InspireMD Congratulates CREST-2 Investigators on Completion of Trial Enrollment
InspireMD (Nasdaq: NSPR) congratulates investigators on completing enrollment in the CREST-2 clinical trials, which evaluate carotid revascularization for stroke prevention. The company's CGuard™ Embolic Prevention Stent System was the only investigational carotid stent approved by FDA for inclusion in the trials, with 23 cases implanted. This approval followed InspireMD's successful IDE supplement application in February 2022.
The CREST-2 trials compare carotid revascularization and intensive medical management to medical management alone in patients with asymptomatic high-grade carotid stenosis. The study aims to determine the optimal treatment for these patients and ensure the use of state-of-the-art innovation for the best possible outcomes.
InspireMD (Nasdaq: NSPR) si congratula con i ricercatori per aver completato l'arruolamento negli studi clinici CREST-2, che valutano la rivascolarizzazione carotidea per la prevenzione dell'ictus. Il sistema di stent per la prevenzione embolica CGuard™ dell'azienda è stato l'unico stent carotideo sperimentale approvato dalla FDA per l'inclusione negli studi, con 23 casi impiantati. Questa approvazione è seguita dalla riuscita domanda di supplemento IDE di InspireMD nel febbraio 2022.
Gli studi CREST-2 confrontano la rivascolarizzazione carotidea e la gestione medica intensiva con la sola gestione medica nei pazienti con stenosi carotidea asintomatica grave. Lo studio mira a determinare il trattamento ottimale per questi pazienti e a garantire l'uso di innovazioni all'avanguardia per i migliori risultati possibili.
InspireMD (Nasdaq: NSPR) felicita a los investigadores por completar el reclutamiento en los ensayos clínicos CREST-2, que evalúan la revascularización carotídea para la prevención de accidentes cerebrovasculares. El sistema de stent de prevención de embolias CGuard™ de la empresa fue el único stent carotídeo en investigación aprobado por la FDA para su inclusión en los ensayos, con 23 casos implantados. Esta aprobación siguió a la exitosa solicitud de suplemento IDE de InspireMD en febrero de 2022.
Los ensayos CREST-2 comparan la revascularización carotídea y la gestión médica intensiva con la gestión médica sola en pacientes con estenosis carotídea grave asintomática. El estudio tiene como objetivo determinar el tratamiento óptimo para estos pacientes y garantizar el uso de innovaciones de última generación para lograr los mejores resultados posibles.
InspireMD (Nasdaq: NSPR)는 뇌졸중 예방을 위한 경동맥 재혈관화에 대한 CREST-2 임상 시험에서 등록이 완료된 연구자들에게 축하를 보냅니다. 이 회사의 CGuard™ 혈전 예방 스텐트 시스템은 이 시험에 포함된 유일한 FDA 승인 경동맥 스텐트로, 23건이 이식되었습니다. 이 승인은 2022년 2월 InspireMD의 성공적인 IDE 보완 신청에 따른 것입니다.
CREST-2 연구는 무증상 고도 경동맥 협착이 있는 환자에서 경동맥 재혈관화와 집중 의료 관리를 단독 의료 관리와 비교합니다. 이 연구는 이러한 환자들에게 최적의 치료를 결정하고 가능한 최고의 결과를 위해 최첨단 혁신을 사용할 수 있도록 하는 것을 목표로 합니다.
InspireMD (Nasdaq: NSPR) félicite les chercheurs pour avoir terminé le recrutement dans les essais cliniques CREST-2, qui évaluent la revascularisation carotidienne pour la prévention des AVC. Le système de stents de prévention des embolies CGuard™ de l'entreprise a été le seul stent carotidien expérimental approuvé par la FDA pour son inclusion dans les essais, avec 23 cas implantés. Cette approbation a suivi la demande de supplément IDE réussie d'InspireMD en février 2022.
Les essais CREST-2 comparent la revascularisation carotidienne et la gestion médicale intensive à la gestion médicale seule chez des patients atteints de sténose carotidienne asymptomatique de haut grade. L'étude vise à déterminer le traitement optimal pour ces patients et à garantir l'utilisation d'innovations de pointe pour obtenir les meilleurs résultats possibles.
