IceCure Announces Positive FDA Development: Understanding on Path Forward for Marketing Authorization of ProSense® Cryoablation in Women 70+ with Early-Stage Breast Cancer
IceCure Medical has made significant progress with the FDA regarding its ProSense® cryoablation system for treating early-stage breast cancer in women aged 70 and over. Following a productive meeting with the FDA's Center for Devices and Radiological Health, the company is preparing for a post-market study as part of its De Novo marketing authorization process.
The planned study will involve 400 patients across 25 sites in the U.S., targeting approximately 46,000 potential patients annually. ProSense® aims to become the first minimally invasive alternative to lumpectomy, offering treatment as an outpatient procedure. The company will submit its post-market study plan within weeks and is actively recruiting clinical sites and doctors at the American Society of Breast Surgeons Annual Meeting.
Procedures will be eligible for reimbursement under the CPT III code, covering $3,800 in facility costs. IceCure's U.S. sales team is prepared for commercialization once final marketing authorization is granted, pending FDA approval of the post-market study plan.
IceCure Medical ha compiuto importanti passi avanti con la FDA riguardo al suo sistema di crioablazione ProSense® per il trattamento del cancro al seno in fase iniziale nelle donne di età pari o superiore a 70 anni. Dopo un incontro produttivo con il Center for Devices and Radiological Health della FDA, l'azienda si sta preparando per uno studio post-commercializzazione nell'ambito del processo di autorizzazione De Novo.
Lo studio previsto coinvolgerà 400 pazienti in 25 centri negli Stati Uniti, mirando a circa 46.000 potenziali pazienti all'anno. ProSense® punta a diventare la prima alternativa minimamente invasiva alla lumpectomia, offrendo un trattamento ambulatoriale. L'azienda presenterà il piano dello studio post-commercializzazione entro poche settimane e sta attivamente reclutando centri clinici e medici durante il meeting annuale dell'American Society of Breast Surgeons.
Le procedure saranno eleggibili per il rimborso sotto il codice CPT III, coprendo 3.800 dollari per i costi della struttura. Il team vendite statunitense di IceCure è pronto per la commercializzazione non appena sarà concessa l'autorizzazione finale, in attesa dell'approvazione della FDA del piano dello studio post-commercializzazione.
IceCure Medical ha logrado avances significativos con la FDA respecto a su sistema de crioablación ProSense® para tratar el cáncer de mama en etapa temprana en mujeres de 70 años o más. Tras una reunión productiva con el Center for Devices and Radiological Health de la FDA, la compañía se está preparando para un estudio post-comercialización como parte de su proceso de autorización de comercialización De Novo.
El estudio planeado incluirá a 400 pacientes en 25 centros en EE. UU., con un objetivo de aproximadamente 46,000 pacientes potenciales anuales. ProSense® busca convertirse en la primera alternativa mínimamente invasiva a la lumpectomía, ofreciendo un tratamiento ambulatorio. La empresa presentará su plan de estudio post-comercialización en las próximas semanas y está reclutando activamente sitios clínicos y médicos en la Reunión Anual de la Sociedad Americana de Cirujanos de Mama.
Los procedimientos serán elegibles para reembolso bajo el código CPT III, que cubre $3,800 en costos de instalación. El equipo de ventas de IceCure en EE. UU. está preparado para la comercialización una vez que se otorgue la autorización final, pendiente de la aprobación de la FDA del plan de estudio post-comercialización.
IceCure Medical는 70세 이상 여성의 초기 유방암 치료를 위한 ProSense® 냉동 절제 시스템과 관련하여 FDA와 중요한 진전을 이루었습니다. FDA의 의료기기 및 방사선 건강 센터와의 생산적인 회의 후, 회사는 De Novo 마케팅 승인 절차의 일환으로 시판 후 연구를 준비하고 있습니다.
