FDA Advisory Panel Votes in Favor of IceCure's ProSense® Cryoablation Benefit-Risk Profile in Early-Stage Low Risk Breast Cancer
IceCure Medical (Nasdaq: ICCM) received a favorable recommendation from the FDA Advisory Panel for its ProSense® cryoablation system with a 9-5 vote supporting its benefit-risk profile for treating early-stage low risk breast cancer. The panel's decision was based on comprehensive data from the ICE3 study and stakeholder testimonies. Three of the dissenting voters indicated they would have voted in favor with adequate FDA special controls. The FDA's final marketing authorization decision is expected in Q1 2025. ProSense® offers a minimally-invasive alternative to lumpectomy by destroying tumors through freezing.
IceCure Medical (Nasdaq: ICCM) ha ricevuto una raccomandazione favorevole dal pannello consultivo della FDA per il suo sistema di criobolazione ProSense®, con un voto di 9-5 a supporto del suo profilo rischio-beneficio per il trattamento del cancro al seno in fase iniziale e a basso rischio. La decisione del pannello si è basata su dati complessivi dello studio ICE3 e sulle testimonianze degli stakeholder. Tre dei votanti contrari hanno indicato che avrebbero votato a favore con adeguati controlli speciali da parte della FDA. Si prevede che la decisione finale di autorizzazione al marketing da parte della FDA sarà resa nota nel primo trimestre del 2025. ProSense® offre un'alternativa minimamente invasiva alla lumpectomia, distruggendo i tumori tramite congelamento.
IceCure Medical (Nasdaq: ICCM) recibió una recomendación favorable del Panel Asesor de la FDA para su sistema de criobulación ProSense®, con una votación de 9-5 que apoya su perfil de beneficio-riesgo para el tratamiento del cáncer de mama en etapa temprana y de bajo riesgo. La decisión del panel se basó en datos exhaustivos del estudio ICE3 y en testimonios de las partes interesadas. Tres de los votantes en contra indicaron que habrían votado a favor si hubiera habido controles especiales adecuados de la FDA. Se espera que la decisión final de autorización de comercialización de la FDA se haga pública en el primer trimestre de 2025. ProSense® ofrece una alternativa mínimamente invasiva a la lumpectomía al destruir tumores a través del congelamiento.
IceCure Medical (Nasdaq: ICCM)은 ProSense® 냉동 절제 시스템에 대해 FDA 자문 위원회로부터 긍정적인 권고를 받았으며, 초기 단계의 저위험 유방암 치료를 위한 이 시스템의 이익-위험 프로필에 대해 9대 5로 지지하는 투표를 하였습니다. 위원회의 결정은 ICE3 연구의 포괄적인 데이터와 이해관계자들의 증언을 바탕으로 하였습니다. 반대 투표를 한 세 명의 위원은 적절한 FDA 특별 통제가 있었다면 찬성 투표를 했을 것이라고 밝혔습니다. FDA의 최종 마케팅 승인 결정은 2025년 1분기에 예상됩니다. ProSense®는 종양을 동결하여 파괴함으로써 수술적 제거에 대한 최소 침습적인 대안을 제공합니다.
IceCure Medical (Nasdaq: ICCM) a reçu une recommandation favorable du panel consultatif de la FDA pour son système de cryoablation ProSense®, avec un vote de 9-5 soutenant son profil risque-bénéfice pour le traitement du cancer du sein à un stade précoce et à faible risque. La décision du panel s'est fondée sur des données complètes de l'étude ICE3 et des témoignages des parties prenantes. Trois des votants dissidents ont indiqué qu'ils auraient voté en faveur s'il y avait eu des contrôles spéciaux adéquats de la FDA. La décision finale d'autorisation de mise sur le marché de la FDA est attendue au premier trimestre 2025. ProSense® propose une alternative peu invasive à la lumpectomie en détruisant les tumeurs par congélation.
IceCure Medical (Nasdaq: ICCM) erhielt eine positive Empfehlung des FDA-Beratungsgremiums für ihr ProSense® Kryoablation-System, das mit einer Abstimmung von 9-5 den Nutzen-Risiko-Profil für die Behandlung von frühzeitigem, niedrigschichtigem Brustkrebs unterstützt. Die Entscheidung des Gremiums basierte auf umfassenden Daten aus der ICE3-Studie und den Zeugenaussagen der Stakeholder. Drei der abweichenden Wähler gaben an, dass sie bei angemessenen speziellen FDA-Kontrollen zugestimmt hätten. Die endgültige Genehmigungsentscheidung der FDA wird im ersten Quartal 2025 erwartet. ProSense® bietet eine minimal-invasive Alternative zur Lumpektomie, indem Tumore durch Frostung zerstört werden.
- Favorable FDA Advisory Panel vote (9-5) for ProSense® system
- Three dissenting voters would support with additional FDA controls
- Potential market authorization in Q1 2025
- Sales and distribution team already prepared for US market entry
- Final FDA approval still pending
- 5 panel members voted against the benefit-risk profile
- Additional FDA special controls may be required
Insights
The FDA Advisory Panel's favorable vote (9-5) for IceCure's ProSense® cryoablation system represents a significant regulatory milestone. The panel's endorsement of the benefit-risk profile for early-stage low-risk breast cancer treatment is particularly noteworthy as it could lead to the first FDA-approved cryoablation device for this indication.
The vote's composition is encouraging, with three of the five opposing voters indicating they would support approval with additional special controls. This suggests the technology's fundamental merit while highlighting manageable regulatory concerns. The ICE3 study data, compared against traditional lumpectomy outcomes, provided the clinical evidence basis.
A Q1 2025 FDA decision timeline positions IceCure for potential market entry in a $3.8 billion breast cancer treatment market. The minimally-invasive nature of cryoablation could disrupt traditional surgical approaches, particularly appealing to patients seeking alternatives to lumpectomy.
This regulatory progress significantly enhances IceCure's market positioning in the breast cancer treatment space. With a current market cap of only
The inclusion of diverse stakeholder input in the panel review, including patient advocacy groups and healthcare providers, suggests strong potential market acceptance. The timing aligns well with growing patient demand for minimally-invasive alternatives, potentially driving rapid adoption upon approval.
Early-stage breast cancer represents a substantial addressable market, with approximately 280,000 new cases diagnosed annually in the U.S. Even capturing a modest market share could translate to significant revenue growth for IceCure.
FDA decision on marketing authorization expected in the first quarter of 2025
"This is a significant milestone on the path towards the marketing authorization of ProSense® cryoablation in the
The Advisory Panel's favorable vote was based on the comprehensive body of data available on ProSense® as a treatment for early-stage low risk breast cancer, including results from the Company's ICE3 study compared with data from the current standard of care, lumpectomy, as well as testimonies and input from a broad range of key stakeholders, including women with breast cancer and their family members, patient advocacy groups, doctors, nurses and researchers.
The purpose of the Advisory Panel was for the FDA 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 invasive breast cancer with cryoablation and adjuvant endocrine therapy. The Advisory Panel included breast surgeons, interventional radiologists, breast oncologists, and representatives from the patient, consumer, and regulatory communities.
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: that this is a significant milestone on the path towards the approval of ProSense® cryoablation in the
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SOURCE IceCure Medical
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