Upcoming FDA Advisory Panel for IceCure's ProSense® Marketing Authorization Receives Large Number of Public Comments from Stakeholders
IceCure Medical (NASDAQ: ICCM) announced significant stakeholder engagement ahead of the FDA Medical Device Advisory Committee Panel scheduled for November 7, 2024. The panel will evaluate the marketing authorization of ProSense® cryoablation system for treating early-stage low risk breast cancer. The Advisory Panel will include breast surgeons, interventional radiologists, and industry experts who will provide recommendations on the benefit-risk profile of ProSense®, a minimally-invasive technology that destroys tumors by freezing as an alternative to surgical removal. Public comments from doctors, nurses, researchers, and breast cancer patients are available on the FDA website, with the FDA's final decision expected by early 2025.
IceCure Medical (NASDAQ: ICCM) ha annunciato un importante coinvolgimento degli stakeholders in vista del Comitato Consultivo sul Dispositivo Medico della FDA, programmato per il 7 novembre 2024. Il panel valuterà l'autorizzazione alla commercializzazione del sistema di crioterapia ProSense® per il trattamento del cancro al seno in fase iniziale a basso rischio. Il Comitato Consultivo includerà chirurghi senologici, radiologi interventisti e esperti del settore che forniranno raccomandazioni sul profilo beneficio-rischio del ProSense®, una tecnologia minimally invasive che distrugge i tumori congelandoli come alternativa alla rimozione chirurgica. I commenti pubblici da parte di medici, infermieri, ricercatori e pazienti affetti da cancro al seno sono disponibili sul sito web della FDA, con la decisione finale della FDA attesa per l'inizio del 2025.
IceCure Medical (NASDAQ: ICCM) anunció un importante compromiso con los interesados antes del Panel del Comité Asesor de Dispositivos Médicos de la FDA programado para el 7 de noviembre de 2024. El panel evaluará la autorización de comercialización del sistema de crioterapia ProSense® para tratar cáncer de mama en etapas tempranas de bajo riesgo. El Panel Asesor incluirá cirujanos de mama, radiólogos intervencionistas y expertos de la industria que proporcionarán recomendaciones sobre el perfil beneficio-riesgo de ProSense®, una tecnología mínimamente invasiva que destruye tumores mediante congelación como alternativa a la extracción quirúrgica. Los comentarios públicos de médicos, enfermeros, investigadores y pacientes con cáncer de mama están disponibles en el sitio web de la FDA, y se espera que la decisión final de la FDA sea emitida a principios de 2025.
아이즈큐어 메디컬(IceCure Medical, NASDAQ: ICCM)은 2024년 11월 7일로 예정된 FDA 의료기기 자문 위원회 패널을 앞두고 주요 이해관계자와의 소통을 발표했습니다. 이 패널은 조기 저위험 유방암 치료를 위한 ProSense® 냉동절제 시스템의 마케팅 허가를 평가할 것입니다. 자문 패널에는 유방외과 의사, 중재 방사선과 의사 및 업계 전문가들이 포함되며, ProSense®의 이점-위험 프로파일에 관한 권고를 제시할 것입니다. ProSense®는 수술적 제거 대신 종양을 동결하여 파괴하는 최소 침습 기술입니다. 의사, 간호사, 연구자 및 유방암 환자들의 공개 의견은 FDA 웹사이트에서 확인할 수 있으며, FDA의 최종 결정은 2025년 초에 나올 예정입니다.
IceCure Medical (NASDAQ: ICCM) a annoncé un engagement significatif des parties prenantes avant la réunion du Comité Consultatif des Dispositifs Médicaux de la FDA prévue pour le 7 novembre 2024. Ce panel évaluera l'autorisation de mise sur le marché du système de cryoablation ProSense® pour traiter le cancer du sein à bas risque à un stade précoce. Le panel consultatif inclura des chirurgiens du sein, des radiologues interventionnels et des experts de l'industrie qui fourniront des recommandations concernant le rapport bénéfice-risque de ProSense®, une technologie peu invasive qui détruit les tumeurs par congélation en alternative à l'ablation chirurgicale. Les commentaires publics de médecins, d'infirmières, de chercheurs et de patients atteints de cancer du sein sont disponibles sur le site web de la FDA, et la décision finale de la FDA est attendue pour début 2025.
