plans to List its Common Stock on Nasdaq at the Upcoming Special Meeting of Stockholders

Tel Aviv, Israel – March 22, 2021 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of the stroke caused by carotid artery disease, today issues a message to stockholders from InspireMD CEO, Marvin Slosman regarding the Company’s Special Meeting of Stockholders.

To our valued Stockholders: 

We have adjourned our Stockholder Meeting until April 14, 2021 in order to provide additional time for stockholders with a record date of February 8, 2021 to vote for the outstanding proposals.

The primary purpose of the vote is to advance our strategy to move to Nasdaq as a preferred platform for our company as provided in the link below to our proxy statement.

https://www.sec.gov/Archives/edgar/data/1433607/000149315221003331/formdef14a.htm

The Company is seeking authorization to affect a reverse stock split to help meet the criteria required to obtain an initial listing on Nasdaq.

I, along with other senior management of the Company, own shares of NSPR just as you do and have voted in favor of the reverse stock split proposal.  As outlined in the proxy statement, we believe that listing our common stock on Nasdaq will make NSPR more attractive to a broader range of investors.

If you are a stockholder of record as of February 8, 2021, please dial the number below to vote.  

WE URGE YOU TO VOTE NOW BY CALLING KINGSDALE ADVISORS AT 1-866-581-1479 or collect at 1-416-867-2272 AND ONE OF THEIR AGENTS WOULD BE HAPPY TO HELP YOU VOTE OVER THE PHONE

Thank you for your support,
Marvin Slosman
CEO
InspireMD

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.  For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.


Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com

 

We Are Contacting You as a Reminder of a Critical Shareholder Vote. InspireMD Inc. Urges Shareholders to Vote FOR Reverse Stock Split Proposal

VOTE NOW BY CALLING KINGSDALE ADVISORS AT 1-866-581-1479.or collect at 1-416-867-2272 AND ONE OF OUR AGENTS WOULD BE HAPPY TO TAKE YOUR VOTE OVER THE PHONE.

Dear InspireMD Inc. (NSPR) Holdings Shareholder:
 
You should have already received proxy material related to InspireMD Inc.’s special shareholder meeting on March 17, 2021.

AMONG THE PROPOSALS SHAREHOLDERS ARE BEING ASKED TO VOTE ON IS  PROPOSAL #1 AUTHORIZATION OF THE BOARD OF DIRECTORS, IN ITS DISCRETION BUT PRIOR TO THE ANNUAL MEETING OF OUR STOCKHOLDERS IN 2021, TO AMEND THE AMENDED AND RESTATED CERTIFICATE OF INCORPORATION OF THE COMPANY TO EFFECT A REVERSE STOCK SPLIT OF THE COMPANY’S COMMON STOCK AT A RATIO IN THE RANGE OF 1-FOR-5 TO 1-FOR-20, SUCH RATIO TO BE DETERMINED BY THE BOARD OF DIRECTORS (THE “REVERSE STOCK SPLIT PROPOSAL”). 

As stated in InspireMD Inc.’s proxy statement:
 
Our board of directors is recommending the Reverse Stock Split for several important reasons. Firstly, the proposed Reverse Stock Split is needed in order to allow the Company to pursue listing our shares of common stock on The Nasdaq Capital Market. We believe that an uplisting of our common stock to The Nasdaq Capital Market will make our common stock more attractive to a broader range of investors than its current listing on the NYSE American. We believe that the Reverse Stock Split is our best option to meet one of the sets of criteria to obtain an initial listing on The Nasdaq Capital Market. The Nasdaq Capital Market requires, among other criteria, an initial bid price of least $4.00 per share or a closing price of at least $3.00 per share (or, if certain other conditions are met, which may not apply to us, a closing price of at least $2.00 per share), depending on the other quantitative listing standards that are met in connection with the initial listing. Following initial listing, The Nasdaq Capital Market requires that a listed company maintain a bid price of at least $1.00 per share. On March 8, 2021, the last reported sale price of our common stock on the NYSE American was $0.79 per share. A decrease in the number of outstanding shares of our common stock resulting from the Reverse Stock Split should, absent other factors, increase the per share market price of our common stock, although we cannot provide any assurance that our minimum bid price would remain over the minimum bid price requirement of The Nasdaq Capital Market following the Reverse Stock Split.

