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[FWP] IceCure Medical Ltd. Free Writing Prospectus

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Rhea-AI Filing Summary

IceCure Medical Ltd. (Nasdaq: ICCM) filed a Free Writing Prospectus (FWP) dated 25 June 2025 in connection with its pending Form F-1 registration. The document promotes ProSense®, a liquid-nitrogen cryoablation system designed to treat benign and malignant tumors through a minimally invasive freezing procedure.

Regulatory footing: ProSense already holds FDA 510(k) clearance for kidney, liver, neurology and fibroadenoma indications, CE mark in Europe and approvals in 15 other countries including China, Brazil and India. A De Novo FDA decision for early-stage, low-risk T1 breast cancer is expected after the agency reviews IceCure’s post-market study plan; an FDA advisory panel voted favorably on benefit-risk in November 2024. IceCure’s next-generation XSense platform has separate 510(k) clearance, with a soft commercial launch targeted for Q1 2026.

Clinical evidence: The U.S. ICE3 trial (194 patients, 19 sites) showed a 96.8 % local-recurrence-free rate when ProSense was followed by endocrine therapy, no serious device-related adverse events and 100 % patient & physician cosmetic satisfaction over five years. Independent external studies reportedly corroborate these findings.

Market context: Global tumor-ablation spend is projected to rise from US$1.0 bn in 2021 to US$2.4 bn in 2028, driven by demand for less-invasive options. In 2025 the U.S. addressable cryoablation market includes about 317 k new invasive breast-cancer cases and significant kidney, liver and lung cancer populations. IceCure owns 54 patents and has secured numerous distribution agreements.

Risks & next steps: The registration statement is not yet effective; investments can only be made via the final prospectus. Marketing expansion, reimbursement upgrades beyond the current CPT III code and additional clinical studies remain forward-looking objectives.

IceCure Medical Ltd. (Nasdaq: ICCM) ha presentato un Free Writing Prospectus (FWP) datato 25 giugno 2025 in relazione alla sua registrazione in corso con il modulo F-1. Il documento promuove ProSense®, un sistema di crioablazione a azoto liquido progettato per trattare tumori benigni e maligni tramite una procedura di congelamento minimamente invasiva.

Quadro normativo: ProSense ha già ottenuto la certificazione FDA 510(k) per indicazioni su rene, fegato, neurologia e fibroadenoma, il marchio CE in Europa e approvazioni in altri 15 paesi, tra cui Cina, Brasile e India. Una decisione De Novo della FDA per il cancro al seno in stadio iniziale e a basso rischio T1 è attesa dopo la revisione del piano di studi post-marketing di IceCure; un panel consultivo della FDA ha espresso parere favorevole sul rapporto benefici-rischi a novembre 2024. La piattaforma di nuova generazione XSense di IceCure ha una certificazione 510(k) separata, con un lancio commerciale soft previsto per il primo trimestre 2026.

Prove cliniche: Lo studio ICE3 negli Stati Uniti (194 pazienti, 19 centri) ha mostrato un tasso del 96,8% di assenza di recidiva locale quando ProSense è stato seguito da terapia endocrina, nessun evento avverso grave correlato al dispositivo e una soddisfazione estetica del 100% da parte di pazienti e medici in un periodo di cinque anni. Studi esterni indipendenti avrebbero confermato questi risultati.

Contesto di mercato: La spesa globale per l’ablazione tumorale è prevista in crescita da 1,0 miliardi di dollari nel 2021 a 2,4 miliardi di dollari nel 2028, trainata dalla domanda di opzioni meno invasive. Nel 2025 il mercato statunitense della crioablazione indirizzabile comprende circa 317.000 nuovi casi di cancro invasivo al seno e significative popolazioni con tumori a rene, fegato e polmone. IceCure detiene 54 brevetti e ha siglato numerosi accordi di distribuzione.

Rischi e prossimi passi: La dichiarazione di registrazione non è ancora efficace; gli investimenti potranno essere effettuati solo tramite il prospetto finale. L’espansione del marketing, l’aggiornamento dei rimborsi oltre l’attuale codice CPT III e ulteriori studi clinici restano obiettivi futuri.

IceCure Medical Ltd. (Nasdaq: ICCM) presentó un Free Writing Prospectus (FWP) fechado el 25 de junio de 2025 en relación con su registro pendiente bajo el formulario F-1. El documento promociona ProSense®, un sistema de crioablación con nitrógeno líquido diseñado para tratar tumores benignos y malignos mediante un procedimiento de congelación mínimamente invasivo.

Marco regulatorio: ProSense ya cuenta con la autorización FDA 510(k) para indicaciones en riñón, hígado, neurología y fibroadenoma, la marca CE en Europa y aprobaciones en 15 países más, incluyendo China, Brasil e India. Se espera una decisión De Novo de la FDA para cáncer de mama en etapa temprana y bajo riesgo T1 tras la revisión del plan de estudio post-comercialización de IceCure; un panel asesor de la FDA votó favorablemente sobre el balance beneficio-riesgo en noviembre de 2024. La plataforma de próxima generación XSense de IceCure tiene una autorización 510(k) independiente, con un lanzamiento comercial suave previsto para el primer trimestre de 2026.

Evidencia clínica: El ensayo ICE3 en EE.UU. (194 pacientes, 19 sitios) mostró una tasa del 96,8 % libre de recurrencia local cuando ProSense fue seguido por terapia endocrina, sin eventos adversos graves relacionados con el dispositivo y una satisfacción cosmética del 100 % tanto de pacientes como de médicos durante cinco años. Estudios externos independientes aparentemente corroboran estos hallazgos.

Contexto de mercado: Se proyecta que el gasto global en ablación tumoral aumente de US$1.0 mil millones en 2021 a US$2.4 mil millones en 2028, impulsado por la demanda de opciones menos invasivas. En 2025, el mercado estadounidense de crioablación abordable incluye aproximadamente 317,000 nuevos casos invasivos de cáncer de mama y poblaciones significativas con cáncer de riñón, hígado y pulmón. IceCure posee 54 patentes y ha asegurado numerosos acuerdos de distribución.

Riesgos y próximos pasos: La declaración de registro aún no está vigente; las inversiones solo pueden realizarse mediante el prospecto final. La expansión del marketing, mejoras en el reembolso más allá del código CPT III actual y estudios clínicos adicionales son objetivos a futuro.

IceCure Medical Ltd. (나스닥: ICCM)는 2025년 6월 25일자 Free Writing Prospectus(FWP)를 제출하여 진행 중인 Form F-1 등록과 관련된 내용을 발표했습니다. 이 문서는 ProSense®를 홍보하는데, 이는 액체 질소 크라이오어블레이션 시스템으로, 최소 침습 냉동 절차를 통해 양성 및 악성 종양을 치료하도록 설계되었습니다.

규제 현황: ProSense는 이미 신장, 간, 신경학 및 섬유선종 적응증에 대해 FDA 510(k) 승인을 받았으며, 유럽 CE 인증과 중국, 브라질, 인도 등 15개국에서 승인을 받았습니다. 초기 단계 저위험 T1 유방암에 대한 FDA De Novo 결정은 IceCure의 시판 후 연구 계획 검토 후 예상되며, FDA 자문위원회는 2024년 11월에 이익-위험 평가에서 긍정적인 의견을 냈습니다. IceCure의 차세대 XSense 플랫폼은 별도의 510(k) 승인을 받았으며, 2026년 1분기에 소프트 상업 출시가 예정되어 있습니다.

임상 증거: 미국 ICE3 임상시험(194명, 19개 기관)에서 ProSense 후 내분비 치료를 받은 경우 5년간 국소 재발 없는 비율이 96.8%였고, 심각한 기기 관련 부작용은 없었으며, 환자 및 의사의 미용 만족도는 100%였습니다. 독립 외부 연구들도 이러한 결과를 뒷받침하는 것으로 알려졌습니다.