계획된 연구는 미국 내 25개 기관에서 400명의 환자를 대상으로 하며, 연간 약 46,000명의 잠재 환자를 목표로 합니다. ProSense®는 유방 절제술에 대한 최초의 최소 침습 대안으로서 외래 진료로 치료를 제공하는 것을 목표로 합니다. 회사는 몇 주 내에 시판 후 연구 계획을 제출할 예정이며, 미국 유방외과학회 연례 회의에서 임상 기관과 의사 모집을 적극 진행하고 있습니다.
절차는 CPT III 코드에 따라 시설 비용 $3,800를 보장받는 보험 청구가 가능합니다. IceCure의 미국 영업팀은 시판 후 연구 계획에 대한 FDA 승인을 기다리며 최종 마케팅 승인이 나면 상용화를 준비하고 있습니다.
IceCure Medical a réalisé des progrès significatifs avec la FDA concernant son système de cryoablation ProSense® pour le traitement du cancer du sein à un stade précoce chez les femmes âgées de 70 ans et plus. Suite à une réunion productive avec le Center for Devices and Radiological Health de la FDA, la société se prépare à une étude post-commercialisation dans le cadre de sa procédure d'autorisation de mise sur le marché De Novo.
L'étude prévue impliquera 400 patients répartis dans 25 sites aux États-Unis, visant environ 46 000 patients potentiels par an. ProSense® ambitionne de devenir la première alternative peu invasive à la tumorectomie, offrant un traitement en ambulatoire. La société soumettra son plan d'étude post-commercialisation dans les semaines à venir et recrute activement des centres cliniques et des médecins lors de la réunion annuelle de l'American Society of Breast Surgeons.
Les procédures seront éligibles au remboursement sous le code CPT III, couvrant 3 800 $ de frais d'établissement. L'équipe commerciale américaine d'IceCure est prête pour la commercialisation dès que l'autorisation finale sera accordée, sous réserve de l'approbation par la FDA du plan d'étude post-commercialisation.
IceCure Medical hat bedeutende Fortschritte mit der FDA bezüglich seines ProSense® Kryoablation-Systems zur Behandlung von Brustkrebs im Frühstadium bei Frauen ab 70 Jahren erzielt. Nach einem produktiven Treffen mit dem Center for Devices and Radiological Health der FDA bereitet das Unternehmen eine Nachmarktstudie im Rahmen des De Novo-Zulassungsverfahrens vor.
Die geplante Studie wird 400 Patienten an 25 Standorten in den USA umfassen und richtet sich jährlich an etwa 46.000 potenzielle Patienten. ProSense® soll die erste minimalinvasive Alternative zur Lumpektomie werden und eine ambulante Behandlung ermöglichen. Das Unternehmen wird seinen Plan für die Nachmarktstudie in den nächsten Wochen einreichen und rekrutiert aktiv klinische Standorte und Ärzte auf dem Jahreskongress der American Society of Breast Surgeons.
Die Verfahren sind erstattungsfähig unter dem CPT III-Code, der 3.800 US-Dollar an Einrichtungskosten abdeckt. Das US-Vertriebsteam von IceCure ist bereit für die Kommerzialisierung, sobald die endgültige Marktzulassung erteilt wird, vorbehaltlich der FDA-Zulassung des Nachmarktstudienplans.
- FDA provided clear path for ProSense marketing authorization in early-stage breast cancer treatment
- Target market of 46,000 annual patients aged 70+ in US represents significant commercial opportunity
- Existing CPT III code provides $3,800 reimbursement coverage for facility costs
- US sales and distribution team already in place for immediate commercialization
- ProSense positioned to be first-in-class minimally invasive treatment option
- Final FDA approval still pending completion of post-market study plan
- Required post-market study needs minimum 400 patients across 25 sites - significant resource investment
- Additional reimbursement coverage dependent on future FDA authorization and other factors
- Clinical site and doctor recruitment still in progress
Insights
FDA pathway established for IceCure's ProSense® in early-stage breast cancer via post-market study requirement - clearing path toward first minimally invasive option.
