NAMSA and InspireMD Announce Strategic Outsourcing Partnership to Accelerate New Product Development
08 Septembre 2022 - 3:00PM
Business Wire
NAMSA, a world-leading MedTech Contract Research Organization
(CRO) offering global end-to-end development services, and
InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic
Prevention System (EPS) for treatment of carotid artery disease and
prevention of stroke, announced today that they have entered into a
strategic outsourcing partnership to accelerate medical device
development and commercialization.
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the full release here:
https://www.businesswire.com/news/home/20220908005151/en/
InspireMD, which was founded in 2005 and became publicly traded
in 2011, focuses on developing and commercializing the innovative
CGuard™ EPS stent platform and related delivery systems that
provide sustained embolic and neurovascular protections. These
products also include medical technologies for stroke prevention
and carotid artery disease (CAD) treatments. With its proprietary
MicroNet™ technology, InspireMD is focused on changing the carotid
and neurovascular market by working to make CGuard™ EPS the
standard of care in CAD while expanding its portfolio of solutions
and pursuing applications of its MicroNet technology in other
peripheral indications.
“We are thrilled that InspireMD has selected NAMSA as their
strategic outsourcing partner of choice,” commented Dr. Christophe
Berthoux, NAMSA CEO. “NAMSA’s mission is to deliver best-in-class
global MedTech solutions through our people, expertise and
technology and this collaboration is quintessential to this
endeavor. With increasing demand to find trusted outsourcing
partners to accelerate efficient clinical development of
life-changing medical products, we are well positioned to work
together in this joint venture. Leveraging NAMSA’s full continuum
of development services, combined with our deep-rooted
cardiovascular and neurovascular expertise, we look forward to
helping accelerate InspireMD’s new product development efforts,”
Dr. Berthoux concluded.
A key driver of success for MedTech Sponsors in the product
development process is speed-to-market. Today, many companies are
experiencing longer development timelines to accommodate an
increasing number of clinical trials for Class II and III products
due to more complex regulatory and clinical requirements. As a
result, trial Sponsors are increasingly seeking strategic
outsourcing partners such as NAMSA that have proven, trusted track
records of decreasing development costs, providing multiple
resource efficiencies, accelerating timelines and providing
immediate access to therapeutic expertise and knowledge.
“InspireMD has always sought ways to safely and efficiently
accelerate product development through strategic outsourcing
partners, and we have now found what we believe to be the ideal
partner in NAMSA,” commented Marvin Slosman, InspireMD CEO. “We
look forward to establishing a more efficient path to market
through NAMSA’s expertise, experience and established relationships
with regulatory authorities. With NAMSA’s support, we can put more
emphasis on integrating MicroNet™ technology to develop products
that are part of the new industry standard for sustained
embolic/neurovascular protections and stroke prevention. Our entire
team looks forward to partnering with NAMSA as we continue to
expand our presence globally and bring much-needed medical
technology advancements to patients around the world,” Slosman
concluded.
ABOUT NAMSA
Helping medical device Sponsors improve healthcare since 1967,
NAMSA is the world’s leading MedTech Contract Research Organization
(CRO) offering global end-to-end development services. Driven by
its global regulatory expertise and in-depth therapeutic knowledge,
NAMSA is dedicated to accelerating medical device product
development, offering only the most proven solutions to move
clients’ products through the development lifecycle efficiently and
cost-effectively. From medical device testing; regulatory,
reimbursement and quality consulting; and clinical research
services, NAMSA is the industry’s premier, trusted partner for
successful development and commercialization outcomes. Web:
namsa.com
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
Nasdaq under the ticker symbol NSPR. Web: inspiremd.com
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”, “scheduled”
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, including the changing regulatory
environment in Europe and the timing of the renewal of certificate
to continue to sell CGuard under the new MDR rule structure, (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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220908005151/en/
NAMSA Media Contact Leah
Davidson, MA, MBA Sr. Manager, Global Marketing Communications
Email: ldavidson@namsa.com
InspireMD Investor Contact
Craig Shore Chief Financial Officer InspireMD, Inc. Email:
craigs@inspiremd.com
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