InspireMD (Nasdaq: NSPR) gratuliert den Forschern zum Abschluss der Rekrutierung für die klinischen Studien CREST-2, die die Karotis-Revaskularisation zur Stroke-Prävention bewerten. Das CGuard™ Embolic Prevention Stent System des Unternehmens war das einzige in der Untersuchung befindliche Karotis-Stent-Produkt, das von der FDA für die Teilnahme an den Studien genehmigt wurde, mit 23 implantierten Fällen. Diese Genehmigung folgte auf den erfolgreichen Antrag auf IDE-Ergänzung von InspireMD im Februar 2022.
Die CREST-2-Studien vergleichen die Karotis-Revaskularisation und intensive medizinische Behandlung mit alleiniger medizinischer Behandlung bei Patienten mit asymptomatischer hochgradiger Karotisstenose. Das Ziel der Studie ist es, die optimale Behandlung für diese Patienten zu bestimmen und den Einsatz modernster Innovationen für die bestmöglichen Ergebnisse sicherzustellen.
- CGuard was the only investigational carotid stent approved by FDA for CREST-2 trials
- 23 cases in CREST-2 used CGuard stent
- Inclusion in CREST-2 may reflect recognition of CGuard as latest stenting technology
- None.
Insights
The completion of enrollment in the CREST-2 trials marks a significant milestone in carotid revascularization research. The inclusion of InspireMD's CGuard stent as the only investigational device approved by the FDA for the trial is noteworthy. With 23 cases using CGuard, this provides a but valuable dataset for evaluating its performance against traditional methods.
The trial's design, comparing stenting and endarterectomy to medical management alone, will offer crucial insights into the optimal treatment for asymptomatic high-grade carotid stenosis. This could potentially reshape treatment guidelines and impact the
While the inclusion of CGuard in CREST-2 is positive for InspireMD, the financial impact remains uncertain. The number of cases (23) using CGuard suggests a minimal immediate revenue boost. However, the trial's completion could serve as a catalyst for future growth if results favor stenting over medical management alone.
Investors should consider the long-term potential rather than short-term gains. A positive outcome could significantly expand CGuard's market share in the
CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials
CREST-2 included 23 cases implanted with CGuard
TEL AVIV, Israel and MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid Revascularization Endarterectomy or Stenting Trial) clinical trials. The CGuard carotid stent, utilizing its proprietary MicroNet™ mesh, was included as a device option for stenting in the CREST-2 trials following FDA approval of InspireMD’s Investigational Device Exemption (IDE) supplement application in February 2022. CREST-2 included 23 cases implanted with CGuard.
Marvin Slosman, chief executive officer of InspireMD, stated, “We would like to thank Dr. Lal and the other investigators who are executing this landmark trial, a remarkable achievement in the field of carotid revascularization and stroke prevention. We are proud to have been the only second-generation investigational device option approved by FDA for inclusion in the stenting arm of the trial, which we believe reflects the desire of the CREST-2 committee to offer the latest stenting technology. It has been our honor to contribute to this important work.”
Brajesh Kumar Lal, MD, Professor of Vascular Surgery at the University of Maryland School of Medicine, and co-principal investigator of the CREST-2 trial, stated, “There continue to be significant advancements in the field of carotid revascularization and stroke prevention, and information from this study will help determine the optimal treatment for carotid stenosis patients without stroke symptoms. This trial, when complete, will ensure that we remain current with state-of-the-art innovation to achieve the best possible short- and long-term patient outcomes. Along with my fellow investigators, we eagerly await topline results from this important study.”
Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial randomized patients in a 1:1 ratio to carotid endarterectomy versus no endarterectomy and another randomized patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management is uniform for all randomized treatment groups and is centrally directed.
For additional information please visit: https://clinicaltrials.gov/study/NCT02089217
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 out 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 significance of InspireMD's CGuard stent in the CREST-2 trials?
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