IceCure's ProSense® Substantially Reduces Abdominal Wall Endometriosis Pain with High Procedural Efficacy
IceCure Medical (NASDAQ: ICCM) reported promising results from an independent study evaluating its ProSense® cryoablation system for treating abdominal wall endometriosis (AWE). The study, conducted at Nîmes University Hospital in France, demonstrated significant pain reduction in patients, with median pain scores dropping from 8/10 to 0/10 at 3-month follow-up.
The study included 14 patients with 23 AWE lesions treated between September 2022 and April 2025. Key outcomes showed complete ablation zone coverage, median procedural time of 93 minutes, and no complications. Only 14% of patients required retreatment. ProSense® is FDA-cleared and EU-approved for gynecological indications, targeting a market of approximately 190 million women globally affected by endometriosis.
IceCure Medical (NASDAQ: ICCM) ha pubblicato risultati promettenti da uno studio indipendente che ha valutato il suo sistema di crioablazione ProSense® per il trattamento dell'endometriosi della parete addominale (AWE). Lo studio, condotto presso l'Hôpital Universitaire di Nîmes in Francia, ha mostrato una riduzione significativa del dolore: il punteggio mediano è passato da 8/10 a 0/10 al follow-up a 3 mesi.
Lo studio ha incluso 14 pazienti con 23 lesioni AWE trattate tra settembre 2022 e aprile 2025. I risultati principali riportano una completa copertura della zona di ablazione, un tempo procedurale mediano di 93 minuti e assenza di complicazioni. Solo il 14% delle pazienti ha richiesto un nuovo trattamento. ProSense® è autorizzato dalla FDA e approvato nell'UE per indicazioni ginecologiche, indirizzandosi a un mercato di circa 190 milioni di donne nel mondo affette da endometriosi.
IceCure Medical (NASDAQ: ICCM) informó resultados prometedores de un estudio independiente que evaluó su sistema de crioablación ProSense® para el tratamiento de la endometriosis de la pared abdominal (AWE). El estudio, realizado en el Hospital Universitario de Nîmes en Francia, demostró una reducción significativa del dolor: la puntuación mediana pasó de 8/10 a 0/10 en el seguimiento a 3 meses.
El estudio incluyó a 14 pacientes con 23 lesiones AWE tratadas entre septiembre de 2022 y abril de 2025. Los resultados clave mostraron cobertura completa de la zona de ablación, un tiempo procedimental mediano de 93 minutos y ausencia de complicaciones. Solo el 14% de las pacientes requirió retratamiento. ProSense® cuenta con la autorización de la FDA y la aprobación en la UE para indicaciones ginecológicas, orientándose a un mercado de aproximadamente 190 millones de mujeres en el mundo afectadas por endometriosis.
IceCure Medical (NASDAQ: ICCM)은 복벽 장액종(AWE) 치료를 위한 ProSense® 크라이오어블레이션 시스템을 평가한 독립 연구에서 유망한 결과를 보고했습니다. 프랑스 님 대학병원에서 실시된 이 연구는 통증이 크게 감소했음을 보여주었으며, 3개월 추적에서 중앙값 통증 점수가 8/10에서 0/10으로 떨어졌습니다.
이 연구에는 2022년 9월부터 2025년 4월까지 치료받은 14명 환자, 23개의 AWE 병변이 포함되었습니다. 주요 결과로는 완전한 소작 영역 커버, 중앙 시술 시간 93분, 합병증 없음이 보고되었습니다. 단지 14%의 환자만 재치료가 필요했습니다. ProSense®는 산부인과 적응증으로 FDA 승인 및 EU 허가를 받았으며, 전 세계 약 1억9천만 명의 여성이 영향을 받는 자궁내막증 시장을 대상으로 합니다.
IceCure Medical (NASDAQ: ICCM) a annoncé des résultats prometteurs d'une étude indépendante évaluant son système de cryoablation ProSense® pour le traitement de l'endométriose de la paroi abdominale (AWE). L'étude, menée au CHU de Nîmes en France, a montré une réduction significative de la douleur : le score de douleur médian est passé de 8/10 à 0/10 au suivi à 3 mois.
L'étude a inclus 14 patientes présentant 23 lésions d'AWE traitées entre septembre 2022 et avril 2025. Les résultats clés indiquent une couverture complète de la zone d'ablation, un temps procédural médian de 93 minutes et l'absence de complications. Seules 14% des patientes ont nécessité un retraitement. ProSense® est autorisé par la FDA et approuvé dans l'UE pour des indications gynécologiques, visant un marché d'environ 190 millions de femmes dans le monde touchées par l'endométriose.
IceCure Medical (NASDAQ: ICCM) meldete vielversprechende Ergebnisse einer unabhängigen Studie, die sein ProSense®-Kryoablationssystem zur Behandlung der abdominalen Wandendometriose (AWE) bewertete. Die Studie, durchgeführt am Universitätsklinikum Nîmes in Frankreich, zeigte eine deutliche Schmerzlinderung: der mediane Schmerzscore sank beim 3‑Monats‑Follow‑up von 8/10 auf 0/10.
