Full Press Release Details
Announces Presentation of Positive One-Year Follow-Up Results from the
U.S. Investigational Device Exemption (IDE) Clinical Trial of CGuard at
demonstrate lowest reported primary endpoint event rate of 1.95% through twelve months post-procedure for any carotid stent or embolic
protection device pivotal trial
results to support a Premarket Approval (PMA) application to FDA in H2 2024
commercial launch of the CGuard Prime Carotid Stent System anticipated in H1 2025, if approved
Aviv, Israel, and Miami, Florida - May 28, 2024 - InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard Embolic
Prevention Stent System (EPS) for the prevention of stroke, today announced the presentation of positive one-year outcomes from its C-GUARDIANS
IDE clinical trial of the CGuard Carotid Stent System for the treatment of carotid artery stenosis at this year's Leipzig
Interventional Course (LINC) 2024, which is being held May 28-31, in Leipzig, Germany.
Slosman, chief executive officer of InspireMD, stated, "We are very pleased to have such a significant presence at this year's
LINC conference, highlighted by a presentation of the primary endpoint results from our C-GUARDIANS clinical study. The independently
adjudicated major adverse event rates through one-year are the lowest reported to date from any carotid stent or embolic protection device
pivotal trial. With these data in-hand, we now have line of sight to a PMA application in the back half of this year, with preparation
ongoing for a robust U.S. commercial launch in the first half of 2025, if approved. In addition to these results, we continue to be enthusiastic
about our plans to introduce both CAS and TCAR solutions serving the broadest community of specialists serving the carotid revascularization
market with the best implant in CGuard Prime."
Chris Metzger, M.D., System Vascular Chief at OhioHealth, and lead investigator of the C-GUARDIANS trial, stated, "We are very
excited that the one-year carefully adjudicated C-GUARDIANS data confirm the extremely low rates of stoke, death, myocardial infarction,
and target vessel revascularization in this prospective trial of high-carotid endarterectomy (CEA) risk patients with obstructive carotid
disease, including 25% who were symptomatic. These data confirm the potential neuroprotective properties' of this unique
MicroNet technology, offering an outstanding front-line option to consider for each patient with obstructive carotid artery disease."
the Leipzig Interventional Course, is strongly committed to contributing to a systematic scientific evaluation and interdisciplinary
discussion of new methods in the field of vascular medicine, allowing conclusions for daily interventional practice. LINC is an interdisciplinary
live course, designed to provide a global platform, permitting the discussion of the "vascular patients" by integrating colleagues
of different specialties from around the world who are performing endovascular interventions.
more information, please visit: https://www.leipzig-interventional-course.com/
C-GUARDIANS clinical trial evaluated the safety and efficacy of the CGuard Carotid Stent System for the treatment of carotid artery
stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe.
trial included both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the
composite of the following: incidence of the following major adverse events: death (all- cause mortality), all stroke, or myocardial
infarction (DSMI) through 30-days post-index procedure, or ipsilateral stroke from 31-365-day follow-up, based on the Clinical Events
Committee (CEC) independent adjudication. The performance goal will be considered to have been met if the upper bound of the two-sided
95% confidence interval calculated from the observed primary endpoint rate is <11.6% and the p-value is <0.025.
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, as well as the timing and outcome of any subsequent results, 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