IceCure's ProSense® Chosen for Breast Cryoablation Study Led by the Prestigious European Institute of Oncology with Sponsorship from the Italian Ministry of Health
IceCure Medical's ProSense® has been selected for the PRECICE study, a major breast cryoablation research initiative led by the European Institute of Oncology. The study, sponsored by the Umberto Veronesi Foundation and Italian Ministry of Health, will exclusively use ProSense® to treat 233 patients aged 50+ with early-stage breast cancer (Luminal A and B).
The study details were published in the European Journal of Cancer Prevention, highlighting cryoablation as a potential alternative to surgical treatment. The research will evaluate technical effectiveness with a five-year median follow-up, examining procedure failure rates through various imaging methods and additional endpoints including quality of life and economic outcomes.
ProSense® di IceCure Medical è stato selezionato per lo studio PRECICE, una importante iniziativa di ricerca sulla criobblazione del seno condotta dall'Istituto Europeo di Oncologia. Lo studio, sponsorizzato dalla Fondazione Umberto Veronesi e dal Ministero della Salute italiano, utilizzerà esclusivamente ProSense® per trattare 233 pazienti di età superiore ai 50 anni con cancro al seno in fase iniziale (Luminale A e B).
I dettagli dello studio sono stati pubblicati nella Rivista Europea della Prevenzione del Cancro, evidenziando la criobblazione come una potenziale alternativa al trattamento chirurgico. La ricerca valuterà l'efficacia tecnica con un follow-up mediano di cinque anni, esaminando i tassi di fallimento della procedura attraverso vari metodi di imaging e ulteriori parametri, inclusi la qualità della vita e i risultati economici.
ProSense® de IceCure Medical ha sido seleccionado para el estudio PRECICE, una importante iniciativa de investigación sobre la crioblación mamaria liderada por el Instituto Europeo de Oncología. El estudio, patrocinado por la Fundación Umberto Veronesi y el Ministerio de Salud italiano, utilizará exclusivamente ProSense® para tratar a 233 pacientes de 50 años o más con cáncer de mama en etapas tempranas (Luminal A y B).
Los detalles del estudio se publicaron en la Revista Europea de Prevención del Cáncer, destacando la crioblación como una alternativa potencial al tratamiento quirúrgico. La investigación evaluará la eficacia técnica con un seguimiento medio de cinco años, examinando las tasas de fallo del procedimiento a través de varios métodos de imagen y otros puntos finales, incluida la calidad de vida y los resultados económicos.
아이스큐어 메디컬의 ProSense®가 유럽 종양학 연구소가 주도하는 주요 유방 냉동 절제 연구인 PRECICE 연구에 선정되었습니다. 이 연구는 움베르토 베로네지 재단과 이탈리아 보건부가 후원하며, 초기 단계 유방암(루미널 A 및 B)에 해당하는 50세 이상의 환자 233명을 치료하기 위해 ProSense®만 사용할 예정입니다.
연구 세부 사항은 유럽 암 예방 저널에 게시되었으며, 냉동 절제를 외과적 치료의 잠재적 대안으로 강조하고 있습니다. 연구는 기술적인 유효성을 평가하며, 5년 중간 추적 평가를 통해 다양한 이미징 방법과 삶의 질 및 경제적 결과와 같은 추가 지표를 통해 절차 실패율을 검토할 것입니다.
ProSense® d'IceCure Medical a été sélectionné pour l'étude PRECICE, une initiative de recherche majeure sur la cryoablation mammaire dirigée par l'Institut Européen d'Oncologie. L'étude, parrainée par la Fondation Umberto Veronesi et le ministère italien de la Santé, utilisera exclusivement ProSense® pour traiter 233 patients de 50 ans et plus atteints d'un cancer du sein à un stade précoce (Luminal A et B).
Les détails de l'étude ont été publiés dans le Journal Européen de Prévention du Cancer, soulignant la cryoablation comme une alternative potentielle au traitement chirurgical. La recherche évaluera l'efficacité technique avec un suivi médian de cinq ans, examinant les taux d'échec de la procédure par le biais de diverses méthodes d'imagerie ainsi que d'autres critères comme la qualité de vie et les résultats économiques.
