Breast Cancer Patients who Underwent IceCure's ProSense® Cryoablation in Japan Reported Significantly Higher Satisfaction than Patients who Underwent Standard of Care Surgery
IceCure Medical (NASDAQ: ICCM) announced significant findings from an independent study published in Gland Surgery, comparing patient satisfaction between their ProSense® cryoablation technology and traditional breast-conserving therapy (BCT) for breast cancer treatment.
The study, conducted at Kameda Medical Center in Japan, revealed that patients who underwent cryoablation reported significantly higher satisfaction scores (71.0±18.6) compared to BCT patients (56.3±16.5), with mean follow-up periods of 4.2 and 4.0 years respectively. The research included 147 Asian female breast cancer patients, with 76 meeting the final analysis criteria (35 cryoablation, 41 BCT).
The study utilized the BREAST-Q questionnaire to assess health-related quality of life and satisfaction. Researchers attributed the higher satisfaction in cryoablation patients to the preservation of breast volume and symmetry, as the procedure doesn't require tissue excision. This data supports the ongoing trend toward de-escalation of breast cancer treatment from surgical to nonsurgical options in Japan.
IceCure Medical (NASDAQ: ICCM) ha annunciato risultati significativi da uno studio indipendente pubblicato su Gland Surgery, che confronta la soddisfazione dei pazienti tra la loro tecnologia di criobblazione ProSense® e la terapia conservativa del seno tradizionale (BCT) per il trattamento del cancro al seno.
Lo studio, condotto presso il Kameda Medical Center in Giappone, ha rivelato che i pazienti sottoposti a crioablazione hanno riportato punteggi di soddisfazione significativamente più elevati (71,0±18,6) rispetto ai pazienti BCT (56,3±16,5), con periodi medi di follow-up di 4,2 e 4,0 anni rispettivamente. La ricerca ha incluso 147 pazienti asiatici di sesso femminile affetti da cancro al seno, di cui 76 hanno soddisfatto i criteri di analisi finale (35 criobblazione, 41 BCT).
Lo studio ha utilizzato il questionario BREAST-Q per valutare la qualità della vita correlata alla salute e la soddisfazione. I ricercatori hanno attribuito la maggiore soddisfazione nei pazienti sottoposti a criobblazione alla preservazione del volume e della simmetria del seno, poiché la procedura non richiede l'escissione dei tessuti. Questi dati supportano la tendenza in corso verso la de-escalation del trattamento del cancro al seno, passando da opzioni chirurgiche a non chirurgiche in Giappone.
IceCure Medical (NASDAQ: ICCM) anunció hallazgos significativos de un estudio independiente publicado en Gland Surgery, que compara la satisfacción del paciente entre su tecnología de crioablación ProSense® y la terapia conservadora del seno tradicional (BCT) para el tratamiento del cáncer de mama.
El estudio, realizado en el Kameda Medical Center en Japón, reveló que los pacientes que se sometieron a crioablación reportaron puntuaciones de satisfacción significativamente más altas (71.0±18.6) en comparación con los pacientes de BCT (56.3±16.5), con períodos medios de seguimiento de 4.2 y 4.0 años respectivamente. La investigación incluyó a 147 pacientes asiáticas con cáncer de mama, de los cuales 76 cumplieron con los criterios de análisis final (35 crioablación, 41 BCT).
El estudio utilizó el cuestionario BREAST-Q para evaluar la calidad de vida relacionada con la salud y la satisfacción. Los investigadores atribuyeron la mayor satisfacción en los pacientes de crioablación a la preservación del volumen y la simetría del seno, ya que el procedimiento no requiere la excisión de tejido. Estos datos respaldan la tendencia actual hacia la desescalada del tratamiento del cáncer de mama, pasando de opciones quirúrgicas a no quirúrgicas en Japón.
IceCure Medical (NASDAQ: ICCM)는 Gland Surgery에 발표된 독립 연구 결과를 발표하며, 그들의 ProSense® 냉동 절제 기술과 전통적인 유방 보존 치료(BCT) 간의 환자 만족도를 비교했습니다.
