InspireMD Announces First Patient Enrolled in the CGUARDIANS II Pivotal Study of the CGuard Prime Carotid Stent System in Transcarotid Artery Revascularization Procedures (TCAR)
InspireMD (NSPR) has announced the enrollment of its first patient in the CGUARDIANS II clinical trial, evaluating the CGuard Prime Carotid Stent System in TCAR procedures. The study, conducted at Good Samaritan Hospital in Cincinnati, enrolled its first patient under Dr. Patrick Muck, who serves as both site principal investigator and co-lead investigator.
The CGUARDIANS II is a prospective, multi-center, single-arm pivotal study aiming to enroll a minimum of 50 evaluable patients. The trial will evaluate acute device success and technical success of CGuard Prime when used with FDA-cleared TCAR neuro-protection systems. The company is approaching potential FDA approval for CGuard Prime with a CAS indication in first half of next year, targeting a TCAR market of approximately 30,000 U.S. procedures annually.
InspireMD (NSPR) ha annunciato l'arruolamento del suo primo paziente nel trial clinico CGUARDIANS II, che valuta il sistema di stent carotideo CGuard Prime nelle procedure TCAR. Lo studio, condotto al Good Samaritan Hospital di Cincinnati, ha arruolato il suo primo paziente sotto la guida del Dr. Patrick Muck, che funge sia da investigatore principale che da co-leader dell'indagine.
Il CGUARDIANS II è uno studio prospettico, multicentrico e a braccio singolo, che mira a arruolare un minimo di 50 pazienti valutabili. Il trial valuterà il successo acuto del dispositivo e il successo tecnico del CGuard Prime quando utilizzato con i sistemi di neuroprotezione TCAR approvati dalla FDA. L'azienda si sta preparando per un potenziale approvazione della FDA per il CGuard Prime con un'indicazione CAS nella prima metà del prossimo anno, mirando a un mercato TCAR di circa 30.000 procedure all'anno negli Stati Uniti.
InspireMD (NSPR) ha anunciado la inclusión de su primer paciente en el ensayo clínico CGUARDIANS II, que evalúa el sistema de stent carotídeo CGuard Prime en procedimientos TCAR. El estudio, realizado en el Good Samaritan Hospital en Cincinnati, incluyó a su primer paciente bajo la dirección del Dr. Patrick Muck, quien actúa como investigador principal y co-investigador líder.
El CGUARDIANS II es un estudio pivotal prospectivo, multicéntrico y de brazo único, que busca incluir un mínimo de 50 pacientes evaluables. El ensayo evaluará el éxito agudo del dispositivo y el éxito técnico del CGuard Prime cuando se utilice con sistemas de neuroprotección TCAR aprobados por la FDA. La empresa se está acercando a una posible aprobación de la FDA para el CGuard Prime con una indicación CAS en la primera mitad del próximo año, apuntando a un mercado de TCAR de aproximadamente 30,000 procedimientos anuales en EE.UU.
InspireMD (NSPR)는 CGUARDIANS II 임상 시험에 첫 환자 등록을 발표했습니다. 이 시험은 TCAR 절차에서 CGuard Prime 카로티드 스텐트 시스템을 평가합니다. 신시내티의 굿 사마리탄 병원에서 진행되는 이 연구는 주 연구자인 Patrick Muck 박사 아래 첫 환자를 등록했습니다.
CGUARDIANS II는 최소 50명의 평가 가능한 환자를 등록하는 것을 목표로 하는 다기관 단일군 중요 연구입니다. 이 시험은 FDA 승인을 받은 TCAR 신경 보호 시스템과 함께 사용할 때 CGuard Prime의 급성 장치 성공 및 기술적 성공을 평가합니다. 이 회사는 내년 상반기에 CAS 적응증을 가진 CGuard Prime에 대한 FDA 승인을 목표로 하고 있으며, 연간 약 30,000 건의 미국 TCAR 시장을 겨냥하고 있습니다.
InspireMD (NSPR) a annoncé l'inclusion de son premier patient dans l'
Le CGUARDIANS II est une étude pivot prospective, multicentrique et à bras unique visant à enregistrer un minimum de 50 patients évaluables. L'essai évaluera le succès aigu du dispositif et le succès technique du CGuard Prime lorsqu'il est utilisé avec des systèmes de neuroprotection TCAR approuvés par la FDA. L'entreprise se rapproche d'une potentielle approbation de la FDA pour le CGuard Prime avec une indication CAS dans la première moitié de l'année prochaine, visant un marché TCAR d'environ 30 000 procédures annuelles aux États-Unis.
InspireMD (NSPR) hat die Einschreibung seines ersten Patienten in die CGUARDIANS II klinische Studie bekannt gegeben, die das CGuard Prime Carotid Stent-System in TCAR-Verfahren bewertet. Die Studie, die im Good Samaritan Hospital in Cincinnati durchgeführt wird, hat ihren ersten Patienten unter Dr. Patrick Muck eingeschrieben, der sowohl als Hauptuntersucher als auch als Co-Leiter der Studie fungiert.
Die CGUARDIANS II ist eine prospektive, multizentrische, einarmige Schlüsselstudie, die mindestens 50 bewertbare Patienten einschreiben will. Die Studie wird den akuten Geräterfolg und den technischen Erfolg von CGuard Prime bewerten, wenn es in Verbindung mit von der FDA zugelassenen TCAR-Neuroprotektion-Systemen verwendet wird. Das Unternehmen strebt eine potenzielle FDA-Zulassung für CGuard Prime mit einer CAS-Indikation in der ersten Jahreshälfte des nächsten Jahres an und zielt auf einen TCAR-Markt von jährlich etwa 30.000 Verfahren in den USA ab.
- Company approaching FDA approval for CGuard Prime in first half of next year
- Product has demonstrated strong clinical outcomes with over 60,000 devices sold
- Targeting expanding TCAR market of 30,000 procedures in U.S.
- None.
Insights
Study represents a significant step forward in Company’s mission to serve the broadest set of physician and patient needs with best-in-class CAS and TCAR solutions
MIAMI, Dec. 09, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that the first patient has been enrolled in the company’s CGUARDIANS II clinical trial evaluating its CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization (TCAR) approach. The patient was enrolled by Dr. Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, Ohio. Dr. Muck serves as both the site principal investigator as well as a co-lead investigator of the CGUARDIANS II study.
Marvin Slosman, Chief Executive Officer of InspireMD, commented, “As we approach potential FDA approval of CGuard Prime with a CAS indication in the first half of next year, we are thrilled to have initiated the CGUARDIANS II study that, if successful, will address an ever-expanding TCAR market of roughly 30,000 procedures performed in the U.S. this year. I would like to thank Dr. Muck for helping us achieve this initial and critical enrollment milestone, and I look forward to the efficient execution of this important study as we work to enable the use of CGuard Prime in the broadest application, offering patients and physicians this next generation stenting platform, which has demonstrated best-in-class clinical outcomes in rigorous clinical studies and with over 60,000 devices sold to date.”
Dr. Patrick Muck, program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, Ohio stated, “As we begin this study of CGuard Prime in a TCAR setting, we value tremendously the prior data from the C-GUARDIANS PMA, the real-world results of this implant and its potential to advance patient care through these unmatched clinical results. The protective qualities of the MicroNet mesh offer patients the sustainable protection which is so important in both short- and long-term outcomes of this procedure. We look forward to the efficient enrollment of this study, contribution from the team of investigators and working with InspireMD on this important program.”
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.
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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