InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System
InspireMD (Nasdaq: NSPR) has submitted a Premarket Approval (PMA) application to the FDA for its CGuard Prime carotid stent system. The application is based on positive one-year data from the C-GUARDIANS pivotal clinical trial, which showed a primary endpoint major adverse event rate of 1.95% through twelve months post-procedure - the lowest reported for any carotid stent or embolic protection device pivotal trial to date. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe. InspireMD anticipates a U.S. commercial launch in H1 2025, if approved, and is building commercial and operational infrastructure for market entry.
InspireMD (Nasdaq: NSPR) ha presentato una domanda di approvazione pre-marketing (PMA) alla FDA per il suo sistema di stent carotideo CGuard Prime. La domanda si basa su dati positivi a un anno dello studio clinico pivotale C-GUARDIANS, che ha mostrato un tasso di eventi avversi maggiori del 1,95% nei dodici mesi successivi alla procedura - il più basso riportato fino ad oggi per qualsiasi trial pivotale di stent carotideo o dispositivo di protezione embolica. Lo studio ha arruolato 316 pazienti in 24 siti di studio negli Stati Uniti e in Europa. InspireMD prevede un lancio commerciale negli Stati Uniti nel primo semestre del 2025, se approvato, e sta costruendo infrastrutture commerciali e operative per l'ingresso nel mercato.
InspireMD (Nasdaq: NSPR) ha presentado una solicitud de Aprobación de Premercado (PMA) a la FDA para su sistema de stent carotídeo CGuard Prime. La solicitud se basa en datos positivos de un año del estudio clínico pivotal C-GUARDIANS, que mostró un tasa de eventos adversos mayores del 1,95% en los doce meses posteriores al procedimiento - el más bajo reportado hasta la fecha para cualquier ensayo pivotal de stent carotídeo o dispositivo de protección embólica. El estudio inscribió 316 pacientes en 24 sitios de ensayo en EE. UU. y Europa. InspireMD anticipa un lanzamiento comercial en EE. UU. en el primer semestre de 2025, si se aprueba, y está construyendo infraestructura comercial y operativa para la entrada al mercado.
InspireMD (Nasdaq: NSPR)는 FDA에 CGuard Prime 경동맥 스텐트 시스템에 대한 사전 승인(PMA) 신청서를 제출했습니다. 이 신청서는 C-GUARDIANS 주요 임상 시험에서 얻은 긍정적인 1년 데이터를 기반으로 하며, 12개월 후 절차에 대한 주요 사건 부작용 비율이 1.95%로 나타났습니다. 이는 현재까지의 모든 경동맥 스텐트 또는 색전 방지 장치 주요 시험 중 가장 낮은 수치입니다. 이 연구는 미국과 유럽의 24개 시험 사이트에서 316명의 환자를 등록했습니다. InspireMD는 승인이 날 경우 2025년 상반기 미국 상용 출시를 예상하고 있으며, 시장 진입을 위한 상업적 및 운영적 인프라를 구축하고 있습니다.
InspireMD (Nasdaq: NSPR) a soumis une demande d'approbation préalable à la FDA pour son système de stent carotidien CGuard Prime. La demande est basée sur des données positives d'un an provenant de l'essai clinique pivot C-GUARDIANS, qui a montré un taux d'événements indésirables majeurs de 1,95% sur douze mois après la procédure - le plus bas jamais rapporté pour un essai pivot de stent carotidien ou de dispositif de protection embolique. L'étude a recruté 316 patients dans 24 sites d'essai aux États-Unis et en Europe. InspireMD prévoit un lancement commercial aux États-Unis au premier semestre 2025, si approuvé, et construit une infrastructure commerciale et opérationnelle pour l'entrée sur le marché.
