InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™
Embolic Prevention System (EPS) for the prevention of the stroke
caused by carotid artery disease, today announced a transaction
intended to achieve distribution of CGuard EPS in mainland China.
InspireMD’s agreement with three China-based investment
partners, including Shanghai Micro Medical (SMM) and QIDI Asia
Medical, stipulates that the Chinese partners will be responsible
for conducting all necessary registration trials for commercial
approval, followed by an eight-year exclusive distribution right in
China. In addition, QIDI has agreed to make a $900,000 investment
in InspireMD’s common stock at the closing price on the day
immediately prior to entering into the transaction in a private
placement. The transactions are expected to close this month.
Following announcement of the transaction the Chinese partners plan
to initiate the process of securing registration with Chinese
regulatory authorities to establish distribution.
“One of our pillars of growth is global expansion of CGuard EPS
into significant markets of opportunity and this step in China
establishes a foundation for our overall Asia plan. China, believed
to be the second fastest growing market for peripheral stent
procedures1, establishes a foundation for Asia and builds on our
goal to establish market leadership throughout the world. This
step, combined with our efforts to achieve commercial registration
in the United States, positions us to expand into the two largest
markets outside of those currently served with true global presence
for our vascular portfolio. We are pleased to have formed a
partnership with an established leader in the medical device field
in this important market,” said Marvin Slosman, CEO of
InspireMD.
Stroke is the leading cause of death in China2. In contrast with
the United States and most European countries, the Asia-Pacific
region performs more stenting procedures as a proportion of overall
carotid artery revascularizations than any region in the
world.3
“The opportunity to distribute InspireMD’s CGuard EPS stent
platform represents a significant opportunity to provide leading
technology to the Chinese market. We believe the superior clinical
results and growing and consistent body of evidence from CGuard
will provide a foundation for success and an optimal solution for
our portfolio to address this significant and ever-growing medical
need,” said Tony Liu, Chairman of Shanghai Micro Medical, one of
the investment partners.
The offer and sale of the foregoing securities are being made in
a transaction not involving a public offering and have not been
registered under the Securities Act of 1933, as amended (the
"Securities Act"), or applicable state securities laws.
Accordingly, the securities may not be reoffered or resold in the
United States except pursuant to an effective registration
statement or an applicable exemption from the registration
requirements of the Securities Act and such applicable state
securities laws.
This press release does not constitute an offer to sell or the
solicitation of an offer to buy the securities, nor shall there be
any sale of the securities in any state in which such offer,
solicitation or sale would be unlawful prior to the registration or
qualification under the securities laws of such state.
About the CGuard® EPSThe CGuard® Embolic
Protection System is an advanced platform solution designed to
deliver the flexibility of the traditional open-cell stent with
advanced protection from peri-procedural and post-procedural
embolic events caused by plaque prolapse through the stent strut
that can lead to stroke. CGuard’s unique MicroNet® technology
mitigates the prolapse and associated embolization and has shown
superior clinical outcomes for patients against alternative carotid
stent types, conventional and next-generation double-layer stents,
as well as invasive procedures such as endarterectomy, a major
surgical procedure. InspireMD’s CGuard™ has created a new
dimension in the protected treatment of carotid artery disease and
has the potential to establish a new standard of care for the
management of carotid artery disease and stroke prevention.
About InspireMD, Inc.InspireMD 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. For
more information,
visit www.inspiremd.com. InspireMD routinely posts
information that may be important to investors in the Investors
section of its website.
Forward-looking StatementsThis 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) the impact of the
COVID-19 pandemic on our manufacturing, sales, business plan and
the global economy, (v) intense competition in the medical device
industry from much larger, multinational companies, (vi) product
liability claims, (vii) product malfunctions, (viii) our limited
manufacturing capabilities and reliance on subcontractors for
assistance, (ix) insufficient or inadequate reimbursement by
governmental and other third party payers for our products, (x) our
efforts to successfully obtain and maintain intellectual property
protection covering our products, which may not be successful, (xi)
legislative or regulatory reform of the healthcare system in both
the U.S. and foreign jurisdictions, (xii) our reliance on single
suppliers for certain product components, (xiii) 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 (xiv) 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 ShoreChief Financial OfficerInspireMD,
Inc.888-776-6804craigs@inspiremd.com
____________________________________________________________________________________________________________________
1 https://www.prnewswire.com/news-releases/peripheral-stent-implants-market-to-close-in-on-us-6-bn-by-2030-driven-by-increasing-peripheral-artery-disease-patient-pool-worldwide---persistence-market-research-301206261.html2
Liu L, Wang D, Wong KS, Wang Y. Stroke and stroke care in
China: huge burden, significant workload, and a national
priority. Stroke. 2011; 42:3651–3654.3
2017 Health Research International Market Report
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