Lastly, we believe that the Reverse Stock Split could enhance the appeal of our common stock to the financial community, including institutional investors, and the general investing public. We believe that a number of institutional investors and investment funds are reluctant to invest in lower-priced securities and that brokerage firms may be reluctant to recommend lower-priced stock to their clients, which may be due in part to a perception that lower-priced securities are less promising as investments, are less liquid in the event that an investor wishes to sell its shares, or are less likely to be followed by institutional securities research firms and therefore to have less third-party analysis of the company available to investors. In addition, certain institutional investors or investment funds may be prohibited from buying stocks whose price is below a certain threshold. We believe that the reduction in the number of issued and outstanding shares of the common stock caused by the Reverse Stock Split, together with the anticipated increased stock price immediately following and resulting from the Reverse Stock Split, may encourage interest and trading in our common stock and thus possibly promote greater liquidity for our stockholders, thereby resulting in a broader market for our common stock than that which currently exists. Finally, we believe that the intended increase in our stock price could decrease price volatility, as currently small changes in the price of our common stock result in relatively large percentage changes in the stock price.

  
For additional information on this and all proposals please refer to the company’s proxy statement at
the following link: 

https://www.sec.gov/Archives/edgar/data/1433607/000149315221003331/formdef14a.htm
 
The Board recommends all shareholders to vote in favor of this very important proposal.
 
If you have any questions or need assistance voting, please contact Kingsdale Advisors:
 
Toll free at 1-866-581-1479.
Collect at 1-416-867-2272
Email at contactus@kingsdaleadvisors.com
   

InspireMD Announces Fourth Quarter and Year-End 2020 Financial Results

 

Management to host investor conference call today, March 9, at 8:30am ET

Tel Aviv, Israel— March 9, 2021 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced financial and operating results for the fourth quarter and year ended December 31, 2020.

Fourth Quarter 2020 and recent highlights:

  • Announced the closing of an upsized underwritten public offering of $20.7 million.
  • Announced the addition of renowned interventional cardiologist Gary Roubin, M.D., Ph.D., to the Board of Directors.
  • Announced the appointment of leading interventional cardiologist Chris Metzger, M.D., system chair of clinical research at Ballad Health System in Eastern Tennessee as the principal investigator for its planned FDA registration trial for CGuard EPS.
  • Secured China-based investment partner for process of seeking regulatory approval and distribution of CGuard EPS in mainland China. 
  • Announced the engagement of Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO) to conduct the clinical trial of CGuard Carotid Stent System in the United States.
  • Conducted multiple presentations regarding CGuard EPS, including a live demonstration, during the Leipzig Interventional Congress.
  • Shipments for the quarter were $738,000

“It was a very remarkable, albeit challenging year for us – and the global community — and we achieved many important milestones toward our goal of changing the standard of care for the prevention of stroke caused by carotid artery disease,” said Marvin Slosman, CEO of InspireMD. “Our team’s performance during the COVID-19 pandemic has remained steadfast, focused on execution, financial stability and commercial growth.  This included maintaining our global presence with CGuard during this most challenging time when elective procedures were impacted.  While the market curtailed our ability to grow revenue, and we took an accounting adjustment to Q4 revenue for a one time historical event from 2014, we remained focus on building our business by investing heavily in our strategic plans, human capital, infrastructure, new market and product development opportunities, all to create more rapid growth potential as the impact from COVID normalizes.  We view 2020 revenue as an unanticipated exception to what otherwise could have been a promising year of growth. As we enter 2021 with more optimism, we reflect on the many foundational achievements 2020 brought to our business.

“Most significantly, in 2020 we received approval of our Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard™ EPS (C-Guardian) in the United States by the FDA.  This triggered a number of critical additions to our team, including renowned interventional cardiologist Gary Roubin, M.D., Ph.D. to our Board of Directors, Dr. Chris Metzger to lead the investigators, a world-class contract research organization (HCC), as well as Christina Brennan, M.D., to assist with trial execution.  The culmination of this good work resulted in an oversubscribed public offering which raised proceeds of $20.7M, providing the financial support needed to complete the effort. We are diligently preparing for initiation of the trial.