일본 카메다 의료 센터에서 실시된 이 연구는 냉동 절제를 받은 환자들이 BCT 환자들보다 만족도 점수가 상당히 높았다는 것을 밝혔습니다 (71.0±18.6 대 56.3±16.5), 평균 추적 기간은 각각 4.2년과 4.0년이었습니다. 이 연구는 147명의 아시아 여성 유방암 환자를 포함했으며, 그 중 76명이 최종 분석 기준을 충족했습니다 (35명 냉동 절제, 41명 BCT).
이 연구는 건강 관련 삶의 질과 만족도를 평가하기 위해 BREAST-Q 설문지를 사용했습니다. 연구자들은 냉동 절제 환자들의 높은 만족도를 유방의 부피와 대칭을 보존하는 것에 기인한다고 설명했으며, 이 절차는 조직 절제가 필요하지 않기 때문입니다. 이 데이터는 일본에서 수술적 치료에서 비수술적 옵션으로의 유방암 치료의 경향을 지지합니다.
IceCure Medical (NASDAQ: ICCM) a annoncé des résultats significatifs d'une étude indépendante publiée dans Gland Surgery, comparant la satisfaction des patients entre leur technologie de cryoablation ProSense® et la thérapie conservatrice du sein traditionnelle (BCT) pour le traitement du cancer du sein.
L'étude, réalisée au Kameda Medical Center au Japon, a révélé que les patients ayant subi une cryoablation ont rapporté des scores de satisfaction significativement plus élevés (71,0±18,6) par rapport aux patients BCT (56,3±16,5), avec des périodes de suivi moyennes de 4,2 et 4,0 ans respectivement. La recherche a inclus 147 patientes asiatiques atteintes de cancer du sein, dont 76 ont satisfait aux critères d'analyse finale (35 cryoablation, 41 BCT).
L'étude a utilisé le questionnaire BREAST-Q pour évaluer la qualité de vie liée à la santé et la satisfaction. Les chercheurs ont attribué la satisfaction plus élevée chez les patients ayant subi une cryoablation à la préservation du volume et de la symétrie des seins, car la procédure ne nécessite pas d'excision de tissu. Ces données soutiennent la tendance actuelle vers la désescalade du traitement du cancer du sein, passant d'options chirurgicales à non chirurgicales au Japon.
IceCure Medical (NASDAQ: ICCM) gab bedeutende Ergebnisse einer unabhängigen Studie bekannt, die in Gland Surgery veröffentlicht wurde und die Patientenzufriedenheit zwischen ihrer ProSense® Kryoablationstechnologie und der traditionellen brusterhaltenden Therapie (BCT) zur Behandlung von Brustkrebs vergleicht.
Die Studie, die im Kameda Medical Center in Japan durchgeführt wurde, zeigte, dass Patienten, die sich einer Kryoablation unterzogen, signifikant höhere Zufriedenheitswerte berichteten (71,0±18,6) im Vergleich zu BCT-Patienten (56,3±16,5), mit durchschnittlichen Nachbeobachtungszeiträumen von 4,2 und 4,0 Jahren. Die Forschung umfasste 147 asiatische weibliche Brustkrebspatientinnen, von denen 76 die Kriterien für die endgültige Analyse erfüllten (35 Kryoablation, 41 BCT).
Die Studie verwendete den BREAST-Q-Fragebogen zur Bewertung der gesundheitsbezogenen Lebensqualität und Zufriedenheit. Die Forscher führten die höhere Zufriedenheit bei Kryoablation-Patienten auf die Erhaltung des Brustvolumens und der Symmetrie zurück, da das Verfahren keine Gewebeentnahme erfordert. Diese Daten unterstützen den aktuellen Trend zur Deeskalation der Brustkrebsbehandlung von chirurgischen zu nicht-chirurgischen Optionen in Japan.
- Significantly higher patient satisfaction scores for ProSense® cryoablation vs traditional surgery (71.0±18.6 vs 56.3±16.5)
- Long-term follow-up data validates treatment efficacy (>4 years)
- Study supports regulatory approval process for ProSense® in Japanese market
- sample size with only 76 patients in final analysis
- Study confined to Asian population, may not be globally representative
Insights
The independent study published in Gland Surgery provides significant clinical validation for IceCure's ProSense® cryoablation technology in early-stage breast cancer patients. With 71.0±18.6 satisfaction scores for cryoablation versus 56.3±16.5 for breast-conserving therapy (BCT), the data demonstrates a 26% improvement in patient satisfaction - a meaningful difference in patient-reported outcomes.
