– Generated 38.8% growth in CGuard™ revenue year-over-year –

– Continued enrollment in the C-Guardian US IDE trial, with 24 sites currently enrolling patients; on track to complete enrollment by approximately end of Q1 2023 –

– Announced strategic partnership with NAMSA, a med tech contract research organization (CRO), to accelerate new medical device development and commercialization –

—

Management to Host Investor Conference Call Today, November 8^th, at 8:30am ET
—

Tel Aviv, Israel— November 8, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease (CAD) and prevention of stroke today announced financial and operating results for the third quarter ended September 30, 2022.

Third Quarter 2022 and Recent Highlights:

• CGuard revenues for the third quarter 2022 were $1,430,836, a 38.8 % increase over the same period in 2021, on 2,624 stent systems sold, as compared to 1,709 stents sold in the same period in 2021.  
• Continued enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial. The company currently has 24 trial sites enrolling patients (19 US, 5 EU) and anticipates adding two more US sites by the end of the year. The company anticipates completing enrollment by approximately end of Q1 2023, consistent with prior guidance.

• Professor Piotr Musialek presented at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) Conference long term patient results from the ongoing CGuard Optima study establishing a new baseline of carotid stent performance.
• Announced strategic outsourcing partnership with NAMSA, a med tech contract research organization (CRO), to accelerate new medical device development and commercialization.

Marvin Slosman, CEO of InspireMD, commented: “During the third quarter, we continued to gain share in our key European markets, contributing to nearly 40% CGuard revenue growth over the prior year period. We continue to work with our Notified Body to secure our CE Mark certification under the MDR, which currently expires November 12, while preparing our customers and distributors with sufficient inventory to mitigate as best as possible any potential delay in the recertification process.

“At the same time, our U.S. IDE trial now has 24 sites enrolling patients. We continue to anticipate having the trial fully enrolled by approximately end of Q1 of next year, a critical step forward in our goal to gain eventual marketing approval in the U.S.”

“We believe we have set the stage for a catalyst-rich 2023, driven by continued share gains in our established markets, ongoing progress with our U.S. IDE trial, conversion of existing endovascular CAD procedures to CGuard from other stent systems, and the introduction of two new delivery systems, our SwitchGuard Trans Carotid (TCAR) , and CGuard Prime Transfemoral (TFEM) platforms which will allow us to continue to address the comprehensive needs for all vascular specialist treating Carotid disease and stroke, including vascular surgeons who continue to treat a significant percentage of Carotid patients,” Mr. Slosman concluded.     

Financial Results for the Third Quarter ended September 30, 2022

For the third quarter of 2022, total revenue increased 33.6%, to $1,431,000, from $1,071,000 during the third quarter of 2021.  This increase was predominantly driven by a 38.8% increase in sales of CGuard EPS, to $1,431,000 in the third quarter of 2022 from $1,031,000 in the same period one year ago. This sales increase was due to growth in existing markets as well as US sales related to stents used in the C-Guardian U.S. Food and Drug Administration (FDA) clinical trial. 

Gross profit for the third quarter of 2022 increased by $274,000, or 297.8%, to $366,000, compared to a gross profit of $92,000 for the third quarter of 2021. This increase resulted from higher revenue and a reduction in write offs of $64,000, training expenses of $64,000 and miscellaneous expenses of $51,000. Gross margin (gross profits as a percentage of revenue) increased to 25.6% during the three months ended September 30, 2022, from 8.6% during the three months ended September 30, 2021.

Total operating expenses for the third quarter of 2022, were $4,976,000, an increase of $853,000, or 20.7% compared to $4,123,000 for the third quarter of 2021.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study and share-based compensation expenses.

Net loss for the third quarter of 2022 totaled $4,529,000, or $0.58 per basic and diluted share, compared to a net loss of $4,071,000, or $0.53 per basic and diluted share, for the same period in 2021.

As of September 30, 2022, cash, cash equivalents and short-term bank deposits were $21.0 million compared to $34.0 million as of December 31, 2021.