“In terms of our global strategy, in 2020 we continued to expand our market presence, including by obtaining registration and distribution for CGuard in Brazil, the largest market for medical devices in Latin America. The Brazilian clearance supports our goals to expand in other Latin and South American markets. We also completed an investment and distribution agreement as part of our strategy to enter mainland China, believed to be the second fastest growing market for peripheral stent procedures, as stroke is the leading cause of death in China. We are currently applying for and planning regulatory and reimbursement approvals in important new markets such as France, Taiwan and Korea and are working on distributor options for Japan to bolster our global footprint.

“Finally, our cash position has improved significantly, after completing a $11.5 million public offering in mid-2020, and a $20.7 million public offering last month as well as other successful equity offerings. We believe that we are now well-positioned financially with the resources needed to execute our global expansion strategy.   Our company focus is built on the foundational value of our CGuard stent system, supportive of all delivery systems and available to all vascular specialists, resulting in the highest patient care with unmatched clinical outcomes,” concluded Mr. Slosman.

Financial Results for the Fourth Quarter and Twelve Months ended December 31, 2020

For the three months ended December 31, 2020, revenue decreased by $855,000, or 84.4%, to $158,000, from $1,013,000 during the three months ended December 31, 2019.  Revenues were negatively impacted by our settlement of litigation with a former distributor relating to a 2014 transaction.  Under the settlement, we agreed to pay them $580,000.  Under US GAAP we were required to charge that amount against sales.  Excluding such impact, revenue decreased by $275,000, or 27.1%, to $738,000, from $1,013,000 during the three months ended December 31, 2019.  This decrease was driven mainly by a 25.2% decrease in sales volume of CGuard EPS from $921,000 during the three months ended December 31, 2019, to $689,000 during the three months ended December 31, 2020, mainly due to the postponement of procedures with CGuard EPS, which are generally scheduled or nonemergency procedures, as hospitals shifted resources to patients affected by COVID-19.  The 46.7% decrease in sales volume of MGuard Prime EPS from $92,000 during the three months ended December 31, 2019, to $49,000 during the three months ended December 31, 2020, was also mainly due to the impact of COVID-19, as mentioned above.

For the three months ended December 31, 2020, gross profit decreased by 250.6%, or $649,000, to a negative $390,000, from $259,000 during the three months ended December 31, 2019.  This decrease in gross profit resulted from the impact of the $580,000 settlement with our former distributor in 2014 as well as $79,000 decrease in revenues less the related material and labor costs (as mentioned above).   This decrease was partially offset by a decrease of $10,000 in miscellaneous expenses during the three months ended December 31, 2020. Gross margin (gross profits as a percentage of revenue) decreased to a negative 246.8% during the three months ended December 31, 2020 from 25.6% during the three months ended December 31, 2019, driven mainly by a negative effect on gross margin of 272.5% due to the settlement with our former distributor.

Total operating expenses for the quarter ended December 31, 2020 were $3,328,000, an increase of 20.4% compared to $2,765,000 for the same period in 2019.  This increase was primarily due to increases of $363,000 in compensation expenses as we added resources to our clinical, product development and sales infrastructure, $134,000 of Directors’ and Officers’ Liability Insurance expense due to recent economic changes in the insurance industry, $96,000 in development expenses associated with CGuard EPS, mainly related to the new advanced delivery system and accessories, and $75,000 of miscellaneous expense. These increases were partially offset by a decrease in travel expenses of $105,000 in light of restrictions imposed by governments worldwide in order to mitigate the spread of COVID-19.

For the three months ended December 31, 2020, financial expenses increased by 385.2%, or $104,000, to $131,000, from $27,000 during the three months ended December 31, 2019.  The increase in financial expenses primarily resulted from changes in exchange rates. 

Net loss for the fourth quarter of 2020 totaled $3,853,000, or $0.10 per basic and diluted share, compared to a net loss of $2,557,000, or $0.57 per basic and diluted share, for the same period in 2019.

For the twelve months ended December 31, 2020, revenue decreased by $1,236,000, or 33.2%, to $2,485,000, from $3,721,000 during the twelve months ended December 31, 2019.  Revenues were negatively impacted by 15.6% due to settlement of our litigation with a former distributor relating to a 2014 transaction under which we agreed to pay them $580,000.  Under US GAAP we were required to charge that amount against sales. Excluding such impact, revenue decreased by $656,000, or 17.6%, to $3,065,000, from $3,721,000 during the 12 months ended December 31, 2019.This decrease was driven mainly by  a 15.3% decrease in sales volume of CGuard EPS from $3,265,000 during the twelve months ended December 31, 2019, to $2,764,000 during the twelve months ended December 31, 2020, mainly due to the postponement of procedures with CGuard EPS, which are generally scheduled or nonemergency procedures, as hospitals shifted resources to patients affected by COVID-19.  There was also a 34.0% decrease in sales volume of MGuard Prime EPS from $456,000 during the twelve months ended December 31, 2019, to $301,000 during the twelve months ended December 31, 2020, mainly due to the impact of COVID-19, as mentioned above.

