TOLEDO, Ohio and TEL AVIV, Israel–(BUSINESS WIRE)–NAMSAa world-leading MedTech Contract Research Organization (CRO) offering end-to-end global development services, and InspireMD, Inc.. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the treatment of carotid artery disease and stroke prevention, today announced that it has entered into a strategic outsourcing partnership to accelerate the development and commercialization of medical devices.
InspireMD, which was founded in 2005 and became publicly traded in 2011, is focused on developing and commercializing the innovative CGuard™ EPS stent platform and associated delivery systems that provide embolic and lasting neurovascular. These products also include medical technologies for stroke prevention and treatments for carotid artery disease (CAD). With his property MicroNet™ technology, InspireMD is focused on advancing the carotid and neurovascular market by striving 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 delighted that InspireMD has selected NAMSA as their strategic outsourcing partner of choice,” commented Dr. Christophe Berthoux, CEO of NAMSA. “NAMSA’s mission is to provide best-in-class global MedTech solutions through our people, expertise and technology and this collaboration is critical to this endeavor. With growing demand to find trusted outsourcing partners to accelerate the effective clinical development of life-changing medical products, we are well positioned to work together in this joint venture. By leveraging NAMSA’s full continuum of development services, combined with our deep-rooted cardiovascular and neurovascular expertise, we look forward to helping to accelerate InspireMD’s new product development efforts,” concluded Dr. Berthoux.
A key success factor for MedTech sponsors in the product development process is speed to market. Today, many companies are experiencing longer development times to accommodate an increasing number of clinical tests for class II and III products due to regulatory and clinical requirements. As a result, trial sponsors are increasingly looking to strategic outsourcing partners such as NAMSA that have a proven track record of reducing development costs, efficiencies across multiple resources, accelerating deadlines and immediate access to therapeutic expertise and knowledge.
“InspireMD has always looked for ways to accelerate product development safely and efficiently through strategic outsourcing partners, and we have now found what we believe is the perfect partner in NAMSA,” commented Marvin Slosman, CEO of InspireMD. “We look forward to establishing a more efficient path to market through NAMSA’s expertise, experience and established relationships with regulatory authorities. With the support of NAMSA, we can place greater emphasis on integrating MicroNet™ technology to develop products that are part of the new industry standard for long-lasting embolic/neurovascular protections and stroke prevention. cerebral. Our entire team looks forward to partnering with NAMSA as we continue to expand our global presence and bring much-needed medical technology advancements to patients around the world,” concluded Slosman.
Helping medical device developers improve healthcare since 1967, NAMSA is the world’s premier MedTech contract research organization (CRO) offering end-to-end global development services. With global regulatory expertise and deep therapeutic knowledge, NAMSA is dedicated to accelerating medical device product development, offering only the most proven solutions to move customers’ products through the development cycle. efficiently and profitably. Medical device testing; regulatory, reimbursement and quality advice; and clinical research services, NAMSA is the industry’s premier trusted partner for successful development and commercialization results. The Web: namsa.com
About InspireMD, Inc.
InspireMD seeks to use its proprietary MicroNet® technology to make its products the industry standard for carotid stenting by providing exceptional acute results and durable, stroke-free, long-term results. Inspire® common stock is listed on Nasdaq under the symbol NSPR. The Web: inspiremd.com
This press release contains “forward-looking statements”. Such statements may be preceded by the words “intends”, “may”, “will”, “plans”, “expects”, “anticipates”, “projects”, “predicts”, “estimates”. , “aim”, “believe”. ‘, ‘hope’, ‘potential’, ‘planned’ 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, therefore, actual results may differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, 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 obtain regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger multinational corporations, (v) claims product liability, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for support, (viii) insufficient or inadequate government reimbursement 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 reform ive or regulatory health system in the United States and foreign jurisdictions, including the evolving regulatory environment in Europe and the timing of certificate renewal to continue selling CGuard under the new structure of MDR rules, (xi) our reliance on sole suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business needs in the future and that such raising of capital may be costly, dilutive or difficult to obtain and (xiii) the fact that we operate in multiple foreign jurisdictions, exposing us to exchange rate fluctuations, logistical and communication challenges, compliance charges and costs to foreign laws and political and economic instability in each jurisdiction. More detailed information about the company and the risk factors that may affect the making 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 Report Reports on Form 10-Q. Investors and security holders are urged to read these materials free of charge on the SEC’s website at http://www.sec.gov. The Company undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.