시장 상황: 전 세계 종양 절제 비용은 2021년 10억 달러에서 2028년 24억 달러로 증가할 것으로 예상되며, 덜 침습적인 옵션에 대한 수요가 증가하고 있습니다. 2025년 미국의 크라이오어블레이션 시장은 약 31만7천 건의 신규 침습성 유방암 사례와 상당한 신장, 간, 폐암 환자군을 포함합니다. IceCure는 54개의 특허를 보유하고 있으며 다수의 유통 계약을 체결했습니다.

위험 및 향후 계획: 등록 명세서는 아직 효력이 발생하지 않았으며, 투자자는 최종 설명서를 통해서만 투자가 가능합니다. 마케팅 확장, 현재 CPT III 코드 이상의 상환 개선 및 추가 임상 연구가 앞으로의 목표입니다.

IceCure Medical Ltd. (Nasdaq : ICCM) a déposé un Free Writing Prospectus (FWP) daté du 25 juin 2025 dans le cadre de son enregistrement en cours via le formulaire F-1. Ce document fait la promotion de ProSense®, un système de cryoablation à l’azote liquide conçu pour traiter les tumeurs bénignes et malignes par une procédure de congélation peu invasive.

Cadre réglementaire : ProSense bénéficie déjà d’une autorisation FDA 510(k) pour les indications rein, foie, neurologie et fibro-adénome, du marquage CE en Europe ainsi que d’approbations dans 15 autres pays dont la Chine, le Brésil et l’Inde. Une décision De Novo de la FDA pour un cancer du sein de stade précoce et à faible risque T1 est attendue après examen du plan d’étude post-commercialisation d’IceCure ; un comité consultatif de la FDA a voté favorablement sur le rapport bénéfice-risque en novembre 2024. La plateforme de nouvelle génération XSense d’IceCure dispose d’une autorisation 510(k) distincte, avec un lancement commercial progressif prévu au premier trimestre 2026.

Preuves cliniques : L’essai ICE3 aux États-Unis (194 patients, 19 centres) a montré un taux de récidive locale de 96,8 % sans récidive lorsque ProSense était suivi d’une thérapie endocrinienne, aucun événement indésirable grave lié au dispositif et une satisfaction esthétique de 100 % chez les patients et les médecins sur cinq ans. Des études externes indépendantes corroborent apparemment ces résultats.

Contexte du marché : Les dépenses mondiales en ablation tumorale devraient passer de 1,0 milliard de dollars en 2021 à 2,4 milliards en 2028, portées par la demande croissante d’options moins invasives. En 2025, le marché américain adressable de la cryoablation comprend environ 317 000 nouveaux cas invasifs de cancer du sein ainsi que d’importantes populations atteintes de cancers du rein, du foie et du poumon. IceCure détient 54 brevets et a conclu de nombreux accords de distribution.

Risques et prochaines étapes : La déclaration d’enregistrement n’est pas encore effective ; les investissements ne peuvent être réalisés qu’au travers du prospectus final. L’expansion commerciale, l’amélioration du remboursement au-delà du code CPT III actuel et des études cliniques supplémentaires restent des objectifs à venir.

IceCure Medical Ltd. (Nasdaq: ICCM) hat am 25. Juni 2025 einen Free Writing Prospectus (FWP) im Zusammenhang mit der ausstehenden Registrierung nach Formular F-1 eingereicht. Das Dokument bewirbt ProSense®, ein Kryoablation-System mit flüssigem Stickstoff, das zur Behandlung von gutartigen und bösartigen Tumoren mittels eines minimalinvasiven Gefrierverfahrens entwickelt wurde.

Regulatorischer Stand: ProSense verfügt bereits über die FDA 510(k)-Zulassung für Indikationen bei Niere, Leber, Neurologie und Fibroadenom, das CE-Kennzeichen in Europa sowie Zulassungen in 15 weiteren Ländern, darunter China, Brasilien und Indien. Eine De Novo-Entscheidung der FDA für Brustkrebs im Frühstadium mit niedrigem Risiko (T1) wird nach Prüfung des Nachmarktstudienplans von IceCure erwartet; ein FDA-Beratungsgremium stimmte im November 2024 positiv zum Nutzen-Risiko-Verhältnis ab. Die nächste Generation der XSense-Plattform von IceCure besitzt eine separate 510(k)-Zulassung, mit einem Soft-Launch im ersten Quartal 2026.

Klinische Evidenz: Die US-amerikanische ICE3-Studie (194 Patienten, 19 Standorte) zeigte eine lokale Rezidivfreiheit von 96,8 % bei ProSense gefolgt von endokriner Therapie, keine schwerwiegenden gerätebezogenen Nebenwirkungen und eine 100 %ige kosmetische Zufriedenheit von Patienten und Ärzten über fünf Jahre. Unabhängige externe Studien bestätigen diese Ergebnisse offenbar.

Marktkontext: Die weltweiten Ausgaben für Tumorablation werden voraussichtlich von 1,0 Mrd. USD im Jahr 2021 auf 2,4 Mrd. USD im Jahr 2028 steigen, getrieben durch die Nachfrage nach weniger invasiven Optionen. Im Jahr 2025 umfasst der adressierbare US-Kryoablationsmarkt etwa 317.000 neue invasive Brustkrebserkrankungen sowie erhebliche Nieren-, Leber- und Lungenkrebsfälle. IceCure besitzt 54 Patente und hat zahlreiche Vertriebsvereinbarungen abgeschlossen.

Risiken & nächste Schritte: Die Registrierungserklärung ist noch nicht wirksam; Investitionen können nur über den endgültigen Prospekt getätigt werden. Marketingausbau, Erhöhung der Erstattungen über den aktuellen CPT-III-Code hinaus und zusätzliche klinische Studien bleiben zukünftige Ziele.

Positive
  • 96.8 % local-recurrence-free rate in ICE3 trial with no serious adverse events over five years.
  • Regulatory footprint in 15 countries plus FDA 510(k) and CE mark establishes global market access.
  • Favorable FDA advisory-panel vote supports ProSense’s benefit-risk profile for early-stage breast cancer.
  • 54 patents protect proprietary liquid-nitrogen cryoablation technology.
  • Tumor-ablation market forecast to reach US$2.4 bn by 2028, providing meaningful growth runway.
Negative
  • FDA De Novo marketing authorization for breast cancer is still pending, leaving material regulatory uncertainty.
  • Current reimbursement limited to CPT III facility code; permanent CPT I coverage is only anticipated, not secured.
  • Additional clinical trials may be required for expanded indications, potentially extending time to market.
  • Offering statement not yet effective; investors cannot purchase until final prospectus is declared effective.

Insights

TL;DR: Strong clinical data and broad approvals, but cash raise depends on still-pending FDA De Novo decision.

The FWP underscores IceCure’s strategic positioning in minimally invasive oncology. Clinically, ICE3’s 96.8 % recurrence-free rate and absence of serious events de-risk the breast-cancer indication relative to surgery, supporting eventual adoption. Regulatory breadth—FDA 510(k), CE, China NMPA—confirms device quality, while the favorable 2024 panel vote de-risks U.S. breast clearance. Yet the De Novo order must still clear CDRH review, leaving timing uncertain. Commercial traction hinges on converting CPT III to a permanent CPT I code and scaling distribution. Capital from this offering will likely fund post-market studies, marketing and the 2026 XSense launch. Overall impact is moderate until definitive FDA authorization arrives.

TL;DR: Multi-region clearances impressive, but final U.S. breast indication approval and reimbursement gap are key constraints.