Financial Results for the Nine Months ended September 30, 2022

For the nine months ended September 30, 2022, total revenue increased by $1,030,000, or 33.1%, to $4,145,000, from $3,115,000 during the nine months ended September 30, 2021. This increase was predominantly driven by a 35.7% increase in sales of CGuard EPS, to $4,097,000 during the nine months ended September 30, 2022 from $3,018,000 during the nine months ended September 30, 2021. This sales increase was mainly due to growth in existing and new markets and sales in the United States related to stents used in our C-Guardians FDA study as enrollment accelerated.

Gross profit for the nine months ended September 30, 2022 increased by $459,000, or 99.8%, to $919,000, compared to a gross profit of $460,000 for the nine months ended September 30, 2021. This increase in gross profit resulted from higher revenue, partially offset by a decrease of $141,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 22.2% during the nine months ended September 30, 2022 from 14.8% during the nine months ended September 30, 2021.

Total operating expenses for the nine months ended September 30, 2022, were $14,696,000, an increase of $3,451,000, or 30.7% compared to $11,245,000 for the nine months ended September 30, 2021.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study, share-based compensation, resumed activities in tradeshows and travel, directors’ and officers’ liability insurance and miscellaneous expenses.

Net loss for the nine months ended September 30, 2022 totaled $13,646,000, or $1.75 per basic and diluted share, compared to a net loss of $10,821,000, or $1.50 per basic and diluted share, for the nine months ended September 30, 2021.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, November 8^th, 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, November 8^th at 8:30 a.m. ET

Domestic:                              1-877-407-4018
International:                       1-201-689-8471
Conference ID:                    13733319
Webcast:                               Webcast Link – Click 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.

For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “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 (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, including the changing regulatory environment in Europe and the timing of the renewal of certificate to continue to sell CGuard under the new MDR rule structure, (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

(1) 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; 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.

(2) All September 30, 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. All December 31, 2021 financial information is derived from the Company’s 2021 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2021 filed with the Securities and Exchange Commission.

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

Tel Aviv, Israel— October 25, 2022 – 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 report third quarter 2022 financial results on Tuesday, November 8^th, 2022, before the financial markets open. 

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

Tel Aviv, Israel — September 13, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke, today announced that the company will deliver a presentation at the 2022 Transcatheter Cardiovascular Therapeutics (TCT) Conference, which is being held September 16-19, 2022, at the Boston Convention and Exhibition Center in Boston, MA.

Details of the presentation are as follows:

Title:             Endovascular Sequestration of High-Risk Carotid Lesions Using the MicroNet™-Covered Embolic Prevention Stent in Consecutive Patients with Symptoms or Signs of Carotid Stenosis-Related Cerebral Injury: An Investigator-Initiated, Intravascular, Ultrasound-Controlled, Multinational, Multispecialty Trial (CGuard OPTIMA)

Presenter:   Prof. Piotr Musialek, Associate Professor of Cardiovascular Medicine, Jagiellonian University Department of Cardiac & Vascular Diseases, Krakow, Poland

Date:             Saturday, September 17, 2022

Time:            4:15 pm ET

Location:     Clinical Science & Endovascular Theatre, Exhibition Level, Hall C

For more information: TCT2022

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.” 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 (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

TOLEDO, OHIO and TEL AVIV, ISRAEL – BUSINESSWIRE—SEPTEMBER 8, 2022—NAMSA, a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, and InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for treatment of carotid artery disease and prevention of stroke, announced today that they have entered into a strategic outsourcing partnership to accelerate medical device development and commercialization.

InspireMD, which was founded in 2005 and became publicly traded in 2011, focuses on developing and commercializing the innovative CGuard™ EPS stent platform and related delivery systems that provide sustained embolic and neurovascular protections. These products also include medical technologies for stroke prevention and carotid artery disease (CAD) treatments. With its proprietary MicroNet™ technology, InspireMD is focused on changing the carotid and neurovascular market by working to make CGuard™ EPS the standard of care in CAD while expanding its portfolio of solutions and pursuing applications of its MicroNet™ technology in other peripheral indications.

