IceCure Submits Filing for Regulatory Approval of its Next-Generation XSense™ Cryoablation System in Israel
IceCure Medical (Nasdaq: ICCM) has submitted a regulatory approval filing to Israel's Ministry of Health for its next-generation XSense™ System and CryoProbes. The application covers multiple indications already approved for ProSense®, including general surgery, dermatology, neurology, thoracic surgery, ENT, gynecology, oncology, proctology, and urology.
The company has already secured FDA marketing authorization for the XSense™ System. The filing aligns with growing trends in surgical de-escalation and increasing adoption of minimally invasive cryoablation procedures. The global minimally invasive surgery market is projected to grow at a 17% CAGR between 2022-2029, reaching $174 billion by 2029.
IceCure Medical (Nasdaq: ICCM) ha presentato una richiesta di approvazione normativa al Ministero della Salute israeliano per il suo sistema di nuova generazione XSense™ e CryoProbes. La domanda copre molteplici indicazioni già approvate per ProSense®, tra cui chirurgia generale, dermatologia, neurologia, chirurgia toracica, Otorinolaringoiatria, ginecologia, oncologia, proctologia e urologia.
L'azienda ha già ottenuto l'autorizzazione al marketing dalla FDA per il sistema XSense™. La richiesta si allinea con le crescenti tendenze nella de-escalation chirurgica e l'aumento dell'adozione di procedure di crioblazione minimamente invasive. Si prevede che il mercato globale della chirurgia minimamente invasiva crescerà a un CAGR del 17% tra il 2022 e il 2029, raggiungendo 174 miliardi di dollari entro il 2029.
IceCure Medical (Nasdaq: ICCM) ha presentado una solicitud de aprobación regulatoria al Ministerio de Salud de Israel para su sistema de próxima generación XSense™ y CryoProbes. La solicitud abarca múltiples indicaciones ya aprobadas para ProSense®, incluyendo cirugía general, dermatología, neurología, cirugía torácica, otorrinolaringología, ginecología, oncología, proctología y urología.
La empresa ya ha obtenido la autorización de marketing de la FDA para el sistema XSense™. La solicitud se alinea con las crecientes tendencias en la desescalada quirúrgica y la creciente adopción de procedimientos de crioblasión mínimamente invasivos. Se proyecta que el mercado global de cirugía mínimamente invasiva crecerá a un CAGR del 17% entre 2022 y 2029, alcanzando 174 mil millones de dólares para 2029.
아이스큐어 메디컬 (Nasdaq: ICCM)은 이스라엘 보건부에 차세대 XSense™ 시스템과 크라이오프로브에 대한 규제 승인 신청서를 제출했습니다. 이 신청서는 ProSense®에 대해 이미 승인된 여러 적응증을 포함하며, 일반 외과, 피부과, 신경과, 흉부 외과, 이비인후과, 부인과, 종양학, 항문학 및 비뇨기과를 포함합니다.
회사는 이미 XSense™ 시스템에 대해 FDA 마케팅 승인을 확보했습니다. 이 신청서는 외과적 단계 축소 및 최소 침습적 냉동 절제술의 채택 증가라는 성장하는 트렌드와 일치합니다. 글로벌 최소 침습 수술 시장은 2022년부터 2029년까지 17%의 CAGR로 성장할 것으로 예상되며, 2029년까지 1,740억 달러에 이를 것으로 보입니다.
IceCure Medical (Nasdaq: ICCM) a soumis une demande d'approbation réglementaire au ministère de la Santé israélien pour son système de nouvelle génération XSense™ et CryoProbes. La demande couvre plusieurs indications déjà approuvées pour ProSense®, y compris la chirurgie générale, la dermatologie, la neurologie, la chirurgie thoracique, l'ORL, la gynécologie, l'oncologie, la proctologie et l'urologie.
L'entreprise a déjà obtenu l'autorisation de mise sur le marché de la FDA pour le système XSense™. La demande s'inscrit dans les tendances croissantes de désescalade chirurgicale et l'adoption accrue de procédures de cryoablation minimales. Le marché mondial de la chirurgie minimalement invasive devrait croître à un TCAC de 17% entre 2022 et 2029, atteignant 174 milliards de dollars d'ici 2029.