IceCure lists 15 country approvals plus CE mark, demonstrating robust dossier management. The single remaining hurdle is the De Novo request for early-stage breast cancer. The favorable advisory-panel vote is encouraging, yet CDRH’s required post-market study complicates the timeline. FDA 510(k) clearance for XSense broadens potential indications, but commercial benefit is deferred to a 2026 soft launch. Present reimbursement is limited to a facility-only CPT III, restricting physician adoption; a permanent CPT I code is merely “expected.” The FWP’s forward-looking language affirms additional clinical trials may be necessary, underscoring regulatory risk. Hence, the filing is informative but not immediately transformative.

IceCure Medical Ltd. (Nasdaq: ICCM) ha presentato un Free Writing Prospectus (FWP) datato 25 giugno 2025 in relazione alla sua registrazione in corso con il modulo F-1. Il documento promuove ProSense®, un sistema di crioablazione a azoto liquido progettato per trattare tumori benigni e maligni tramite una procedura di congelamento minimamente invasiva.

Quadro normativo: ProSense ha già ottenuto la certificazione FDA 510(k) per indicazioni su rene, fegato, neurologia e fibroadenoma, il marchio CE in Europa e approvazioni in altri 15 paesi, tra cui Cina, Brasile e India. Una decisione De Novo della FDA per il cancro al seno in stadio iniziale e a basso rischio T1 è attesa dopo la revisione del piano di studi post-marketing di IceCure; un panel consultivo della FDA ha espresso parere favorevole sul rapporto benefici-rischi a novembre 2024. La piattaforma di nuova generazione XSense di IceCure ha una certificazione 510(k) separata, con un lancio commerciale soft previsto per il primo trimestre 2026.

Prove cliniche: Lo studio ICE3 negli Stati Uniti (194 pazienti, 19 centri) ha mostrato un tasso del 96,8% di assenza di recidiva locale quando ProSense è stato seguito da terapia endocrina, nessun evento avverso grave correlato al dispositivo e una soddisfazione estetica del 100% da parte di pazienti e medici in un periodo di cinque anni. Studi esterni indipendenti avrebbero confermato questi risultati.

Contesto di mercato: La spesa globale per l’ablazione tumorale è prevista in crescita da 1,0 miliardi di dollari nel 2021 a 2,4 miliardi di dollari nel 2028, trainata dalla domanda di opzioni meno invasive. Nel 2025 il mercato statunitense della crioablazione indirizzabile comprende circa 317.000 nuovi casi di cancro invasivo al seno e significative popolazioni con tumori a rene, fegato e polmone. IceCure detiene 54 brevetti e ha siglato numerosi accordi di distribuzione.

Rischi e prossimi passi: La dichiarazione di registrazione non è ancora efficace; gli investimenti potranno essere effettuati solo tramite il prospetto finale. L’espansione del marketing, l’aggiornamento dei rimborsi oltre l’attuale codice CPT III e ulteriori studi clinici restano obiettivi futuri.

IceCure Medical Ltd. (Nasdaq: ICCM) presentó un Free Writing Prospectus (FWP) fechado el 25 de junio de 2025 en relación con su registro pendiente bajo el formulario F-1. El documento promociona ProSense®, un sistema de crioablación con nitrógeno líquido diseñado para tratar tumores benignos y malignos mediante un procedimiento de congelación mínimamente invasivo.

Marco regulatorio: ProSense ya cuenta con la autorización FDA 510(k) para indicaciones en riñón, hígado, neurología y fibroadenoma, la marca CE en Europa y aprobaciones en 15 países más, incluyendo China, Brasil e India. Se espera una decisión De Novo de la FDA para cáncer de mama en etapa temprana y bajo riesgo T1 tras la revisión del plan de estudio post-comercialización de IceCure; un panel asesor de la FDA votó favorablemente sobre el balance beneficio-riesgo en noviembre de 2024. La plataforma de próxima generación XSense de IceCure tiene una autorización 510(k) independiente, con un lanzamiento comercial suave previsto para el primer trimestre de 2026.

Evidencia clínica: El ensayo ICE3 en EE.UU. (194 pacientes, 19 sitios) mostró una tasa del 96,8 % libre de recurrencia local cuando ProSense fue seguido por terapia endocrina, sin eventos adversos graves relacionados con el dispositivo y una satisfacción cosmética del 100 % tanto de pacientes como de médicos durante cinco años. Estudios externos independientes aparentemente corroboran estos hallazgos.

Contexto de mercado: Se proyecta que el gasto global en ablación tumoral aumente de US$1.0 mil millones en 2021 a US$2.4 mil millones en 2028, impulsado por la demanda de opciones menos invasivas. En 2025, el mercado estadounidense de crioablación abordable incluye aproximadamente 317,000 nuevos casos invasivos de cáncer de mama y poblaciones significativas con cáncer de riñón, hígado y pulmón. IceCure posee 54 patentes y ha asegurado numerosos acuerdos de distribución.

Riesgos y próximos pasos: La declaración de registro aún no está vigente; las inversiones solo pueden realizarse mediante el prospecto final. La expansión del marketing, mejoras en el reembolso más allá del código CPT III actual y estudios clínicos adicionales son objetivos a futuro.

IceCure Medical Ltd. (나스닥: ICCM)는 2025년 6월 25일자 Free Writing Prospectus(FWP)를 제출하여 진행 중인 Form F-1 등록과 관련된 내용을 발표했습니다. 이 문서는 ProSense®를 홍보하는데, 이는 액체 질소 크라이오어블레이션 시스템으로, 최소 침습 냉동 절차를 통해 양성 및 악성 종양을 치료하도록 설계되었습니다.

규제 현황: ProSense는 이미 신장, 간, 신경학 및 섬유선종 적응증에 대해 FDA 510(k) 승인을 받았으며, 유럽 CE 인증과 중국, 브라질, 인도 등 15개국에서 승인을 받았습니다. 초기 단계 저위험 T1 유방암에 대한 FDA De Novo 결정은 IceCure의 시판 후 연구 계획 검토 후 예상되며, FDA 자문위원회는 2024년 11월에 이익-위험 평가에서 긍정적인 의견을 냈습니다. IceCure의 차세대 XSense 플랫폼은 별도의 510(k) 승인을 받았으며, 2026년 1분기에 소프트 상업 출시가 예정되어 있습니다.

임상 증거: 미국 ICE3 임상시험(194명, 19개 기관)에서 ProSense 후 내분비 치료를 받은 경우 5년간 국소 재발 없는 비율이 96.8%였고, 심각한 기기 관련 부작용은 없었으며, 환자 및 의사의 미용 만족도는 100%였습니다. 독립 외부 연구들도 이러한 결과를 뒷받침하는 것으로 알려졌습니다.

시장 상황: 전 세계 종양 절제 비용은 2021년 10억 달러에서 2028년 24억 달러로 증가할 것으로 예상되며, 덜 침습적인 옵션에 대한 수요가 증가하고 있습니다. 2025년 미국의 크라이오어블레이션 시장은 약 31만7천 건의 신규 침습성 유방암 사례와 상당한 신장, 간, 폐암 환자군을 포함합니다. IceCure는 54개의 특허를 보유하고 있으며 다수의 유통 계약을 체결했습니다.

위험 및 향후 계획: 등록 명세서는 아직 효력이 발생하지 않았으며, 투자자는 최종 설명서를 통해서만 투자가 가능합니다. 마케팅 확장, 현재 CPT III 코드 이상의 상환 개선 및 추가 임상 연구가 앞으로의 목표입니다.

IceCure Medical Ltd. (Nasdaq : ICCM) a déposé un Free Writing Prospectus (FWP) daté du 25 juin 2025 dans le cadre de son enregistrement en cours via le formulaire F-1. Ce document fait la promotion de ProSense®, un système de cryoablation à l’azote liquide conçu pour traiter les tumeurs bénignes et malignes par une procédure de congélation peu invasive.