“We are thrilled that InspireMD has selected NAMSA as their strategic outsourcing partner of choice,” commented Dr. Christophe Berthoux, NAMSA CEO. “NAMSA’s mission is to deliver best-in-class global MedTech solutions through our people, expertise and technology and this collaboration is quintessential to this endeavor. With increasing demand to find trusted outsourcing partners to accelerate efficient clinical development of life-changing medical products, we are well positioned to work together in this joint venture. Leveraging NAMSA’s full continuum of development services, combined with our deep-rooted cardiovascular and neurovascular expertise, we look forward to helping accelerate InspireMD’s new product development efforts,” Dr. Berthoux concluded.

A key driver of success for MedTech Sponsors in the product development process is speed-to-market. Today, many companies are experiencing longer development timelines to accommodate an increasing number of clinical trials for Class II and III products due to more complex regulatory and clinical requirements. As a result, trial Sponsors are increasingly seeking strategic outsourcing partners such as NAMSA that have proven, trusted track records of decreasing development costs, providing multiple resource efficiencies, accelerating timelines and providing immediate access to therapeutic expertise and knowledge.

“InspireMD has always sought ways to safely and efficiently accelerate product development through strategic outsourcing partners, and we have now found what we believe to be the ideal partner in NAMSA,” commented Marvin Slosman, InspireMD CEO. “We look forward to establishing a more efficient path to market through NAMSA’s expertise, experience and established relationships with regulatory authorities. With NAMSA’s support, we can put more emphasis on integrating MicroNet™ technology to develop products that are part of the new industry standard for sustained embolic/neurovascular protections and stroke prevention. Our entire team looks forward to partnering with NAMSA as we continue to expand our presence globally and bring much-needed medical technology advancements to patients around the world,” Slosman concluded.

ABOUT NAMSA
Helping medical device Sponsors improve healthcare since 1967, NAMSA is the world’s leading MedTech Contract Research Organization (CRO) offering global end-to-end development services. Driven by its global regulatory expertise and in-depth therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move clients’ products through the development lifecycle efficiently and cost-effectively. From medical device testing; regulatory, reimbursement and quality consulting; and clinical research services, NAMSA is the industry’s premier, trusted partner for successful development and commercialization outcomes. Web: namsa.com

NAMSA Media Contact
Leah Davidson, MA, MBA
Sr. Manager, Global Marketing Communications
Email: ldavidson@namsa.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 under the ticker symbol NSPR. Web: inspiremd.com

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “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 (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, including the changing regulatory environment in Europe and the timing of the renewal of certificate to continue to sell CGuard under the new MDR rule structure, (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.

InspireMD Investor Contact
Craig Shore
Chief Financial Officer
InspireMD, Inc.
Email: craigs@inspiremd.com

– Generated 47.8% growth in CGuard™ revenue year-over-year –

– Delivered several presentations at LINC 2022 featuring CGuard™ EPS, including a successful live case transmission –

– Announced that endovascular pioneer Dr. Juan Parodi has agreed to act as strategic advisor to the company –

—

Management to Host Investor Conference Call Today, August 9^th, at 8:30am ET
—

Tel Aviv, Israel— August 9, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention 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, 2022.

Second Quarter 2022 and Recent Highlights:

• CGuard revenues for the second quarter 2022 were $1,505,000, a 47.8% increase over the same period in 2021, on 2,602 stent systems sold, as compared to 1,623 stents sold in the same period in 2021.  
• Continued enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial. The Company completed its first European enrollment in April, led by co-principal investigator Professor Piotr Musialek, at John Paul II Hospital, in Krakow, Poland. The company currently has 20 trial sites enrolling patients and anticipates adding seven more by the end of the year. The company anticipates completing enrollment in Q1 2023.

