Data on IceCure's ProSense® Cryoablation for Low-Risk Breast Cancer Presented at Radiological Society of North America's 2024 Annual Meeting
IceCure Medical (NASDAQ: ICCM) presented data from its ICE3 trial of ProSense® cryoablation technology at the Radiological Society of North America's 2024 Annual Meeting. The study, presented by ICE3 Co-Principal Investigator Dr. Kenneth Tomkovich, demonstrated promising results for treating early-stage low-risk breast cancer.
Key findings include a five-year recurrence rate of 3.7% with adjuvant endocrine therapy and 4.3% in the eligible trial population, comparable to surgical lumpectomy outcomes. The procedure offers significant advantages over surgery, including outpatient treatment with local anesthesia, minor adverse events, and 100% patient satisfaction with cosmetic outcomes.
Following a favorable FDA Advisory Panel vote in November 2024, the FDA's marketing authorization decision is expected in Q1 2025. The ICE3 trial, being the largest of its kind, supports the transition towards less invasive breast cancer treatment options.
IceCure Medical (NASDAQ: ICCM) ha presentato dati dal suo studio ICE3 sulla tecnologia di crioblazione ProSense® durante l'Annual Meeting della Radiological Society of North America del 2024. Lo studio, presentato dal Co-Capoinvestigatore dell'ICE3, Dr. Kenneth Tomkovich, ha dimostrato risultati promettenti per il trattamento del cancro al seno in fase iniziale a basso rischio.
I risultati chiave includono un tasso di ricorrenza a cinque anni del 3,7% con terapia endocrina adiuvante e del 4,3% nella popolazione idonea allo studio, comparabile ai risultati della lumpectomia chirurgica. La procedura offre significativi vantaggi rispetto alla chirurgia, incluso il trattamento ambulatoriale con anestesia locale, eventi avversi minori e 100% di soddisfazione dei pazienti per i risultati cosmetici.
Dopo un voto favorevole del Comitato Consultivo dell'FDA nel novembre 2024, si prevede che la decisione sull'autorizzazione al commercio dell'FDA arrivino nel primo trimestre del 2025. Lo studio ICE3, essendo il più grande del suo genere, supporta il passaggio verso opzioni di trattamento del cancro al seno meno invasive.
IceCure Medical (NASDAQ: ICCM) presentó datos de su ensayo ICE3 sobre la tecnología de crioablación ProSense® en la Reunión Anual de la Sociedad Radiológica de América del Norte 2024. El estudio, presentado por el Co-Investigador Principal del ICE3, Dr. Kenneth Tomkovich, demostró resultados prometedores para el tratamiento del cáncer de mama en estadios iniciales de bajo riesgo.
Entre los hallazgos clave se incluye una tasa de recurrencia a cinco años del 3.7% con terapia endocrina adyuvante y del 4.3% en la población elegible del ensayo, comparable a los resultados de la lumpectomía quirúrgica. El procedimiento ofrece ventajas significativas sobre la cirugía, incluyendo tratamiento ambulatorio con anestesia local, eventos adversos menores y 100% de satisfacción del paciente con los resultados estéticos.
Tras un voto favorable del Panel Asesor de la FDA en noviembre de 2024, se espera que la decisión sobre la autorización de comercialización de la FDA llegue en el primer trimestre de 2025. El ensayo ICE3, siendo el más grande de su tipo, apoya la transición hacia opciones de tratamiento menos invasivas para el cáncer de mama.
IceCure Medical (NASDAQ: ICCM)는 2024년 북미 방사선 학회 연례 회의에서 ProSense® 냉동 절제 기술에 대한 ICE3 시험 데이터를 발표했습니다. ICE3 공동 주 연구자인 Kenneth Tomkovich 박사가 발표한 이 연구는 조기 저위험 유방암 치료를 위한 유망한 결과를 보여주었습니다.
주요 발견 사항으로는 보조 내분비 요법을 통한 5년 재발률이 3.7%이며, 시험에 적합한 인구에서는 4.3%로, 이는 수술적인 유방 절제술 결과와 유사합니다. 이 절차는 국소 마취로 진행되는 외래 치료, 경미한 부작용, 그리고 100%의 환자 만족도를 포함한 미용 결과 등 수술에 비해 상당한 이점을 제공합니다.
2024년 11월 FDA 자문 위원회의 긍정적인 투표 이후, FDA의 마케팅 승인 결정은 2025년 1분기에 예상됩니다. 가장 큰 규모의 ICE3 연구는 덜 침습적인 유방암 치료 옵션으로의 전환을 지원합니다.
IceCure Medical (NASDAQ: ICCM) a présenté des données de son essai ICE3 sur la technologie de cryoablation ProSense® lors de la Réunion Annuelle de la Société Radiologique d'Amérique du Nord 2024. L'étude, présentée par le co-responsable de l'étude ICE3, Dr. Kenneth Tomkovich, a montré des résultats prometteurs pour le traitement du cancer du sein à un stade précoce à faible risque.
