Full Press Release Details
Announces Approval of Investigational Device Exemption (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid
Florida - October 7, 2024 - InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention Stent System
(EPS) for the prevention of stroke, today announced that the U.S. Food and Drug Administration (FDA) has approved the company's
Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent
System during transcarotid revascularization (TCAR) procedures.
February 2024, InspireMD announced that Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington
University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan
Hospital in Cincinnati, OH, have agreed to act as lead investigators for the trial.
Slosman, Chief Executive Officer of InspireMD, stated, "The approval of our CGUARDIANS II IDE is an important milestone and a significant
step forward in our mission to serve the broadest range of physician and patient needs with a comprehensive set of tools that can deliver
our best-in-class carotid stent system, CGuard Prime, for both CAS and TCAR procedures. The CGUARDIANS II study is intended to facilitate
approval of the use of CGuard Prime in an optimized TCAR version and indication."
parallel, we continue to advance development of our comprehensive next generation TCAR Neuroprotection System, SwitchGuard NPS. Each
of these initiatives helps pave the way, once approved, for us to initiate commercial sales and strive for market leadership in the United
States. Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company
toward U.S. expansion and global success. Additionally, as we previously announced, we are thrilled to have Dr. Patrick Geraghty and
Dr. Patrick Muck as co-principal investigators for the study, as well as a world class group of investigators committed to the trial's
success," 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
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 one-year results from such trial presented
at LINC 2024, the C-GUARDIANS II trial, including the timing of its commencement, as well as the timing and outcome of any subsequent
results, potential FDA approval, or potential launch or commercialization in the U.S. or elsewhere. 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 our 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