For the twelve months ended December 31, 2020, gross profit (revenue less cost of revenues) decreased by 89.0%, or $673,000, to $83,000, compared to a $756,000 for the same period in 2019. This decrease in gross profit resulted from the impact of the $580,000 settlement with our former distributor in 2014 as well as $198,000 decrease in revenues less the related material and labor costs (as mentioned above).  This decrease was partially offset by a decrease of $69,000 in expenses related to upgrades made to our production facilities during the year ended December 31, 2019, which did not reoccur during the year ended December 31, 2020 and a decrease of $36,000 in miscellaneous expenses during the year ended December 31, 2020. Gross margin (gross profits as a percentage of revenue) decreased to 3.3% during the year ended December 31, 2020 from 20.3% during the year ended December 31, 2019, driven mainly by a negative effect on gross margin of 18.3% due to the settlement with our former distributor offset by a 1.3% gross margin increase due to the upgrades made to our production facilities and miscellaneous expenses as mentioned above.

Total operating expenses for the twelve months ended December 31, 2020 were $10,463,000, a decrease of 1.0% compared to $10,572,000 for the same period in 2019.  This decrease was primarily due to a decrease of $861,000 in clinical expenses associated with CGuard EPS, mainly related to the IDE approval process, for which an approval from the FDA was received on September 8, 2020, $421,000 in travel expenses in light of restrictions imposed by governments worldwide in order to mitigate the spread of COVID-19, $354,000 due to settlement expenses that were paid to a former service provider pursuant to a settlement agreement during the twelve months ended December 31, 2019,  $136,000 in quality assurance and regulatory expenses related to the development of various projects and $129,000 in promotional expenses, primarily related to having already built our social media infrastructure in 2019.  These decreases were partially offset by an increase in expenses of $531,000 in development expenses related to CGuard EPS new advanced delivery system and accessories, $400,000 due to the settlement agreement with the underwriter of our prior offerings paid during the twelve months ended December 31, 2020, $386,000 in compensation expenses as we added resources to our clinical, product development and sales infrastructure, $249,000 in our Directors’ and Officers’ Liability Insurance expenses, partially due to recent changes in the insurance industry, and $177,000 in regulatory expenses required for new regulatory standards set by the European Union, and $49,000 of miscellaneous expenses.

Financial expenses for the twelve months ended December 31, 2020 was $160,000 compared to $200,000 for the same period in 2019.  The decrease in financial expenses primarily resulted from changes in exchange rates. 

Net loss for the twelve months ended December 31, 2020 totaled $10,544,000, or $0.46 per basic and diluted share, compared to a net loss of $10,040,000, or $4.80 per basic and diluted share, for the same period in 2019.

As of December 31, 2020, cash and cash equivalents were $12,645,000 compared to $5,514,000 as of December 31, 2019. During the first quarter of 2021, the Company raised $35.1 million net through various equity transactions.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, March 9, 2021, to review financial results and provide an update on corporate developments.  Following management’s formal remarks, there will be a question-and-answer session.  

Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or unable to pre-register may dial in by calling: 1-844-854-4417 (domestic), 1-412-317-5739 (international) or 1-80-9212373 (Israel).  All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the InspireMD call.

The conference call will also be available through a live webcast found here: https://services.choruscall.com/links/nspr210309.html.

 

Additionally, it will be broadcast live through the Company’s website via the following link: https://www.inspiremd.com/en/investors/investor-relations/.

 

A webcast replay of the call will be available approximately one hour after the end of the call through June 9, 2021 at the above links.  A telephonic replay of the call will be available through March 23, 2021 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10152728.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.

