IceCure's ICESECRET Kidney Cancer Cryoablation Study Interim Results Presented at European Association of Urology Conference in Spain: 88.7% Recurrence-Free Rate
IceCure Medical (NASDAQ: ICCM) has presented interim results from its ICESECRET study on ProSense® cryoablation for small renal masses at the European Association of Urology Conference in Madrid. The study demonstrated an 88.7% recurrence-free rate in patients with tumors ≤3 cm at a mean follow-up of 3.4 years.
The study evaluated 111 patients with a mean age of 69, of whom 84.2% had comorbidities. Safety results showed 17 mild adverse events, 3 moderate events, and 1 severe complication. The data supports cryoablation as a viable alternative for patients ineligible for kidney-preserving surgery, particularly for tumors ≤3 cm.
ProSense®, which uses liquid nitrogen-based cryoablation technology to destroy tumors by freezing, is currently approved for benign and malignant kidney tumors in the U.S., Europe, and other countries.
IceCure Medical (NASDAQ: ICCM) ha presentato i risultati intermedi del suo studio ICESECRET sulla crioablazione ProSense® per piccole masse renali durante la Conferenza dell'Associazione Europea di Urologia a Madrid. Lo studio ha dimostrato un tasso di assenza di recidive dell'88,7% nei pazienti con tumori ≤3 cm a un follow-up medio di 3,4 anni.
Lo studio ha valutato 111 pazienti con un'età media di 69 anni, dei quali l'84,2% presentava comorbidità. I risultati di sicurezza hanno mostrato 17 eventi avversi lievi, 3 eventi moderati e 1 complicazione grave. I dati supportano la crioablazione come un'alternativa valida per i pazienti non idonei a interventi chirurgici di conservazione renale, in particolare per tumori ≤3 cm.
ProSense®, che utilizza la tecnologia di crioablazione a base di azoto liquido per distruggere i tumori congelandoli, è attualmente approvato per tumori renali benigni e maligni negli Stati Uniti, in Europa e in altri paesi.
IceCure Medical (NASDAQ: ICCM) ha presentado resultados intermedios de su estudio ICESECRET sobre la crioablación ProSense® para pequeñas masas renales en la Conferencia de la Asociación Europea de Urología en Madrid. El estudio demostró una tasa de ausencia de recurrencias del 88,7% en pacientes con tumores ≤3 cm a un seguimiento medio de 3,4 años.
El estudio evaluó a 111 pacientes con una edad media de 69 años, de los cuales el 84,2% tenía comorbilidades. Los resultados de seguridad mostraron 17 eventos adversos leves, 3 eventos moderados y 1 complicación grave. Los datos respaldan la crioablación como una alternativa viable para pacientes no elegibles para cirugía de conservación renal, particularmente para tumores ≤3 cm.
ProSense®, que utiliza tecnología de crioablación a base de nitrógeno líquido para destruir tumores mediante congelación, está actualmente aprobado para tumores renales benignos y malignos en EE. UU., Europa y otros países.
아이스큐어 메디컬 (NASDAQ: ICCM)은 마드리드에서 열린 유럽 비뇨기과 협회 회의에서 작은 신장 종양을 위한 프로센스® 냉동 절제술에 대한 ICESECRET 연구의 중간 결과를 발표했습니다. 이 연구는 평균 3.4년의 추적 관찰 기간 동안 종양 크기가 ≤3 cm인 환자에서 88.7%의 재발 없는 비율을 보여주었습니다.
이 연구는 평균 연령이 69세인 111명의 환자를 평가했으며, 이 중 84.2%가 동반 질환을 가지고 있었습니다. 안전성 결과는 17건의 경미한 부작용, 3건의 중간 정도의 사건, 1건의 심각한 합병증을 보여주었습니다. 이 데이터는 신장 보존 수술에 적합하지 않은 환자에게 냉동 절제술이 유효한 대안이 될 수 있음을 지지합니다, 특히 종양 크기가 ≤3 cm인 경우에 해당합니다.
프로센스®는 액체 질소 기반의 냉동 절제 기술을 사용하여 종양을 얼려 파괴하는 방식으로, 현재 미국, 유럽 및 기타 국가에서 양성 및 악성 신장 종양에 대해 승인받았습니다.
IceCure Medical (NASDAQ: ICCM) a présenté des résultats intermédiaires de son étude ICESECRET sur la cryoablation ProSense® pour de petites masses rénales lors de la Conférence de l'Association Européenne d'Urologie à Madrid. L'étude a montré un taux sans récidive de 88,7% chez les patients ayant des tumeurs ≤3 cm avec un suivi moyen de 3,4 ans.
L'étude a évalué 111 patients avec un âge moyen de 69 ans, dont 84,2% avaient des comorbidités. Les résultats de sécurité ont montré 17 événements indésirables légers, 3 événements modérés et 1 complication sévère. Les données soutiennent la cryoablation comme une alternative viable pour les patients inéligibles à une chirurgie de préservation rénale, en particulier pour les tumeurs ≤3 cm.
