Full Press Release Details
Announces First Patient Enrolled in the CGUARDIANS II Pivotal Study of the CGuard Prime Carotid Stent System in Transcarotid Artery Revascularization
represents a significant step forward in Company's mission to serve the broadest set of physician and patient needs with best-in-class
CAS and TCAR solutions
Florida - December 9, 2024 - InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic Prevention Stent
System (EPS) for the prevention of stroke, today announced that the first patient has been enrolled in the company's CGUARDIANS
II clinical trial evaluating its CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid
Artery Revascularization (TCAR) approach. The patient was enrolled by Dr. Patrick Muck at Good
Samaritan Hospital, part of the TriHealth System in Cincinnati, Ohio. Dr. Muck serves as both the site principal investigator as well
as a co-lead investigator of the CGUARDIANS II study.
Slosman, Chief Executive Officer of InspireMD, commented, "As we approach potential FDA approval of CGuard Prime with a CAS indication
in the first half of next year, we are thrilled to have initiated the CGUARDIANS II study that, if successful, will address an ever-expanding
TCAR market of roughly 30,000 procedures performed in the U.S. this year. I would like to thank Dr. Muck for helping us achieve this
initial and critical enrollment milestone, and I look forward to the efficient execution of this important study as we work to enable
the use of CGuard Prime in the broadest application, offering patients and physicians this next generation stenting platform, which has
demonstrated best-in-class clinical outcomes in rigorous clinical studies and with over 60,000 devices sold to date."
Patrick Muck, program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, Ohio stated, "As we begin
this study of CGuard Prime in a TCAR setting, we value tremendously the prior data from the C-GUARDIANS PMA, the real-world results of
this implant and its potential to advance patient care through these unmatched clinical results. The protective qualities of the MicroNet
mesh offer patients the sustainable protection which is so important in both short- and long-term outcomes of this procedure. We look
forward to the efficient enrollment of this study, contribution from the team of investigators and working with InspireMD on this important
II is a prospective, multi-center, single arm pivotal study that aims to enroll a minimum of 50 evaluable patients. The objective of
this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared
TCAR neuro-protection system in patients at high risk for adverse events from carotid endarterectomy.
information on the study can be found at: NCT06653387
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. Forward-looking statements include, but are not
limited to, statements regarding InspireMD or its management team's or directors' expectations, hopes, beliefs, intentions
or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation,
including potential U.S. commercial 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 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