Announces hiring of Patrick Verta, MD, as Executive VP of Clinical and Medical Affairs

Cheryl Tal joins as VP of Quality Assurance and Regulatory Affairs

Shane Gleason, current General Manager of North America & VP of Global Marketing, promoted to Chief Commercial Officer

Reports Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

Tel Aviv, Israel, and Miami, Florida — October 3, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced senior leadership additions and changes intended to support the company’s commercial growth initiatives, including potential approval of the CGuard Prime stent platform in the U.S., development of new stent delivery systems, and growth in existing approved territories outside of the U.S.

The company announced today that it has hired Patrick Verta, MD, as Executive Vice President of Clinical and Medical Affairs and Cheryl Tal as Vice President of Quality Assurance and Regulatory Affairs. In addition, Shane Gleason, who previously served as InspireMD’s General Manager of North America and VP of Global Marketing, has been promoted to Chief Commercial Officer.

Marvin Slosman, Chief Executive Officer of InspireMD, stated, “As we build toward growing our business and leadership of carotid revascularization solutions and prepare for the potential approval of the CGuard Prime carotid stent platform in the U.S., we continue to expand our leadership team to keep pace with our advancing business needs. We are attracting top-tier talent with highly relevant expertise in the field of vascular interventions capable of providing the next-level leadership needed to fully capitalize on our rapidly expanding potential.” 

“Patrick adds tremendous experience in the carotid field having supported much of the clinical advancement over the past 20 years, and he brings an impeccable reputation amongst the Key Opinion Leader (KOL), medical and regulatory communities. Leveraging the superior clinical data of CGuard and establishing a new standard by which clinical and patient outcomes are measured will continue to be a priority for our company. Additionally, as we advance our CGuard Prime stent platform with its enhanced CAS delivery system, develop a TCAR neuro protection system, and commence focus on the acute stroke segment, we will look to Patrick to shepherd our clinical and medical functions through each of these strategic pathways.

“Cheryl Tal joins us to lead our Quality Assurance and Regulatory Affairs function with tremendous expertise in building businesses’ scale and capacity on a global level.

“Finally, after six months as our General Manager of North America & VP of Global Marketing, Shane Gleason has been promoted to Chief Commercial Officer, expanding his responsibilities to support our global commercial growth, including continuing to advance our plans for the launch of CGuard Prime following a potential U.S. approval in the first half of 2025.

“I am very excited to announce these additions to our leadership team and I look forward to each of their contributions,” Mr. Slosman concluded.   

Dr. Patrick Verta joins InspireMD from Canary Medical, a developer of implantable remote patient monitoring sensor technology and complementary data and analytics, where he served as Chief Medical Officer. Prior to that, he was Founder and Chief Executive Officer of Axelmed LLC, a consultancy focused on strategy and clinical, scientific, medical, and regulatory affairs for medical device companies. Before Axelmed, he spent the prior five years in various roles at Edwards Lifesciences (NYSE:EW), most recently as VP of Global Medical Affairs, Clinical Science and Biometrics in the Transcatheter Mitral and Tricuspid Therapies (TMTT) division. Earlier in his career, he held senior leadership positions at Sunshine Heart, Neomend, Abbott Vascular (part of Abbott, NYSE:ABT) and Guidant (acquired by Abbott), among others. Dr. Verta received his Doctor of Medicine (M.D.) from Faculté de Médecine in Paris.

Cheryl Tal joins InspireMD from New Phase Ltd., where she served as Director of Regulatory Affairs. Prior to that, she served as Regulatory Affairs and Quality Assurance (RAQA) Manager at Change Healthcare (previously McKesson, NYSE:MCK). Before that, she served as VP of Regulatory Affairs at ITGI Medical. Earlier in her career, Cheryl served in RAQA roles at Orsan Medical Technologies Ltd., Redent Nova Ltd., Galil Medical, Impliant Ltd., and A. Lapidot Pharmaceuticals Ltd.

