InspireMD and NAMSA to Partner on CGUARDIANS II Pivotal Clinical Trial of the CGuard Prime™ 80 cm Carotid Stent System for Use in TCAR procedures
TOLEDO, Ohio and MIAMI, Feb. 13, 2025 (GLOBE NEWSWIRE) — InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Prime Carotid Stent System for the prevention of stroke related to carotid stenosis, and NAMSA, a world-leading MedTech Contract Research Organization (CRO) offering global end-to-end development services, today announced that, pursuant to a previously announced strategic outsourcing partnership, the companies are working together to conduct the CGUARDIANS II pivotal study of InspireMD’s CGuard Prime™ 80 cm carotid stent system for use in Transcarotid Artery Revascularization (TCAR) procedures.
Marvin Slosman, Chief Executive Officer of InspireMD, commented, “With more than 30,000 TCAR procedures performed in the U.S. each year, TCAR is a rapidly growing procedure that represents a significant potential expansion of our addressable market and the lynchpin of our effort to serve the broadest patient population by supporting both CAS and TCAR carotid stenting procedures. We are very pleased to be working with NAMSA and leveraging their vascular clinical and regulatory expertise to execute this important study as efficiently as possible.”
Dr Adam Saltman, NAMSA’s Chief Medical Officer, added, “The CGUARDIANS II study is a well-designed pivotal study that will evaluate the safety and effectiveness of the TCAR procedure as performed with the novel CGuard Prime stent platform with an FDA-authorized embolic protection device. CGUARDIANS II is an excellent example of how NAMSA and our clinical leaders collaborate and provide support by leveraging our more-than-four-decades of investigative experience in carotid disease in general, and carotid artery stenting in particular, most recently through a TCAR approach. We look forward to continuing our work with the InspireMD team and their advisors in this and other investigations of novel therapies.”
On December 9, 2024, InspireMD announced that the first patient had been enrolled into the CGUARDIANS II clinical study.
CGUARDIANS II is a prospective, multi-center, single arm pivotal study that aims to enroll a minimum of 50 evaluable patients. The objective of this study is to evaluate acute device success and technical success of the CGuard Prime when used in conjunction with an FDA-cleared TCAR neuro-protection system in patients at high risk for adverse events from carotid endarterectomy.
More information on the study can be found at: NCT06653387
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.
We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com.
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: www.namsa.com
Forward-looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding the future. 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 include, but are not limited to, statements regarding InspireMD or its management team’s or directors’ expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation, including potential U.S. commercial launch. 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 our history of recurring losses and negative cash flows from operating activities, significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives, and substantial doubt regarding our ability to continue as a going concern; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute our stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; 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; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. 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 Shore
Chief Financial Officer
InspireMD, Inc.
888-776-6804
craigs@inspiremd.com
Chuck Padala, Managing Director
LifeSci Advisors
646-627-8390
chuck@lifesciadvisors.com
investor-relations@inspiremd.com