 

InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

 

CORE IR
investor-relations@inspiremd.com

 

 

CONSOLIDATED STATEMENTS OF OPERATIONS (1)

 

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

 

 

 

 

Twelve months ended

 

 

 

Three months ended

 

 

December 31,

 

December 31,

 

 

2020

 

2019

 

2020

 

2019

 

Revenues

$158

 

$1,013

 

$2,485

 

$3,721

 

Cost of revenues

548

 

754

 

2,402

 

2,965

 

 

 

 

 

 

 

 

 

 

Gross Profit

(390)

 

259

 

83

 

756

 

 

 

 

 

 

 

 

 

 

Operating Expenses:

 

 

 

 

 

 

 

 

Research and development

720

 

522

 

2,233

 

2,954

 

Selling and marketing

617

 

605

 

2,103

 

2,396

 

General and administrative

1,991

 

1,638

 

6,127

 

5,222

 

 

 

 

 

 

 

 

 

 

Total operating expenses

3,328

 

2,765

 

10,463

 

10,572

 

 

 

 

 

 

 

 

 

 

Loss from operations

(3,718)

 

(2,506)

 

(10,380)

 

(9,816)

 

 

 

 

 

 

 

 

 

 

Financial expenses (income)

131

 

27

 

160

 

200

 

 

 

 

 

 

 

 

 

 

Loss before tax expenses

(3,849)

 

(2,533)

 

(10,540)

 

(10,016)

 

 

 

 

 

 

 

 

 

 

Tax expenses

4

 

24

 

4

 

24

 

 

 

 

 

 

 

 

 

 

Net Loss

$(3,853)

 

$(2,557)

 

$(10,544)

 

$(10,040)

 

 

 

 

 

 

 

 

 

 

Net loss per share – basic and diluted

$(0.10)

 

$(0.57)

 

$(0.46)

 

$(4.80)

 

 

 

 

 

 

 

 

 

 

Weighted average number of shares of common stock used in computing net loss per share – basic and diluted

38,009,045

 

4,449,020

 

22,686,590

 

2,089,964

 

                       

 

 

 

CONSOLIDATED BALANCE SHEETS (2)

(U.S. dollars in thousands)

ASSETS

December 31,

 

December 31,

2020

 

2019

Current Assets:

 

 

 

Cash and cash equivalents

$12,645

 

$5,514

Accounts receivable:

 

 

 

     Trade, net

476

 

823

     Other

146

 

150

Prepaid expenses

334

 

87

Inventory

1,415

 

1,236

Receivable for sale of Shares

323

 

 

 

 

 

Total current assets

15,339

 

7,810

 

 

 

 

 

 

 

 

Non-current assets:

 

Property, plant and equipment, net

448

 

547

Operating lease right of use assets

1,265

 

937

Funds in respect of employee rights upon retirement

725

 

586

 

 

 

 

Total non-current assets

2,438

 

2,070

 

 

 

 

Total assets

$17,777

 

$9,880

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND EQUITY

December 31,

 

December 31,

2020

 

2019

Current liabilities:

 

 

 

Accounts payable and accruals:

 

 

 

     Trade

$236

 

$646

     Other

3,469

 

2,469

Total current liabilities

3,705

 

3,115

 

 

 

 

Long-term liabilities:

 

 

 

Operating lease liabilities

999

 

653

Liability for employee rights upon retirement

910

 

729

Total long-term liabilities

1,909

 

1,382

 

 

 

 

Total liabilities

5,614

 

4,497

 

 

 

 

Equity:

 

 

 

Common stock, par value $0.0001 per share; 150,000,000 shares authorized at December 31, 2020 and 2019; 49,264,830 and 3,916,134 shares issued and outstanding at December 31, 2020 and 2019, respectively

5

 

Preferred B shares, par value $0.0001 per share;

500,000 shares authorized at December 31, 2020 and 2019; 17,303 shares issued and outstanding at December 31, 2020 and 2019, respectively

 

Preferred C shares, par value $0.0001 per share;

1,172,000 shares authorized at December 31, 2020 and 2019; 2,343 and 34,370 shares issued and outstanding at December 31, 2020 and 2019, respectively

 

Additional paid-in capital

180,334

 

163,015

Accumulated deficit

(168,176)

 

(157,632)

 

 

 

 

Total equity

12,163

 

5,383

 

 

 

 

Total liabilities and equity

$17,777

 

$9,880

 

 

 

 

 

 

 

 

(1) All financial information for the twelve months ended December 31, 2020 is derived from the Company’s 2020 audited financial statements and all financial information for the twelve months ended December 31, 2019 is derived from the Company’s 2019 audited financial statements, included in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2020 filed with the Securities and Exchange Commission.  All financial information for the three months ended December 31, 2020 and 2019 is derived from the Company’s unaudited, financial statements.

