InspireMD Announces Approval of Investigational Device Exemption (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid Stent System
InspireMD (Nasdaq: NSPR) has received FDA approval for its Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of the CGuard Prime 80cm Carotid Stent System for transcarotid revascularization (TCAR) procedures. This approval marks a significant milestone in the company's mission to provide comprehensive tools for carotid stent procedures.
The study aims to facilitate approval for using CGuard Prime in an optimized TCAR version and indication. InspireMD is also developing the SwitchGuard NPS, a next-generation TCAR Neuroprotection System. These initiatives are part of the company's strategy to enter the U.S. market and achieve global success in stroke prevention and carotid disease management.
Dr. Patrick Geraghty and Dr. Patrick Muck have been appointed as co-principal investigators for the CGUARDIANS II study.
InspireMD (Nasdaq: NSPR) ha ricevuto l'approvazione della FDA per la sua Domanda di Esenzione per Dispositivi Sperimentali (IDE) per avviare lo studio pivot CGUARDIANS II del Sistema di Stent Carotideo CGuard Prime da 80 cm per procedure di rivascolarizzazione transcarotidea (TCAR). Questa approvazione segna un traguardo significativo nella missione dell'azienda di fornire strumenti completi per le procedure di stent carotideo.
Lo studio mira a facilitare l'approvazione per l'uso del CGuard Prime in una versione e indicazione TCAR ottimizzata. InspireMD sta anche sviluppando lo SwitchGuard NPS, un Sistema di Neuroprotezione TCAR di nuova generazione. Queste iniziative fanno parte della strategia dell'azienda per entrare nel mercato statunitense e raggiungere un successo globale nella prevenzione degli ictus e nella gestione delle malattie carotidi.
Il Dott. Patrick Geraghty e il Dott. Patrick Muck sono stati nominati co-ricercatori principali per lo studio CGUARDIANS II.
InspireMD (Nasdaq: NSPR) ha recibido la aprobación de la FDA para su Solicitud de Exención de Dispositivo Experimental (IDE) para iniciar el estudio pivot CGUARDIANS II del Sistema de Stent Carotídeo CGuard Prime de 80 cm para procedimientos de revascularización transcarotídea (TCAR). Esta aprobación marca un hito significativo en la misión de la empresa de proporcionar herramientas completas para los procedimientos de stent carotídeo.
El estudio tiene como objetivo facilitar la aprobación para el uso del CGuard Prime en una versión e indicación optimizadas de TCAR. InspireMD también está desarrollando el SwitchGuard NPS, un Sistema de Neuroprotección TCAR de próxima generación. Estas iniciativas son parte de la estrategia de la empresa para ingresar al mercado estadounidense y lograr un éxito global en la prevención de derrames cerebrales y el manejo de enfermedades carotídeas.
El Dr. Patrick Geraghty y el Dr. Patrick Muck han sido nombrados co-investigadores principales para el estudio CGUARDIANS II.
InspireMD (Nasdaq: NSPR)는 경동맥 재관류(TCAR) 절차를 위한 CGuard Prime 80cm 경동맥 스텐트 시스템의 CGUARDIANS II 주요 연구를 시작하기 위해 FDA의 연구 장치 면제(IDE) 승인서를 받았습니다. 이 승인은 경동맥 스텐트 절차를 위한 포괄적인 도구를 제공하려는 회사의 사명에서 중요한 이정표를 의미합니다.
이 연구는 최적화된 TCAR 버전 및 적응증에서 CGuard Prime 사용 승인을 용이하게 하는 것을 목표로 합니다. InspireMD는 차세대 TCAR 신경 보호 시스템인 SwitchGuard NPS도 개발하고 있습니다. 이러한 이니셔티브는 미국 시장에 진출하고 뇌졸중 예방 및 경동맥 질환 관리에서 글로벌 성공을 달성하기 위한 회사의 전략의 일환입니다.
Patrick Geraghty 박사와 Patrick Muck 박사가 CGUARDIANS II 연구의 공동 수석 연구원으로 임명되었습니다.
