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InspireMD Announces Abstract of 30-Day Results from the C-Guardians U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at VIVA23 Tel Aviv, Israel, and Miami, Florida

Key Takeaway: InspireMD, Inc. (NSPR) announced that an abstract detailing the 30-day results from its C-Guardians U.S. IDE clinical trial has been accepted for presentation at the Vascular InterVentional Advances (VIVA23) conference. The trial evaluates the safety and efficacy of the CGuard Carotid Stent System for treating carotid artery stenosis. The presentation is scheduled for November 1, 2023, by Dr. Chris Metzger, the lead investigator. The company also plans to share one-year data next year that could support a Premarket Approval Application (PMA) for the device.

Market Sentiment Analysis

POSITIVE FACTORS

  • Acceptance of the abstract for presentation at a significant conference (VIVA23)
  • Positive expectations regarding short- and long-term patient outcomes from CGuard EPS
  • Anticipation of one-year data in the second half of next year that may support PMA
  • Enrollment completion and the evaluation of a large patient group in the trial

Full Press Release Details

Announces Abstract of 30-Day Results from the
U.S. Investigational Device Exemption (IDE) Clinical Trial Accepted for Presentation at VIVA23
Aviv, Israel, and Miami, Florida - August 31, 2023 - InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard
Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that an abstract detailing upcoming 30-day results
from its C-Guardians U.S. IDE clinical trial has been accepted for presentation as a late-breaking clinical trial at the Vascular InterVentional
Advances Annual Meeting (VIVA23), which is being held October 30 through November 2 in Las Vegas.
Title: 30-Day Results from the C-Guardians Pivotal Trial of the CGuard Carotid Stent System
Presenter: Chris Metzger, M.D., System Chair of Clinical Research at Ballad Health System and lead investigator of the C-Guardians trial
Date: Wednesday, November 1, 2023
Time: 10:45am-12:00pm PT (1:45pm-3:00pm ET)
Slosman, chief executive officer of InspireMD, stated, "We are very pleased that an abstract detailing our 30-day follow-up data
from our C-Guardians IDE trial has been accepted for presentation at this year's VIVA conference, which is among the most important
gatherings of endovascular specialists each year. We believe CGuard EPS, with its novel MiroNet technology, offers next-level
neuroprotection that translates into superior short- and long-term patient outcomes, something we aim to demonstrate with this important
trial. We also look forward to sharing one-year data from C-Guardians in the second half of next year that, if positive, may support
a Premarket Approval Application (PMA) and allow us to potentially launch the CGuard Prime EPS stent system in the U.S. in the first
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 25 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 following: incidence of the following major adverse events: death (all- cause mortality), all stroke, and myocardial
infarction (DSMI) through 30-days post-index procedure, based on the Clinical Events Committee (CEC) adjudication or ipsilateral stroke
from 31-365-day follow-up, based on CEC 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.
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 and that such
results will be available to presented as a late-breaking clinical trial at VIVA23, 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

Frequently Asked Questions

What is the focus of InspireMD's C-Guardians trial?

The C-Guardians trial evaluates the CGuard Carotid Stent System for treating carotid artery stenosis.

When will the 30-day results be presented?

The 30-day results will be presented on November 1, 2023, at VIVA23.

Who will present the trial results at VIVA23?

Dr. Chris Metzger, lead investigator, will present the trial results.

How many patients are enrolled in the trial?

The trial has enrolled 316 patients across 25 sites in the U.S. and Europe.

What is the primary endpoint of the C-Guardians trial?

The primary endpoint includes major adverse event rates through 30 days post-procedure.

Last updated: Aug 31, 2023