InspireMD Announces Regulatory Approval of CGuard EPS in India; Signs Agreement with Leading Indian Medical Device Distributo...
January 03 2018 - 8:56AM
InspireMD, Inc. (NYSE AMER: NSPR), a leader in embolic
prevention systems (EPS) / thrombus management technologies and
neurovascular devices, today announced that it has received
regulatory approval for the CGuard™ Embolic Prevention System (EPS)
in India. The approval was granted by India’s Central Drugs
Standard Control Organisation within the Ministry of Health &
Family Welfare. The Company also announced it signed Hester
Diagnostics Pvt. Ltd. as its exclusive distributor in India. This
partnership follows similar distribution agreements across Asia,
including Hong Kong, Taiwan, Australia, New Zealand and Vietnam.
Hester Diagnostics brings over 25 years of
distribution and marketing experience in India, including medical
devices, diagnostic kits and a wide range of additional products
for the healthcare industry. Hester works with many of the leading
medical device companies in the United States, Europe and Japan
covering clinical specialties that include interventional
cardiology, interventional neuroradiology, and interventional
radiology.
Sanjiv Gandhi, Managing Director of Hester
Diagnostics, commented, “We are excited to partner with InspireMD,
given the extensive clinical data illustrating the safety
advantages of CGuard™ EPS. We are now gearing up and look forward
to commencing the formal commercial launch of the
product.”
“The approval of CGuard™ EPS in India marks
another commercial milestone as we continue to expand our global
footprint,” said Agustin Gago, EVP and Chief Commercial Officer of
InspireMD. “We are excited to partner with Hester
Diagnostics, which brings an impressive track record launching
medical devices in India and to the key clinical specialties that
treat carotid artery disease.”
About InspireMD, Inc.
InspireMD seeks to utilize its proprietary
MicroNet™ technology to make its products the industry standard for
embolic protection and to provide a superior solution to the key
clinical issues of current stenting in patients with a high risk of
distal embolization, no reflow and major adverse cardiac
events.
InspireMD intends to pursue applications of this
MicroNet technology in coronary, carotid (CGuard™), neurovascular,
and peripheral artery procedures. 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:
InspireMD, Inc.
Craig Shore
Chief Financial Officer
Phone: 1-888-776-6804 FREE
Email: craigs@inspiremd.com
Crescendo Communications, LLC
David Waldman
Phone: (212) 671-1021
Email: NSPR@crescendo-ir.com