IceCure Medical (NASDAQ: ICCM) hat eine bedeutende Einbindung von Interessengruppen angekündigt, bevor das Panel des Medizinproduktberater-Ausschusses der FDA am 7. November 2024 tagt. Das Panel wird die Genehmigung zur Vermarktung des ProSense® Kryoablation-Systems zur Behandlung von frühzeitigem, niedrigem Risiko Brustkrebs bewerten. Das Beratungsgremium wird Brustchirurgen, interventionelle Radiologen und Branchenexperten umfassen, die Empfehlungen zum Nutzen-Risiko-Profil von ProSense®, einer minimalinvasiven Technologie zur Zerstörung von Tumoren durch Einfrieren als Alternative zur chirurgischen Entfernung, abgeben werden. Öffentliche Kommentare von Ärzten, Krankenschwestern, Forschern und Brustkrebspatienten sind auf der Website der FDA verfügbar, und die endgültige Entscheidung der FDA wird voraussichtlich Anfang 2025 getroffen.
- FDA Advisory Panel review indicates progress in regulatory pathway
- Strong stakeholder engagement demonstrated through numerous public comments
- Potential market expansion into early-stage breast cancer treatment
- Final FDA approval still pending and uncertain
- Marketing authorization depends on Advisory Panel recommendations
Insights
The upcoming FDA Advisory Panel meeting for ProSense® represents a critical regulatory milestone, but the current news about public comments does not materially impact investment decisions. While stakeholder feedback is important for the regulatory process, the actual panel meeting on November 7 and subsequent FDA decision in early 2025 will be the truly impactful events.
The large volume of supportive public comments from healthcare professionals and patients may indicate positive sentiment, but this alone does not predict the panel's recommendation or final FDA decision. The De Novo marketing submission for early-stage low-risk breast cancer represents a significant market opportunity, but investors should wait for the actual panel outcome rather than react to preliminary feedback.
- Comments from key stakeholders, including doctors, nurses, researchers, and breast cancer patients, are available on FDA website
- FDA Advisory Panel providing recommendations and vote on information concerning the benefit-risk profile for a De Novo marketing submission of the IceCure ProSense® Cryoablation System in early-stage low risk breast cancer scheduled for November 7, 2024
The Advisory Panel's Public Docket for ProSense®, which is publicly available here: https://www.regulations.gov/docket/FDA-2024-N-4057 provides details and comments made by stakeholders including breast cancer patients oncologists, surgeons, radiologists, nurses, researchers, other experts, and those expressing they wished ProSense® had been available for their loved one. A live webcast of the Advisory Panel meeting is available to the public at the following HYPERLINK: https://www.youtube.com/watch?v=PMS5dJRtLIo
"We are highly encouraged by the large number of comments received for the Advisory Panel's consideration regarding the role of ProSense® as a minimally-invasive treatment option for early-stage low risk breast cancer patients. Key stakeholders, including breast cancer patients, have shared their first-hand experience with ProSense®," stated IceCure's CEO, Eyal Shamir. "We look forward to the public forum on November 7, along with the Advisory Panel's vote, which the FDA will consider in making its decision, expected by early 2025."
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment option to destroy tumors by freezing them. The system uniquely harnesses the power of liquid nitrogen to create large lethal zones for maximum efficacy in tumor destruction in benign and cancerous lesions, including breast, kidney, lung, and liver.
ProSense® enhances patient and provider value by accelerating recovery, reducing pain, surgical risks, and complications. With its easy, transportable design and liquid nitrogen utilization, ProSense® opens that door to fast and convenient office-based procedure for breast tumors.
About IceCure Medical
IceCure Medical (Nasdaq: ICCM) develops and markets advanced liquid-nitrogen-based cryoablation therapy systems for the treatment 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 upcoming FDA Advisory Panel and the composition thereof; and the prospective outcome of the Advisory Panel and FDA decision and timing thereof. 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
IR Contact:
Email: investors@icecure-medical.com
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SOURCE IceCure Medical
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