IceCure Medical (Nasdaq: ICCM) hat einen Antrag auf behördliche Genehmigung beim israelischen Gesundheitsministerium für sein nächstgeneration XSense™ System und CryoProbes eingereicht. Der Antrag umfasst mehrere Indikationen, die bereits für ProSense® genehmigt sind, darunter Allgemeinchirurgie, Dermatologie, Neurologie, Thoraxchirurgie, HNO, Gynäkologie, Onkologie, Proktologie und Urologie.
Das Unternehmen hat bereits die FDA-Marketinggenehmigung für das XSense™ System erhalten. Der Antrag steht im Einklang mit den wachsenden Trends zur chirurgischen Deeskalation und der zunehmenden Akzeptanz minimalinvasiver Kryoablationstechniken. Der globale Markt für minimalinvasive Chirurgie wird voraussichtlich von 2022 bis 2029 mit einer CAGR von 17% wachsen und bis 2029 174 Milliarden Dollar erreichen.
- FDA marketing authorization already secured for XSense™ System
- Broad range of approved indications covering multiple medical specialties
- Operating in a market projected to reach $174 billion by 2029 with 17% CAGR
- None.
Insights
The regulatory submission for XSense™ in Israel marks a significant milestone in IceCure's market expansion strategy, building upon their existing FDA approval. This next-generation single cryoprobe system represents an evolution in their technology portfolio, potentially offering improved operational efficiency and clinical outcomes across multiple specialties.
The filing's scope is particularly noteworthy, encompassing nine distinct medical specialties including oncology, general surgery, and specialized procedures. This broad-spectrum approach is strategically important for three reasons:
- It maximizes the potential revenue streams across different medical departments and healthcare settings
- It reduces dependency on any single medical specialty, creating a more resilient business model
- It positions IceCure to capture a larger share of the rapidly growing minimally invasive surgery market
The timing of this filing is particularly strategic, coinciding with the global healthcare trend toward minimally invasive procedures. With the market projected to reach
The regulatory process in Israel typically serves as a valuable reference point for other international markets, particularly in the Middle East and parts of Asia. A successful approval could accelerate regulatory pathways in other jurisdictions, potentially creating a domino effect for market access. The company's existing FDA approval for XSense™ provides a strong foundation for regulatory confidence, potentially expediting the Israeli approval process.
From a commercial perspective, the expansion of IceCure's product portfolio with XSense™ could drive market penetration through two key mechanisms: offering healthcare providers more options within their cryoablation platform and potentially capturing new market segments that may have specific requirements not met by their current ProSense® system.
Application covering a wide range of indications is in line with trends in de-escalation of surgery and growth in minimally invasive cryoablation procedures, pointing to strong potential for increasing demand
The filing contains a request for approval of all indications for which ProSense® has already received approval in
"As a leader in liquid-nitrogen based cryoablation technologies, we continue to innovate and bring to market healthcare advancements that support the global move toward de-escalation of surgery and the substantial increase in minimally invasive surgery procedures," stated IceCure's Chief Executive Officer, Eyal Shamir. "While de-escalation of surgery is a trend specific to the treatment of breast cancer, we see growing opportunities for our cryoablation systems to offer minimally invasive solutions in a wide range and expanding number of indications. We are optimistic about receiving regulatory clearance for XSense™ in
The global minimally invasive surgery market is forecast to grow by a CAGR of
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 Company's view that opportunities for its cryoablation systems are growing in a wide range and expanding number of indications; the impending decision on regulatory clearance for XSense™ in
IR Contact:
Email: investors@icecure-medical.com
Michael Polyviou
Phone: 732-232-6914
Todd Kehrli
Phone: 310-625-4462
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SOURCE IceCure Medical
FAQ
What indications is IceCure (ICCM) seeking approval for with XSense™ in Israel?
Has the XSense™ System received FDA approval?
What is the projected growth rate of the minimally invasive surgery market through 2029?
When does IceCure (ICCM) expect to receive Israeli regulatory approval for XSense™?