Cadre réglementaire : ProSense bénéficie déjà d’une autorisation FDA 510(k) pour les indications rein, foie, neurologie et fibro-adénome, du marquage CE en Europe ainsi que d’approbations dans 15 autres pays dont la Chine, le Brésil et l’Inde. Une décision De Novo de la FDA pour un cancer du sein de stade précoce et à faible risque T1 est attendue après examen du plan d’étude post-commercialisation d’IceCure ; un comité consultatif de la FDA a voté favorablement sur le rapport bénéfice-risque en novembre 2024. La plateforme de nouvelle génération XSense d’IceCure dispose d’une autorisation 510(k) distincte, avec un lancement commercial progressif prévu au premier trimestre 2026.

Preuves cliniques : L’essai ICE3 aux États-Unis (194 patients, 19 centres) a montré un taux de récidive locale de 96,8 % sans récidive lorsque ProSense était suivi d’une thérapie endocrinienne, aucun événement indésirable grave lié au dispositif et une satisfaction esthétique de 100 % chez les patients et les médecins sur cinq ans. Des études externes indépendantes corroborent apparemment ces résultats.

Contexte du marché : Les dépenses mondiales en ablation tumorale devraient passer de 1,0 milliard de dollars en 2021 à 2,4 milliards en 2028, portées par la demande croissante d’options moins invasives. En 2025, le marché américain adressable de la cryoablation comprend environ 317 000 nouveaux cas invasifs de cancer du sein ainsi que d’importantes populations atteintes de cancers du rein, du foie et du poumon. IceCure détient 54 brevets et a conclu de nombreux accords de distribution.

Risques et prochaines étapes : La déclaration d’enregistrement n’est pas encore effective ; les investissements ne peuvent être réalisés qu’au travers du prospectus final. L’expansion commerciale, l’amélioration du remboursement au-delà du code CPT III actuel et des études cliniques supplémentaires restent des objectifs à venir.

IceCure Medical Ltd. (Nasdaq: ICCM) hat am 25. Juni 2025 einen Free Writing Prospectus (FWP) im Zusammenhang mit der ausstehenden Registrierung nach Formular F-1 eingereicht. Das Dokument bewirbt ProSense®, ein Kryoablation-System mit flüssigem Stickstoff, das zur Behandlung von gutartigen und bösartigen Tumoren mittels eines minimalinvasiven Gefrierverfahrens entwickelt wurde.

Regulatorischer Stand: ProSense verfügt bereits über die FDA 510(k)-Zulassung für Indikationen bei Niere, Leber, Neurologie und Fibroadenom, das CE-Kennzeichen in Europa sowie Zulassungen in 15 weiteren Ländern, darunter China, Brasilien und Indien. Eine De Novo-Entscheidung der FDA für Brustkrebs im Frühstadium mit niedrigem Risiko (T1) wird nach Prüfung des Nachmarktstudienplans von IceCure erwartet; ein FDA-Beratungsgremium stimmte im November 2024 positiv zum Nutzen-Risiko-Verhältnis ab. Die nächste Generation der XSense-Plattform von IceCure besitzt eine separate 510(k)-Zulassung, mit einem Soft-Launch im ersten Quartal 2026.

Klinische Evidenz: Die US-amerikanische ICE3-Studie (194 Patienten, 19 Standorte) zeigte eine lokale Rezidivfreiheit von 96,8 % bei ProSense gefolgt von endokriner Therapie, keine schwerwiegenden gerätebezogenen Nebenwirkungen und eine 100 %ige kosmetische Zufriedenheit von Patienten und Ärzten über fünf Jahre. Unabhängige externe Studien bestätigen diese Ergebnisse offenbar.

Marktkontext: Die weltweiten Ausgaben für Tumorablation werden voraussichtlich von 1,0 Mrd. USD im Jahr 2021 auf 2,4 Mrd. USD im Jahr 2028 steigen, getrieben durch die Nachfrage nach weniger invasiven Optionen. Im Jahr 2025 umfasst der adressierbare US-Kryoablationsmarkt etwa 317.000 neue invasive Brustkrebserkrankungen sowie erhebliche Nieren-, Leber- und Lungenkrebsfälle. IceCure besitzt 54 Patente und hat zahlreiche Vertriebsvereinbarungen abgeschlossen.

Risiken & nächste Schritte: Die Registrierungserklärung ist noch nicht wirksam; Investitionen können nur über den endgültigen Prospekt getätigt werden. Marketingausbau, Erhöhung der Erstattungen über den aktuellen CPT-III-Code hinaus und zusätzliche klinische Studien bleiben zukünftige Ziele.

Filed Pursuant to Rule 433

Issuer Free Writing Prospectus

Dated June 25, 2025

Relating to Preliminary Prospectus,

dated June 25, 2025

Registration No. 333-288062

 

Freezing Cancer in its Tracks Enabling minimally invasive destruction of benign and cancerous tumors with cryoablation (Nasdaq: ICCM) www.icecure - medical.com June 2025 Filed Pursuant to Rule 433 Issuer Free Writing Prospectus Dated June 25, 2025 Relating to Preliminary Prospectus, dated June 16, 2025 Registration No. 333 - 288062

 

 

Forward Looking Statement 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 Medical Ltd . (“ IceCure ”, “ IceCure Medical” or the “Company”) is using forward looking statements in this press release when it discusses : the anticipated timing of the FDA decision on the marketing authorization of ProSense ; the Company’s post - market study plan and the prospective approval thereof by the FDA’s Center for Devices and Radiological Health ; that Terumo Corporation is expected to submit its request for breast cancer clearance to the Japanese Pharmaceuticals and Medical Devices Agency in the second half of 2025 ; its cash position ; business, regulatory, marketing and commercialization strategy ; prospective regulatory approvals and the expected timing thereof for its various products worldwide ; that the FDA 510 (k) regulatory clearance for XSense and its commercialization may lead to new uses for certain other clinical indications ; the prospective soft launch of XSense in the first quarter of 2026 ; certain projections in the tumor ablation market ; the expected number of total breast cancer diagnoses in 2025 ; that cryoablation may require further clinical trial studies ; that additional coverage is expected upon the establishment of the permanent CPT Category I code ; that the Company anticipates greater market traction in the rest of the world based on positive U . S . ICE 3 final results ; that more data is expected with ongoing studies of ProSense in 2025 ; that there is a growing number of distribution partnerships with numerous recent regulatory approvals ; and that the potential benefits and impact IceCure’s products could have on improving patient health care . 2

 

 

Free Writing Prospectus This presentation highlights basic information about IceCure Medical Ltd. (“IceCure" or the "Company") and the offering to which this presentation relates. As this presentation is a summary, it does not contain all of the information that you should consider before investing in our securities. The Company has filed its Registration Statement on Form F - 1 (File No. 333 - 288062) ("Registration Statement"), including a preliminary prospectus, dated June 25, 2025 (the "Preliminary Prospectus"), with the U.S. Securities and Exchange Commission (the "SEC") for the offering to which this presentation relates. The Registration Statement is not yet effective. Before you invest, you are encouraged to read the Registration Statement, the Preliminary Prospectus, the documents incorporated by reference therein and, when available, the final prospectus, including the risk factors contained or incorporated by reference therein, and other documents that the Company has filed with the SEC for more complete information about the Company and the offering. Prospective investors are able to access these documents for free, including the Preliminary Prospectus, by proceeding to the EDGAR section of the SEC website (www.sec.gov/edgar). Alternatively, the Company and the Dealer - Manager of this offering can arrange to deliver the Preliminary Prospectus and, when available, the final prospectus and/or any supplements thereto by contacting Maxim Group LLC, Prospectus Department, 300 Park Avenue 16th Floor, New York, New York 10022, telephone (212) 895 - 3745 or e - mail: syndicate@maximgrp.com. This presentation does not constitute an offer or invitation for the sale or purchase or to engage in any other transaction with IceCure or its affiliates. The information in this presentation is not targeted at any residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local law or regulation. The offering will only be made by means of a prospectus included in the Registration Statement as and when the Registration Statement is declared effective by the SEC. Any decision to purchase the Company's securities in the proposed offering should be made solely on the basis of the information contained in such prospectus. 3

