99.74% Recurrence Free Rate for Women with Breast Cancer Treated with IceCure's ProSense® Cryoablation System: Key Findings Delivered at 32nd Annual Meeting of the Japanese Breast Cancer Society
IceCure Medical (Nasdaq: ICCM) reported key findings from three clinical studies of its ProSense® cryoablation system for breast cancer treatment at the 32nd Annual Meeting of the Japanese Breast Cancer Society. Highlights include:
1. An independent study by Prof. Fukuma showed a 99.74% recurrence-free rate in 389 patients treated over 10 years.
2. Another study by Prof. Kawamoto found 0% local recurrence in a five-year follow-up.
3. Terumo , IceCure's distribution partner, plans to submit an application for regulatory clearance in Japan by Q1 2025.
The demand for minimally invasive breast cancer treatments was a major theme at the conference, with ProSense® gaining traction due to its efficacy, favorable cosmetic results, and potential immune system benefits.
IceCure Medical (Nasdaq: ICCM) ha riportato risultati significativi da tre studi clinici sul suo sistema di crioblassamento ProSense® per il trattamento del cancro al seno durante il 32° Congresso Annuale della Società Giapponese di Cancro al Seno. I punti salienti includono:
1. Uno studio indipendente del Prof. Fukuma ha mostrato un tasso di recidiva zero del 99,74% in 389 pazienti trattati per un periodo di 10 anni.
2. Un altro studio del Prof. Kawamoto ha trovato 0% di recidiva locale in un follow-up di cinque anni.
3. Terumo, partner di distribuzione di IceCure, prevede di presentare una domanda per l'approvazione normativa in Giappone entro il primo trimestre del 2025.
La domanda per trattamenti minimamente invasivi per il cancro al seno è stata una tematica centrale della conferenza, con ProSense® che ha guadagnato attenzione grazie alla sua efficacia, ai risultati cosmetici favorevoli e ai potenziali benefici per il sistema immunitario.
IceCure Medical (Nasdaq: ICCM) reportó hallazgos clave de tres estudios clínicos de su sistema de crioblasión ProSense® para el tratamiento del cáncer de mama en la 32ª Reunión Anual de la Sociedad Japonesa de Cáncer de Mama. Los aspectos destacados incluyen:
1. Un estudio independiente del Prof. Fukuma mostró una tasa de recurrencia libre del 99,74% en 389 pacientes tratados durante 10 años.
2. Otro estudio del Prof. Kawamoto encontró 0% de recurrencia local en un seguimiento de cinco años.
3. Terumo, socio de distribución de IceCure, planea presentar una solicitud para la autorización regulatoria en Japón para el primer trimestre de 2025.
La demanda de tratamientos mínimamente invasivos para el cáncer de mama fue un tema principal en la conferencia, con ProSense® ganando impulso debido a su eficacia, resultados cosméticos favorables y posibles beneficios para el sistema inmunológico.
아이스큐어 메디컬 (Nasdaq: ICCM)는 일본 유방암 학회의 제32차 연례 회의에서 유방암 치료를 위한 프로센스® 크라이오 절제 시스템의 세 가지 임상 연구에서 핵심 발견을 보고했습니다. 주요 내용은 다음과 같습니다:
1. 후쿠마 교수의 독립 연구에서 10년 동안 치료한 389명의 환자에서 99.74%의 재발 없는 비율이 나타났습니다.
2. 카와모토 교수의 다른 연구는 5년 추적 조사에서 0%의 국소 재발을 발견했습니다.
3. 아이스큐어의 유통 파트너인 테루모는 2025년 1분기까지 일본에서 규제 승인 신청서를 제출할 계획입니다.
최소 침습적 유방암 치료에 대한 수요는 컨퍼런스의 주요 주제로, 프로센스®는 효과, 유리한 미용 결과 및 잠재적인 면역 체계 이점 덕분에 주목받고 있습니다.
IceCure Medical (Nasdaq: ICCM) a rapporté des résultats clés de trois études cliniques de son système de cryoablation ProSense® pour le traitement du cancer du sein lors de la 32e Réunion Annuelle de la Société Japonaise du Cancer du Sein. Les points forts incluent :
1. Une étude indépendante du Prof. Fukuma a montré un taux de récidive de 99,74% chez 389 patients traités pendant 10 ans.
