Full Press Release Details
Receives CE Mark Recertification Under EU's New Medical Device Regulation (MDR) Regulatory Framework
Aviv, Israel, and Miami, FL - January 31, 2024 - 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.
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."
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.
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.
routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
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.
Padala, Managing Director