 

 

Introducing ProSense ® Non - surgical, next - generation, cryoablation technology • Cryoablation is a minimally - invasive treatment performed under guided imaging – ultrasound (US) or computerized tomography (CT) – treatment that uses extreme cold to freeze and accurately destroy diseased tissue in the tumor zone • IceCure’s flagship product, ProSense ® , cryoablates tumors quickly and with minimal pain • ProSense ® utilizes the ultracold power of liquid nitrogen (LN2) for maximum freezing, safety and efficacy https://vimeo.com/911112459?share=copy 4

 

 

Company Highlights Regulatory approvals in 15 countries, including the U.S. FDA, CE (Europe), Brazil, India, and China 5 Growing number of global distribution agreements Wide market applications: $2.4B tumor market by 2028¹ FDA decision on 510k De - Novo marketing authorization in early - stage breast cancer expected after its review of IceCure's post - market study plan 2024 Winner of Scientific Impact Award at American Society of Breast Surgeons 2 (ASBrS) for ICE3 data Reimbursement: CPT III for breast cancer cryoablation facility fee established 54 patents in IP portfolio for advanced LN2 cryoablation technology FDA 510(k) clearance granted for XSense next generation cryoablation system Excellent patient & physician feedback 1 Estimated, according to Grand View Research, Inc. ( www.grandviewresearch.com/industry - analysis/tumor - ablation - market ) Data is for all tumor ablation technologies and indications, including heat ablation Cryoablation, RF, MW, and others. The inf ormation herein has not been independently verified by the company ​ 2 https://opmed.doximity.com/articles/a - record - year - for - the - 25th - annual - meeting - of - the - asbrs ​

 

 

Market Opportunities 1 Estimated, according to Grand View Research, Inc. (www.grandviewresearch.com/industry - analysis/tumor - ablation - market) Data is for all tumor ablation technologies and indications, including heat ablation Cryoablation, RF, MW and others. The information herein has not been independently verified by the company ​ 6 Tumor Ablation Market Expected to Reach $2.4B in 2028 1 US Cryoablation Market 2025 Breast Tumors • Approximately 316,950 new invasive breast cancer patients 2 • 10% of US women estimated to have fibroadenomas 3 Interventional Radiology • 81,610 new kidney cases 4 • 42,240 new liver cancer cases 5 • 226,650 new lung cancer cases 6 2 https://www.cancer.org/cancer/types/breast - cancer/about/how - common - is - breast - cancer.html 3 https://www.ncbi.nlm.nih.gov/books/NBK535345/#article - 18600.s6 4 https://www.cancer.org/cancer/types/kidney - cancer/about/key - statistics.html - 2024 numbers 5 https://www.cancer.org/cancer/types/liver - cancer/about/what - is - key - statistics.html 6 https://www.cancer.org/cancer/types/lung - cancer/about/key - statistics.html $1.0B $2.4B 2021 2028 Compound annual growth rate (CAGR) driven by non/minimally invasive treatments like cryoablation Growing cancer burden Increasing demands for non/minimally invasive solutions Push for reduced cost of care by insurers and payers

 

 

Regulatory Approvals Worldwide Rest of the world approvals : India, Thailand, Israel, Brazil, Canada, Singapore, Hong Kong, Australia, and South Africa have similar clinical indications as CE approval for ProSense®. Russia, Taiwan, Costa Rica, and Mexico have ProSense approvals although clinical indications vary by country. • FDA Clearance for general minimally - invasive cryoablation applications with specific indications including: kidney, liver, neurology, fibroadenoma • FDA Marketing Authorization decision expected for early - stage, low - risk T1 invasive breast cancer in patients aged 70+ with adjuvant endocrine therapy following the FDA's review of IceCure's post - market study plan; An FDA Advisory Panel in November 2024 voted favorably of ProSense ®'s benefit - risk profile 7 • CE mark for benign or malignant tissue of the breast, lung, liver, kidney, musculoskeletal (bone), including palliative interventions • NMPA approval in China for ICESense3 System and disposable cryoprobes; clinical indications similar to CE approval

 

 

ProSense ® is Superior to Competing Thermal Ablation Technologies Thermal Ablation (Radiofrequency & Microwave) Cryoablation IceCure ProSense ® Very painful 4 Minimal to no pain 4 Pain Heavy sedation / Full anesthesia Local Anesthesia Limited visualization 1 Excellent contour under ultrasound & CT 2 Visualization Low High Accuracy Limited Positive Stimulation 3 Immune Response 10 – 30 mins 10 – 40 mins Procedure Time 8 1 Casal RF, Tam AL, Eapen GA. Radiofrequency ablation of lung tumors . Clin Chest Med. 2010;31(1):. doi:10.1016/j.ccm.2009.08.021 2 Goto T, Izumi Y, Nakatsuka S, Nomori H. Percutaneous cryoablation as a salvage therapy for local recurrence of lung cancer. Ann Thorac Surg. 2012;94(2):e31 - e33. doi:10.1016/j.athoracsur.2012.01.090 3 ​ Aarts, B M et al. “Cryoablation and immunotherapy: an overview of evidence on its synergy.” Insights into imaging vol. 10,1 5 3. 20 May. 2019, doi:10.1186/s13244 - 019 - 0727 - 5 4 Kwak, Kijung et al. “Recent progress in cryoablation cancer therapy and nanoparticles mediated cryoablation.” Theranostics vol. 12,5 2175 - 2204. 14 Feb. 2022, doi:10.7150/thno.67530

 

 

9 Breast Tumor Market Activities

 

 

Patient Experience: Lumpectomy 1. Pre - surgical screening/ Medical Clearance 7. Recovery at home Pain control, Potential continued nausea from anesthesia, Higher risk of post - operative bleeding or seroma 2. Fasting Begins at midnight. Anxiously await 3. Radiology Start day in radiology dept. to insert localization device 4. Pre - surgical prep Meet with surgeon and anesthesiologist. WAIT 5. Full anesthesia Lumpectomy procedure lasts 1 - 2 hours, tumor is surgically excised 6. Recovery room 1 hour in recovery, waiting for anesthesia to wear off. May experience pain, nausea. Need to be driven home 8. Re - excision 14 - 20% of patients may undergo re - excision after lumpectomy due to unclear margins 1 1. https://link.springer.com/article/10.1245/s10434 - 019 - 07247 - 5; https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.576 10

 

 

Patient Experience: Lumpectomy vs. Cryoablation 1. https://link.springer.com/article/10.1245/s10434 - 019 - 07247 - 5; https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.576 7. Recovery at home 4. Pre - surgical prep 8. Re - excision 2. Breakfast Enjoy a healthy breakfast 3. Option to drive yourself to cryoablation appointment 4. Cryoablation • Local anesthesia • Small bandage placed on insertion site • One hour start to finish 5. Resume normal activities start your journey towards being a breast cancer survivor 1hr 1. Pre - treatment screening 11 6 . Recovery Room

 

 