Inducement Grant Under NASDAQ Listing Rule 5635(c)(4)

In connection with the appointment of Dr. Patrick Verta as Executive Vice President of Clinical and Medical Affairs, InspireMD has granted Dr. Verta 139,740 shares of restricted stock and stock options to purchase 46,580 shares of InspireMD’s common stock. The grant of restricted stock and stock options was approved by the Compensation Committee of InspireMD’s Board of Directors and was granted outside of InspireMD’s 2021 Equity Compensation Plan, with a grant date of October 2, 2023, as an inducement material to Dr. Verta entering into employment with InspireMD, in accordance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock and stock options vest over three years, with one-third vesting on the first anniversary of the grant and the remainder vesting in two equal installments on the second and third anniversaries of the grant date, subject to Dr. Verta being continuously employed by InspireMD as of such vesting dates. The stock options have a ten-year term and an exercise price of $3.30, the closing sales price of InspireMD’s common stock on the grant date.

InspireMD is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

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.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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 

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com

Tel Aviv, Israel, and Miami, Florida — August 31, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract detailing upcoming 30-day results from its C-Guardians U.S. IDE clinical trial has been accepted for presentation as a late-breaking clinical trial at the Vascular InterVentional Advances Annual Meeting (VIVA23), which is being held October 30 through November 2 in Las Vegas.

Presentation details:

Title:            30-Day Results from the C-Guardians Pivotal Trial of the CGuard™ Carotid Stent System

Presenter:   Chris Metzger, M.D., System Chair of Clinical Research at Ballad Health System and lead investigator of the C-Guardians trial

Date:            Wednesday, November 1, 2023

Time:            10:45am-12:00pm PT (1:45pm-3:00pm ET)

Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased that an abstract detailing our 30-day follow-up data from our C-Guardians IDE trial has been accepted for presentation at this year’s VIVA conference, which is among the most important gatherings of endovascular specialists each year. We believe CGuard™ EPS, with its novel MiroNet™ technology, offers next-level neuroprotection that translates into superior short- and long-term patient outcomes, something we aim to demonstrate with this important trial. We also look forward to sharing one-year data from C-Guardians in the second half of next year that, if positive, may support a Premarket Approval Application (PMA) and allow us to potentially launch the CGuard Prime EPS stent system in the U.S. in the first half of 2025.”

About C-Guardians

The C-Guardians clinical trial is evaluating the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study, which completed enrollment in June 2023, enrolled 316 patients across 25 trial sites in the U.S. and Europe.

The trial includes both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, and myocardial infarction (DSMI) through 30‐days post‐index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke from 31‐365-day follow‐up, based on CEC adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.

The company anticipates primary endpoint results from the study in H2 2024.

About VIVA

VIVA (Vascular InterVentional Advances) is a global educational event for specialists caring for patients with vascular disease. VIVA brings together attendees and faculty specializing in vascular surgery, interventional cardiology, interventional radiology, vascular medicine, neurointervention/neurosurgery, and cardiothoracic surgery, offering a uniquely comprehensive educational experience with access to some of the best minds in endovascular care.

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.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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. Examples of such statements include, but are not limited to, statements relating to the C-Guardians U.S. IDE clinical trial, including 30-day results from such trial and that such results will be available to presented as a late-breaking clinical trial at VIVA23, as well as the timing and outcome of any subsequent results, PMA or potential launch. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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 

Chuck Padala, Managing Director
LifeSci Advisors|
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com

– Completed transformational private placement for up to $113.6 million, including $42.2 million upfront –

– Completed enrollment in the C-Guardians US IDE trial; on track to announce primary and secondary endpoints and, if successful, submit PMA application in H2 2024 –

– Generated Q2 2023 CGuard EPS revenue of $1.6 million, an increase of nearly 10% over Q2 2022 

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

Tel Aviv, Israel, and Miami, FL — August 8, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for treatment of carotid artery disease and prevention of stroke today announced financial and operating results for the second quarter ended June 30, 2023.

