Revenue rebound, strong procedural recovery

Management to host investor conference call today, August 10, 2021, at
8:30am ET

Tel Aviv, Israel— August 10, 2021 – InspireMD, Inc. (Nasdaq: 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 as of and for the second quarter ended June 30, 2021.

Second Quarter 2021 and recent highlights

• Revenue of $1,038,000 an increase of 231.6% compared to the same period in 2020

• Initiated U.S. enrollment in the “C-Guardians” IDE clinical trial. Eleven (11) patients treated and enrolled in the first 2 weeks at Ballad Health Systems (Kingsport, TN) by Principal Investigator Dr. Christopher Metzger
• Transferred the listing of the company’s common stock and warrants to the Nasdaq Capital Market for access to broader and more fundamental investor base

• Appointed seasoned marketing executive Kathryn Arnold to the company’s Board of Directors
• Appointed acclaimed interventional cardiologist Kenneth Rosenfield, M.D. as Chair of the company’s newly formed Medical Advisory Board (MAB)

Marvin Slosman, InspireMD CEO commented, “We are pleased with our second quarter results that showed strong procedural recovery and market demand of CGuard EPS. Our ultimate goal is to change the standard of care in the treatment of carotid artery disease away from surgical endarterectomy to the minimally invasive use of CGuard EPS Carotid Stent System.   

“Our commercial efforts in driving global expansion, through expanding use of CGuard EPS in our 33 served markets, combined with growing our footprint into the U.S. and Asia, has created awareness of the clinical advantages of CGuard EPS.  Initiating our U.S Food and Drug Administration (FDA) C-Guardians IDE trial this quarter marked a milestone for the company in establishing awareness and experience with CGuard EPS among U.S. physicians treating carotid artery disease.  To date, Interventional Cardiologist Chris Metzger, M.D., our principal investigator, and system chair of clinical research at Ballad Health System (Kingsport, TN) has already enrolled 11 patients in the trial in the first two weeks.

“During the second quarter, we successfully transferred the listing of our shares and warrants to the Nasdaq Capital Market, which we believe will help broaden our shareholder base and increase interest by institutional and fundamental investors to create additional long-term shareholder value.

“Additionally, we appointed seasoned MedTech marketing executive Kathryn Arnold to our Board of Directors.  Ms. Arnold brings more than two decades of strategy and commercialization experience in the medical device industry. Her knowledge and leadership will be invaluable in helping the company shape our strategic planning and expanding our commercial and business development.

“We also formed a Medical Advisory Board composed of global Key Opinion Leaders (KOL’s) who treat carotid artery disease to provide the company guidance and direction on clinical strategy, product pipeline, and technology advancements. To lead this Board, we have appointed acclaimed interventional cardiologist, Kenneth Rosenfield, M.D. as Chair. Dr. Rosenfield is the Section Head for Vascular Medicine and Intervention and chairs the Acute Myocardial Infarction (STEMI) Committee for the Cardiac Catheterization Laboratory at Massachusetts General Hospital.   

“We continue to advance our global growth plans in our Asian markets. In China we are progressing with our distributor partners to initiate our regulatory trial toward market approval, and we continue our commercial expansion efforts into the markets of Japan, Taiwan and South Korea.

“We are making significant progress advancing our product pipeline with new innovation and offerings.  CGuard Prime, our next generation trans-femoral delivery system is scheduled for regulatory submission in early 2022 with commercial launch in the second half 2022.  Additionally, we are making great progress on a new embolic protection device (EPD) and delivery system, expanding our toolset and offerings to the vascular surgical community,” concluded Mr. Slosman.

Financial Results for the Second Quarter ended June 30, 2021

For the three months ended June 30, 2021, revenue increased by $725,000, or 231.6%, to $1,038,000, from $313,000 during the three months ended June 30, 2020. This increase was predominantly driven by a 276.0% increase in sales volume of CGuard EPS from $271,000 during the three months ended June 30, 2020, to $1,019,000 during the three months ended June 30, 2021.  This sales increase was mainly due to the fact that in the three months ended June 30, 2021, procedures with CGuard EPS, which are generally scheduled for non-emergency cases, began to return to normal levels as compared to the three months ended June 30, 2020, when procedures with CGuard EPS were mostly postponed as hospitals shifted resources to patients affected by COVID-19.  This increase in sales of CGuard EPS was partially offset by a decrease of 54.8% in sales of MGuard Prime EPS from $42,000 during the three months ended June 30, 2020, to $19,000 during the three months ended June 30, 2021, largely driven by the predominant industry preferences favoring drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients.

