IceCure Reports Updated Timeline and Progress with FDA Regarding Marketing Authorization for ProSense® Cryoablation in Early-Stage Breast Cancer
IceCure Medical (Nasdaq: ICCM) provided an update on its FDA marketing authorization timeline for ProSense® cryoablation system in early-stage breast cancer treatment. The company now expects the FDA's decision after Q1 2025, extending beyond the initial timeline.
The FDA process has involved extensive stakeholder engagement due to the product's novelty and breast cancer's public health significance. In November 2024, an FDA Medical Device Advisory Committee Panel, comprising breast surgeons, interventional radiologists, oncologists, and patient representatives, voted favorably on ProSense®'s benefit-risk profile for treating early-stage low-risk breast cancer with endocrine therapy.
ProSense® uses minimally-invasive cryoablation technology that destroys tumors by freezing, offering an alternative to surgical tumor removal. The company continues to work closely with the FDA towards a De Novo marketing authorization decision.
IceCure Medical (Nasdaq: ICCM) ha fornito un aggiornamento sulla tempistica di autorizzazione al marketing da parte della FDA per il sistema di crioblassaggio ProSense® nel trattamento del cancro al seno in fase iniziale. L'azienda ora si aspetta che la decisione della FDA arrivi dopo il primo trimestre del 2025, estendendo così la tempistica iniziale.
Il processo FDA ha comportato un ampio coinvolgimento delle parti interessate a causa della novità del prodotto e dell'importanza del cancro al seno per la salute pubblica. Nel novembre 2024, un Comitato Consultivo sui Dispositivi Medici della FDA, composto da chirurghi senologi, radiologi interventisti, oncologi e rappresentanti dei pazienti, ha votato favorevolmente sul profilo di beneficio-rischio di ProSense® per il trattamento del cancro al seno in fase iniziale a basso rischio con terapia endocrina.
ProSense® utilizza una tecnologia di crioblassaggio minimamente invasiva che distrugge i tumori congelandoli, offrendo un'alternativa alla rimozione chirurgica del tumore. L'azienda continua a lavorare a stretto contatto con la FDA per una decisione di autorizzazione al marketing De Novo.
IceCure Medical (Nasdaq: ICCM) proporcionó una actualización sobre su cronograma de autorización de comercialización por parte de la FDA para el sistema de crioablación ProSense® en el tratamiento del cáncer de mama en etapas tempranas. La empresa ahora espera la decisión de la FDA después del primer trimestre de 2025, extendiendo así el cronograma inicial.
El proceso de la FDA ha implicado un amplio compromiso de las partes interesadas debido a la novedad del producto y la importancia del cáncer de mama para la salud pública. En noviembre de 2024, un Panel del Comité Asesor de Dispositivos Médicos de la FDA, compuesto por cirujanos de mama, radiólogos intervencionistas, oncólogos y representantes de pacientes, votó favorablemente sobre el perfil de beneficio-riesgo de ProSense® para tratar el cáncer de mama en etapas tempranas de bajo riesgo con terapia endocrina.
ProSense® utiliza tecnología de crioablación mínimamente invasiva que destruye tumores congelándolos, ofreciendo una alternativa a la extirpación quirúrgica del tumor. La empresa continúa trabajando en estrecha colaboración con la FDA para una decisión de autorización de comercialización De Novo.
IceCure Medical (Nasdaq: ICCM)는 초기 유방암 치료를 위한 ProSense® 냉동 절제 시스템의 FDA 마케팅 승인 일정에 대한 업데이트를 제공했습니다. 회사는 이제 FDA의 결정이 2025년 1분기 이후에 있을 것으로 예상하며, 이는 초기 일정보다 연장된 것입니다.
FDA 프로세스는 제품의 혁신성과 유방암의 공공 건강 중요성으로 인해 광범위한 이해관계자 참여를 포함했습니다. 2024년 11월, 유방 외과의사, 중재 방사선과 의사, 종양학자 및 환자 대표로 구성된 FDA 의료기기 자문 위원회 패널이 초기 저위험 유방암 치료를 위한 ProSense®의 이익-위험 프로필에 대해 긍정적으로 투표했습니다.
ProSense®는 종양을 얼려서 파괴하는 최소 침습적 냉동 절제 기술을 사용하여 종양 제거 수술에 대한 대안을 제공합니다. 회사는 FDA와 긴밀히 협력하여 De Novo 마케팅 승인 결정을 위해 계속 노력하고 있습니다.
IceCure Medical (Nasdaq: ICCM) a fourni une mise à jour sur son calendrier d'autorisation de mise sur le marché par la FDA pour le système de cryoablation ProSense® dans le traitement du cancer du sein à un stade précoce. L'entreprise s'attend désormais à la décision de la FDA après le premier trimestre 2025, prolongeant ainsi le calendrier initial.