Second Quarter 2023 and Recent Developments:

• Successfully completed a transformational private placement of common shares, prepaid warrants and warrants for up to $113.6 million in gross proceeds, including $42.2 million upfront and additional proceeds of up to $71.4 million upon exercise of milestone-driven warrants.
• Completed enrollment in the C-Guardians Investigational Device Exemption (IDE) Clinical Trial. The Company anticipates announcing primary and secondary endpoints and, if successful, submitting a Premarket Approval (PMA) application to FDA in the second half of 2024.
• Announced the first-in-human cases successfully performed with its CGuard Prime CAS stent delivery platform as part of C-Guardians trial enrollment.
• Generated record CGuard revenue for the second quarter 2023 of $1,649,000, a 9.6 % increase over the same period in 2022 and a 33% increase over the first quarter of 2023.
• Sold 2,804 CGuard EPS stent systems in the second quarter of 2023, as compared to 2,602 in the second quarter of 2022, an increase of 7.8%, and compared to 2,033 in the first quarter of 2023, an increase of 38%.

Marvin Slosman, CEO of InspireMD, commented: “Our second quarter was marked by several transformational milestones for our business, including the financing of up to $113.6 million that we announced in May. This capital allows us to advance our business towards multiple value-creating milestones, including obtaining potential regulatory approval of and launching our CGuard stent system in the U.S., initiating regulatory pathways for new advanced indications for CGuard, and developing new products, while at the same time continuing to grow our business in approved markets outside of the United States.

“We also announced completion of enrollment in our C-Guardians IDE trial, which includes the first ever cases performed with our CGuard Prime CAS stent delivery platform that we also plan to include in our regulatory submissions. Importantly, enrollment was completed efficiently in under 24 months and gives us line of sight to results and, if successful, a PMA submission in the second half of next year. In parallel, we continue to advance critical pre-commercial activities in the U.S. with the goal of launching CGuard Prime in the first half of 2025, if approved.

“The ongoing shift toward an endovascular standard of care with both CAS and TCAR, highlighted by the current CMS proposed decision memo to expand reimbursement for CAS, further validates our strategic direction. We are striving to serve all physician specialties that treat carotid disease, both CAS and TCAR, with our best-in-class CGuard EPS implant. We believe we are optimally positioned to make the CGuard EPS stent system the standard of care, not only in the U.S. but globally,” Mr. Slosman concluded.

Financial Results for the Second Quarter ended June 30, 2023

For the three months ended June 30, 2023, revenue increased by $118,000, or 7.7%, to $1,649,000, from $1,531,000 during the three months ended June 30, 2022. This increase was predominantly driven by a 9.6% increase in sales of CGuard EPS from $1,505,000 during the three months ended June 30, 2022, to $1,649,000 during the three months ended June 30, 2023.

For the three months ended June 30, 2023, gross profit (revenue less cost of revenues) increased by $60,000, or 14.0%, to $491,000, from $431,000 during the three months ended June 30, 2022. This increase in gross profit resulted from a $90,000 increase in revenues (as mentioned above), less the associated related material and labor offset by $30,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.8% during the three months ended June 30, 2023, from 28.1% during the three months ended June 30, 2022, driven by the factors mentioned above.

Total operating expenses for the second quarter of 2023, were $5,806,000, an increase of $694,000 or 13.6% compared to $5,122,000 for the second quarter of 2022. This increase was primarily due to an increase in compensation expenses.

Net loss for the second quarter of 2023 totaled $5,077,000 or $0.24 per basic and diluted share, compared to a net loss of $4,636,000, or $0.59 per basic and diluted share, for the same period in 2022.

As of June 30, 2023, cash, cash equivalents and short-term investments and bank deposits were $47.0 million compared to $17.8 million as of December 31, 2022. This includes the initial net funding of $37.5 million received upon closing of the transformational private placement that was announced in May, after deducting transaction expenses.