InspireMD (Nasdaq: NSPR) a reçu l'approbation de la FDA pour sa demande d'exemption pour dispositif expérimental (IDE) afin de lancer l'
L'étude vise à faciliter l'approbation de l'utilisation du CGuard Prime dans une version et une indication TCAR optimisées. InspireMD développe également le SwitchGuard NPS, un système de neuroprotection TCAR de nouvelle génération. Ces initiatives font partie de la stratégie de l'entreprise pour entrer sur le marché américain et réussir à l'échelle mondiale dans la prévention des AVC et la gestion des maladies carotidiennes.
Le Dr Patrick Geraghty et le Dr Patrick Muck ont été nommés co-investigateurs principaux de l'étude CGUARDIANS II.
InspireMD (Nasdaq: NSPR) hat von der FDA die Genehmigung für seinen Antrag auf Untersuchungsausschluss (IDE) erhalten, um die CGUARDIANS II Hauptstudie des CGuard Prime 80cm Carotid Stent Systems für transcarotidale Revaskularisierungsverfahren (TCAR) zu beginnen. Diese Genehmigung markiert einen wichtigen Meilenstein in der Mission des Unternehmens, umfassende Werkzeuge für Carotid-Stent-Verfahren bereitzustellen.
Die Studie zielt darauf ab, die Genehmigung für die Verwendung von CGuard Prime in einer optimierten TCAR-Version und -Indikation zu erleichtern. InspireMD entwickelt auch das SwitchGuard NPS, ein neuartiges TCAR-Neuroprotection-System. Diese Initiativen sind Teil der Strategie des Unternehmens, in den US-Markt einzutreten und globalen Erfolg in der Schlaganfallprävention und im Management von Karotiderkrankungen zu erzielen.
Dr. Patrick Geraghty und Dr. Patrick Muck wurden als Co-Hauptforscher für die CGUARDIANS II-Studie ernannt.
- FDA approval of IDE Application for CGUARDIANS II pivotal study
- Potential expansion into the U.S. market upon approval
- Development of comprehensive next-generation TCAR Neuroprotection System (SwitchGuard NPS)
- None.
MIAMI, Oct. 07, 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 U.S. Food and Drug Administration (FDA) has approved the company’s Investigational Device Exemption (IDE) Application to initiate the CGUARDIANS II pivotal study of its CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures.
In February 2024, InspireMD announced that Patrick Geraghty, M.D., professor of surgery and radiology, section of vascular surgery at Washington University School of Medicine in St. Louis, MO, and Patrick Muck, M.D., program director and chief of vascular surgery at Good Samaritan Hospital in Cincinnati, OH, have agreed to act as lead investigators for the trial.
Marvin Slosman, Chief Executive Officer of InspireMD, stated, “The approval of our CGUARDIANS II IDE is an important milestone and a significant step forward in our mission to serve the broadest range of physician and patient needs with a comprehensive set of tools that can deliver our best-in-class carotid stent system, CGuard Prime, for both CAS and TCAR procedures. The CGUARDIANS II study is intended to facilitate approval of the use of CGuard Prime in an optimized TCAR version and indication.”
“In parallel, we continue to advance development of our comprehensive next generation TCAR Neuroprotection System, SwitchGuard NPS. Each of these initiatives helps pave the way, once approved, for us to initiate commercial sales and strive for market leadership in the United States. Our mission to improve stroke prevention and carotid disease management with our CGuard platforms continues as we build our company toward U.S. expansion and global success. Additionally, as we previously announced, we are thrilled to have Dr. Patrick Geraghty and Dr. Patrick Muck as co-principal investigators for the study, as well as a world class group of investigators committed to the trial’s success,” Mr. Slosman concluded.
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. Examples of such statements include, but are not limited to, statements relating to the C-GUARDIANS U.S. IDE clinical trial, including one-year results from such trial presented at LINC 2024, the C-GUARDIANS II trial, including the timing of its commencement, as well as the timing and outcome of any subsequent results, potential FDA approval, or potential launch or commercialization in the U.S. or elsewhere. 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
What is the purpose of InspireMD's CGUARDIANS II pivotal study?
Who are the lead investigators for InspireMD's CGUARDIANS II study?
What is InspireMD's stock symbol?
What other product is InspireMD developing alongside the CGuard Prime system?
