TEL AVIV, Israel, Sept. 24, 2018 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the
CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of carotid artery disease, today
announced that its novel CGuard™ Embolic Prevention System (EPS) has been granted regulatory approval by COFEPRIS (the Mexican
Ministry of Health) for commercial sale in Mexico.
“The expansion of our commercial footprint into new key geographies is a fundamental component of our growth strategy,” said
James Barry, PhD, Chief Executive Officer of InspireMD. “We are pleased to have received regulatory approval for the commercial
sale of CGuard EPS in Mexico, and very grateful for the support provided by our distribution partner, LevBeth Medical, throughout
this rigorous approval process.”
Mr. Mauro Levinton, Managing Director of LevBeth Medical S.A. de C.V, noted, “We have been eagerly following the clinical data
being generated on CGuard™ as it continues to demonstrate its superiority over conventional stents, and we look forward to
launching this innovative product and technology and making it available to patients in Mexico who suffer from carotid artery
disease.”
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet® technology to make its products the industry standard for treatment of carotid
arter disease by providing outstanding acute results and durable stroke free long-term outcomes.
InspireMD’s common stock is quoted on the NYSE American under the ticker symbol NSPR and certain warrants are quoted on the NYSE
American under the ticker symbol NSPR.WS.
Forward-looking Statements
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,”
“plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words.
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 (i) market acceptance of our existing
and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure
regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger,
multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and
reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party
payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our
products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign
jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise
additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or
difficult to obtain and (xiii) 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. 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.
Investor Contacts:
Craig Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com
Jeremy Feffer
LifeSci Advisors, LLC
212-915-2568
jeremy@lifesciadvisors.com