Financial Results for the Six Months ended June 30, 2023

For the six months ended June 30, 2023, revenue increased by $174,000, or 6.4%, to $2,888,000, from $2,714,000 during the six months ended June 30, 2022. This increase was predominantly driven by a 8.3% increase in sales volume of CGuard EPS from $2,666,000 during the six months ended June 30, 2022, to $2,888,000 during the six months ended June 30, 2023.

For the six months ended June 30, 2023, gross profit (revenue less cost of revenues) increased by 56.2%, or $311,000, to $864,000, compared to a $553,000 for the same period in 2022. This increase in gross profit resulted from a decrease in write-offs of $181,000 and a $161,000 increase in revenues (as mentioned above) less the associated related material and labor costs. This increase was partially offset by an increase of $31,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 29.9% during the six months ended June 30, 2023, from 20.4% during the six months ended June 30, 2022, driven by the reasons mentioned above.

Total operating expenses for the six months ended June 30, 2023, were $10,560,000, an increase of $840,000, or 8.6% compared to $9,720,000 for the six months ended June 30, 2022. This increase was primarily due to an increase in compensation and other general and administrative expenses.

Net loss for the six months ended June 30, 2023 totaled $9,333,000, or $0.64 per basic and diluted share, compared to a net loss of $9,117,000, or $1.17 per basic and diluted share, for the six months ended June 30, 2022.

Conference Call and Webcast Details

Management will host a conference call today, Tuesday, August 8, at 8:30 AM 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.  

Tuesday, August 8^th, at 8:30 a.m. ET

Domestic:                         1-844-826-3035

International:                  1-412-317-5195

Conference ID:               10180798

Call me™                           Link here

Webcast:                          Link 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 Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete  business objectives; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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

Chuck Padala, Managing Director

LifeSci Advisors

646-627-8390

chuck@lifesciadvisors.com

investor-relations@inspiremd.com

CONSOLIDATED STATEMENTS OF OPERATIONS⁽¹⁾

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

(1) All 2023 financial information is derived from the Company’s 2023 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2022 financial information is derived from the Company’s 2022 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, 2023 financial information is derived from the Company’s 2023 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, 2022 financial information is derived from the Company’s 2022 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2022 filed with the Securities

Trial designed to support potential U.S. marketing approval of the CGuard™ Prime EPS stent system

Study also included first-in-human cases treated with CGuard Prime CAS stent delivery platform 

Company anticipates study results and Premarket Approval (PMA) submission in H2 2024, potential U.S. approval in H1 2025

Tel Aviv, Israel — June 26, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it completed enrollment of its ongoing C-Guardians U.S. Investigational Device Exemption (IDE) clinical trial, designed to support potential U.S. marketing approval of the CGuard Prime EPS stent system.

Marvin Slosman, chief executive officer of InspireMD, stated, “The completion of enrollment in our IDE trial is a significant milestone and brings us one step closer to potential U.S. approval of the CGuard Prime EPS stent system. Notably, the trial was fully enrolled in less than two years, including first-in-human cases treated with our next generation CGuard Prime CAS delivery platform. We believe the rapid enrollment reflects the comfort and support of the CGuard stent system by our investigators as we work to be the only company developing comprehensive next generation delivery and neuro protection platforms that achieve best implant performance and patient outcomes though both transfemoral (CAS) and trans carotid (TCAR) solutions. Completing enrollment of the C-Guardians trial, advancing our PMA submission and obtaining FDA approval would allow us to launch CGuard Prime EPS commercially in the U.S. and catalyze market adoption. We look forward to building on our global expansion and fulfilling our mission to deliver best patient therapy for carotid disease and stroke prevention.”  

The C-Guardians clinical trial is evaluating the safety and efficacy of the CGuard™ Carotid Stent System for the treatment of carotid artery stenosis. The study, which commenced enrollment in July 2021, enrolled 315 patients across 25 trial sites in the U.S. and Europe.

