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InspireMD Announces Live Case Broadcast at ISET 2022 Conference Following the Supplement Approval by the FDA Regarding its Pivotal C-Guardians Trial

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InspireMD, Inc. (Nasdaq: NSPR) announced a live case demonstration of its CGuard™ Embolic Prevention Stent System at the ISET 2022 Conference on January 18, 2022. The presentation, led by Dr. Chris Metzger, aims to showcase the advantages of CGuard in preventing strokes caused by Carotid Artery Disease. With 40 patient enrollments in the C-Guardians IDE trial, the company received global recognition for CGuard’s safety and efficacy. InspireMD continues to strive to establish its technology as the industry standard for carotid stenting.

Positive
  • Selected for a live case presentation at ISET 2022, enhancing credibility.
  • Global recognition of CGuard's safety and efficacy supports continued market acceptance.
  • 40 patient enrollments in the C-Guardians IDE trial indicate growing interest.
Negative
  • Forward-looking statements indicate potential risks in market acceptance and regulatory approvals.
  • Dependence on single suppliers may pose supply chain risks.
  • Need for additional capital may lead to dilution for existing shareholders.

Live Case will be Broadcasted Today at 11:00am ET

TEL AVIV, Israel, Jan. 18, 2022 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for prevention of stroke caused by Carotid Artery Disease (CAD), today announced that a live case demonstration featuring CGuard™ EPS will be broadcasted at the International Symposium on Endovascular Therapy (ISET) 2022 Conference by Dr. Chris Metzger, Chair of Clinical Research at Ballad Health on Tuesday, January 18, 2022.

“We are extremely grateful to have been selected and approved for a Live Case Presentation at this year’s ISET Conference demonstrating the advantages of CGuard,” said Marvin Slosman, Chief Executive Officer of InspireMD. “The global recognition of the CGuard stent system continues to demonstrate clinical evidence and data supporting CGuard’s safety and efficacy and we are pleased to have been selected for a live case as an advanced device for treatment of CAD at this important conference.”

“Our team at Ballad Health have completed 40 patient enrollments in the C-Guardians IDE trial.  We are pleased with our device performance experience thus far,” said Dr. Chris Metzger, trial Principal Investigator. “The opportunity to highlight the CGuard stent system in a live case at the ISET conference offers the interventional community the chance to observe the CGuard with its unique MicroNet mesh protection in an important clinical setting."

About International Symposium on Endovascular Therapy (ISET)
For more than 30 years, ISET has served as the premier arena for pioneering and practical endovascular education. Alumni have gone on to transform the fields of interventional radiology, interventional cardiology, vascular surgery, and more. There simply is no comparison. ISET is where legends—current and future—come together to explore groundbreaking techniques, technologies, and procedures while exchanging discussion and debate that ultimately drive patient care forward.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR, and certain warrants are quoted on the Nasdaq under the symbol NSPRZ.

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. For example, the company is using forward-looking statements when it discusses that its international expansion of CGuard represents further efforts to grow the geographic reach of its products when treating CAD. 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


FAQ

What is the significance of the live case demonstration of CGuard EPS on January 18, 2022?

The live case demonstration at ISET 2022 aims to showcase CGuard's effectiveness in preventing strokes, enhancing its visibility in the medical community.

What are the results of the C-Guardians IDE trial for InspireMD?

InspireMD has completed 40 patient enrollments in the C-Guardians IDE trial, which reflects positive initial performance experiences with CGuard.

What are the potential risks mentioned in InspireMD's press release regarding CGuard?

Risks include market acceptance challenges, regulatory approval issues, and reliance on single suppliers for components.

How does InspireMD plan to establish CGuard as the industry standard?

InspireMD aims to leverage its proprietary MicroNet technology for superior performance in carotid stenting.

InspireMD, Inc.

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