Cryoablation with ProSense ® – Value for All x Minimally invasive x Excellent cosmetic results 1 x Safe, simpler, faster & with minimal pain x Rapid Recovery 2 x Preventing re - excision after lumpectomy¹ x Increased ROI x Faster procedure* = more patients x Expands user base x Easy - to - use, in office/outpatient procedure x Low risk, safe procedure x Faster, outpatient procedure x Excellent safety profile 1 x No new infrastructure x Environmentally & storage friendly 12 x Lower reimbursement expense vs. surgery x Does not require hospitalization x Value based care Patients Physicians Insurers Healthcare Systems Liquid nitrogen (LN2) Maximum Efficacy – Benefits Patients, Physicians, Insurers, and Healthcare Systems 1 ICE3 trial; 2 ICE3 trial patients experienced recovery to normal activity within median 1 day (range of 0 - 8 days) 3 https://link.springer.com/article/10.1245/s10434 - 019 - 07247 - 5 ; https://ascopubs.org/doi/abs/10.1200/JCO.2020.38.15_suppl.576 * Compared to surgical excision; average cryoablation procedure is ~45 minutes ​​

 

 

ICE3 Trial: US Breast Cancer Cryoablation Analysis 13 194 Eligible Patients 96.8% Local Recurrence Free Rate For patients who received ProSense® cryoablation and received endocrine therapy 1,2 Safe Procedure No serious adverse events related to the study or procedure were reported 1 100% Patient & Physician Cosmetic Satisfaction After 5 years follow up with Minimal scarring or change to the shape or size of the breast 1 De Novo Classification Request submitted to FDA for marketing authorization of ProSense ® Cryoablation for patients with early - stage, low - risk T1 invasive breast cancer patients with adjuvant endocrine therapy • Full Data Analysis Submitted to the FDA • FDA Advisory Panel Voted Favorably for ProSense ®'s Cryoablation Benefit - Risk Profile for Early - Stage Low - Risk Breast Cancer • Final FDA Decision Expected after the FDA’s Center for Devices and Radiological Health (CDRH) approves IceCure’s Post - Market Study Plan The efficacy data of our minimally invasive ProSense ® cryoablation procedure followed by endocrine therapy shows similar outcomes in recurrence compared to more invasive breast surgery, the current standard of care for early - stage breast cancer** 1 Fine RE, Gilmore RC, Dietz JR, et al. Cryoablation Without Excision for Low - Risk Early - Stage Breast Cancer: 3 - Year Interim Ana lysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial. Ann Surg Oncol. 2021;28(10):5525 - 5534. doi:10.1245/s10434 - 021 - 10501 - 4 ​ 2 Ipsilateral breast tumor recurrence rate (IBTR) of 3.2% (4/124) in the subset of patients who underwent cryoablation and en doc rine therapy only. ** Per the analysis, at the 5 - year follow - up evaluation, 96.3% of the subgroup of patients who received ProSense ® cryoablation, followed by endocrine therapy, were estimated to be free from local recurrence. A comparison of this result, fro m the ICE3 study, shows similar outcomes in 5 - year recurrence rates compared to patients who were treated with lumpectomy followed by endocrine therapy in the L UMINA study, which reported a 97.7% recurrence free rate at 5 - year follow up and the PRISMA meta - study, which included Lumina, reporting a 97.19% recurrence free rate at 5 - year follow up. Largest controlled multi - location (19 prestigious U.S. institutions) clinical trial completed for LN2 cryoablation of small, low - risk breast cancer

 

 

Independent Studies Confirm ICE3 Results 14 In women with early - stage breast cancer who declined surgery (3) Study conducted by Principal Investigator Lucía Graña - López, MD, PhD, a radiologist who specializes in breast and women's imaging, Head of the Breast Unit at University Hospital Lucus Augusti , Spain — presented at European Society of Breast Imaging Annual Scientific Meeting 2023 96.8% Success rate In women deemed inoperable for breast cancer (2) Study conducted by Principal Investigator Dr. F. Di Naro, of Azienda Ospedaliero - Universitaria Careggi, Diagnostic Senology Unit, Florence, Italy — presented at European Society of Breast Imaging Annual Scientific Meeting 2023 100% Free from local recurrence 93.4 - 96.8% Tumor reduction rate In women with early - stage breast cancer (1) Study conducted by Principal Investigator Hisanori Kawamoto, of Breast and Imaging Center , St. Marianna University School of Medicine, Kawasaki - Shi, Japan — published in “Breast Cancer” Journal 1. https://pubmed.ncbi.nlm.nih.gov/38678120/ 2. ​ https://ir.icecure - medical.com/news - events/press - releases/detail/98/women - deemed - inoperable - for - breast - cancer - benefitted - from - ic ecure - medicals - prosense - as - an - independent - study - performed - in - italy - showed - a - tumor - reduction - rate - of - 93 - 43 - to - 96 - 81 3. https://ir.icecure - medical.com/news - events/press - releases/detail/97/independent - study - validates - icecures - prosense - cryoablation - i s - safe - effective - outpatient - procedure - for - breast - cancer - with - 96 - 8 - success - rate

 

 

U.S. Clinical Market Analysis of Invasive Breast Cancer Initial addressable market based on proposed FDA indication of ~46,000 2,4 breast cancer patients per year in the U.S. For patients aged 70+ with low risk, early stage, T1 invasive breast cancer with adjuvant endocrine therapy • 316,950 new cases of invasive breast cancer will be diagnosed in 2025 in the U.S.¹ • Luminal - A is the most common breast cancer subtype and represents 68% of all subtypes 2 • Tumor size distribution suggests that T1(2cm or smaller) is 66% of all breast cancers tumors 3 15 316,950 New cases of invasive breast cancer ¹ 215,526 Luminal A 2 142,247 T1 3 46,410 2,4 Aged 70 & above 1 American Cancer Society: https://www.cancer.org/cancer/types/breast - cancer/about/how - common - is - breast - cancer.html American Cancer Society - Breast Cancer Facts & Figures 2022 - 2024 https://www.cancer.org/content/dam/cancer - org/research/cancer - f acts - and - statistics/breast - cancer - facts - and - figures/2022 - 2024 - breast - cancer - fact - figures - acs.pdf Schoenborn NL, Blackford AL, Joshu CE, Boyd CM, Varadhan R. Life expectancy estimates based on comorbidities and frailty to i nfo rm preventive care. J Am Geriatr Soc. 2022 Jan;70(1):99 - 109. doi : 10.1111/jgs. 17468. 2 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4127612/ ​ 3 https://www.nejm.org/doi/full/10.1056/nejmoa1600249 ​ 4 Schoenborn NL, Blackford AL, Joshu CE, Boyd CM, Varadhan R. Life expectancy estimates based on comorbidities and frailty to in form preventive care. J Am Geriatr Soc. 2022 Jan;70(1):99 - 109. doi : 10.1111/jgs.17468.