The trial includes both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the composite of the following: incidence of the following major adverse events: death (all‐ cause mortality), all stroke, and myocardial infarction (DSMI) through 30‐days post‐index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke from 31‐365-day follow‐up, based on CEC adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided 95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.

The company anticipates results from the study in H2 2024.

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.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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.

Tel Aviv, Israel and Miami, Florida — May 18, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that, in connection with the appointment of Shane Gleason as General Manager of North America and VP of Global Marketing in February 2023, InspireMD granted Mr. Gleason 256,450 shares of restricted stock and stock options to purchase 85,480 shares of InspireMD’s common stock. The grant of restricted stock and stock options was approved by the Compensation Committee of InspireMD’s Board of Directors and was granted outside of InspireMD’s 2021 Equity Compensation Plan, with a grant date of May 17, 2023, as an inducement material to Mr. Gleason entering into employment with InspireMD, in accordance with Nasdaq Listing Rule 5635(c)(4).

The restricted stock and stock options vest over three years, with one-third vesting on the first anniversary of the grant and the remainder vesting in two equal installments on the second and third anniversaries of the grant date, subject to Mr. Gleason being continuously employed by InspireMD as of such vesting dates. The stock options have a ten-year term and an exercise price of $1.76, the closing sales price of InspireMD’s common stock on the grant date.

InspireMD is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

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.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited statements related to the private placement, the expected gross proceeds, the expected use of proceeds and the expected closing date. 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. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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 

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com

– Completed transformational private placement for up to $113.6 million, including $42.2 million upfront –

– Generated Q1 2023 CGuard EPS revenue of $1.2 million, an increase of 6.7% over Q1 2022 despite the temporary expiration of the Company’s CE Mark certification until mid-March –

– Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework; Anticipates re-certification under new Medical Device Regulation (MRD) framework in coming weeks –

– Continued enrollment in the C-Guardian US IDE trial; on track to complete enrollment by end of Q2 2023 –

Management to host investor conference call today, May 16^th, at 8:30am ET

Tel Aviv, Israel— May 16, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for treatment of carotid artery disease (CAD) and prevention of stroke today announced financial and operating results for the first quarter ended March 31, 2023.

First Quarter 2023 and Recent Developments:

• Successfully completed a transformational private placement of common shares, prepaid warrants and warrants for up to $113.6 million in gross proceeds, including $42.2 million upfront and additional proceeds of up to $71.4 million if milestone-driven warrants are exercised. Proceeds are intended to be used to advance the company’s business towards achieving several notable milestones, including obtaining potential regulatory approval and launch of CGuard in the U.S., initiating new regulatory pathways for advanced applications of its CGuard stent platform, and developing new products, while at the same time continuing to grow its business outside of the United States.
• Generated CGuard revenue for the first quarter 2023 of $1,239,064, a 6.7% increase over the same period in 2022. Shipments for the first half of the quarter were negatively impacted by the temporary expiration of the Company’s CE Mark. During the second half of the quarter, the CE Mark was reinstated under the MDD allowing the Company to resume shipments to EU countries. The Company continues to work through the backlog of orders resulting from the temporary CE Mark lapse.
• Sold 2,033 CGuard EPS stent systems in the first quarter of 2023, as compared to 1,910 in the first quarter of 2022, an increase of 6.4%. 
• Announced that the U.S. Food and Drug Administration (FDA) approved the Company’s next generation stent delivery system, CGuard Prime, for use in its ongoing U.S. IDE trial.
• Hired medical device commercial veteran Shane Gleason as General Manager of North America and Vice President of Global Marketing to position InspireMD to capitalize on the US market upon expected FDA approval.
• Promoted the Company’s Vice President of Global Sales and Marketing, Andrea Tommasoli, to Chief Operating Officer to meet increasing demand for CGuard globally.
• Continued enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial. The Company currently has 20 trial sites enrolling patients. The Company anticipates completing enrollment by approximately the end of Q2 2023, consistent with prior guidance.

