Full Press Release Details
Presents Positive 30-Day Follow-Up Results from the C-GUARDIANS
Investigational Device Exemption (IDE) Clinical Trial at VIVA23
demonstrate a low major adverse event rate of 0.95% through 30 days post-procedure.
Aviv, Israel, and Miami, Florida - November 1, 2023 - InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard
Embolic Prevention Stent System (EPS) for the prevention of stroke, today presented 30-day results from the C-GUARDIANS U.S. Investigational
Device Exemption (IDE) clinical trial at the Vascular InterVentional Advances (VIVA) meeting, which is being held October 30 through
November 2 in Las Vegas, NV. The presentation, which was accepted as a late-breaking abstract, was delivered by Dr. Chris Metzger, System
Vascular Chief at OhioHealth in Columbus, OH and principal investigator of the C-GUARDIANS trial.
is a pivotal trial designed to evaluate the safety and efficacy of the CGuard Carotid Stent System when used to treat symptomatic
and asymptomatic carotid artery stenosis in patients undergoing carotid artery stenting (CAS) and at a high risk for carotid endarterectomy
| From July 2021 to June 2023, 316 patients were prospectively enrolled in this single-arm carotid artery stenting study performed at 24 sites in the US and the EU. | ||
| The primary endpoint is a composite of: (1) incidence of major adverse events including death (all-cause mortality), any stroke, or myocardial infarction (DSMI) through 30-days post index procedure, or (2) ipsilateral stroke from day 31 to day 365 post-procedure. | ||
| Stenting with the C-Guard carotid stent system in patients with carotid artery stenosis and at high risk for carotid endarterectomy had a DSMI rate of 0.95%, from procedure through 30 days follow-up. |
Slosman, chief executive officer of InspireMD, stated, "The follow-up data from C-GUARDIANS once again supports the safety
of the C-Guard EPS stent, with its novel MicroNet technology, as reflected in the low rate of major adverse events observed through
30 days. We believe the neuroprotective qualities of C-Guard set it apart from competing stents on the market and should help accelerate
the ongoing shift in carotid revascularizations from surgery first' to an endovascular stent first' approach.
We look forward to reporting 12-month results as we continue to advance CGuard EPS toward potential FDA approval in the first half of
anticipates reporting primary endpoint results from C-GUARDIANS in the second half of 2024 that may support a Premarket Approval (PMA)
C-GUARDIANS clinical trial is evaluating the safety and efficacy of the CGuard Carotid Stent System for the treatment of carotid
artery stenosis. The study, which completed enrollment in June 2023, enrolled 316 patients across 24 trial sites in the U.S. and Europe.
trial includes both symptomatic and asymptomatic patients undergoing carotid artery stenting (CAS). The primary endpoint includes the
composite of the incidence of the following major adverse events: death (all-cause mortality), any stroke, or myocardial infarction (DSMI)
through 30-days post-index procedure or ipsilateral stroke from 31-365-day follow-up, based on Clinical Events Committee (CEC) adjudication.
The trial will be considered a success if the upper bound of the two-sided 95% confidence interval calculated from the observed primary
endpoint rate is less than the performance goal of 11.6%.
company anticipates primary endpoint results from the study in H2 2024.
(Vascular InterVentional Advances) is a global educational event for specialists caring for patients with vascular disease. VIVA brings
together attendees and faculty specializing in vascular surgery, interventional cardiology, interventional radiology, vascular medicine,
neurointervention/neurosurgery, and cardiothoracic surgery, offering a uniquely comprehensive educational experience with access to some
of the best minds in endovascular care.
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 30-day results from such trial, 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