• Delivered several presentations at LINC 2022 featuring CGuard™ EPS, including a live case transmission on a 62-year-old asymptomatic male with progressive and calcified internal carotid critical stenosis. The procedure was successfully performed with the 10mm x 30mm CGuard™ EPS and produced an excellent angiographic result.
• Announced that endovascular pioneer Dr. Juan Parodi has agreed to act as strategic advisor to the company. Dr. Parodi is credited with performing the first endovascular repair procedure in 1990 and the first TCAR procedure in 1994.

Marvin Slosman, CEO of InspireMD, commented: “Our second quarter revenue results again demonstrated our ability to gain share in our key European markets. With 48% growth in revenue in the quarter, respectively, over the same quarterly period last year, we believe we are well on our way to establishing CGuard™ EPS as a ‘new’ standard of care for the management of carotid artery disease and stroke prevention.”

“Regarding our U.S. IDE trial, we now have 22 sites enrolling patients, and plan to bring an additional seven online by the end of the year. Enrollment is accelerating and tracking nicely, and we continue to anticipate having the trial fully enrolled by approximately Q1 of next year.”

“We expect future growth to be driven by continued market share gains, additional geographic expansion, and the introduction of our new stent delivery systems, CGuard Prime and Switchguard. I look forward to continued momentum and I am beyond excited for what the future holds, not only for our company, but for CAD patients and their treating physicians as well,” Mr. Slosman concluded.       

Financial Results for the Second Quarter ended June 30, 2022

For the second quarter of 2022, total revenue increased 47.6%, to $1,531,000, from $1,038,000 during the second quarter of 2021.  This increase was predominantly driven by a 47.8% increase in sales volume of CGuard EPS, to $1,505,000 in the second quarter of 2022 from $1,019,000 in the same period one year ago. This sales increase was mainly due to growth in existing and new markets as well as US sales related to stents used in the C-Guardian U.S. Food and Drug Administration (FDA) clinical trial. 

Gross profit for the second quarter of 2022 increased by $169,000, or 64.4%, to $431,000, compared to a gross profit of $262,000 for the second quarter of 2021. This increase resulted from higher revenue and a reduction in miscellaneous expenses of $55,000, partially offset by a $83,000 reduction in costs of goods sold due to an inventory adjustment that occurred during the three months ended June 30, 2021 which did not occur during the three months ended June 30, 2022. Gross margin (gross profits as a percentage of revenue) increased to 28.1% during the three months ended June 30, 2022 from 25.2% during the three months ended June 30, 2021.

Total operating expenses for the second quarter of 2022, were $5,112,000, an increase of $1,410,000, or 38.1% compared to $3,702,000 for the second quarter of 2021.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study, resumed activities in tradeshows, travel and share-based compensation.

Net loss for the second quarter of 2022 totaled $4,636,000, or $0.59 per basic and diluted share, compared to a net loss of $3,507,000, or $0.46 per basic and diluted share, for the same period in 2021.

As of June 30, 2022, cash, cash equivalents and short-term bank deposits were $26.5 million compared to $34.0 million as of December 31, 2021.

Financial Results for the Six Months ended June 30, 2022

For the six months ended June 30, 2022, total revenue increased by $670,000, or 32.8%, to $2,714,000, from $2,044,000 during the six months ended June 30, 2021. This increase was predominantly driven by a 34.2% increase in sales volume of CGuard EPS, to $2,666,000 during the six months ended June 30, 2022 from $1,987,000 during the six months ended June 30, 2021. This sales increase was mainly due to growth in existing and new markets and sales in the United States related to stents used in our C-Guardians FDA study which occurred in the six months ended June 30, 2022, but not in the corresponding period in 2021.

Gross profit for the six months ended June 30, 2022 increased by $185,000, or 50.2%, to $553,000, compared to a gross profit of $368,000 for the six months ended June 30, 2021. This increase in gross profit resulted from higher revenue, partially offset by an increase of $38,000 in miscellaneous expenses. Gross margin (gross profits as a percentage of revenue) increased to 20.4% during the six months ended June 30, 2022 from 18% during the six months ended June 30, 2021.