Marvin Slosman, CEO of InspireMD, commented: “The clear highlight since our last quarterly update was the truly transformational financing that we successfully completed, with participation from leading fundamental healthcare investors. This significant transaction allows us to advance our business towards several very meaningful milestones, including potential FDA approval and launch of CGuard EPS in the U.S., initiation of new regulatory pathways for advanced applications of our CGuard stent platform, and development of new products, while at the same time continuing to grow our business outside of the United States. It also provides invaluable validation of our Company’s strategy to lead the carotid revascularization market globally with a stent-focused, clinical outcomes-based approach.

“Regarding the first quarter, we were able to generate year-over-year growth in CGuard EPS revenue and units shipped even as the temporary lapse of our CE Mark certification prevented us from selling into our key markets until approximately the second half of the quarter, when we were permitted to resume sales under the pre-existing MDD framework as we await final recertification under MDR. We believe this speaks to growing awareness of CGuard’s superior short- and long-term clinical outcomes, demonstrated across numerous clinical studies, that differentiate it from competing stent systems and make it a compelling alternative to far more invasive surgery.

“In parallel, our critical U.S. IDE trial continues to progress, with the recent completion of the first-in-human stenting procedure using the CGuard Prime CAS delivery system. We anticipate completing enrollment by approximately the end of this quarter. Obtaining U.S. marketing approval of CGuard EPS remains a top priority and would represent a watershed opportunity in the direction for our company.

“With the planned introduction of a new stent delivery system in CGuard Prime, along with our SwitchGuard TCAR neuro protection system, we believe we are well positioned to accelerate the ongoing conversion of carotid surgical procedures to endovascular stent-based interventions, where carotid artery disease significantly lags other endovascular procedure categories. At the same time, with the likely recertification of our CE Mark under MDR occurring imminently, we plan to continue to grow market share in our approved served markets. We are incredibly encouraged by the potential of these transformational milestones for our company and look forward to our focus on growth and market leadership,” Mr. Slosman concluded.  

Financial Results for the First Quarter ended March 31, 2023

For the three months ended March 31, 2023, revenue increased by $56,000, or 4.7%, to $1,239,000, from $1,183,000 during the three months ended March 31, 2022. This increase was predominantly driven by a 6.7% increase in sales of CGuard EPS from $1,161,000 during the three months ended March 31, 2022, to $1,239,000 during the three months ended March 31, 2023.

During the second half of the quarter, the company’s CE mark was reinstated under the MDD directive allowing the company to resume sales and shipments to the EU countries. The Company worked through the remainder of the quarter shipping product to reduce the backlog of orders that accumulated over the past few months. InspireMD believes the quarter-over-quarter increase in revenue during the first quarter of 2023 is not representative of the real underlying market demand for CGuard EPS, due to the Company’s inability to ship product for the first half of the quarter. The Company continues to work to expedite the review process for recertification under the MDR.

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

Total operating expenses for the first quarter of 2023, were $4,754,000, an increase of $146,000 or 3.2% compared to $4,608,000 for the first quarter of 2022. This increase was primarily due to increases in expenses related to C-Guardians FDA study, sales and marketing expenses, and regulatory expenses.

Net loss for the first quarter of 2023 totaled $4,256,000 or $0.53 per basic and diluted share, compared to a net loss of $4,481,000, or $0.57 per basic and diluted share, for the same period in 2022.

As of March 31, 2023, cash, cash equivalents and short-term bank deposits were $12.9 million compared to $17.8 million as of December 31, 2022. As noted, subsequent to the end of the first quarter 2023, the Company completed a private placement that resulted in upfront gross proceeds of $42.2 million.

Conference Call and Webcast Details

Management will host a conference call today, Tuesday, May 16^th, at 8:30 AM 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.  