 

(2) All December 31, 2020 financial information is derived from the Company’s 2020 audited financial statements and all December 31, 2019 financial information is derived from the Company’s 2019 audited financial statements, as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2020 filed with the Securities and Exchange Commission.

 

 

InspireMD to Report Fourth Quarter and Year-End 2020 Financial Results on Tuesday, March 9, 2021 and Provide Corporate Update

Earnings conference call to be held Tuesday, March 9, 2021 at 8:30 a.m. ET

 

Tel Aviv, Israel — March 2, 2021 – InspireMD, Inc. (NYSE American: NSPR) (“InspireMD” or the “Company”), the developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announces it will report fiscal fourth quarter and year-end 2020 financial results on Tuesday, March 9, 2021 before the market opens. 

Management will host a conference call on Tuesday, March 9, at 8:30 a.m. ET to review financial results and provide an update on corporate developments.  Following management’s formal remarks, there will be a question-and-answer session.

Participants are asked to pre-register for the call through the following link: https://dpregister.com/sreg/10152728/e35be85ff8.

Please note that registered participants will receive their dial in number upon registration and will dial directly into the call without delay. Those without internet access or unable to pre-register may dial in by calling: 1-844-854-4417 (domestic), 1-412-317-5739 (international) or 1-80-9212373 (Israel).  All callers should dial in approximately 10 minutes prior to the scheduled start time and ask to be joined into the InspireMD call.

 

The conference call will also be available through a live webcast found here: https://services.choruscall.com/links/nspr210309.html.

 

Additionally, it will be broadcast live through the Company’s website via the following link: https://www.inspiremd.com/en/investors/investor-relations/.

A webcast replay of the call will be available approximately one hour after the end of the call through June 9, 2021 at the above links.  A telephonic replay of the call will be available through March 23, 2021 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088(international) and using access code 10152728.

 

About InspireMD, Inc.

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.

 

InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE American under the ticker symbol NSPR.WS and NSPR.WSB.

 

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

 

CORE IR
investor-relations@inspiremd.com

 

InspireMD Engages Hart Clinical Consultants to Conduct Clinical Trial for CGuard Carotid Stent System in the United States

Tel Aviv, Israel – February 24, 2021 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease, announced today that it has engaged Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO) to conduct the clinical trial for its CGuard Carotid Stent System in the United States.

“HCC is ideally suited to manage this trial having supported clinical trial operations for a variety of products and indications, including with multiple carotid intervention procedures,” stated Marvin Slosman, InspireMD’s CEO.  “This is an important step in our goal to achieve commercial registration of the CGuard System in the United States, one of the largest and most important markets for the sale and distribution of our device.  This will be the first U.S.-based study of CGuard and our opportunity to demonstrate its potential for the prevention of stroke caused by carotid artery disease in patients in the United States. Now that we have also identified our stellar lead investigator in Dr. Chris Metzger and closed a $20.7 million public offering, which provides the company the financial resources needed to complete the trial, we believe that we are well positioned to continue to execute on our global expansion strategy.”

“We look forward to working with InspireMD on this pivotal trial of the CGuard System to help establish a new standard of care for the management of carotid artery disease and stroke prevention.  We differentiate our organization from other CRO’s in that our staff has either direct interventional cath lab or cardio-thoracic operating room experience.  This allows us to function extremely well in technical areas when carrying out clinical trial operations or conducting device training,” said Jim Hart, CEO of HCC.

About the CGuard® EPS

The CGuard® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke.  CGuard’s unique MicroNet™® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional and next-generation double-layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure.  InspireMD’s CGuard™ has created a new dimension in the protected treatment of carotid artery disease and has the potential to establish a new standard of care for the management of carotid artery disease and stroke prevention.


About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.  For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.

About Hart Clinical Consultants

Hart Clinical Consultants (HCC) is a specialized Functional Service Provider (FSP) that partners innovators of technical, novel medical devices with highly skilled clinical research professionals. HCC specializes in clinical trial operations, study execution, physician training and case proctoring.

Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com

InspireMD Appoints Leading Interventional Cardiologist Chris Metzger, M.D. as Principal Investigator for CGuard Registration Trial in the United States

Tel Aviv, Israel – February 9, 2021 – InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of the stroke caused by carotid artery disease, announced today the appointment of Chris Metzger, M.D., system chair of clinical research at Ballad Health System in Eastern Tennessee as the principal investigator for its planned FDA registration trial for CGuard EPS.

“InspireMD is extremely fortunate to have Chris Metzger enthusiastically agree to shepherd the CGuard clinical trial. Chris is an extremely skilled, high volume cardiovascular and carotid stent operator.  He is also a highly regarded mentor and educator. His vast clinical trial experience will bring strong leadership to this landmark FDA study,” stated Gary Roubin, M.D., Ph.D., InspireMD Director and internationally renowned interventional cardiologist recognized for his pioneering work in carotid stenting and embolic and protection devices. 

Dr. Metzger currently serves as medical director of the Interventional and Diagnostic Catheterization Labs at Holston Valley Medical Center and medical director of clinical research at Ballard Health Systems, both located in Eastern Tennessee and Southwestern Virginia.  Dr. Metzger is widely published and has participated in more than 100 clinical studies, in most of which he served as principal investigator. 

“Following a close review of the extensive European experience and clinical outcomes, I’m looking forward to participating in the upcoming U.S. pivotal trial for CGuard.  There remains a significant need to address stroke prevention in the United States and based on CGuard’s protective MicroNet™ technology, I’m intrigued with the potential for success here,” commented Dr. Metzger.

“The appointment of Chris Metzger as our principal investigator is an important step toward the initiation of our pivotal clinical trial for CGuard in the United States.  We are confident that connecting the study to such a well-respected and experienced practitioner will help guide the continued development and execution of the study to a successful conclusion, reflective of the results we have seen internationally.  We are grateful to Dr. Metzger for his collaboration and look forward to providing updates on the trial’s development,” added Marvin Slosman, CEO of InspireMD.

About the CGuard® EPS

The CGuard® Embolic Protection System is an advanced platform solution designed to deliver the flexibility of the traditional open-cell stent with advanced protection from peri-procedural and post-procedural embolic events caused by plaque prolapse through the stent strut that can lead to stroke.  CGuard’s unique MicroNet™® technology mitigates the prolapse and associated embolization and has shown superior clinical outcomes for patients against alternative carotid stent types, conventional and next-generation double-layer stents, as well as invasive procedures such as endarterectomy, a major surgical procedure.  InspireMD’s CGuard™ has created a new dimension in the protected treatment of carotid artery disease and has the potential to establish a new standard of care for the management of carotid artery disease and stroke prevention.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes.  For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.


Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) the impact of the COVID-19 pandemic on our manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (x) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) our reliance on single suppliers for certain product components, (xiii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com

INSPIREMD ANNOUNCES CLOSING OF AN UPSIZED $20.7 MILLION UNDERWRITTEN PUBLIC OFFERING AND FULL EXERCISE OF OVER-ALLOTMENT OPTION

Tel Aviv, Israel, Feb. 08, 2021 (GLOBE NEWSWIRE) — InspireMD, Inc. (“InspireMD”) (NYSE:NSPR), a medical device company focused on the development and commercialization of proprietary MicroNet™ stent platform technology for the treatment of vascular and coronary diseases in Europe, Latin America, the Middle East and Asia, today announced the closing of an upsized underwritten public offering of units for gross proceeds of approximately $20.7 million, which includes the full exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by InspireMD.

The offering is comprised of 29,032,258 Units, priced at a public offering price of $0.62 per Unit, with each Unit consisting of one share of Common Stock and one Series G Warrant to purchase one-half of one share of Common Stock, at an exercise price of $0.682 per share and expiring on the fifth anniversary of the date of issuance. The underwriter also exercised an over-allotment option to purchase an additional 4,354,838 Units consisting of 4,354,838 shares of Common Stock and/or Series G Warrants to purchase 2,177,419 shares of Common Stock in the offering. 

A.G.P./Alliance Global Partners acted as the sole book-running manager in connection with the offering.

The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-252199), which was declared effective by the U.S. Securities and Exchange Commission (“SEC”) on February 3, 2021.