2. Une autre étude du Prof. Kawamoto a trouvé 0% de récidive locale lors d'un suivi de cinq ans.
3. Terumo, partenaire de distribution d'IceCure, prévoit de soumettre une demande d'autorisation réglementaire au Japon d'ici le premier trimestre 2025.
La demande de traitements de cancer du sein minimement invasifs était un thème majeur de la conférence, avec ProSense® gagnant en popularité grâce à son efficacité, ses résultats cosmétiques favorables et ses bénéfices potentiels pour le système immunitaire.
IceCure Medical (Nasdaq: ICCM) berichtete über wichtige Ergebnisse aus drei klinischen Studien zu seinem ProSense® Kryoablation System zur Behandlung von Brustkrebs auf der 32. Jahrestagung der Japanischen Gesellschaft für Brustkrebs. Zu den wichtigsten Erkenntnissen gehören:
1. Eine unabhängige Studie von Prof. Fukuma zeigte eine 99,74% Rückfallfreie Rate bei 389 Patienten, die über einen Zeitraum von 10 Jahren behandelt wurden.
2. Eine weitere Studie von Prof. Kawamoto fand 0% lokale Rückfälle in einer fünfjährigen Nachuntersuchung.
3. Terumo, der Vertriebspartner von IceCure, plant, im ersten Quartal 2025 einen Antrag auf behördliche Genehmigung in Japan einzureichen.
Die Nachfrage nach minimal-invasiven Brustkrebsbehandlungen war ein zentrales Thema der Konferenz, wobei ProSense® aufgrund seiner Wirksamkeit, positiver kosmetischer Ergebnisse und potenzieller Vorteile für das Immunsystem an Bedeutung gewann.
- 99.74% recurrence-free rate in 389 breast cancer patients treated with ProSense® over 10 years
- 0% local recurrence or distant metastasis in a 5-year follow-up study
- Planned regulatory submission for ProSense® in Japan by Q1 2025 through partnership with Terumo
- Growing demand for minimally invasive breast cancer treatments in Japan
- Excellent cosmetic outcomes and improved patient satisfaction reported
- None.
Insights
The findings from the Japanese Breast Cancer Society's annual meeting reveal significant potential for IceCure's ProSense® cryoablation system. A 99.74% recurrence-free rate over ten years and 0% local recurrence over five years are exceptionally high success rates for any cancer treatment. These results suggest that ProSense® could become a leading method for minimally invasive breast cancer treatment, especially in a market as advanced as Japan. Importantly, the fact that these findings are based on independent studies adds to their credibility.
From a medical research perspective, these results are promising not only due to their efficacy but also because of the additional benefits highlighted, such as improved cosmetic outcomes and potential immunological benefits. These factors could make ProSense® an attractive option for both patients and healthcare providers. The high success rates and minimal adverse effects reported are noteworthy and could significantly shift treatment paradigms if they continue to be validated in broader clinical settings.
Given that Japan has a high incidence of breast cancer and a well-established healthcare infrastructure, the adoption of cryoablation could set a precedent that other countries might follow. The partnership with Terumo Corporation ensures that IceCure has a reputable and influential ally in introducing this technology to the Japanese market.
For investors, the news surrounding IceCure Medical's ProSense® cryoablation system is highly favorable. The very high success rates reported in the studies presented at the Japanese Breast Cancer Society annual meeting provide strong validation for the technology, which is a critical aspect for both market adoption and regulatory approval. The anticipated regulatory filing by Terumo Corporation in the first quarter of 2025 is a significant milestone. If approved, this could substantially open up the Japanese market, which is one of the largest for medical devices.
From a financial standpoint, this could lead to a notable increase in sales and market share for IceCure. The partnership with Terumo Corporation, a major player in Japan, adds substantial credibility and market reach. Investors should watch for the PMDA’s decision, as approval could serve as a catalyst for the stock. Furthermore, the overall positive reception at the conference adds to the credibility of the technology, which can spur increased investor interest and confidence.