For the three months ended June 30, 2021, gross profit (revenue less cost of revenues) increased by $382,000, to $262,000, from a gross loss of $120,000 during the three months ended June 30, 2020. This increase in gross profit resulted from a $237,000 increase in revenues less the related material and labor costs (as described above), a decrease in write-offs of $144,000, which were driven mainly by changes related to components supply issues and a decrease of $1,000 in miscellaneous expenses during the three months ended June 30, 2021. Gross margin (gross profits as a percentage of revenue) increased to 25.2% during the three months ended June 30, 2021 from (38.3)% during the three months ended June 30, 2020, driven mainly by the decrease in write-offs mentioned above.

Total operating expenses for the quarter ended June 30, 2021 were $3,702,000, an increase of 59.2% compared to $2,326,000 for the same period in 2020.  This increase was primarily due to increases of $705,000 in salary expenses and related accrual expenses mainly driven by temporary salary reductions during the three months ended June 30, 2020, that were implemented in response to the COVID-19 effect on revenues as well as additional resources mainly in our product development and sales infrastructure, $437,000 in expenses related to the commencement of the C-Guardians FDA study, $315,000 in share-based compensation-related expenses due to the expense recognition of grants made after June 30, 2020, $297,000 in development expenses associated with CGuard EPS accessory solutions, and $108,000 of Directors’ and Officers’ Liability Insurance expense due to increased premiums caused by recent trends in the overall insurance industry. This increase was partially offset by a decrease of $400,000 relating to a settlement agreement with an underwriter of our prior offerings which occurred in the three months ended June 30, 2020 and a reduction of $86,000 of miscellaneous expense.

For the three months ended June 30, 2021, financial expenses were $67,000, compared to $34,000 during the three months ended June 30, 2020. Net loss for the second quarter of 2021 totaled $3,507,000, or $0.46 per basic and diluted share, compared to a net loss of $2,480,000, or $2.93 per basic and diluted share, for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 7,704,707 in Q2 2021 and 845,451 in Q2 2020, both adjusted to reflect the 1:15 reverse split effected by us on April 26, 2021.

Financial Results for the Six Months ended June 30, 2021

For the six months ended June 30, 2021, revenue increased by $697,000, or 51.7%, to $2,044,000, from $1,347,000 during the six months ended June 30, 2020. This increase was predominantly driven by a 60.0% increase in sales volume of CGuard EPS from $1,242,000 during the six months ended June 30, 2020, to $1,987,000 during the six months ended June 30, 2021.  This sales increase was mainly due to the fact that in the six months ended June 30, 2021, procedures with CGuard EPS, which are generally scheduled for non-emergency procedures began to return to normal levels as compared to the six months ended June 30, 2020, when procedures with CGuard EPS were postponed as hospitals shifted resources to patients affected by COVID-19 beginning in February 2020.  This increase in sales of CGuard EPS was partially offset by a decrease of 45.7% in sales of MGuard Prime EPS from $105,000 during the six months ended June 30, 2020, to $57,000 during the six months ended June 30, 2021, largely driven by the predominant industry preferences favoring drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in STEMI patients.

For the six months ended June 30, 2021, gross profit (revenue less cost of revenues) increased by $193,000, to $368,000, compared to a $175,000 for the same period in 2020. This increase in gross profit resulted from a $257,000 increase in revenues less the related material and labor costs (as described above). This increase was partially offset by an increase of $64,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 18.0% during the six months ended June 30, 2021 from 13.0% during the six months ended June 30, 2020, driven by the reasons mentioned above.

Total operating expenses for the six months ended June 30, 2021 were $7,122,000, an increase of 53.4% compared to $4,642,000 for the same period in 2020.  This increase was primarily due to increases of $1,136,000 in salary expenses and related accrual expenses mainly driven by temporary salary reductions during the six months ended June 30, 2020, that were implemented in response to the COVID-19 effect on revenues as well as additional resources mainly in our product development and sales infrastructure, $563,000 in share-based compensation-related expenses due to the expense recognition of grants made after June 30, 2020, $521,000 in development expenses associated with CGuard EPS accessory solutions, $483,000 in expenses related to the commencement of the C-Guardians FDA study, $226,000 of Directors’ and Officers’ Liability Insurance expense due to increased premiums caused by recent trends in the overall insurance industry. This increase was partially offset by a decrease of $400,000 relating to a settlement agreement with an underwriter of our prior offerings which occurred in the three months ended June 30, 2020 and a reduction of $49,000 of miscellaneous expense.