Tuesday, May 16^th, at 8:30 a.m. ET

Domestic:                            1-844-826-3035

International:                     1-412-317-5195

Conference ID:                  10178031

Call me™                              Link here

Webcast:                             Link 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 Nasdaq under the ticker symbol NSPR.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete  business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com

investor-relations@inspiremd.com

CONSOLIDATED STATEMENTS OF OPERATIONS⁽¹⁾

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

(1) All 2023 financial information is derived from the Company’s 2023 unaudited financial statements, as disclosed in the Company’s Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission; all 2022 financial information is derived from the Company’s 2022 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, 2023 financial information is derived from the Company’s 2023 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, 2022 financial information is derived from the Company’s 2022 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2022 filed with the Securities and Exchange Commission.

Led by Marshall Wace with participation from OrbiMed, Rosalind, Nantahala, Soleus, Velan and certain InspireMD Board members

$42.2 million financing upfront with up to an additional $71.4 million tied to exercise of milestone-driven warrants

Tel Aviv, Israel and Miami, Florida — May 15, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the Company has signed a securities purchase agreement with certain healthcare-focused institutional investors that have agreed to provide up to $113.6 million in gross proceeds to InspireMD through a private placement that includes initial upfront funding of $42.2 million. The financing is being led by Marshall Wace with participation from OrbiMed, Rosalind, Nantahala, Soleus, Velan and certain InspireMD Board members.

“We are very pleased to have achieved this important milestone with leading fundamental healthcare investors who have chosen to participate in this transformational financing of our company,” stated Marvin Slosman, chief executive officer of InspireMD. “This infusion of capital allows us to advance our business towards achieving milestones, including obtaining potential regulatory approval and launching of CGuard in the U.S., initiating new regulatory pathways for advanced applications of our CGuard stent platform, and developing new products, while at the same time continuing to grow our business outside of the United States.”

“Advancing our growing product pipeline, including our new CGuard Prime Transfemoral (CAS) delivery system along with our SwitchGuard trans carotid (TCAR) neuroprotection system (NPS), positions our company to serve the entire carotid revascularization market, continuing our mission of delivering implant focused patient outcomes.” 

About the Private Placement

Pursuant to the securities purchase agreement, the Company has agreed to issue an aggregate of 25,828,164 shares of common stock (or prepaid warrants) and four series of unregistered warrants to purchase an aggregate of 51,656,328 shares of common stock for a purchase price of $1.6327 per share and associated warrants (less $0.0001 in the case of prepaid warrants), priced at-the-market under Nasdaq rules. Each warrant is exercisable at $1.3827 per share as follows:

• Series H warrants for an aggregate cash exercise price of approximately $17.9 million exercisable until the earlier of five years from issuance and 20 trading days following the Company’s public release of primary and secondary end points related to one year follow up study results from the Company’s C-Guardians pivotal trial;
• Series I warrants for an aggregate cash exercise price of approximately $17.9 million exercisable until the earlier of five years from issuance and 20 trading days following the Company’s announcement of receipt of Premarket Approval (PMA) from the FDA for the CGuard Prime Carotid Stent System (135 cm);
• Series J warrants for an aggregate cash exercise price of approximately $17.9 million exercisable until the earlier of five years from issuance and 20 trading days following the Company’s announcement of receipt of FDA approval for the SwitchGuard trans carotid system and CGuard Prime 80 cm; and
• Series K warrants for an aggregate cash exercise price of approximately $17.9 million exercisable until the earlier of five years from issuance and 20 trading days following the end of the fourth fiscal quarter after the fiscal quarter in which the first commercial sales of the CGuard Carotid Stent System in the United States commence.

In connection with the securities purchase agreement, the Company entered into a registration rights agreement pursuant to which the Company will subsequently file a registration statement to register for resale the common stock purchased in the transaction and the common stock underlying the prepaid warrants and warrants.

Piper Sandler is serving as exclusive capital markets advisor to the Company. A.G.P./Alliance Global Partners is serving as financial advisor in the offering.

LifeSci Capital LLC is acting as the exclusive placement agent for the private placement.