 

 

U.S. Breast Cancer Go - To - Market Strategy • FDA Decision Expected after the CDRH approves IceCure’s Post - Market Study Plan • IceCure has delivered a post - market study plan for approval which will include approximately 400 patients aged 70+ across 25 sites • Marketing & Distribution Ready • Direct sales to physicians, clinics, hospitals led by VP of North American Sales, Account Managers, and Clinical Experts • Developing breast cancer cryoablation treatment guidelines and courses with professional medical societies for breast surgeons ( ASBrS ) and radiologists (SBI, SIO, SIR) • Exploring strategic partnerships • Economics & Reimbursement • CMS assigned CPT Category III** at approximately $3,800 for the facility fee alone • Post - market study procedures eligible for reimbursement • Additional coverage, including physician fee, is expected upon establishment of the permanent CPT Category I code 16 **CPT or Current Procedural Terminology is a medical code used by physicians, health insurance companies and accreditation or gan izations for reimbursement CPT Category I: The largest body of codes, consisting of those commonly used by providers to report their services and procedures. CPT® Category III: Temporary codes used to report emerging and experimental services and procedures. Source: https://www.aapc.com/resources/medical - coding/cpt.aspx#:~:text=CPT%C2%AE%20Category%20I%3A%20The,and%20experimental%20services%2 0and%20procedures ; Establishment of CPT Category I is conditioned on factors including the Company's receipt of FDA marketing authorization of ProS ense® for breast cancer ​ ​

 

 

Breast Cancer - Terumo Japan Agreement For >6 years ProSense ® has been sold through a Private Import License - now leveraging an agreement with Terumo to expand distribution and acquire PMDA approval Exclusive strategic distribution agreement with Terumo to accelerate commercialization of ProSense® in Japan $ 29.02 B 1 market cap $ 6.36 B 2 annual revenue 91,916 new breast cancer cases in Japan in 2022 3 • Total proceeds of $13.2M for the initial term x $ 5M for initial order and milestone - based payments x $ 4M received • Key terms: x Exclusive distribution of ProSense ® for breast cancer in Japan for 5 years post regulatory approval in Japan x Responsible for Japanese regulatory and reimbursement approvals x Terumo is expected to submit the request for breast cancer clearance to the Pharmaceuticals and Medical Devices Agency (PMDA) in H2 2025 1 As of June 5 2025; https://finance.yahoo.com/quote/4543.T/?guccounter=1 2 (TTM 3/31/2025); https://finance.yahoo.com/quote/4543.T/financials/ 3 392 - japan - fact - sheet.pdf 17

 

 

Interventional Radiology 18

 

 

Interventional Radiology Applications - Global Kidney Cancer Lung Cancer MSK * Cancer Liver Cancer Europe 1 : 718,898 Women's Health 1 – https://gco.iarc.who.int/media/globocan/factsheets/populations/908 - europe - fact - sheet.pdf 2 - https://gco.iarc.who.int/media/globocan/factsheets/populations/905 - northern - america - fact - sheet.pdf 3 - https://gco.iarc.who.int/media/globocan/factsheets/populations/76 - brazil - fact - sheet.pdf 4 - https://gco.iarc.who.int/media/globocan/factsheets/populations/392 - japan - fact - sheet.pdf 5 - https://gco.iarc.who.int/media/globocan/factsheets/populations/356 - india - fact - sheet.pdf 6 - https://gco.iarc.who.int/media/globocan/factsheets/populations/160 - china - fact - sheet.pdf 7 - https://www.who.int/news - room/fact - sheets/detail/endometriosis 8 - https://www.womenshealth.gov/a - z - topics/endometriosis - FDA Clearance for Gynecology 19 Cases of kidney, lung, & liver cancer by region: Brazil 3 : 68,902 India 5 : 137,931 Japan 4 : 199,318 China 6 : 1,501,897 North America 2** : 385,538 Independent clinical trials are investigating the use of cryoablation in the treatment of endometriosis, a condition that impacts 10% of women (190 million) 7 and 6.5 million 8 women in the U.S. *Musculoskeletal/bone lesions are generally not considered primary cancer and not included in many cancer statistics; in thes e c ases, cryoablation is used to treat metastasis and provide pain palliation ** Includes USA & Canada

 

 

Kidney Cancer 88.7% recurrence - free rate Endometriosis 92.8% avoid secondary surgery IceCure ’ s ICESECRET ProSense® Trial Interim Results: • Highly effective for kidney tumors < 3 cm and a safe procedure for kidney tumors < 5 cm in people ineligible for surgery • 88.7 % were recurrence free at mean follow - up of period of 3.4 years Independent Study with ProSense® • 92 % recurrence free at mean follow - up of period of 22.2 months • 100 % secondary control rate when recurrent lesions are cryoablated Independent Clinical Trial in Japan with ProSense®: • No recurrence in patients with tumor size up to 1.2 cm • 4% recurrence in patients with tumor size between 1.3 – 1.7cm • 33% recurrence in patients with tumor size larger than 1.8 cm Lung Cancer 77% - 100% recurrence - free rate ProSense® One of Two Systems Used in Independent Study: • Efficacy rate in avoiding secondary surgery was 92.8% per patient and 93.6% per nodule treated • Median pain - free survival rates were 93.75% at 6 months and 82.72% after 12 months, 24 months, and 36 months collectively Interventional Radiology: Expanding Product Line Clinical data demonstrates ProSense ® ’s impact on various other indications 20

 

 

IceCure ’ s Global Reach Available directly or through distributors in the following countries EMEA – France, Germany, Italy, Spain, Poland, Romania, Hungary, Turkey, South Africa, Israel Asia – China, Hong Kong, Japan, India LATAM – Brazil, Costa Rica North America – USA & Canada 21

 

 

Business Model – Revenue Generators Console related revenues x Sales of consoles x Consoles loaned for a minimum purchase of probes per month x Service & maintenance – recurring revenue x Accessories Probes and introducers x Recurring Revenue ProSense ® console sales/placement + consumable probe recurring revenues 22

 

 

Upcoming Milestones and Strategy • FDA Decision Expected after the FDA’s Center for Devices and Radiological Health (CDRH) approves IceCure’s Post - Market Study Plan • Terumo, IceCure's distributor in Japan, is expected to submit the request for breast cancer clearance to Japan's Pharmaceuticals and Medical Devices Agency in H2 2025 • Greater market traction expected in the rest of world, based on positive U.S. ICE3 results data reported • More publications expected from ongoing independent studies of ProSense® worldwide in 2025 • Increasing direct sales of ProSense® systems and disposable probes in U.S. led by VP of Sales North America and U.S. team • Growing number of distribution partnerships to drive sales in rest of world with numerous recent regulatory approvals • Next generation XSense Cryoablation System received FDA 510(K) clearance, soft launch expected Q1 2026; XSense commercialization may lead to use for new clinical indications ProSense ® gaining global recognition as the leading cryoablation system for minimally invasive procedures in a $2.4 billion tumor ablation market 23

 

 

Well - Positioned to Advance Commercialization of ProSense ® ICCM Ticker $1.03 Share Price (05/28/25) $60 M Market Cap (05/28/25) 58.6 M Shares Outstanding (05/28/25) 265 K Avg. Daily Trading Volume (05/28/25) $3.3 M 2024 Revenues $6.2 M Cash, Cash Equivalents, and Short - Term Deposits* (05/27/25) 24 Well - positioned for commercial, development, and regulatory advancements No outstanding warrants * I ncludes a $ 2 million unsecured bridge loan from Epoch Partner Investments Limited ("Epoch"), the Company's largest shareholder (the "Loan"). The Loan bears an interest rate equal to a 12 - month U.S. Treasury bond on May 17 , 2025 , to be repaid at the earlier of May 17 , 2026 or when the Company raises money in an equity transaction in which Epoch participates, other than through an at - the - market facility and/ or an equity line.