What's particularly compelling is the long-term follow-up period averaging 4+ years, addressing previous gaps in evidence for Asian populations. This study aligns perfectly with the ongoing trend toward treatment de-escalation in breast cancer, as patients and providers increasingly seek less invasive alternatives to traditional surgery.
The research was conducted at Japan's Kameda Medical Center by experienced ProSense® users, including Dr. Eisuke Fukuma who has personally performed over 600 procedures, lending substantial credibility to the findings. This extensive clinical experience suggests the technology has already gained significant physician acceptance in Japan despite pending regulatory approval.
For IceCure Medical, these results strengthen their position as Terumo , their Japanese distribution partner, pursues regulatory approval in that market. With breast-conserving therapy currently representing approximately 60% of breast cancer cases in Japan, the addressable market opportunity is substantial if ProSense® can capture even a modest share of these procedures.
- Independent study published in Gland Surgery and conducted at Kameda Medical Center in
Japan by ProSense® users including Dr. Kizuki Matsumoto and Dr. Eisuke Fukuma - Patients who underwent cryoablation compared to breast-conserving therapy (BCT) reported significantly higher satisfaction (71.0±18.6 vs. 56.3±16.5) in the primary outcome with a mean follow-up of 4.2 and 4.0 years, respectively
- Data support continued move toward de-escalation of breast cancer treatment from BCT (lumpectomy) to nonsurgical options including cryoablation
In
"In this study we aimed to evaluate and compare patient satisfaction after BCT and cryoablation. Assessing the patient's health-related quality of life ("HRQOL") holds significant clinical importance and studies examining long-term satisfaction following cryoablation, particularly in Asian patients, are limited," stated Dr. Kizuki Matsumoto. "Because of improved survival outcomes, breast cancer is becoming a chronic disease, making the survivor's quality of life and satisfaction a major focus of treatment. We were pleased with the outcome of the study and believe the use of cryoablation in breast cancer will be more widespread in the future."
IceCure's Chief Executive, Eyal Shamir commented, "We are grateful to the team at Kameda Medical Center for initiating this important study which focuses on women's satisfaction. The data clearly demonstrate that cryoablation resulted in greater quality of life and patient satisfaction than standard of care surgery in this early-stage breast cancer patient population. We believe these results will support our distribution partner, Terumo Corporation, in its application for regulatory approval of ProSense® for breast cancer in
Highlights from the study:
- A total of 147 Asian female breast cancer patients underwent cryoablation with ProSense® (n=42) or BCT (n=105). Among the 112 patients with stage 0 or 1 disease, 36 met the exclusion criteria and were excluded from the analysis. The remaining 76 (35 from the cryoablation group and 41 from the BCT group) were included in the analysis.
- The study used the BREAST-Q questionnaire to assess patient HRQOL and satisfaction.
- Patients who underwent cryoablation compared to BCT reported significantly higher satisfaction (71.0±18.6 vs. 56.3±16.5) in the primary outcome, with a mean follow-up of 4.2 and 4.0 years, respectively. This satisfaction trend was consistent across all the other measures.
- The authors of the study indicate they believe patient satisfaction is higher with cryoablation of breast cancer as it does not involve excision, leaving breast volume and symmetry unchanged.
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 assessing HRQOL holds significant clinical performance; the belief that cryoablation for treating breast cancer will be more widespread in the future; the belief that the data from the Kameda Medical Center study demonstrate that cryoablation resulted in greater quality of life and patient satisfaction than standard of care surgery in the early-stage breast cancer patient population; and the belief that the results from the Kameda Medical Center study will support Terumo Corporation in its application for regulatory approval of ProSense® for breast cancer in
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 were the satisfaction scores for ICCM's ProSense cryoablation compared to traditional surgery?
How many patients were included in the ICCM ProSense breast cancer study in Japan?
What is the average follow-up period for ICCM's ProSense cryoablation study?
Why did patients prefer ICCM's ProSense cryoablation over traditional surgery?
