InspireMD Gains Registration Clearance of its CGuard™ Embolic Prevention System (EPS) in Brazil
July 23 2020 - 8:00AM
InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard™
Embolic Prevention System (EPS) for the prevention of stroke caused
by carotid artery disease (CAD), today announced it has obtained
registration from the Brazilian registration authority, Agéncia
Nacional de Vigiláncia Sanitária (ANVISA), for its CGuard™
MicroNet®- covered stent, clearing it for sale and distribution in
Brazil.
“As the largest market for medical devices in Latin America and
one of the top overall global markets for carotid artery disease,
the Brazilian registration clearance for CGuard™ is an important
accomplishment for our company and represents a significant
opportunity to serve an emerging healthcare system. The global
carotid artery disease market is expected to reach up to $11.6
billion by 2023, and with an expected 12% CAGR in the overall stent
market in Brazil, it is a pillar of our 2020 and 2021 growth
strategy,” said Marvin Slosman, InspireMD’s CEO. “We look forward
to working with our Brazilian partner, SUPRI Artigos Médicos
Hospitalares Ltda, to reach and serve this crucial market with our
advanced technology.”
Regulatory approval of CGuard™ EPS in Brazil reflects not only
the ANVISA'S recognition of CGuard’s differentiating features
versus conventional carotid stents, but also the need for safer
treatments for carotid artery disease. Brazil ranks as the
sixth largest populated country in world and the largest
healthcare market in Latin America. With a population over 213
million, Brazil represents an important step toward expanding
commercial availability of InspireMD products into new
territories.
“The Brazilian clearance further supports our goals of broader
expansion into South America, particularly into adjacent markets
such as Argentina, Mexico and Columbia, and as part of our global
expansion strategy, capitalizing on the potential of CGuard™ EPS –
and its novel MicroNet® technology – to fundamentally disrupt the
current standard of care in carotid artery disease. While the
COVID-19 related interruptions have had an impact on elective
surgeries worldwide, we expect a resumption in elective procedures
as the healthcare system gains a foothold in returning to more
normalized operations, as is occurring in our key markets in Europe
and other parts of the world. The Brazilian clearance for our
CGuard™ EPS represents a milestone in our broader strategy to
continue growing our market share in existing markets while
expanding in growth markets such as South America, Asia/Pacific,
and the U.S. We are also continuing our concerted focus on numerous
opportunities for growing our pipeline, leveraging new indications
for use of CGuard™ and MicroNet® along with our research into a
peri procedural protection device technology as we seek to build
upon our strong growth performance in the first quarter of 2020,”
Mr. Slosman concluded.
Marcos Ramin of SUPRI Artigos Médicos Hospitalares Ltda,
added, “At SUPRI, we strive to bring the latest technologies to
health care professionals across Brazil, and we are pleased to add
CGuard™️ EPS to our portfolio, the most innovative and effective
carotid stent available today to prevent embolic stroke of
Brazilians.”
The CGuard® Embolic Protection System is an advanced platform
solution designed to deliver the flexibility of the traditional
open cell stent with an 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 or 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 protected treatment of carotid
artery disease with the potential to truly establish a new standard
of care for 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.
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 and
NSPR.WSB.
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 ShoreChief Financial
OfficerInspireMD, Inc.888-776-6804craigs@inspiremd.com
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