Le processus de la FDA a impliqué un large engagement des parties prenantes en raison de la nouveauté du produit et de l'importance du cancer du sein pour la santé publique. En novembre 2024, un panel du Comité consultatif sur les dispositifs médicaux de la FDA, composé de chirurgiens mammaires, de radiologues interventionnels, d'oncologues et de représentants des patients, a voté favorablement sur le profil bénéfice-risque de ProSense® pour le traitement du cancer du sein à un stade précoce à faible risque avec une thérapie endocrinienne.
ProSense® utilise une technologie de cryoablation peu invasive qui détruit les tumeurs par congélation, offrant une alternative à l'ablation chirurgicale de la tumeur. L'entreprise continue de travailler en étroite collaboration avec la FDA pour une décision d'autorisation de mise sur le marché De Novo.
IceCure Medical (Nasdaq: ICCM) hat ein Update zu seinem Zeitplan für die FDA-Marktzulassung des ProSense® Kryoablation-Systems zur Behandlung von Brustkrebs im frühen Stadium bereitgestellt. Das Unternehmen erwartet nun die Entscheidung der FDA nach dem ersten Quartal 2025, was über den ursprünglichen Zeitplan hinausgeht.
Der FDA-Prozess beinhaltete umfangreiche Beteiligungen von Interessengruppen aufgrund der Neuartigkeit des Produkts und der öffentlichen Gesundheitsrelevanz von Brustkrebs. Im November 2024 stimmte ein medizinischer Gerätebeirat der FDA, der aus Brustchirurgen, interventionellen Radiologen, Onkologen und Patientenvertretern besteht, dem Nutzen-Risiko-Profil von ProSense® für die Behandlung von Brustkrebs im frühen Stadium mit niedrigem Risiko unter endokriner Therapie positiv zu.
ProSense® nutzt eine minimal-invasive Kryoablationstechnologie, die Tumore durch Einfrieren zerstört und eine Alternative zur chirurgischen Tumorentfernung bietet. Das Unternehmen arbeitet weiterhin eng mit der FDA an einer De Novo-Marktzulassungsentscheidung.
- FDA Advisory Panel voted favorably on ProSense's benefit-risk profile
- Continued progress in FDA marketing authorization process
- Product offers minimally-invasive alternative to surgery
- FDA decision timeline extended beyond Q1 2025
- Extended regulatory review process due to product novelty
IceCure working in close collaboration with FDA towards De Novo decision
"Given the novelty of our product and the importance of breast cancer in public health, the FDA has included many stakeholders in the discussion of the De Novo marketing clearance for ProSense® for the treatment of early-stage, low-risk breast cancer with endocrine therapy" stated IceCure's Chief Executive Officer, Eyal Shamir.
"We appreciate the attention of many at the FDA despite the evolving situation at the agency as we work productively together towards a decision on marketing authorization," Shamir added.
Due to the public health importance of breast cancer, the FDA convened a Medical Device Advisory Committee Panel ("Advisory Panel") in November 2024 to obtain independent non-binding expert advice on scientific, technical and policy matters related to the potential granting of marketing authorization of ProSense® for treating patients with early-stage low risk breast cancer with endocrine therapy. The Advisory Panel, which included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities, voted in favor of ProSense®'s benefit-risk profile in early-stage low risk breast cancer.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the destruction of tumors (benign and cancerous) by freezing, with the primary focus areas being breast, kidney, bone and lung cancer. Its minimally invasive technology is a safe and effective alternative to hospital surgical tumor removal that is easily performed in a relatively short procedure. The Company's flagship ProSense® system is marketed and sold worldwide for the indications cleared and approved to date including in the
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Words such as "expects," "anticipates," "intends," "plans," "believes," "seeks," "estimates" and similar expressions or variations of such words are intended to identify forward-looking statements. For example, IceCure is using forward looking statements in this press release when it discusses the expected timing of the FDA's marketing authorization decision. Historical results of scientific research and clinical and preclinical trials do not guarantee that the conclusions of future research or trials will suggest identical or even similar conclusions. Important factors that could cause actual results, developments and business decisions to differ materially from those anticipated in these forward-looking statements include, among others: the Company's planned level of revenues and capital expenditures; the Company's available cash and its ability to obtain additional funding; the Company's ability to market and sell its products; legal and regulatory developments in the United States and other countries; the Company's ability to maintain its relationships with suppliers, distributors and other partners; the Company's ability to maintain or protect the validity of its patents and other intellectual property; the Company's ability to expose and educate medical professionals about its products; political, economic and military instability in the Middle East, specifically in Israel; as well as those factors set forth in the Risk Factors section of the Company's Annual Report on Form 20-F for the year ended December 31, 2023 filed with the SEC on April 3, 2024, and other documents filed with or furnished to the SEC which are available on the SEC's website, www.sec.gov. The Company undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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FAQ
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