ProSense® von IceCure Medical wurde für die PRECICE-Studie ausgewählt, eine bedeutende Forschungsinitiative zur Brustkryoablation, die vom Europäischen Institut für Onkologie geleitet wird. Die Studie, die von der Umberto Veronesi Stiftung und dem italienischen Gesundheitsministerium finanziert wird, wird ProSense® ausschließlich verwenden, um 233 Patienten im Alter von über 50 Jahren mit frühem Brustkrebs (Luminal A und B) zu behandeln.
Die Einzelheiten der Studie wurden im Europäischen Journal für Krebsprävention veröffentlicht, das die Kryoablation als potenzielle Alternative zur chirurgischen Behandlung hervorhebt. Die Forschung wird die technische Wirksamkeit mit einer medianen Nachbeobachtungszeit von fünf Jahren bewerten und die Ausfallraten des Verfahrens durch verschiedene bildgebende Verfahren sowie zusätzliche Endpunkte wie Lebensqualität und wirtschaftliche Ergebnisse untersuchen.
- Selection of ProSense® as exclusive treatment device for large-scale study of 233 patients
- Prestigious institutional backing from European Institute of Oncology and Italian Ministry of Health
- Expansion of potential patient population beyond ICE3 study parameters
- None.
Insights
This clinical study represents a significant advancement in breast cancer treatment research, with notable implications. The PRECICE study's scope of 233 patients and inclusion of both Luminal A and B breast cancers in patients over 50 years expands upon previous research parameters. The backing from prestigious institutions like the European Institute of Oncology and Italian Ministry of Health adds substantial credibility.
Key differentiators include the comprehensive evaluation metrics spanning technical effectiveness, quality of life and economic outcomes over a 5-year follow-up period. The study's focus on cryoablation as an alternative to surgical intervention could potentially reshape standard treatment protocols for early-stage breast cancer. However, market impact remains contingent on positive study outcomes and subsequent regulatory approvals.
The exclusive use of ProSense® in this large-scale European study provides ICCM with significant market positioning advantages. This research could potentially expand the addressable market by including a broader patient demographic than previous studies. The economic outcomes evaluation component is particularly relevant for future market adoption and insurance coverage decisions.
For a small-cap company (
PRECICE study, financed by the Umberto Veronesi Foundation and the Italian Ministry of Health, is led by multidisciplinary collaborators including breast surgeons, interventional radiologists, and breast imaging and pathology specialists
PRECICE is exclusively using ProSense® to treat all 233 Luminal A and B patients >50 years of age with early-stage breast cancer, a wider population of patients than ICE3
Article published in European Journal of Cancer Prevention describes the PRECICE study and presents the role of cryoablation in the move toward de-escalation of surgical treatment
The article, authored by breast surgeons and interventional radiologists including Director of Interventional Radiology at the European Institute of Oncology in
"The scientific assumption moving researchers is that cryoablation could represent a precise and safe alternative to the surgery itself for a selected subgroup of women."
The article highlights the Percutaneous Cryoablation of Low-risk Early Breast Cancer (PRECICE) study, led by Principal Investigator, Dr. Orsi. PRECICE is an independent prospective observational 233 patient study that has commenced the enrollment of women 50 years of age and older with unifocal, small (up to 15 mm in diameter), clinically node-negative, luminal A and B breast cancer.
The PRECICE study, which will exclusively use ProSense® to conduct all procedures, will evaluate the technical effectiveness of cryoablation with a median follow-up of five years (with early primary and secondary outcomes after three years). The procedure failure rate will be evaluated for possible residual tumor by mammography, ultrasound, and nuclear MRI at two months before radiotherapy and six months after radiotherapy. If relapse is suspected, an image-guided breast biopsy will be performed. Additional endpoints including quality of life, psychological impact, and economic outcomes will also be evaluated.
"Dr. Orsi and his team are leading one of the largest studies of cryoablation in early-stage breast cancer and examining cryoablation's role as an alternative to lumpectomy. Importantly, PRECICE is using ProSense® to examine a wider population of patients than ICE3 did, including women as young as 50 and those diagnosed with luminal B breast cancer," stated IceCure's CEO, Eyal Shamir. "The accelerating move towards the de-escalation of surgical treatment further supports the potential for excellent patient outcomes, improved healthcare economics, and increased market penetration for ProSense®."
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 potential of cryoablation as a precise and safe alternative to surgery, the details of the PRECICE study, and the belief that the accelerating move towards the de-escalation of surgical treatment further supports the potential for excellent patient outcomes, improved healthcare economics, and increased market penetration for ProSense®. 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
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FAQ
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