Total operating expenses for the six months ended June 30, 2022, were $9,720,000, an increase of $2,598,000, or 36.5% compared to $7,122,000 for the six months ended June 30, 2021.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study, share-based compensation and resumed activities in tradeshows and travel.

Net loss for the six months ended June 30, 2022 totaled $9,117,000, or $1.17 per basic and diluted share, compared to a net loss of $6,750,000, or $0.98 per basic and diluted share, for the six months ended June 30, 2021.

Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, August 9, 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 9^th at 8:30 a.m. ET

Domestic:                              855-327-6837
International:                       631-891-4304
Conference ID:                    10019719
Webcast:                               Webcast Link – Click 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.

For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “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 (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, including the changing regulatory environment in Europe and the timing of the renewal of certificate to continue to sell CGuard under the new MDR rule structure, (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

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 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; 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.

(2) All June 30, 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. All December 31, 2021 financial information is derived from the Company’s 2021 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2021 filed with the Securities and Exchange Commission.

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

 Tel Aviv, Israel— August 1, 2022 – 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 report second quarter 2022 financial results on Tuesday, August 9^th, 2022, before the financial markets open. 

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

Credited with performing the first ever endovascular repair procedure in 1990

Tel Aviv, Israel — July 14, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke, today announced the appointment of endovascular pioneer Dr. Juan Parodi as a strategic advisor to the Company.

Marvin Slosman, Chief Executive Officer of InspireMD, commented, “Dr. Parodi’s world renowned achievements in the field of vascular surgery are remarkable, including having performed the first ever endovascular repair procedure in 1990. He also performed the first carotid TCAR procedure in 1994, utilizing reverse flow for cerebral protection. Dr. Parodi offers our company incredible experience, unique perspective and guidance as we build new solutions to advance stroke prevention and long-term patient outcomes, across the broadest range of vascular specialists and device options.”

Dr. Parodi stated, “My passion and years of work advancing breakthrough technology and clinical solutions is what drew me to the InspireMD team, as they exemplify a company with innovation in its DNA, building solutions that are practical, meaningful, market driven and foundationally driven by clinical performance as measured by patient outcomes. I believe CGuard™ EPS, with its unique conformability and proprietary MicroNet™ mesh protection, offers carotid artery disease patients’ better outcomes and greater long-term protection from post-procedural cerebral embolization than competing stents currently on the market. The transition of carotid disease management from open surgery to endovascular standard of care is well underway and being aligned with InspireMD offers a unique opportunity to contribute to their good work leading this important change.”     

Dr. Parodi currently serves as Honorary Professor of Surgery at both Universidad de Buenos Aires in Argentina and at Washington University School of Medicine in St. Louis. Dr. Parodi received his Physician and Surgeon Honor Certificate from Universidad del Salvador, Buenos Aires, Argentina, his Board Certificate in General Surgery from the University of Buenos Aires, and his Board Certificate in Vascular Surgery from the Argentinean College of Medicine Argentinean College of Cardiovascular Surgery, Buenos Aires Province.

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.” 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 (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

Successful live case transmission again demonstrated CGuard’s™ differentiated patient protection features and ease of use

Tel Aviv, Israel — June 9, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke, today provided the following highlights from multiple presentations and live case transmission, all featuring its CGuard™ Embolic Prevention Stent System, from LINC 2022, which was held June 6-9.

“Our participation and presentations at this years’ LINC conference allowed us to demonstrate the compelling features of the CGuard™ Embolic Prevention Stent System that we believe are building a new standard of care in carotid revascularization,” said Marvin Slosman, chief executive officer of InspireMD. “Of particular note, CGuard™ was featured in a very successful live case that clearly demonstrated the advantages of optimal vessel conformability with sustainable MicroNet™ mesh protection for best patient outcomes. LINC remains an important medical congress, and our growing presence year after year is a clear reflection of our progress and growing market leadership in carotid stenting and stroke prevention”

Highlights of this year’s LINC presentations include:
Title: CGuard Live case transmission from Heart Center, Leipzig, Germany
Operators: Dr Andrej Schmidt and Dr Andreas Fischer
The live case was conducted by Dr. Andrej Schmidt and Dr. Andreas Fischer, interventional Angiologists at University Hospital, Leipzig, Germany. The patient was a 62 year old asymptomatic male with progressive and calcified internal carotid critical stenosis. The procedure was successfully performed with the 10mm x 30mm CGuard™ EPS, obtaining an excellent angiographic result.