InspireMD (Nasdaq: NSPR) hat einen Antrag auf Vorabgenehmigung (PMA) bei der FDA für ihr CGuard Prime Carotisstent-System eingereicht. Der Antrag basiert auf positiven Ein-Jahres-Daten aus der C-GUARDIANS entscheidenden klinischen Studie, die eine Hauptendpunkt-Rate schwerwiegender unerwünschter Ereignisse von 1,95% über zwölf Monate nach dem Eingriff zeigte - der niedrigste Wert, der bislang für eine karotidale Stent- oder embolische Schutzeinrichtung in einem entscheidenden Versuch berichtet wurde. In der Studie wurden 316 Patienten an 24 Prüfstandorten in den USA und Europa eingeschlossen. InspireMD erwartet ein kommerziellen Markteintritt in den USA im ersten Halbjahr 2025, sofern genehmigt, und baut eine kommerzielle und operationale Infrastruktur für den Markteintritt auf.
- Submission of PMA application to FDA for CGuard Prime carotid stent system
- Lowest reported primary endpoint major adverse event rate (1.95%) in pivotal trials for carotid stents
- Potential U.S. market entry in H1 2025 if approved
- Building U.S. commercial and operational infrastructure for market launch
- None.
Insights
The submission of InspireMD's Premarket Approval (PMA) application for the CGuard Prime carotid stent system is a significant milestone in the company's regulatory journey. The 1.95% major adverse event rate reported in the C-GUARDIANS trial is remarkably low, potentially setting a new standard in carotid stenting. This could position CGuard Prime as a leading option for carotid artery stenosis treatment, potentially reducing stroke risk more effectively than current alternatives. However, it's important to note that FDA approval is not guaranteed and the review process can be lengthy and unpredictable. The anticipated H1 2025 launch, if approved, gives InspireMD time to build a robust commercial infrastructure, which could be key to market penetration in the competitive U.S. medical device landscape.
This PMA submission is a positive development for InspireMD (NSPR), potentially opening up the lucrative U.S. market for their CGuard Prime system. The carotid stent market in the U.S. is estimated to be worth over
The CGuard Prime system, if approved, could disrupt the U.S. carotid stent market. The exceptionally low adverse event rate could drive rapid adoption among interventional cardiologists and vascular surgeons, potentially taking market share from established players. However, market penetration will depend on factors beyond clinical efficacy, including pricing strategy, reimbursement policies and physician education. InspireMD's emphasis on building a "world class U.S. commercial and operational infrastructure" suggests they're preparing for a competitive market entry. The company's success will hinge on their ability to effectively communicate the clinical benefits to both healthcare providers and payers. Given the potential for improved patient outcomes, there could be strong interest from both clinical and cost-effectiveness perspectives, potentially accelerating market adoption if approved.
PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May
U.S. commercial launch anticipated in H1 2025, if approved
TEL AVIV, Israel and MIAMI, Sept. 16, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seeking marketing approval for the CGuard Prime carotid stent system in the U.S.
The PMA application is based on the overwhelmingly positive one-year data from the Company’s C-GUARDIANS pivotal clinical trial that were presented at the Leipzig Interventional Course (LINC) 2024 in May. The C-GUARDIANS clinical trial evaluated the safety and efficacy of CGuard for the treatment of carotid artery stenosis. The study enrolled 316 patients across 24 trial sites in the U.S. and Europe.
The C-GUARDIANS results showed a primary endpoint1 major adverse event rate of
Marvin Slosman, chief executive officer of InspireMD, stated, “The submission of our PMA application to the FDA represents a significant step forward in our quest for U.S. approval of our next generation CGuard Prime stent to address carotid artery disease and stroke prevention with its best-in-class clinical outcomes. We look forward to the agency’s review of our application, which we have provided in a modular submission to facilitate the most efficient review process. Concurrently, we continue to build what I consider to be world class U.S. commercial and operational infrastructure to enter the U.S. market with as much momentum as possible to offer to this breakthrough technology.”
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, as well as the timing and outcome of any subsequent results, PMA or potential 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
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1 The primary endpoint was a composite of death, stroke or myocardial infarction (DSMI) through 30 days or ipsilateral stroke 31 - 365 days post-index procedure.
FAQ
What is the primary endpoint major adverse event rate for InspireMD's CGuard Prime in the C-GUARDIANS trial?
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How many patients were enrolled in the C-GUARDIANS clinical trial for InspireMD's CGuard Prime?
What is the purpose of InspireMD's CGuard Prime carotid stent system?