ProSense®, qui utilise une technologie de cryoablation à base d'azote liquide pour détruire les tumeurs par congélation, est actuellement approuvé pour les tumeurs rénales bénignes et malignes aux États-Unis, en Europe et dans d'autres pays.
IceCure Medical (NASDAQ: ICCM) hat auf der Konferenz der Europäischen Urologie-Vereinigung in Madrid vorläufige Ergebnisse seiner ICESECRET-Studie zur ProSense®-Kryoablation für kleine Nierenmassen präsentiert. Die Studie zeigte eine Rückfallrate von 88,7% bei Patienten mit Tumoren ≤3 cm nach einer durchschnittlichen Nachbeobachtungszeit von 3,4 Jahren.
In der Studie wurden 111 Patienten mit einem Durchschnittsalter von 69 Jahren untersucht, von denen 84,2% Begleiterkrankungen hatten. Die Sicherheitsdaten zeigten 17 leichte unerwünschte Ereignisse, 3 moderate Ereignisse und 1 schwere Komplikation. Die Daten unterstützen die Kryoablation als eine praktikable Alternative für Patienten, die für eine nieren-erhaltende Operation nicht in Frage kommen, insbesondere bei Tumoren ≤3 cm.
ProSense®, das eine auf flüssigem Stickstoff basierende Kryoablationstechnologie verwendet, um Tumore durch Einfrieren zu zerstören, ist derzeit in den USA, Europa und anderen Ländern für gutartige und bösartige Nierentumoren zugelassen.
- 88.7% recurrence-free rate for tumors ≤3 cm after 3.4 years
- ProSense® already approved in major markets (US, Europe) for kidney tumors
- Strong safety profile with predominantly mild adverse events
- One severe complication reported in the study
- efficacy data for tumors larger than 3cm
Insights
The ICESECRET study interim results demonstrate compelling efficacy for ProSense® cryoablation in kidney tumor treatment. The 88.7% recurrence-free rate for tumors ≤3 cm at 3.4 years follow-up represents strong clinical performance for this patient population. This is particularly significant given that 84.2% of the study subjects had comorbidities, suggesting real-world applicability in complex patients who cannot undergo surgical intervention.
The safety profile appears favorable with predominantly mild adverse events, which is crucial for this higher-risk population (mean age 69). The technology's ability to preserve kidney function while effectively treating tumors addresses a substantial unmet need in nephron-sparing approaches for patients ineligible for surgical options.
What makes these results particularly meaningful is the relatively long follow-up period of approximately 3 years, which provides greater confidence in the durability of response compared to studies with shorter endpoints. The consistent efficacy across different subgroup analyses (87.8% for low-risk tumors and 87.2% for all tumors ≤3 cm) suggests robust performance across various patient profiles within the target population.
These ICESECRET study results significantly strengthen IceCure's position in the minimally invasive tumor ablation market. With ProSense® already approved in the US, Europe, and other markets for kidney tumors, this clinical validation directly supports commercial adoption rather than merely advancing toward regulatory approval.
The data specifically defines an optimal target population - patients with tumors ≤3 cm who are ineligible for kidney-preserving surgery - providing clear positioning for the technology against competing approaches. This precision in identifying the ideal use case helps streamline marketing efforts and physician education.
Presentation at the European Association of Urology Conference provides high-visibility exposure to key proceduralists who would be utilizing the technology. The combination of strong efficacy data with a favorable safety profile in a vulnerable population (with 77% having hypertension and 47% having diabetes) creates a compelling value proposition for both providers and payers.
For a company with IceCure's $70M market capitalization, establishing clinical credibility in a specific high-need application is a critical milestone that could accelerate technology adoption and potentially support premium positioning in reimbursement discussions.
Interim Data confirm ProSense® cryoablation is highly effective for kidney tumors ≤3 cm and a safe procedure for kidney tumors ≤5 cm in people ineligible for surgery
"We are very pleased to see these impressive data shared at a major urology conference in
- Cryoablation is a viable alternative for SRMs, especially for tumors ≤3 cm;
- 111 patients were evaluated at a mean follow-up of approximately 3 years;
- Recurrence free rate was
88.7% in patients with tumors ≤3 cm, low risk and a successful procedure at a mean follow up of 3.4 years; - Recurrence free rate was
87.8% in patients with tumors ≤3 cm at low risk with at a mean follow up of 3.4 years; - Recurrence free rate was
87.2% in patients with tumor size ≤3 cm at a mean follow up of 3.5 years; - Safety results include 17 mild adverse events, 3 moderate events, and 1 severe complication observed; and
- The mean age of the patients was 69 and
84.2% had comorbidities, the most common of which were hypertension (77% ) and diabetes (47% ).
ProSense® is approved for benign and malignant kidney tumors in the
About ICESECRET
ICESECRET, a prospective, multicenter, single-arm clinical trial is being performed at Bnai Zion Medical Center in
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 data from the ICESECRET study interim analysis support the adoption of cryoablation as a safe and effective option for patients who are otherwise ineligible for kidney preserving surgery. 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, 2023 filed with the SEC on April 3, 2024, 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
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FAQ
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