Full Press Release Details
Announces Regulatory Approval of CGuard Embolic Prevention System in Mexico
Launch to Occur Immediately
Aviv, Israel- September 24, 2018 - 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.
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."
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
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.
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.
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.