 

 

Proven Leadership Team Ronen Tsimerman, CFO and COO Nearly 20 years’ experience as a CFO of public and private companies Ron Mayron, Chairman of the Board Served for 20 years in several positions at Teva including as VP – Israel & Africa & CEO of Teva Israel Shay Levav, VP Clinical, Regulatory & QA Nearly 20 years’ experience in regulatory and quality assurance in the healthcare sector Tlalit Bussi Tel - Tzure , VP Global Business Development & Marketing Over 15 years’ experience in Sales, Biz Dev & Marketing in medical devices Naum Muchnick, VP R&D Nearly 20 years of experience in medical device design, engineering, and operations, including over 13 years with GE UltraSound Eyal Shamir, CEO Over 15 years as CEO of medical device companies (B - Cure Laser, Hanita Lenses etc.) Merav Nir Dotan, VP Human Resources Over 20 years of experience in human resources and organizational management Galit Bar Malik, VP Operations & Service Over 20 years of experience medical device operations Shad Good, VP Sales North America Nearly 20 years of medical device sales and leadership with experience in minimally invasive breast diagnostic and therapeutic systems 25

 

 

Thank You! 26 Eyal Shamir, CEO Ronen Tsimerman – CFO/COO E: investors@icecure - medical.com T: + 972 - 4 - 623 - 0333

 

 

Appendix Additional Resources 27

 

 

Interventional Radiology – U.S. Strategy FDA Approvals x General minimally - invasive cryoablation applications x Kidney cancer x Liver cancer Reimbursement x CPT I¹ approval and coverage for cryoablation of kidney, liver, lung & bone x CPT II¹ approval and coverage for cryoablation of bone cancer 28 1 CPT or Current Procedure Terminology is a medical code used by physicians, health insurance companies and accreditation organ iza tions. CPT Category I: The largest body of codes, consisting of those commonly used by providers to report their services and procedures. CPT Category II: Supplemental tracking codes used for performance management. Source: h ttp s://www.aapc.com/resources/medical - coding/cpt.aspx#:~:text=CPT%C 2 %AE% 20 Category% 20 I% 3 A% 20 The,and% 20 experimental% 20 services% 20 and% 20 procedures ​ * 2 American Cancer Society - https://www.cancer.org/cancer/types/liver - cancer/about/what - is - key - statistics.html 3 American Cancer Society - https://www.cancer.org/cancer/types/kidney - cancer/about/key - statistics.html - 2024 numbers 42K Liver cancer patients 2 82K Kidney cancer patients 3

 

 

ICE Secret Clinical Trial – Bnai Zion Medical Center, Israel 29 111 Patients Mean Follow Up 36 months 88.7% Recurrence - Free Rate ProSense® cryoablation is highly effective for kidney tumors < 3 cm and a safe procedure for kidney tumors < 5 cm in people ineligible for surgery 1. Shprits S et al. Poster presentation European Urology Association (EUA), 2019 . Safety, feasibility and oncologic efficacy of treatment for small renal masses using an innovative liquid nitrogen - based cryog enic device 2. ICESECRET study interim Press Release – March 24 , 2025 Cryoablation for patients with small renal masses (SRM) who cannot be offered kidney preserving surgery 117 Lesions

 

 

List of publications – Breast Cancer Country Publication Title # Japan Matsumoto K et al 2025 Post - treatment patient satisfaction in early - stage breast cancer: comparison of cryoablation versus breas t conservation therapy using BREAST - Q 1 Japan Matsumoto K et al 2024 CA as the primary treatment in a HER2 positive Stage IV BC patient - 5 years term FU case report 2 USA Fine et al 2024 Cryoablation Without Excision for Early - Stage Breast Cancer: ICE3 Trial 5 - Year Follow - Up on Ipsilateral Breast Tumor Recurrence 3 Spain Graña - López et al 2024 Acceptance and results of cryoablation for the treatment of early breast cancer in non - surgical patients 4 USA Oueidat K et al 2024 CA of Primary Breast Cancer in Patients Ineligible for Clinical Trials - A Multi - institutional Study 5 Germany Vogl et al 2024 CT - Guided Percutaneous Cryoablation of Breast Cancer 6 Japan Kawamoto H et al 2024 Percutaneous US guided Cryoablation for early - stage Breast Cancer 7 Hong Kong / Japan Kwong A, Co M, Fukuma E. 2023 Prospective Clinical Trial on Expanding Indications for Cryosurgery for Early Breast Cancers 8 USA Khan et al 2023 Cryoablation Allows the Ultimate De - escalation of Surgical Therapy for Select Breast Cancer Patients 9 Spain Graña - López L et al 2022 Cryoablation of breast lesions: our experience 10 Netherlands van de Voort et al 2021 Thermal Ablation - Alternative for Surgical Resection of Small (= or smaller 2 cm) BC - A Meta - Analysis 11 30

 

 

List of publications – Breast Cancer Country Publication Title # USA Fine et al 2021 - Cryoablation Without Excision - 3 - Year Interim ICE3 Trial 12 Japan Kawamoto et al 2021 - VAB +MRI Following Cryoablation for Primary Early - Stage Breast Cancer - Pilot Study 13 Japan Adaci et al 2020 - Fluorodeoxyglucose positron emission tomography findings after Cryoablation of early Breast Cancer 14 Japan Machida 2019 - MRI Findings After Cryoablation of Primary Breast Cancer Without Surgical Resection 15 31

 

 

List of publications – Fibroadenoma Country Publication Title # Spain de Bustamante Durbán et al 2024 Cryoablation - Our experience as an alternative to surgery for fibroadenoma 1 Spain Graña - López L et al 2022 Cryoablation of breast lesions - our experience 2 USA Sheth M et al 2019 - With Cryoablation Therapy for Fibroadenomas Molecular Science and Post - Therapy Imaging Follow UP 3 Germany Golatta et al 2015 - Ultrasound - guided Cryoablation of breast fibroadenoma_ a pilot trial 4 Czech Republic / Germany Hahn et al 2013 – Ultrasound Guided Cryoablation of Fibroadenoma 5 32

 

 

List of publications – Interventional Radiology Country Publication Title Indication Italy Aurilio G et al - 2023 Image - Guided Ablations in Patients with Recurrent Renal Cell Carcinoma Kidney France Moulin et al 2023 Single - Probe Percutaneous Cryoablation with Liquid Nitrogen Korea Shin et al 2019 Apoptotic cell clearance in the tumor microenvironment_ a potential cancer therapeutic target Israel Shprits et al 2019 Cryoablation - for - recurrent - renal - tumors Japan Nomori H et al 2022 - Cryoablation Using Liquid Nitrogen for Metastatic Lung Lung Japan Nomori H et al 2020 - Cryoablation for T1N0M0 non - small cell lung cancer using liquid nitrogen. European Journal of Radiology France Berte et al 2017 - A new cryoenergy for ventricular tachycardia ablation - a proof - of - concept study Japan Nomori H et al 2017 The cryoablation of lung tissue using liquid nitrogen in gel and in the ex vivo pig lung Germany Hübner et al. - 2020 - Evaluation of the thermal sensitivity of porcine liver in CT - guided cryoablation an initial study - annotated Liver Italy Orsi et al 2024 Liquid nitrogen - based cryoablation: complication rates for lung, bone, and soft tissue tumors cryoablation Multiple Indications USA Geevarghese R, et al 2024 Interventional Oncology - 2024 Update France Kammoun T et all 2022 Feasibility and Safety of Single - Probe Cryoablation with Liquid Nitrogen France, USA Najdawi M et al Cornelis FH 2023 Pain - Free Survival after Percutaneous Image - Guided Cryoablation of Extraperitoneal Endometriosis Endometriosis USA Alshebremi M et al 2023 Functional tumor cell - intrinsic STING drives antitumor immunity and therapy efficacy following Cryoablation Cryoimmunology 33

 

FAQ

When is the FDA expected to decide on IceCure Medical’s (ICCM) ProSense breast-cancer application?

A decision is anticipated after the FDA’s Center for Devices and Radiological Health approves the company’s post-market study plan.

What clinical results support ProSense® according to the FWP?

The ICE3 trial showed a 96.8 % local-recurrence-free rate over five years with no serious device-related adverse events.

Which territories have already cleared IceCure’s technology?

Regulatory approvals exist in the U.S., EU (CE mark), China, Brazil, India and nine additional countries.

What is the size of the addressable tumor-ablation market cited by ICCM?

Grand View Research projects the market to grow from US$1.0 bn in 2021 to US$2.4 bn by 2028.

Does IceCure have reimbursement for breast-tumor cryoablation?

A CPT Category III facility fee is established; a permanent CPT Category I code is expected but not yet granted.
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