For the six months ended June 30, 2021, financial income was $4,000, compared to $9,000 during the six months ended June 30, 2020. Net loss for the six months ended June 2021 totaled $6,750,000, or $0.98 per basic and diluted share, compared to a net loss of $4,458,000, or $7.73 per basic and diluted share, for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 6,918,090 for the six months ended June 2021 and 576,827 for the six months ended June 2020, both adjusted to reflect the 1:15 reverse split effected by us on April 26, 2021.

As of June 30, 2021, cash and cash equivalents were $41.4 million compared to $12.6 million as of December 31, 2020.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, August 10, 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), or 1-412-317-5739 (international). 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/mediaframe/webcast.html?webcastid=a2t5MXpf.

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 November 10, 2021, at the above links.  A telephonic replay of the call will be available through August 24, 2021, and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10158721.

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 Nasdaq under the ticker symbol NSPR, and certain warrants are quoted on the Nasdaq under the symbol NSPRZ.

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”, “scheduled” or similar words. For example, the company is using forward-looking statements when it discusses its future plans with respect to its CGuard EPS stent, its belief that its efforts has created potential future momentum for its CGuard EPS stent, the potential benefits of its listing on Nasdaq, the intends regulatory submission and commercial launch of its CGuard Prime and the belief that it has sufficient cash reserves and liquidity to fund its planned operations. 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

(1) All 2021 financial information is derived from the Company’s 2021 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2020 financial information is derived from the Company’s 2020 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All June 30, 2021 financial information is derived from the Company’s 2021 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2020 financial information is derived from the Company’s 2020 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.

Tel Aviv, Israel— July 23, 2021 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease (CAD) and stroke prevention, today announces the initiation of enrollment and successful completion of the first cases of the Company’s U.S. registration C-Guardian trial of CGuard EPS.

The first patients, who were under the care of principal investigator, Chris Metzger, M.D., system chair of clinical research at Ballad Health System in Eastern Tennessee, were successfully implanted with the CGuard EPS stent device.  These are the first of 315 patients who are expected to be enrolled in the trial and treated with CGuard EPS in the treatment of carotid artery stenosis in symptomatic and asymptomatic patients undergoing carotid artery stenting.

“I believe that the initiation of this trial marks an important milestone for the potential approval of CGuard EPS and the potential of CGuard EPS in advancing the treatment of CAD and stroke prevention,” commented Dr. Metzger. “The wealth of clinical evidence and real-world experience outside the U.S. in the approved served markets with CGuard, demonstrating positive outcomes for patients was very compelling, which drew us to lead this trial to advance the CGuard EPS in the U.S. We are thrilled to participate in such an important effort to bring next generation devices to the growing therapeutic effort of treating CAD.”

InspireMD CEO, Marvin Slosman, added, “This milestone marks the beginning of what we consider to be the next step in our journey of establishing CGuard EPS as the leading stent device for treatment of CAD and the transition from surgical intervention to endovascular therapy.  The U.S. market has been a priority for our company and we believe that the C-Guardian trial will potentially pave the way to CGuard becoming available to physicians and their patients to realize the ongoing results from our current 33 served global markets.  We are grateful to Dr. Metzger and the Ballad Health System for leading this effort and their commitment to advancing our collective goals to improve patient outcomes and stroke prevention.”  

InspireMD Director, and renowned Cardiologist and Carotid expert, Dr. Gary Roubin, shared, “I am thrilled to contribute to the realization of this important milestone for InspireMD and encouraged to see the many years of advancing the treatment of Carotid Artery Disease take another step with the potential of having CGuard available to the medical community in the U.S.”  

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.