• Following the procedure, Dr. Schmidt commented, “The CGuard EPS stent has superb conformability with its open cell design and having the MicroNet™ mesh technology gives my patient the greatest protection available in carotid stenting.”
Title: Randomized Controlled Trial of a First-Generation Carotid Stent vs. the MicroNet™-Covered Stent: 12-Month Outcomes
Presenter: Savr Bugurov
This presentation highlighted key secondary endpoint data from the Randomized Control Trial comparing the MicroNet™TM covered stent (CGuard) versus first generation open cell Abbott’s Acculink™ stent.
Key highlights include:
• The cumulative incidence of death, stroke or myocardial infarction (DSMI) at 1 year for Abbott Acculink N=5 (10%) versus InspireMD’s CGuard N=1 (2%).
• The incidence of restenosis or vessel occlusion at 1 year for Abbott’s Acculink N=4 (8%) versus InspireMD N=0 (0%).
• Conclusion: In the randomized controlled study, 12-month outcomes showed in the Acculink™ stent a higher prevalence of death, stroke, MI (DSMI), restenosis / vessel occlusion, when compared with the CGuard MicroNet™ protected stent arm.
Title: MicroNet™-Covered Stent in Stroke Prevention and Treatment: New Evidence
Presenter: Piotr Musialek
PARADIGM-500 includes 500 patients enrollment with 533 procedures performed; the largest all-comer single-center registry of neuroprotected CGuard carotid artery stenting procedures.
• Peri-procedural events (within 48 hours of procedure) were 3 events (2 minor strokes and 1 MI, no death or major stroke (N=3 (0.56%)).
• At 30 days there were no strokes, but 2 deaths resulting in a cumulative total 30-day DSMI rate of N=5 (0.94%)
• At 12 months no major ipsilateral stroke
• At 12 months in stent restenosis/target lesion revascularization (duplex ultrasound follow up) of N=2 (0.41%)
• Piotr Musialek concluded by stating, “Competent carotid artery stenting, with a tailored use of the access route (transfemoral, transradial, transcarotid), tailored use of a proximal/distal embolic protection device, and a 100% embolic prevention stent use shows unprecedented safety and efficacy in asymptomatic and increased-stroke-risk asymptomatic patients.”
Title: Stent properties and vessel adaptability: could these factors influence procedural outcomes?1
Presenter: Matteo Stefanini
• CGuard was the only stent which maintained the original vessel morphology while the compared stents, Wallstent and Roadsaver significantly altered the vessel shapes.
• The investigator concluded that CGuard optimizes conformability compared to Wallstent and RoadSaver stents.

About LINC
LINC, the LEIPZIG INTERVENTIONAL COURSE is strongly committed to contribute to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the “vascular patients” by integrating colleagues of different specialties from around the world who are performing endovascular interventions.
For more information, please visit: https://www.leipzig-interventional-course.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 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.” 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 (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

 Live case transmission designed to demonstrate ease-of-use and exceptional patient safety features of

CGuard™ Embolic Prevention System (EPS)

 Tel Aviv, Israel — June 2, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke, today announced that the company will participate in the Leipzig Interventional Course (LINC) 2022, which is being held June 6-9 in Leipzig, Germany. The company will occupy Booth #36 during the conference.

“We are very pleased to again have a significant presence at this year’s LINC conference, including an opportunity to showcase the CGuard™ EPS stent system in a live case procedure that is designed to demonstrate its clinical utility, design superiority with sustainable protection, resulting in superior patient outcomes and safety,” said Marvin Slosman, chief executive officer of InspireMD. “This unique setting will give interventionalists an opportunity to see CGuard™ EPS in real-time and, we believe, add to the increasing number of clinicians who champion CGuard™ EPS with our unique MicroNet™ technology.