Additionally, the consistent high demand for minimally invasive treatments aligns well with broader healthcare trends, where there's a shift toward less invasive procedures with quicker recovery times and better patient outcomes. These trends generally drive higher adoption rates, thus potentially leading to increased revenue streams.
The presentation of ProSense® cryoablation system's success rates at the Japanese Breast Cancer Society’s annual meeting highlights a growing market trend toward minimally invasive breast cancer treatments. With a 99.74% recurrence-free rate over ten years and 0% local recurrence in five years, these results are significantly above average for the industry. This positions ProSense® as a disruptive technology within the breast cancer treatment market.
Market demand for minimally invasive procedures is on the rise due to factors such as reduced recovery times, lower healthcare costs and improved patient outcomes. This trend suggests a strong market fit for ProSense®, especially in Japan, where healthcare providers and patients are open to adopting advanced medical technologies. The collaboration with Terumo Corporation is strategic, as it not only facilitates regulatory approval but also leverages Terumo’s extensive distribution network to accelerate market penetration.
Given these factors, the outlook for IceCure in the Japanese market is optimistic. If the technology continues to deliver as promised, it could capture a significant share of the breast cancer treatment market. Investors should monitor regulatory progress and market adoption rates closely, as these will be key indicators of the product's long-term success.
- Demand for minimally invasive breast cancer treatment was overarching theme of the conference
- In one independent study led by Professor Fukuma, 389 patients treated for up to 10 years had
99.74% recurrence free rate - Another independent study led by Professor Kawamoto found
0% breast cancer local recurrence in five-year follow up - ProSense® expected to gain further traction in
Japan , as distribution partner Terumo Corporation plans to submit application to the Pharmaceuticals and Medical Devices Agency ("PMDA") for regulatory clearance for breast cancer in the first quarter of 2025
During a symposium titled, "New techniques and strategies in breast surgery", chaired by Professor Takayuki Kinoshita, Division of Breast Surgery, NHO Tokyo Medical Center, data on breast cancer cryoablation with ProSense® were presented by Prof. Eisuke Fukuma, Breast Center, Kameda Medical Center, and Prof. Hisanori Kawamoto, Department of Breast Surgery, Breast and Imaging Center at St. Marianna University School of Medicine.
Demand for minimally invasive breast cancer treatment was an overarching theme of the Japanese Breast Cancer Society Annual Meeting and of high interest to the over 3,500 meeting attendees. The data on cryoablation was well received at the symposium. Symposium Chair Professor Kinoshita commented, "cryoablation for treating breast cancer has the potential to become an alternative to open surgery and other minimally invasive solutions in
Professor Fukuma, who has performed over 600 breast cryoablation procedures with ProSense®, presented a summary of IceCure's ICE3 study data as well the latest data from his ongoing research of ProSense® to treat breast cancer at Kameda Medical Center. From April 2014 through August 2020, 389 breast cancer patients with tumor lesions of less than 15 millimeters in diameter were treated with ProSense®. The ipsilateral breast tumor recurrence rate (IBTR) was
"The results with ProSense® continue to be excellent, and this is why cryoablation is becoming a common procedure here," Professor Fukuma stated. "Patients are becoming more interested. They are coming in and asking to learn more about it. In addition to great efficacy on treating tumors and favorable cosmetic results, there is evidence that cryoablation has potentially favorable impacts on the immune system, further improving longer term outcomes."
Professor Kawamoto presented data from an independent study he led which demonstrated zero (
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About ProSense®
The ProSense® Cryoablation System provides a minimally invasive treatment 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 procedure for breast tumors.
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 that cryoablation for treating breast cancer has the potential to become an alternative to open surgery and other minimally invasive solutions in
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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FAQ
What was the recurrence-free rate for breast cancer patients treated with IceCure's ProSense® (ICCM) in Prof. Fukuma's study?
When is Terumo planning to submit an application for ProSense® (ICCM) regulatory clearance in Japan?
What was the local recurrence rate in Prof. Kawamoto's 5-year follow-up study of ProSense® (ICCM) for breast cancer?
How many breast cryoablation procedures has Prof. Fukuma performed with ProSense® (ICCM)?
