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NAMSA and InspireMD Announce Strategic Outsourcing Partnership to Accelerate New Product Development
Rhea-AI Impact
(Neutral)
Rhea-AI Sentiment
(Positive)
Tags
partnership
Rhea-AI Summary
InspireMD, Inc. (NASDAQ: NSPR) has partnered with NAMSA for strategic outsourcing to enhance medical device development and commercialization. This collaboration aims to expedite the launch of InspireMD's CGuard™ Embolic Prevention System for carotid artery disease and stroke prevention. Both companies focus on accelerating clinical development through NAMSA's expertise in navigating regulatory requirements. InspireMD plans to leverage this partnership to advance its MicroNet™ technology, aiming to establish it as a standard in the carotid stenting market.
Positive
Partnership with NAMSA aims to accelerate medical device development.
Focus on CGuard™ EPS and MicroNet™ technology could enhance market competitiveness.
Access to NAMSA's expertise may reduce development timelines and costs.
Negative
Dependence on outsourcing could pose risks to quality control.
Potential delays in product development could arise from regulatory complexities.
TOLEDO, Ohio & TEL AVIV, Israel--(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.
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.