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. For example, the Company is using forward-looking statements when it discusses the number of expected patients to be enrolled in the trial, that the initiation of the trial marks an important milestone for the potential approval of the CGuard EPS and towards advancing the treatment of CAD and stroke prevention, and that the initiation of the trial marks the beginning of the next step in the Company’s journey towards CGuard EPS being utilized in the U.S. 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

Tel Aviv, Israel— June 2, 2021 – InspireMD, Inc. (Nasdaq-CM: NSPR) developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by Carotid Artery Disease (CAD), announced today that Chief Executive Officer Marvin Slosman will present a corporate overview at the three-day LD Micro Virtual Invitational Conference being held on June 8 – 10, 2021.

Mr. Slosman will deliver his corporate presentation on June 9 at 11:30am ET, Track 3.

Investors can register to watch the presentation here.

Investors interested in scheduling a meeting with management should contact assistant@ldmicro.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.

InspireMD’s common stock is quoted on the Nasdaq-CM under the ticker symbol NSPR. The Company’s warrants, NSPR.WS and NSPR.WSB, currently traded on the NYSE: American, have been approved for listing on The Nasdaq Capital Market (“Nasdaq”). Trading is expected to begin on June 8, 2021, under the symbols NSPRW and NSPRZ on the Nasdaq.  

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

CORE IR
investor-relations@inspiremd.com

Ticker to remain NSPR

 
 Tel Aviv, Israel— May 21, 2021 – InspireMD, Inc. (Nasdaq-CM: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by Carotid Artery Disease (CAD), today announced that the Company’s shares will commence trading on The Nasdaq Capital Market (“Nasdaq-CM”), today, May 21, 2021, under the symbol NSPR.
 
InspireMD CEO Marvin Slosman said, “The trading of our shares on the Nasdaq Capital Market is a yet another very important step in the continued evolution of InspireMD as we seek to create improved awareness of the Company, broaden our shareholder base, and improve trading liquidity in our efforts to establish a new standard of care in the treatment 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.
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
 
 
 

Tel Aviv, Israel— May 14, 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), announced today that management will participate at the Investor Summit Conference on May 17, 2021.

Chief Executive Officer Marvin Slosman will deliver his corporate presentation at 11:00am ET on May 17, 2021.

Investors can also request a one-on-one meeting with Mr. Slosman to be arranged following the conclusion of the conference.

Investors can register for the conference here.

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.

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

CORE IR
investor-relations@inspiremd.com

 Tel Aviv, Israel – May 12, 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 it has appointed seasoned marketing executive Kathryn (Katie) Arnold to its Board of Directors. With more than two decades of strategy and commercialization experience within the medical device industry, Ms. Arnold joins as the company advances global commercialization and enrollment in the U.S. IDE trial of its novel CGuard EPS technology.

“We are pleased to welcome Katie to the InspireMD Board. She is a proven marketing professional with a track record for delivering flawless launch execution and implementing key business strategies,” commented Paul Stuka, Chairman of the InspireMD Board. “Her wealth of knowledge and strong leadership will be instrumental in guiding our strategic plan and expand our commercial footprint.”

Ms. Arnold is the Founder and CEO of SPRIG Consulting, a strategic marketing consulting firm with over a decade of success in the medical space. Since its inception, the firm has engaged with over 200 medical companies ranging from venture-backed startups to Fortune 500 companies. Prior to founding SPRIG, Ms. Arnold held sales and marketing management roles with Guidant Corporation (acquired by Abbott Laboratories and Boston Scientific) and Kensey Nash Corporation (acquired by Spectranetics Corporation / Royal Philips). She has managed vascular and endovascular businesses, built strong commercial teams, and led numerous successful global product launches. Additionally, Ms. Arnold is an adjunct faculty member at the Kellogg School of Management at Northwestern University where she teaches a course specific to medical product commercialization and financing. Ms. Arnold received a bachelor of arts in environmental science from the University of Vermont and a master’s degree from the Kellogg School of Management at Northwestern University.

“I am excited to be joining InspireMD’s board at a time of significant organic growth and expansion through commercial and business development activities,” says Ms. Arnold. “Despite advances in the stenting space, a clear unmet need remains for a solution that effectively treats carotid artery disease. I am very impressed with the unique design of the CGuard stent and the robust clinical data validating its performance. I am excited to work with the management team and the board as we maximize opportunities for the company to reduce the worldwide stroke burden and transform the treatment of carotid artery disease.”

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.

As of May 21, 2021, InspireMD’s common stock will be quoted on the Nasdaq under the ticker symbol NSPR.