The closing of the private placement is expected to occur on May 15, 2023, subject to customary closing conditions.

InspireMD currently intends to use the net proceeds from the offering for product and clinical development, obtaining regulatory approvals, expansion of manufacturing capabilities, commercial readiness activities to support potential new product launches including CGuard Prime and SwitchGuard in the US and EU as well as working capital and other general corporate purposes.

The securities issued in the private placement and unregistered warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the unregistered shares, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

For further information, please see the Company’s current report on Form 8-K to be filed with the SEC.

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.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited statements related to the private placement, the expected gross proceeds, the expected use of proceeds and the expected closing date. 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. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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 

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com

-Conference call and webcast to be held at 8:30 a.m. EDT- 

Tel Aviv, Israel— May 12, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today that it will host its conference call and webcast to review first quarter 2023 financial and operating results on Tuesday, May 16^th, 2023, before the markets open.

The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.

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”, “scheduled” 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. For example, the company is using forward looking statements when it discusses the expansion of its portfolio and potential indications and that the CGuard Carotid stent provides a foundational advantage for improved patient outcomes and prevention of stroke.  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

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com

-Conference call and webcast to be held at 8:30 a.m. EDT-

Tel Aviv, Israel— May 5, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) device for the treatment of Carotid Artery Disease and stroke prevention, announced today it will now report first quarter 2023 financial results on Monday, May 15^th, 2023. 

Management will host a conference call and webcast with the investment community at
8:30 am (EDT) that same day to review financial results and provide an update on corporate developments. 

The webcast should be accessed 15 minutes prior to the conference call start time. A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company’s website.

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”, “scheduled” 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. For example, the company is using forward looking statements when it discusses the expansion of its portfolio and potential indications and that the CGuard Carotid stent provides a foundational advantage for improved patient outcomes and prevention of stroke.  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

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com

Procedure performed as part of the company’s ongoing CGuardians U.S. Investigational Device Exemption (IDE) trial designed to support potential U.S. marketing approval of the CGuard stent system.

CGuardians enrollment on track to be completed by the end of Q2 2023

Tel Aviv, Israel — May 1, 2023 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the first carotid artery disease patient has been treated utilizing CGuard Prime, the company’s next generation CAS stent platform. The procedure was performed by Dr. Anish Thomas of Mercy Hospital South in St. Louis, MO, as part of InspireMD’s ongoing CGuardians U.S. IDE trial.

Marvin Slosman, chief executive officer of InspireMD, stated, “We are very pleased to have achieved this remarkable milestone – the successful first-in-human stenting procedure using CGuard Prime – as the final step in a lengthy development process as we work to advance new technology to build on our well established CGuard stent performance. I am very proud of the entire InspireMD organization for their tireless work building this platform and I would like to thank Dr. Anish Thomas and his staff for their leadership in performing these procedures. Our next generation feature set incorporated into CGuard Prime provides physicians with greater capabilities and confidence in the deployment of CGuard, our third generation MicroNet mesh protected stent. I am excited for our future as we continue to innovate and provide advanced technologies.”

Dr. Anish Thomas, cardiologist at Mercy Hospital South, St. Louis, added, “The favorable post-procedural short- and long-term patient outcomes for carotid artery disease patients treated with CGuard EPS have been well documented across a number of rigorously designed clinical studies. With the advanced features of the CGuard Prime CAS delivery system, including its innovative handle design, and catheter and tip construction, the ease of stent trackability and deployment have been taken to the next level, which should only accelerate its uptake among interventionalists and surgeons alike. I am delighted to have successfully performed the first case with CGuard Prime, and I am pleased to play a continuing role in advancing this novel stent technology toward potential FDA approval.”

InspireMD anticipates completing enrollment in the CGuardians U.S. IDE trial by the end of the second quarter 2023. The company will provide an additional update on this and other recent developments during its regularly scheduled Q1 2023 earnings conference call.

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.

We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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 

Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com