InspireMD Announces Christina Brennan, M.D., MBA to Serve in Advisory Role for Pivotal Study of CGuard Carotid Stent System
September 10 2020 - 6:30AM
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 the addition of
Dr. Christina Brennan as a strategic advisor to the company to
assist with planning and execution of a pivotal study of the
CGuard™ Carotid Stent System, CARENET-III, for prevention of stroke
in patients in the United States. The company recently announced
that it had received approval from the FDA for the company to
proceed with this pivotal study.
“We are pleased to have Dr. Brennan join the
team as we advance our efforts of planning and execution of the
CARENET-III pivotal trial. Dr. Brennan brings a wealth of
experience to InspireMD with specific expertise in vascular and
stent related research and clinical trial development and
execution,” said Marvin Slosman, InspireMD’s CEO. “Our
expectations are to accelerate the planning and preparation efforts
for our pivotal study with Dr. Brennan’s help.”
Christina Brennan, M.D. has devoted her career
to clinical research and currently serves as Northwell Health’s
vice president of clinical research. Committed to the
advancement of science and medicine, Dr. Brennan has more than 20
years of extensive clinical research experience, including over 15
years in management roles. She is on the board of trustees for the
Association of Clinical Research Professionals. She is the
immediate past president of the NY Metropolitan Chapter of the
Association of Clinical Research Professionals and she is an
active member of the Clinical Trial Transformation Initiative
(CCTI), with Duke University and the FDA, where she actively sits
on some of their committees. She is on the leadership council
for Society for Clinical Research Sites (SCRS), where she also sits
on the oncology advisory board and technology site advocacy
group. She is an adjunct professor for a Masters of Science
program with Yeshiva University teaching a clinical trial &
research management class. She is also an active member of
the Women in Bio and the American College of Healthcare
Executives.
Her clinical research interest is in carotid
artery disease. She began her clinical research career 20
years ago working at Lenox Hill Hospital in NY alongside the
internationally renowned interventional cardiologist and the
pioneer of carotid artery stenting – Dr. Gary Roubin. For
over 10 years she had the opportunity to have him as her mentor and
work with him, Dr. Sriram Iyer and the late Dr. Jiri Vitek.
Together they worked on many important carotid artery trials,
including the global NIH CREST trial where over 2,500 subjects were
recruited. They enrolled the first ACT I trial patient in
which Abbott Vascular later went on to receive FDA approval of
their X.ACT stent and embolic protection device.
Dr. Brennan also has authored chapters in
textbooks, coauthored many manuscripts and abstracts, and has
presented at numerous scientific and research meetings.
“We have an opportunity for CGuard EPS to create
a paradigm shift in the field of carotid artery stenting, bringing
it to the next level, and I look forward to bringing my years of
expertise in the management and operations of carotid stent trials
to the CARENET-III trial with InspireMD,” added Dr. Brennan.
About The CGuard® EPS The 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 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 the protected treatment of carotid artery disease with
the potential to truly 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.
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) 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
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