IceCure's meeting with the FDA represents a significant regulatory advancement for their ProSense® cryoablation technology. The FDA has outlined a path forward, requesting a post-market study following marketing authorization, which typically indicates the agency sees merit in the technology but wants additional real-world evidence.
The proposed study scope - 400 patients across 25 sites - is substantial and will generate valuable data. This dual-purpose study satisfies regulatory requirements while building clinical experience to accelerate adoption.
Targeting women aged 70+ with early-stage low-risk breast cancer is strategically sound, as these patients often benefit most from less invasive approaches. The 46,000 annual patients in the U.S. represents a significant market opportunity.
If authorized, ProSense® would become the first-in-class minimally invasive cryoablation option for this indication - potentially shifting treatment from inpatient surgery to outpatient procedures with faster recovery.
The existing CPT III reimbursement of
IceCure's FDA regulatory advancement reduces approval uncertainty, establishes commercialization timeline, and positions company to address 46,000-patient annual market.
IceCure's productive FDA meeting represents a significant de-risking event from an investment perspective. The regulatory pathway is now clearer, with marketing authorization decision expected following approval of their post-market study plan, which the company intends to submit within weeks.
The transition to a post-market study requirement (rather than additional pre-market data) typically accelerates the path to revenue generation. For IceCure, this means their U.S. sales team can prepare for near-term market entry, as indicated by their statement that the team is "ready for commercialization."
The economic foundation for initial adoption exists through the established CPT III reimbursement code providing
Targeting a 46,000-patient annual market in the U.S. provides substantial commercial potential. The focus on women 70+ with early-stage low-risk breast cancer is strategically sound, as this population has the clearest risk-benefit profile for minimally invasive approaches.
While execution risks remain in completing the post-market study and securing final authorization, the company appears well-positioned with its regulatory strategy, reimbursement foundation, and commercial preparations.
- Final marketing authorization decision for early-stage breast cancer is expected upon the FDA's approval of IceCure's post-market study plan
- IceCure to engage with potential clinical sites, breast surgeons and radiologists for the post-market study including at the upcoming American Society of Breast Surgeons (ASBrS) Annual Meeting
- ProSense® would become the first-in-class minimally invasive choice—a major advancement in women's health and a new paradigm in breast cancer care as a simple out-patient procedure
U.S. sales and distribution team ready to drive sales of ProSense® systems and disposable probes—supporting medical community and patients looking for a new minimally invasive option to lumpectomy
During the meeting, the FDA requested that IceCure conduct a study after marketing authorization has been granted ("the post-market study"), with the aim of producing additional data in this indication. IceCure will present its post-market study plan, which is expected to include a minimum of 400 patients at 25 sites, to the FDA, and upon the CDRH's approval of such plan, the FDA's final marketing authorization decision is expected.
IceCure is now working diligently on the plan of the post-market study which IceCure plans to submit in approximately a few weeks. The Company is in the process of recruiting clinical sites and doctors across the
"This is a very positive development, and we are pleased to have had such a positive discussion with the FDA's CDRH leadership so that women aged 70 and over across America can have access to a minimally invasive option for early-stage breast cancer with ProSense®," stated Eyal Shamir, IceCure's Chief Executive Officer. "We are laser focused on the plan of our post-market study and look forward to finalizing it following deep engagement with the leading breast surgeons and radiologists in the
Post-market study procedures will have access to reimbursement under the CPT III code, which covers
About ProSense®
The ProSense® Cryoablation System is a minimally invasive cryosurgical tool that provides the 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 procedures for breast tumors.
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 prospective post-market study plan, the Company's intention to submit such plan in approximately a few weeks and the presentation of the post-market study plan; the expectation of the FDA's final marketing authorization decision for ProSense® upon the CDRH's approval of the post-market study plan; the Company's belief that the post-market study will support accelerated market adoption of ProSense® in early-stage breast cancer; the Company's prospective engagement with leading breast surgeons and radiologists in the
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FAQ
What is IceCure's (ICCM) ProSense FDA approval status for breast cancer treatment in 2025?
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