Les principales conclusions incluent un taux de récidive sur cinq ans de 3,7% avec une thérapie endocrinienne adjuvante et 4,3% dans la population éligible à l'étude, comparable aux résultats des résultats de la tumorectomie chirurgicale. La procédure offre des avantages significatifs par rapport à la chirurgie, y compris un traitement en ambulatoire avec anesthésie locale, des événements indésirables mineurs et 100% de satisfaction des patients concernant les résultats esthétiques.
Après un vote favorable du Comité Consultatif de la FDA en novembre 2024, la décision d'autorisation de commercialisation de la FDA est attendue au premier trimestre 2025. L'essai ICE3, étant le plus grand de son genre, soutient la transition vers des options de traitement moins invasives pour le cancer du sein.
IceCure Medical (NASDAQ: ICCM) hat auf dem Jahreskongress der Radiological Society of North America 2024 Daten aus seiner ICE3-Studie zur ProSense®-Kryoablationstechnologie vorgestellt. Die Studie, die von Dr. Kenneth Tomkovich, dem Co-Hauptprüfer des ICE3, präsentiert wurde, zeigte vielversprechende Ergebnisse zur Behandlung von Brustkrebs im Frühstadium mit geringem Risiko.
Wichtige Ergebnisse umfassen eine Fünfjahres-Rückfallquote von 3,7% mit unterstützender endokriner Therapie und 4,3% in der für die Studie geeigneten Bevölkerungsgruppe, vergleichbar mit den Ergebnissen von chirurgischen Lumpektomien. Das Verfahren bietet im Vergleich zur Chirurgie bedeutende Vorteile, einschließlich ambulanter Behandlung mit Lokalanästhesie, geringer Nebenwirkungen und 100% Patientenzufriedenheit mit kosmetischen Ergebnissen.
Nach einer positiven Abstimmung des FDA-Beratungsgremiums im November 2024 wird die Entscheidung zur Marktzulassung der FDA für das erste Quartal 2025 erwartet. Die ICE3-Studie, die die größte ihrer Art ist, unterstützt den Übergang zu weniger invasiven Behandlungsoptionen für Brustkrebs.
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- ICE3 trial results presented by ICE3 Co-Principal Investigator Dr. Kenneth Tomkovich
- FDA Advisory Panel voted in favor of IceCure's ProSense® cryoablation benefit-risk profile in early-stage low risk breast cancer in Nov. 2025
- FDA's marketing authorization decision expected in Q1, 2025
Dr. Tomkovich commented, "The significance of the ICE3 results in the field of radiology, especially among breast radiologists, cannot be overstated. As the largest study of its kind, ICE3 provides crucial data that can support the shift towards the de-escalation of breast cancer care with cryoablation as a less invasive procedure, enabling the cohort of patients included in ICE3 to have a safe and effective option to surgical lumpectomy."
"ProSense®'s ICE3 results are gaining increasing prominence across a range of medical specialty conferences globally, as well as through prominent peer reviewed journals. This is critical support for market adoption leading up to the expected decision of the
The presentation's findings included the following:
- The overall five-year recurrence rate of
3.7% in combination with adjuvant endocrine therapy and4.3% in the eligible ICE3 trial population is similar to reported recurrence rates for the current standard of care, surgical lumpectomy. - Substantial benefits, as compared to surgery, include performance in an outpatient setting using local anesthesia, the only reported adverse events being minor in severity, and
100% patient satisfaction with cosmetic outcomes. - Results of the ICE3 trial suggest that cryoablation for small low-risk breast cancers is a safe and effective primary treatment option alternative to surgical lumpectomy.
- Sentinel lymph node biopsy is likely not required in this cohort of patients
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 belief that the significance of the ICE3 results in the field of radiology, especially among breast radiologists, cannot be overstated, the belief that ICE3 provides crucial data that can support the shift towards the de-escalation of breast cancer care with cryoablation as a less invasive procedure, enabling the cohort of patients included in ICE3 to have a safe and effective option to surgical lumpectomy, and that ProSense®'s ICE3 results gaining increasing prominence is critical support for market adoption leading up to the expected decision of the FDA regarding marketing authorization of ProSense® for early-stage breast cancer in the
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
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SOURCE IceCure Medical
FAQ
What are the key results of IceCure's ICE3 trial for breast cancer treatment?
When is the FDA expected to make a decision on ProSense's marketing authorization?
What advantages does ProSense cryoablation offer over traditional surgery for breast cancer?
What size breast tumors were treated in the ICCM ICE3 trial?
Where was IceCure's ICE3 trial data presented in December 2024?