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

Company Completes Up-List to Nasdaq Capital Market, with Trading Becoming Effective May 21, 2021

Management to host investor conference call today, May 11, 2021, at 8:30am ET

Tel Aviv, Israel— May 11, 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 first quarter ended March 31, 2021.

First Quarter 2021 and recent highlights:

• Announced the up-list to the Nasdaq Capital Market, on which the company’s stock will be traded beginning May 21, 2021
• Announced reverse stock split of 1:15 with subsequent successful up-listing of shares on the Nasdaq Capital Market.
• Announced the closing of an upsized underwritten public offering combined with other capital raising transactions in Q1 2021, which netted the Company a total of $35.1 million.
• Announced the appointment of leading interventional cardiologist Chris Metzger, M.D., as the principal investigator for planned the C-Guardian FDA trial for CGuard EPS.
• Secured China distribution agreement including investment and partnership for seeking regulatory approval for 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.
• Selected for multiple presentations for CGuard EPS, including a live demonstration during the Leipzig Interventional Congress (LINC).

“Our persistent and tireless focus on execution continues as we build on our quest to change the standard of care in the treatment of carotid artery disease and stroke prevention, with CGuard EPS and our novel MicroNet™ mesh.  Our Q1 achievements have set up 2021 to be a meaningful year of progress toward our goals of global expansion, commercial revenue growth, progress toward FDA approval, growing our unmatched body of clinical evidence, and differentiating CGuard as a truly unique and preferred stent solution for carotid artery disease,” said Marvin Slosman, CEO of InspireMD.

“Most recently, we announced a successful up-listing approval of our common stock on the Nasdaq Capital Market as a part of a reverse stock split approved by stockholders.  We believe listing on Nasdaq will help broaden our stockholder base, increase interest by institutional and fundamental investors, and create stockholder value. The anticipated date for our shares to begin trading on NASDAQ is May 21, 2021.

“As we ramp up the start of the C-Guardian  U.S. pivotal trial  for CGuard EPS — an important step in our goal to achieve commercial registration in the United States — we announced that leading interventional cardiologist Chris Metzger, M.D., system chair of clinical research at Ballard Health System in eastern Tennessee, has accepted a role as principle investigator in the U.S., along with Piotr Musialek, who will serve as  co-principal investigator focusing on the European enrollment in the trial. Hart Clinical Consultants (HCC), a leading Contract Research Organization (CRO), will spearhead the effort managing the trial execution.

“Executing on our global expansion strategy, we announced this quarter an agreement with three China-based investment partners who will be responsible for conducting all necessary registration and establish distribution for the CGuard EPS in mainland China.  This is a foundational building block for our overall Asia growth plan.  Stroke is the leading cause of death in China, and the country is believed to be the second largest market for peripheral stent procedures.  We continue our push to expand into new the markets of France, Taiwan and Korea.

“Lastly, we have strengthened our balance sheet and cash reserves and believe that we are well positioned and have the resources needed to fund our trial, global expansion and build a pipeline of new products poised to transform the access and delivery of CGuard EPS.

“Advancing into 2021, we are optimistic and encouraged by the direction of our business and the potential for CGuard EPS to change the carotid disease treatment market with the most advanced stent system available,” concluded Mr. Slosman.

Financial Results for the First Quarter ended March 31, 2021

For the three months ended March 31, 2021, revenue decreased by $28,000, or 2.7%, to $1,006,000, from $1,034,000 during the three months ended March 31, 2020. CGuard revenue remained essentially unchanged at $969,000 during the three months ended March 31, 2021 as compared to $971,000 during the three months ended March 31, 2020, in spite of the continued postponement of many elective procedures as a result of the residual COVID directed resources. However, MGuard Prime EPS revenue decreased by a 41.3% from $63,000 during the three months ended March 31, 2020, to $37,000 during the three months ended March 31, 2021, largely driven by the predominant industry preferences favoring drug-eluting stents rather than bare metal stents such as MGuard Prime EPS in ST-Elevation Myocardial Infarction (“STEMI”) patients. 

