InspireMD Receives CE Mark Recertification Under EU’s New Medical Device Regulation (MDR) Regulatory Framework
InspireMD, Inc. (NSPR) has received CE Mark recertification under the European Union's new Medical Device Regulation for its CGuard™ Embolic Prevention Carotid Stent System. The company is also making progress on the Premarket Approval Application for the C-GUARDIANS U.S. IDE trial and looks forward to primary endpoint results in mid-2024. InspireMD continues to work towards multiple value-creating milestones, including potential U.S. approval of the CGuard Prime EPS stent system in the first half of 2025.
The recertification of InspireMD's CGuard Embolic Prevention Carotid Stent System under the European Union's new Medical Device Regulation (MDR) marks a significant regulatory milestone. The MDR is a stringent set of regulations that came into effect in May 2021, replacing the Medical Devices Directive (MDD). It imposes more rigorous clinical evidence requirements, post-market surveillance and quality management systems for medical devices. The transition to MDR has been a rigorous process for many manufacturers, as it demands a higher level of transparency and traceability throughout a product's lifecycle.
For InspireMD, this recertification not only ensures continued access to the European market but also potentially strengthens the company's position in terms of product credibility and patient safety. The MDR's emphasis on clinical evidence could facilitate the adoption of CGuard EPS by healthcare providers, given the heightened assurance of the product's efficacy and safety under the new framework. Furthermore, the recertification might provide a competitive advantage over products that have yet to comply with MDR, potentially leading to increased market share and revenue streams within the EU.
Receiving CE Mark recertification is a critical event for InspireMD from a financial perspective. The European market is substantial for medical devices and maintaining access to this market is essential for revenue sustainability and growth. The announcement could have positive implications for InspireMD's stock as it reflects the company's ability to navigate complex regulatory landscapes and secure its market presence in the EU.
Investors may view this news as a positive indicator of the company's regulatory competence and product quality, potentially leading to increased investor confidence. Additionally, the mention of the ongoing Premarket Approval Application (PMA) for the U.S. market and the anticipated timeline for potential U.S. approval of the CGuard Prime EPS could signal future growth opportunities. These milestones are likely to be closely monitored by investors, as U.S. market entry could significantly expand InspireMD's total addressable market and drive long-term financial growth.
The carotid artery stent market is expected to grow due to the increasing prevalence of cardiovascular diseases and the aging population. With the CE Mark recertification under the MDR, InspireMD's CGuard EPS is well-positioned to capitalize on this growth within the EU. The recertification suggests that CGuard EPS meets the high standards of safety and performance required by the new regulatory framework, which may influence purchasing decisions of healthcare providers looking for compliant and reliable stent systems.
Moreover, the company's focus on making CGuard EPS the standard of care for carotid artery revascularization indicates a strategic move to increase market penetration and secure long-term adoption. The advancement of new products in the pipeline under MDR also hints at a robust product development strategy that could address unmet medical needs and drive future market expansion. The overall impact on the business could be substantial if the company successfully leverages its regulatory achievements to gain market share and establish leadership in the carotid artery stent segment.
01/31/2024 - 07:00 AM
TEL AVIV, Israel and MIAMI, Jan. 31, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Carotid Stent System (EPS) for the prevention of stroke, today announced that it has received CE Mark recertification under the European Union’s new Medical Device Regulation (MDR) regulatory framework. MDR replaced the previous MDD framework, which had governed the approval and marketing of medical devices in the EU until May of 2021.
Marvin Slosman, chief executive officer of InspireMD, stated, “The transition from MDD to MDR has been challenging and has required us, and others in the medical device industry, to be comprehensive and persistent in our approach to addressing changes in requirements, timelines, and priorities during this process. We are very pleased to have now received formal recertification of our CE Mark under MDR, allowing us to continue to work to make CGuard EPS the standard of care for carotid artery revascularization in our existing commercial territories while also advancing our new product pipeline using the pathway provided under MDR.”
“In parallel, our work on the Premarket Approval Application (PMA) for the C-GUARDIANS U.S. IDE trial continues to progress nicely, and we look forward to primary endpoint results in mid-2024, followed by submission of the final module of the PMA application to FDA in the second half of this year. We continue to aggressively work toward multiple value creating milestones, including the potential U.S. approval of the CGuard Prime EPS stent system in the first half of 2025,” Mr. Slosman concluded.
About InspireMD, Inc. ® technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free, long-term outcomes. InspireMD’s common stock is quoted on the Nasdaq under the ticker symbol NSPR.
We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com .
Forward-looking Statements This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” “scheduled” or similar words. Examples of such statements include, but are not limited to, statements relating to the C-GUARDIANS U.S. IDE clinical trial, including 30-day results from such trial, as well as the timing and outcome of any subsequent results, the EFS, PMA or potential launch. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
Investor Contacts:
Craig Shore
Chuck Padala, Managing Director
What is the significance of InspireMD receiving CE Mark recertification under the European Union's new Medical Device Regulation?
The recertification allows InspireMD to continue working to make CGuard EPS the standard of care for carotid artery revascularization in existing commercial territories while also advancing its new product pipeline using the pathway provided under MDR.
What is the status of InspireMD's work on the Premarket Approval Application for the C-GUARDIANS U.S. IDE trial?
The company's work on the PMA for the trial continues to progress nicely, and it looks forward to primary endpoint results in mid-2024, followed by submission of the final module of the PMA application to FDA in the second half of this year.
What milestones is InspireMD working towards?
InspireMD is aggressively working toward multiple value-creating milestones, including the potential U.S. approval of the CGuard Prime EPS stent system in the first half of 2025.