“We also look forward to talks by Drs. Savr Bugurov and Matteo Stefanini who will review their published evidence demonstrating the superiority of CGuard™ EPS relative to conventional first-generation open stent systems and to Professor Piotr Musialek’s new clinical evidence. The LINC conference continues to be an important platform for our engagement with the global clinical community and we are thrilled to be able to be back to a live format,” Mr. Slosman concluded.  

Details of CGuard™ clinical presentations are as follows:

Date: Monday, June 6^th

Time: 4:15pm – 4:20pm CEST

Room: 3 – Speaker’s Corner

Session: Latest results from clinical trials and innovations: Carotid/Venous/AV

Moderators: Manuela Kohnert, Daniela Branzan

Title:        Randomized Controlled Trial of a First-Generation Carotid Stent vs. the MicroNet™-Covered Stent: 12-Month Outcomes

Presenter: Savr Bugurov

Date: Wednesday, June 8^th

Time: 11:00am – 11:45am CEST

Room: 1 – Main Arena

Session: Latest Techniques for Carotid Revascularization

Moderator: Dierk Scheinert

Panel: Piotr Musialek, Matteo Stefanini, Ralf Langhoff

11:00am CEST: CGuard Live case transmission from Heart Center, Leipzig, Germany

Operator: Andrej Schmidt

Title: MicroNet™-Covered Stent in Stroke Prevention and Treatment: New Evidence

Presenter: Piotr Musialek

Title: Stent properties and vessel adaptability: could these factors influence procedural outcomes?

Presenter: Matteo Stefanini

About LINC

LINC, the LEIPZIG INTERVENTIONAL COURSE is strongly committed to contribute to a systematic scientific evaluation and interdisciplinary discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary live course, designed to provide a global platform, permitting the discussion of the “vascular patients” by integrating colleagues of different specialties from around the world who are performing endovascular interventions.  

For more information, please visit: https://www.leipzig-interventional-course.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 under the ticker symbol NSPR.

For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “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 (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

– 20% growth in CGuard™ revenue Year-over-Year –

– C-Guardian FDA IDE Trial Completes First European Enrollment –

– Held Key Opinion Leader (KOL) Webinar on Carotid Artery Disease Management and Stroke Prevention, highlighting CGuard™ clinical advantages –

– European logistics hub established with BOMI Group –for direct market access as well as establishing the commercial footprint for a growing portfolio of new systems across different channels –

– Upcoming Clinical Evidence and Live Case to be presented at LINNC 2022-

—

Management to Host Investor Conference Call Today, May 10, at 8:30am ET
—

Tel Aviv, Israel— May 10, 2022 – InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for treatment of carotid artery disease and prevention of stroke today announced financial and operating results for the first quarter ended March 31, 2022.

First Quarter 2022 and Recent Highlights:

• CGuard revenues for the first quarter 2022 were $1,161,000 a 20% increase over the same period in 2021 on 1,910 stent systems sold.   
• Enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial accelerated and continues to progress on track across both the United States and Europe. The Company completed its first European enrollment in April, led by co-principal investigator, Professor Piotr Musialek, at John Paul II Hospital, in Krakow, Poland which is now one of the 14 trial sites actively enrolling or recruiting patients worldwide.
• On March 22, internationally recognized Key Opinion Leaders and members of the Company’s Scientific Advisory Board, Chris Metzger, MD, PhD, from Ballad Health System, Adnan Siddiqui, MD, PhD, FACS, FAHA, FAANS, from State University of New York at Buffalo’s Jacobs School of Medicine and Biomedical Sciences, and Sean Lyden, MD, from Cleveland Clinic, chaired an interactive discussion around the current endovascular trends in the carotid and neurovascular market, and presented their perspective of how InspireMD’s CGuard stent system and expanding pipeline have the potential to offer better clinical outcomes.

