IceCure Receives High Level of Interest from Breast Surgeons at ASBrS 2025 Annual Meeting Following Recent Positive FDA Development on ProSense® Cryoablation
IceCure Medical (NASDAQ: ICCM) reported strong interest from breast surgeons at the ASBrS 2025 Annual Meeting following recent positive FDA developments for their ProSense® cryoablation system. The company's ICE3 study was recognized as one of the "Best Papers of 2024" and received favorable mention during the ASBrS Presidential Address.
The FDA has requested a post-market study for ProSense® in treating early-stage low-risk breast cancer in women aged 70+ when combined with adjuvant endocrine therapy. The planned study will include 400 patients across 25 sites. The company's participation at ASBrS included system demonstrations, ultrasound course training, and an expert booth meeting featuring former ASBrS President Dr. Nathalie Johnson.
IceCure Medical (NASDAQ: ICCM) ha registrato un forte interesse da parte dei chirurghi mammari durante il Convegno Annuale ASBrS 2025, a seguito dei recenti sviluppi positivi della FDA per il loro sistema di crioablazione ProSense®. Lo studio ICE3 dell'azienda è stato riconosciuto come uno dei "Migliori Articoli del 2024" e ha ricevuto una menzione favorevole durante il Discorso Presidenziale ASBrS.
La FDA ha richiesto uno studio post-commercializzazione per ProSense® nel trattamento del carcinoma mammario a basso rischio in fase iniziale nelle donne di età superiore ai 70 anni, in combinazione con la terapia endocrina adiuvante. Lo studio previsto includerà 400 pazienti distribuiti in 25 centri. La partecipazione dell'azienda all'ASBrS ha previsto dimostrazioni del sistema, corsi di formazione all'ecografia e un incontro presso uno stand con l'esperta e ex Presidente ASBrS, la Dott.ssa Nathalie Johnson.
IceCure Medical (NASDAQ: ICCM) reportó un gran interés por parte de cirujanos de mama en la Reunión Anual ASBrS 2025 tras los recientes avances positivos de la FDA para su sistema de crioablación ProSense®. El estudio ICE3 de la compañía fue reconocido como uno de los "Mejores Artículos de 2024" y recibió una mención favorable durante el Discurso Presidencial de ASBrS.
La FDA ha solicitado un estudio post-comercialización para ProSense® en el tratamiento del cáncer de mama en etapa temprana y bajo riesgo en mujeres mayores de 70 años, combinado con terapia endocrina adyuvante. El estudio planificado incluirá a 400 pacientes en 25 centros. La participación de la empresa en ASBrS incluyó demostraciones del sistema, formación en ecografía y una reunión en un stand con la experta y ex presidenta de ASBrS, la Dra. Nathalie Johnson.
IceCure Medical (NASDAQ: ICCM)는 최근 FDA의 긍정적인 발전에 힘입어 ASBrS 2025 연례 회의에서 유방 외과 의사들로부터 큰 관심을 받았습니다. 회사의 ICE3 연구는 "2024년 최고의 논문" 중 하나로 인정받았으며 ASBrS 대통령 연설에서 긍정적으로 언급되었습니다.
FDA는 ProSense®가 보조 내분비 치료와 병행할 경우 70세 이상 여성의 초기 저위험 유방암 치료를 위한 시장 후 연구를 요청했습니다. 계획된 연구에는 25개 기관에서 400명의 환자가 포함될 예정입니다. 회사의 ASBrS 참여는 시스템 시연, 초음파 교육 과정, 전 ASBrS 회장인 Nathalie Johnson 박사와의 전문가 부스 미팅을 포함했습니다.
IceCure Medical (NASDAQ : ICCM) a suscité un vif intérêt de la part des chirurgiens du sein lors de la Réunion Annuelle ASBrS 2025, suite aux récentes avancées positives de la FDA concernant leur système de cryoablation ProSense®. L'étude ICE3 de la société a été reconnue comme l'un des "Meilleurs Articles de 2024" et a été favorablement mentionnée lors du discours présidentiel de l'ASBrS.
La FDA a demandé une étude post-commercialisation pour ProSense® dans le traitement du cancer du sein à faible risque et à un stade précoce chez les femmes de plus de 70 ans, en association avec une thérapie endocrinienne adjuvante. L'étude prévue inclura 400 patientes réparties sur 25 sites. La participation de la société à l'ASBrS comprenait des démonstrations du système, une formation en échographie et une rencontre au stand avec l'experte et ancienne présidente de l'ASBrS, le Dr Nathalie Johnson.
IceCure Medical (NASDAQ: ICCM) verzeichnete großes Interesse von Brustchirurgen auf dem ASBrS 2025 Jahrestreffen nach den jüngsten positiven Entwicklungen der FDA für ihr ProSense® Kryoablation-System. Die ICE3-Studie des Unternehmens wurde als eines der "Besten Papers 2024" anerkannt und erhielt während der ASBrS-Präsidentschaftsrede eine positive Erwähnung.
Die FDA hat eine Post-Market-Studie für ProSense® zur Behandlung von frühstadialem, niedrigrisikobehaftetem Brustkrebs bei Frauen ab 70 Jahren in Kombination mit adjuvanter endokriner Therapie gefordert. Die geplante Studie wird 400 Patienten an 25 Standorten umfassen. Die Teilnahme des Unternehmens an der ASBrS beinhaltete Systemdemonstrationen, Ultraschallkurse und ein Expertenstand mit der ehemaligen ASBrS-Präsidentin Dr. Nathalie Johnson.