In die Studie wurden 14 Patientinnen mit 23 AWE‑Läsionen eingeschlossen, die zwischen September 2022 und April 2025 behandelt wurden. Wichtige Ergebnisse waren vollständige Abdeckungen der Ablationszone, eine mediane Prozedurdauer von 93 Minuten und keine Komplikationen. Nur 14% der Patientinnen benötigten eine erneute Behandlung. ProSense® ist für gynäkologische Indikationen von der FDA freigegeben und in der EU zugelassen und adressiert einen Markt von etwa 190 Millionen Frauen weltweit, die von Endometriose betroffen sind.
- None.
- 14% of patients required retreatment
- Small study size of only 14 patients may limit statistical significance
- Relatively long procedure time of 93 minutes per treatment
Insights
ProSense® cryoablation demonstrates remarkable pain reduction for abdominal wall endometriosis, significantly strengthening IceCure's position in gynecological applications.
The independent study from Nîmes University Hospital provides compelling evidence for ProSense®'s effectiveness in treating abdominal wall endometriosis (AWE), a painful condition affecting women who've undergone cesarean sections. The results are remarkable – patients experienced a dramatic reduction in pain scores from median 8/10 to 0/10 following treatment, a statistically significant improvement (p<0.0001).
This minimally invasive approach offers several advantages over traditional surgical excision. The procedure time averaged just 15 minutes for the ablation itself and 93 minutes overall, substantially shorter than surgical alternatives. Additionally, the absence of complications and excellent cosmetic outcomes (no visible scarring) represents a significant quality-of-life improvement for patients.
The retreatment rate of only 14% further validates the procedure's effectiveness. Those two patients achieved satisfactory outcomes with a second cryoablation session, indicating the technology provides viable solutions even for initially incomplete responses.
With endometriosis affecting approximately 10% of reproductive-age women globally (190 million people) according to WHO data, and AWE specifically occurring in 0.03-3.5% of women, IceCure is targeting a substantial market. The study strengthens ProSense®'s commercial potential in gynecological applications, complementing its existing FDA clearance and EU approval for these indications.
This evidence suggests ProSense® could become an important treatment option within multidisciplinary care for AWE, potentially expanding IceCure's market penetration in women's health applications beyond its existing oncology focus.
Independent study reports pain scores declined from a median of 8 on a scale of 0-10 to a median of 0 for patients who had ProSense® cryoablation procedures
ProSense® is FDA cleared and approved in the European Union for gynecological indications
AWE is a debilitating condition, often occurring in surgical scars after caesarean sections. It is characterized by cyclic pain and a palpable mass, significantly impacting the quality of life of the individual. Traditional treatments, including hormonal therapy and surgery, have their limitations, which has prompted interest in minimally invasive techniques such as cryoablation.
The peer-reviewed study, published in Journal of Personalized Medicine, titled "Efficacy and Safety of Percutaneous Single-Probe Cryoablation Using Liquid Nitrogen in the Treatment of Abdominal Wall Endometriosis," was conducted at Nîmes University Hospital in Nîmes,
"We are very pleased to share the results of this independent study which concluded that percutaneous cryoablation with ProSense® is a safe and effective minimally invasive cryosurgical tool for abdominal wall endometriosis, offering significant pain relief and excellent cosmetic outcomes," stated IceCure's Chief Executive Officer, Eyal Shamir. The researchers went on to state it should be considered as part of multidisciplinary care for women with AWE. Evidence of ProSense®'s efficacy in multiple gynecological indications further supports its commercial potential and momentum.
Key Study Highlights include the following:
- Substantial Pain Relief: Median pain scores declined from 8/10 (range: 6–10) pre-treatment to 0/10 (range: 0–2) at 3-month follow-up (p < 0.0001)
- High Procedural Efficacy: MRI confirmed complete coverage of the ablation zone and disappearance of hemorrhagic inclusions in all cases
- Streamlined Procedure: Median ablation and overall procedural times were 15 minutes and 93 minutes, respectively
- Safe and Excellent Cosmetic Outcomes: No peri- or post-procedural complications were reported; no visible scars were observed
- Low Retreatment Rate: Only two patients (
14% ) required a second treatment using the same modality, both achieving satisfactory outcomes
According to the World Health Organization, endometriosis affects about
About ProSense®
The ProSense® Cryoablation System provides a minimally invasive method 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 benefits of percutaneous cryoablation with ProSense®; that ProSense® is a safe and effective minimally invasive cryosurgical tool for abdominal wall endometriosis, offering significant pain relief and excellent cosmetic outcomes; and the belief that ProSense®'s efficacy in multiple gynecological indications supports its commercial potential and momentum. 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, 2024 filed with the SEC on March 27, 2025, 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.
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SOURCE IceCure Medical
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