TEL AVIV, Israel, June 09, 2022 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for stroke prevention, today provided the points following highlights of several presentations and live transmission of cases, all featuring its CGuard™ Embolic Prevention Stent System, from LINC 2022, held June 6-9.

“Our participation and presentations at this year’s LINC conference allowed us to demonstrate the compelling features of the CGuard™ Embolic Stent System that we believe sets a new standard of care in carotid revascularization,” said Marvin Slosman, CEO of InspireMD. . “Of particular note, CGuard™ was demonstrated in a very successful real-world case that clearly demonstrated the benefits of optimal vessel conformability with durable MicroNet mesh protection for improved patient outcomes. LINC remains an important medical congress, and our growing attendance year after year is a clear reflection of our progress and growing market leadership in carotid stenting and stroke prevention.”

Highlights from this year’s CLIC 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 an asymptomatic 62-year-old man with progressive and calcified critical internal carotid artery stenosis. The procedure was successfully performed with the CGuard™ EPS 10 mm x 30 mm, obtaining an excellent angiographic result.

  • After the procedure, Dr. Schmidt commented, “The CGuard EPS stent has excellent conformability due to its open cell design and the MIcroNet mesh technology provides my patient with the best carotid stent protection available.

Title: Randomized Controlled Trial of First-Generation Carotid Stent Versus MicroNet-Coated Stent: 12-Month Results

Presenter: Savr Bugurov

This presentation highlighted key data on the secondary endpoints of the randomized controlled trial comparing the MicroNetMT covered stent (CGuard) versus Abbott’s first-generation open-cell Acculink™ stent.

Key highlights include:

  • The cumulative incidence of death, stroke or myocardial infarction (DSMI) at 1 year for Abbott Acculink N=5 (10%) compared to CGuard N=1 (2%) by InspireMD.
  • Incidence of restenosis or vascular occlusion at 1 year for Abbott’s Acculink N=4 (8%) versus Inspire® N=0 (0%).
  • Conclusion: In the randomized controlled study, 12-month results showed with the Acculink™ stent a higher prevalence of death, stroke, MI (DSMI), restenosis/vascular occlusion, compared to the arm stent protected by CGuard MicroNet.

Title: MicroNet™ Coated Stent in Stroke Prevention and Treatment: Emerging Evidence

Presenter: Piotr Musialek

PARADIGM-500 includes enrollment of 500 patients with 533 procedures performed; the largest single-center registry of all to come from neuroprotected CGuard carotid artery stenting procedures.

  • Peri-procedural events (within 48 hours of surgery) 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 total cumulative 30-day DSMI rate of N=5 (0.94%)
  • At 12 months no major ipsilateral stroke
  • At 12 months in case of restenosis on stent/revascularization of the target lesion (follow-up by duplex ultrasound) of N = 2 (0.41%)
  • Piotr Musialek concluded by stating: “Competent carotid artery stenting, with appropriate use of the access route (transfemoral, transradial, transcarotid), appropriate use of proximal/distal embolic protection device and use of a 100% embolic prevention stent shows unprecedented safety. and efficacy in asymptomatic and at increased risk of stroke patients.

Title: Stent properties and vessel adaptability: could these factors influence the results of the procedure?1

Presenter: Matteo Stefanini

  • CGuard was the only stent that maintained the original vessel morphology, while the comparison stents, Wallstent and Roadsaver, significantly altered the shape of the vessels.
  • The investigator concluded that CGuard optimizes conformability over the Wallstent and RoadSaver stents.

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

For more information, go to: https://www.leipzig-interventional-course.com/

About InspireMD, Inc.
InspireMD seeks to use its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing exceptional acute results and durable, stroke-free, long-term results. Inspire® common stock is listed on Nasdaq under the symbol NSPR.

We regularly 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”. , “aim”, “believe”. ‘, ‘hope’, ‘potential’, ‘planned’ 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, therefore, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, 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 obtain regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger multinational corporations, (v) claims product liability, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for support, (viii) insufficient or inadequate government reimbursement 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 reform ive or regulatory health care system in the United States and foreign jurisdictions, (xi) our reliance on sole suppliers for certain product components, (xii) the fact that we will need to raise capital to meet our business needs in the future and that raising such capital may be costly, dilutive or difficult to obtain and (xiii) the fact that we operate in multiple foreign jurisdictions, exposing us to risks of exchange rate fluctuations, logistical and communication challenges, foreign law compliance burdens and costs, and political and economic instability in each jurisdiction. More detailed information about the company and the risk factors that may affect the making 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 Report Reports on Form 10-Q. Investors and security holders are urged to read these materials free of charge on the SEC’s website at http://www.sec.gov. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

Investor contacts:

Craig Coast
Financial director
InspireMD, Inc.
888-776-6804
[email protected]

Chuck Padala, General Manager
LifeSci Advisors
646-627-8390
[email protected]
[email protected]