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
InspireMD (NSPR) and NAMSA announced their partnership for the CGUARDIANS II pivotal study of the CGuard Prime™ 80 cm carotid stent system for Transcarotid Artery Revascularization (TCAR) procedures. The study, which enrolled its first patient in December 2024, aims to evaluate the safety and effectiveness of the TCAR procedure using CGuard Prime with an FDA-authorized embolic protection device.
The prospective, multi-center, single-arm pivotal study targets a minimum enrollment of 50 evaluable patients at high risk for adverse events from carotid endarterectomy. With over 30,000 TCAR procedures performed annually in the U.S., this represents a significant market expansion opportunity for InspireMD's carotid stenting solutions.
InspireMD (NSPR) e NAMSA hanno annunciato la loro partnership per lo studio pivotale CGUARDIANS II del sistema di stent carotideo CGuard Prime™ da 80 cm per le procedure di Rivascolarizzazione dell'Arteria Carotidea Transcarotidea (TCAR). Lo studio, che ha arruolato il suo primo paziente a dicembre 2024, mira a valutare la sicurezza e l'efficacia della procedura TCAR utilizzando CGuard Prime con un dispositivo di protezione embolica autorizzato dalla FDA.
Lo studio prospettico, multicentrico e a braccio singolo prevede un arruolamento minimo di 50 pazienti valutabili ad alto rischio di eventi avversi a causa dell'endarterectomia carotidea. Con oltre 30.000 procedure TCAR eseguite annualmente negli Stati Uniti, questo rappresenta un'opportunità significativa di espansione del mercato per le soluzioni di stent carotideo di InspireMD.
InspireMD (NSPR) y NAMSA anunciaron su asociación para el estudio pivotal CGUARDIANS II del sistema de stent carotídeo CGuard Prime™ de 80 cm para procedimientos de Revascularización de la Arteria Carotídea Transcarotídea (TCAR). El estudio, que inscribió a su primer paciente en diciembre de 2024, tiene como objetivo evaluar la seguridad y efectividad del procedimiento TCAR utilizando CGuard Prime con un dispositivo de protección embólica autorizado por la FDA.
El estudio prospectivo, multicéntrico y de brazo único tiene como objetivo una inscripción mínima de 50 pacientes evaluables en alto riesgo de eventos adversos por endarterectomía carotídea. Con más de 30,000 procedimientos TCAR realizados anualmente en EE. UU., esto representa una oportunidad significativa de expansión del mercado para las soluciones de stent carotídeo de InspireMD.
InspireMD (NSPR)와 NAMSA는 CGUARDIANS II 주요 연구를 위해 80cm CGuard Prime™ 경동맥 스텐트 시스템의 경동맥 경유 재관류(TCAR) 절차를 위한 파트너십을 발표했습니다. 2024년 12월 첫 환자를 등록한 이 연구는 FDA에 의해 승인된 색전 보호 장치를 사용한 TCAR 절차의 안전성과 효과를 평가하는 것을 목표로 하고 있습니다.
이 연구는 고위험 경동맥 내막 절제술로 인한 부작용이 발생할 가능성이 있는 최소 50명의 평가 가능한 환자를 대상으로 하는 다기관 단일군 연구입니다. 미국에서 매년 30,000건 이상의 TCAR 절차가 수행되고 있어, 이는 InspireMD의 경동맥 스텐트 솔루션에 대한 상당한 시장 확장 기회를 나타냅니다.
InspireMD (NSPR) et NAMSA ont annoncé leur partenariat pour l'étude pivot CGUARDIANS II du système de stent carotidien CGuard Prime™ de 80 cm pour les procédures de Revascularisation de l'artère carotidienne par voie transcarotidienne (TCAR). L'étude, qui a recruté son premier patient en décembre 2024, vise à évaluer la sécurité et l'efficacité de la procédure TCAR utilisant CGuard Prime avec un dispositif de protection embolique autorisé par la FDA.
L'étude prospective, multicentrique et à bras unique vise un recrutement minimum de 50 patients évaluables à haut risque d'événements indésirables suite à une endartériectomie carotidienne. Avec plus de 30 000 procédures TCAR réalisées chaque année aux États-Unis, cela représente une opportunité d'expansion significative du marché pour les solutions de stents carotidiens d'InspireMD.
InspireMD (NSPR) und NAMSA haben ihre Partnerschaft für die CGUARDIANS II entscheidende Studie des CGuard Prime™ 80 cm Carotis-Stentsystems für transcarotidale Arterienrevaskularisationsverfahren (TCAR) bekannt gegeben. Die Studie, die im Dezember 2024 ihren ersten Patienten eingeschrieben hat, zielt darauf ab, die Sicherheit und Wirksamkeit des TCAR-Verfahrens mit dem CGuard Prime in Verbindung mit einem von der FDA zugelassenen embolischen Schutzgerät zu bewerten.
Die prospektive, multizentrische, einarmige entscheidende Studie hat ein Mindestziel von 50 evaluierbaren Patienten, die ein hohes Risiko für unerwünschte Ereignisse bei der karotiden Endarteriektomie aufweisen. Mit über 30.000 TCAR-Verfahren, die jährlich in den USA durchgeführt werden, stellt dies eine bedeutende Marktchancen für die Carotisstent-Lösungen von InspireMD dar.
- Potential market expansion with access to 30,000+ annual TCAR procedures in the U.S.
- First patient already enrolled in the CGUARDIANS II pivotal study
- Partnership with established MedTech CRO (NAMSA) for study execution
- Small study size of only 50 patients minimum
- Single-arm study design may limit comparative effectiveness data
- Results and FDA approval still pending, creating market uncertainty
Insights
The partnership between InspireMD and NAMSA for the CGUARDIANS II pivotal trial marks a strategic advancement in the carotid stent market. The study targets the rapidly growing TCAR (Transcarotid Artery Revascularization) segment, which currently accounts for over 30,000 procedures annually in the U.S. This represents a substantial market opportunity for InspireMD's CGuard Prime technology.
The trial's design is particularly noteworthy. As a prospective, multi-center, single-arm study targeting 50 evaluable patients, it focuses on high-risk patients who may not be suitable candidates for traditional carotid endarterectomy. This patient population represents a critical unmet need in the market. The study's emphasis on both acute device success and technical success with an FDA-cleared neuroprotection system demonstrates a comprehensive approach to safety and efficacy validation.
NAMSA's involvement as a CRO brings significant value, particularly given their four-decade experience in carotid disease research. Their expertise in both traditional carotid artery stenting and newer TCAR approaches could potentially accelerate the study's execution and enhance its credibility with regulators.
The market implications are substantial. By developing a stent system compatible with both CAS (Carotid Artery Stenting) and TCAR procedures, InspireMD is positioning itself to serve a broader patient population. This dual-approach strategy could provide a competitive advantage in the carotid stenosis treatment market, where procedure flexibility and optimal patient outcomes are paramount.
The successful completion of patient enrollment initiated in December 2024 suggests the study is progressing according to plan. Given the focused patient population and clear endpoints, this trial could provide a relatively straightforward path to potential FDA approval, assuming positive results.
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
FAQ
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