 

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The offering is being made solely by means of a prospectus. A final prospectus relating to this offering will be filed by InspireMD with the SEC. When available, copies of the final prospectus can be obtained at the SEC’s website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022, or by email at prospectus@allianceg.com.

 

About InspireMD, Inc.

 InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.

 

Forward-Looking Statements

 This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements in this press release include, but are not limited to, statements related to the offering of InspireMD’s units, including the closing of the offering and the satisfaction of customary closing conditions to the offering. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond InspireMD’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of InspireMD’s existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of InspireMD’s products, (iv) the impact of the COVID-19 pandemic on InspireMD’s manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for InspireMD’s products, (x) efforts to successfully obtain and maintain intellectual property protection covering InspireMD’s products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) reliance on single suppliers for certain product components, (xiii) the fact that InspireMD will need to raise additional capital to meet its business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that InspireMD conducts business in multiple foreign jurisdictions, exposing it to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about InspireMD and the risk factors that may affect the realization of forward-looking statements is set forth in InspireMD’s filings with the SEC, including InspireMD’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as required by SEC rules, InspireMD assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

INSPIREMD ANNOUNCES PRICING OF UPSIZED $18 MILLION UNDERWRITTEN PUBLIC OFFERING

Tel Aviv, Israel / February 4, 2021 / InspireMD, Inc. (“InspireMD”) (NYSE:NSPR), a medical device company focused on the development and commercialization of proprietary MicroNet™ stent platform technology for the treatment of vascular and coronary diseases in Europe, Latin America, the Middle East and Asia, today announced the pricing of an upsized underwritten public offering of securities for gross proceeds of $18 million (or $20.7 million if the underwriters exercise their option to purchase additional securities) prior to deducting underwriting discounts and estimated offering expenses payable by InspireMD.

The offering is comprised of 29,032,258 Units, priced at a public offering price of $0.62 per Unit, with each Unit consisting of one share of Common Stock and one Series G Warrant to purchase one-half of one share of Common Stock, at an exercise price of $0.682 per share and expiring on the fifth anniversary of the date of issuance.

The closing of the offering is expected to take place on or about February 8, 2021, subject to the satisfaction or waiver of customary closing conditions.

A.G.P./Alliance Global Partners is acting as sole book-running manager in connection with the offering.

A total of 29,032,258 Units will be issued and sold in the offering. In addition, InspireMD has granted the underwriters a 45-day option to purchase up to 4,354,838 Units consisting of 4,354,838 shares of Common Stock and/or 2,177,419 Series G Warrants, solely to cover over-allotments, if any. The securities were offered pursuant to a registration statement on Form S-1 (File No. 333-252199), which was declared effective by the U.S. Securities and Exchange Commission (“SEC”) on February 3, 2021.

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction. The offering is being made solely by means of a prospectus. A final prospectus relating to this offering will be filed by InspireMD with the SEC. When available, copies of the final prospectus can be obtained at the SEC’s website at www.sec.gov or from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, New York 10022, or by email at prospectus@allianceg.com.

About InspireMD

InspireMD seeks to utilize its proprietary MicroNet™® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. For more information, visit www.inspiremd.com. InspireMD routinely posts information that may be important to investors in the Investors section of its website.

Forward-Looking Statement

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements in this press release include, but are not limited to, statements related to the offering of InspireMD’s units, including the closing of the offering and the satisfaction of customary closing conditions to the offering. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond InspireMD’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of InspireMD’s existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of InspireMD’s products, (iv) the impact of the COVID-19 pandemic on InspireMD’s manufacturing, sales, business plan and the global economy, (v) intense competition in the medical device industry from much larger, multinational companies, (vi) product liability claims, (vii) product malfunctions, (viii) limited manufacturing capabilities and reliance on subcontractors for assistance, (ix) insufficient or inadequate reimbursement by governmental and other third party payers for InspireMD’s products, (x) efforts to successfully obtain and maintain intellectual property protection covering InspireMD’s products, which may not be successful, (xi) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xii) reliance on single suppliers for certain product components, (xiii) the fact that InspireMD will need to raise additional capital to meet its business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiv) the fact that InspireMD conducts business in multiple foreign jurisdictions, exposing it to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about InspireMD and the risk factors that may affect the realization of forward-looking statements is set forth in InspireMD’s filings with the SEC, including InspireMD’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. Except as required by SEC rules, InspireMd assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

 

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com