- Recent positive FDA development regarding marketing authorization pathway for ProSense®
- ICE3 study recognized as one of the 'Best Papers of 2024'
- High interest from breast surgeons in participating in post-market study
- Favorable mention of cryoablation technology in ASBrS Presidential Address
- FDA requires additional post-market study before final marketing authorization
- Marketing authorization still pending FDA approval
- Limited initial market to women aged 70 and over with early-stage low-risk breast cancer
Insights
FDA signals clear approval pathway for IceCure's breast cancer cryoablation, requiring only post-market study rather than pre-approval data.
The recent developments for IceCure's ProSense® cryoablation system represent a significant milestone in the breast cancer treatment landscape. The FDA's request for a post-market study rather than additional pre-approval data suggests regulatory confidence in existing clinical results - a crucial signal that the technology is progressing favorably through the authorization process.
The recognition of IceCure's ICE3 study as one of the "Best Papers of 2024" provides important scientific validation. This peer recognition strengthens the technology's credibility within the medical community, which is essential for eventual clinical adoption.
The planned post-market study's scope (400 patients across 25 sites) is substantial enough to generate meaningful real-world evidence while not being overly burdensome. The high interest from breast surgeons at ASBrS indicates potential clinical champions eager to incorporate this technology.
It's worth noting that the current indication focus is specific: early-stage low-risk breast cancer with adjuvant endocrine therapy for women aged 70+. This represents a defined initial market segment with clear unmet needs, where the benefits of minimally-invasive approaches are particularly valuable given potential comorbidities and quality-of-life concerns in this population.
The favorable mention of cryoablation during the ASBrS Presidential Address further validates that this technology aligns with the evolution of breast cancer care toward less invasive options that preserve breast tissue and function.
FDA pathway requiring only post-market data suggests high confidence in ProSense's safety profile, establishing clear route to potential approval.
The FDA's approach to IceCure's De Novo marketing authorization request represents a favorable regulatory development. By requesting a post-market study rather than additional pre-market clinical trials, the agency signals relative comfort with the existing safety and efficacy data for ProSense®.
This regulatory strategy significantly reduces the burden to market entry. The specified requirements (400 patients, 25 sites) establish a clear pathway forward without the delays and costs associated with additional pre-approval studies. While the timeline remains unspecified, the delineated steps create regulatory predictability.
The De Novo classification pathway is appropriate given the novel nature of using cryoablation specifically for early-stage breast cancer treatment. This regulatory route acknowledges that ProSense® represents a new technological approach without substantial equivalence to existing approved devices.
The target indication's specificity (women 70+ with early-stage low-risk breast cancer using adjuvant endocrine therapy) represents a strategic approach to gaining initial market entry. This focused population allows for a more straightforward benefit-risk assessment while potentially enabling label expansion with additional evidence.
The mention of cryoablation in the ASBrS Presidential Address is regulatory significant as professional society endorsement often influences FDA perspectives on novel technologies. The statement that this technology should be "in the hands of breast surgeons" suggests growing clinical consensus about its value, which typically supports favorable regulatory outcomes.
- Breast surgeons expressed strong interest in participating in IceCure's planned post-market study for ProSense® in the treatment of early-stage breast cancer
- ICE3 study named as one of the "Best Papers of 2024"
- Cryoablation was mentioned favorably during the ASBrS Presidential Address
"We couldn't be more pleased with the high level of interest in ProSense® at the ASBrS 2025 Annual Meeting and the reaction of breast surgeons to the recent positive
The Company's participation included:
- Exhibiting its ProSense® cryoablation system at its booth and providing hands-on demonstrations;
- Sponsoring and participating in the pre-conference ultrasound course where hands-on ProSense® training was provided; and
- Hosting an Expert Booth meeting titled "The Future of Cryoablation in Breast Cancer: A Focus on the Patient Journey" with featured speaker Dr. Nathalie Johnson, former ASBrS President, and guest speaker Dr. Richard Fine, ICE3 Investigator
During the ASBrS Presidential Address, cryoablation was positively mentioned and the importance of breast surgeons needing to have the skills to provide all therapeutic procedures for their patients was underscored—including minimally invasive and percutaneous procedures, such as cryoablation. The address specifically mentioned the ICE3 study and stated that the ASBrS awaits a final decision from the FDA for breast cancer cryoablation.
Additionally, the ICE3 study was included in the Best Papers of 2024 review where a summary of the data was presented, and it was noted that cryoablation is a technique that should be "in the hands of" breast surgeons.
On April 30, 2025, IceCure announced it concluded a meeting with the FDA's Center for Devices and Radiological Health regarding the Company's De Novo marketing authorization request for ProSense® in the treatment of early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over. During the meeting, the FDA requested that IceCure conduct a study after marketing authorization has been granted, 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 approval of such plan, the FDA's final marketing authorization decision is expected.
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 participation of doctors in the planned post-market study; the Company's belief that its technology can offer greater choice to women with early-stage breast cancer; the prospective final decision from the FDA for marketing authorization for ProSense in the treatment of early-stage low risk breast cancer when combined with adjuvant endocrine therapy for women aged 70 and over; and the Company's prospective post-market study plan presentation. 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, 2024 filed with the SEC on March 27, 2025, 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
Logo: https://mma.prnewswire.com/media/2319310/IceCure_Medical_Logo.jpg
View original content:SOURCE IceCure Medical
FAQ
What is the status of IceCure's ProSense FDA approval for breast cancer treatment?
What recognition did ICCM's ICE3 study receive at ASBrS 2025?
What is the scope of IceCure's planned post-market study for ProSense?
How did breast surgeons respond to ICCM's ProSense at ASBrS 2025?