• Executed a logistics agreement with BOMI Group which is designed to support a growing commercial infrastructure dedicated to the expansion of InspireMD’s direct sales program. The BOMI agreement provides a logistics hub to allow greater flexibility as the Company expands its portfolio across direct channels.

Marvin Slosman, CEO of InspireMD, commented: “The first quarter marked important progress, as we continued to execute our commercial strategies, increase our market share, and grow revenue across most of our served markets in particular in Europe. The CGuard, with the unique MicroNet™ mesh for sustained cerebral protection, continues to demonstrate steady physician adoption by improving the endovascular standard of care for the prevention of stroke caused by carotid artery disease. Our focus on superior stent performance translates directly to best patient outcomes serving all vascular specialties. As we expand our delivery systems around CGuard, we expect to continue to grow our market share and drive conversion of surgeries to stenting.

Our pipeline of innovative delivery solutions such as CGuard Prime and SwitchGuard are anticipated to launch early 2023, to facilitate greater utilization of our devices as first line solution for carotid artery disease management. 

Ongoing enrollment in the C-Guardians IDE pivotal study in the United States has now expanded to include European participation, which we believe will continue to accelerate enrollment with experienced CGuard investigators,” said Marvin Slosman, CEO of InspireMD.

“We remain committed to our core mission to establish a new standard of care for addressing carotid artery disease and stroke prevention, delivering best patient outcomes both short and long term through stent performance, which delivers unmatched clinical results to this ever-expanding endovascular focused market. We believe our CGuard EPS stent with MicroNet™ mesh combined with the broadest range of new delivery options, will establish a new standard of care,” Marvin Slosman added.   

Financial Results for the First Quarter ended March 31, 2022

For the first quarter of 2022, revenue increased 17.6%, to $1,183,000, from $1,006,000 during the first quarter of 2021.  This increase was predominantly driven by a 19.8% increase in sales volume of CGuard EPS from $969,000 in the same period one year ago, to $1,161,000 for the first quarter 2022.  This sales increase was mainly due to growth in existing and new markets as well as the returning demand from hospitals in a post COVID 19 environment.  In addition, US sales increased related to stents used in the C-Guardian U.S. Food and Drug Administration (FDA) clinical trial.  The increase in sales of CGuard EPS was slightly offset by a lack of sales to Russia, Belarus and the Ukraine in quarter due to the regional conflict and related currency restrictions.

Gross profit for the first quarter of 2022 increased by $16,000, to $122,000, compared to a gross profit of $106,000 for the first quarter of 2021. This increase in gross profit resulted from a $30,000 decrease in write-offs which were driven mainly by components supply issues.  Gross margin decreased to 10.3% during the three months ended March 31, 2022 from 10.5% during the three months ended March 31, 2021, driven by the factors mentioned above.

Total operating expenses for the first quarter of 2022, were $4,608,000, an increase of $1,188,000, or 34.7% compared to $3,420,000 for the first quarter of 2021.  This increase was primarily due to increases in expenses related to the commencement of the C-Guardians FDA study and share based compensation.

Net loss for the first quarter of 2022 totaled $4,481,000, or $0.57 per basic and diluted share, compared to a net loss of $3,243,000, or $0.53 per basic and diluted share, for the same period in 2021.

As of March 31, 2022, cash, cash equivalents and short-term bank deposits were $29.9 million compared to $34.0 million as of December 31, 2021.

 Conference Call and Webcast Details

Management will host a conference call at 8:30AM ET today, May 10, 2022, 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 10, 2022 at 8:30 a.m. ET

Domestic:                              877-407-4018

International:                       201-689-8471

Conference ID:                    13729033

Webcast:                               Webcast Link – Click 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.

For more information, please visit www.inspiremd.com.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “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 (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

CONSOLIDATED STATEMENTS OF OPERATIONS⁽¹⁾

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

(1) 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; 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.

(2) All March 31, 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. All December 31, 2021 financial information is derived from the Company’s 2021 audited financial statements as disclosed in the Company’s Annual Report on Form 10-K, for the twelve months ended December 31, 2021 filed with the Securities and Exchange Commission.