Full Press Release Details
InspireMD Announces CE Mark Approval for CGuard
Prime Embolic Prevention System (EPS) Under European MDR for the Prevention of Stroke
Miami, Florida - June 13, 2025 (GLOBE NEWSWIRE)
- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Prime carotid stent system for the prevention of stroke,
today announced the company has received CE Mark approval under the European Medical Device Regulation (MDR) for the CGuard
CGuard Prime was developed incorporating
extensive user feedback and optimizes deliverability and deployment of the proven CGuard stent. With its proprietary MicroNet
mesh, CGuard is designed to reduce both early and late embolic events by trapping debris against the vessel wall, preventing plaque prolapse
and embolization that can cause stroke.
"Securing CE Mark certification under the
EU MDR is a major milestone that demonstrates InspireMD's commitment to advancing our next generation platforms, regulatory rigor,
and execution," said Marvin Slosman, CEO of InspireMD. "This approval clears the path for the commercial launch of CGuard
Prime EPS across our current CE marked served markets, taking a pivotal step forward in our growth as a commercial-stage company
and further strengthening our leadership in carotid stenting innovation. Additionally, this
is the same platform that we intend to launch in the United States later this year, subject to FDA approval, enabling greater scale as
we move towards offering a unified platform across our served markets"
The CGuard Embolic Prevention System (EPS) is a novel mesh-covered
carotid stent designed to widen narrowed carotid arteries in patients who are at high risk for complications from surgery and need a less
invasive treatment and to improve patient safety through sustained embolic protection. CGuard combines the largest open-cell frame of
available carotid stents with the smallest mesh pore size, preventing plaque prolapse and embolization through the stent, for lasting
protection demonstrated beyond five years.
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.
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uncertainties associated with our history of recurring losses and negative cash flows from operating activities; substantial doubt about
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capital raising may be costly or difficult to obtain and could dilute out stockholders' ownership interests; market acceptance of
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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
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problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and
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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.