For the three months ended March 31, 2021, gross profit (revenue less cost of revenues) decreased by 64.1%, or $189,000, to $106,000, from $295,000 during the three months ended March 31, 2020. This decrease in gross profit resulted from an increase in write-offs of $156,000, which were driven mainly by a component supply issue during the three months ended March 31, 2021 and an increase of $33,000 in miscellaneous expenses during the three months ended March 31, 2021. Gross margin (gross profits as a percentage of revenue) decreased to 10.5% during the three months ended March 31, 2021 from 28.5% during the three months ended March 31, 2020, driven by the factors mentioned above.

Total operating expenses for the quarter ended March 31, 2021 were $3,420,000, an increase of 47.7% compared to $2,316,000 for the same period in 2020.  This increase was primarily due to increases of $430,000 in salary expenses and related accrual expenses mainly driven by additional resources in our product development and sales infrastructure, $248,000 in share-based compensation-related expenses due to the expense recognition of grants made in the second half of 2020, $136,000 in development expenses associated with CGuard EPS, mainly related to the new advanced delivery system and accessories, $118,000 of Directors’ and Officers’ Liability Insurance expense due to increased premiums caused by recent trends in the overall insurance industry, an increase of $108,000 in stockholder related expenses due to the special stockholder meeting and $64,000 of miscellaneous expense.

For the three months ended March 31, 2021, financial income increased by 65.1%, or $28,000, to $71,000, from $43,000 during the three months ended March 31, 2020.  The increase in financial income primarily resulted from changes in exchange rates. 

Net loss for the first quarter of 2021 totaled $3,243,000, or $0.53 per basic and diluted share, compared to a net loss of $1,978,000, or $6.42 per basic and diluted share, for the same period in 2020. The average amount of shares outstanding used for the earnings per share calculation were 6,122,690 in Q1 2021 and 308,202 in Q1 2020, both adjusted to reflect the 1:15 reverse split.

As of March 31, 2021, cash and cash equivalents were $44.0 million compared to $12.6 million as of December 31, 2020. 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, May 11, 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/mediaframe/webcast.html?webcastid=yieueRnJ.

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 August 11, 2021 at the above links.  A telephonic replay of the call will be available through May 25, 2021 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10155884.

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)

CONSOLIDATED BALANCE SHEETS⁽²⁾
(U.S. dollars in thousands)

(1) All 2021 financial information is derived from the Company’s 2021 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2020 financial information is derived from the Company’s 2020 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission.

(2) All March 31, 2021 financial information is derived from the Company’s 2021 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission. All December 31, 2020 financial information is derived from the Company’s 2020 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.

Ticker to remain NSPR

Tel Aviv, Israel— May 10, 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 the Company’s shares have been approved for listing on The Nasdaq Capital Market (“Nasdaq”). Trading is expected to begin on May 21, 2021, under the symbol NSPR on the Nasdaq.  

InspireMD CEO Marvin Slosman commented, “We believe that moving to the Nasdaq Capital Market is a strategically important change that places us in the company of our peers and allows us greater access to a wider set of investors, thereby enabling us to build our fundamental base of investors.  InspireMD is 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.  We are extremely pleased to now be a part of the Nasdaq exchange and value our new relationship.”  

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.

As of May 21, 2021, InspireMD’s common stock will be quoted on the Nasdaq under the ticker symbol NSPR.

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

Tel Aviv, Israel— May 6, 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), announced today that management will participate at the Benzinga Global Small Cap Conference on May 14, 2021.

Chief Executive Officer Marvin Slosman will deliver his corporate presentation at 11:10am ET on May 14, 2021.

Investors can also request a one-on-one meeting with Mr. Slosman to be arranged following the conclusion of the conference.

Investors can register for the conference here:   

https://www.benzinga.com/events/small-cap/global/.

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.

Investor Contacts:

Craig Shore

Chief Financial Officer

InspireMD, Inc.

888-776-6804

craigs@inspiremd.com 

CORE IR
investor-relations@inspiremd.com

Earnings conference call to be held Tuesday, May 11, 2021 at 8:30 a.m. ET

Tel Aviv, Israel — May 4, 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 first quarter 2021 financial results on Tuesday, May 11, 2021 before the market opens. 

Management will host a conference call on Tuesday, May 11, 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/10155884/e7e882ac64.

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/mediaframe/webcast.html?webcastid=yieueRnJ.

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 August 11, 2021 at the above links.  A telephonic replay of the call will be available through May 25, 2021 and may be accessed by calling 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and using access code 10155884.

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