Icecure Medical Ltd. Stock Price, News & Analysis

IceCure Medical Ltd. (Nasdaq: ICCM) is a commercial-stage medical device company in the surgical and medical instrument manufacturing industry. According to the company, it develops and markets advanced liquid-nitrogen-based cryoablation therapy systems designed to destroy benign and cancerous tumors by freezing them as a minimally invasive option to surgical tumor removal. IceCure’s primary focus areas include breast, kidney, bone, and lung cancer, and its technology is intended to be performed in relatively short procedures.

The company’s flagship product is the ProSense® Cryoablation System. ProSense® is described as a minimally invasive cryosurgical tool that uses liquid nitrogen (LN2) to create large lethal zones for tumor destruction in benign and malignant lesions. The system is used in tissues such as the breast, kidney, lung, liver, and musculoskeletal (bone), including palliative interventions. IceCure states that ProSense® enhances value for patients and providers by accelerating recovery and reducing pain, surgical risks, and complications. Its design and use of liquid nitrogen are described as enabling fast and convenient office-based procedures for breast tumors.

Business focus and technology

IceCure positions its cryoablation technology as a minimally invasive alternative to hospital-based surgical tumor removal. The company emphasizes liquid-nitrogen-based systems and single-probe cryoablation platforms. ProSense® is marketed and sold worldwide for indications cleared and approved to date, including in the U.S., Europe, and Asia. IceCure also highlights a next-generation cryoablation platform called XSense™, which is described as a next-generation liquid-nitrogen-based system intended to further improve patient outcomes.

The company reports that its intellectual property portfolio in cryoablation includes patents granted and allowed across multiple jurisdictions. For example, IceCure announced a Notice of Allowance in China for a patent titled "Cryogen Flow Control" related to its next-generation XSense™ cryoablation system and probes, and notes that a patent for this invention has been granted in Japan and is pending in the European Union, the U.S., and other markets. The company states that this cryogen flow control technology is designed to regulate cryogen flow using sensor data to achieve precise temperature control at the distal tip of catheters and probes, which it describes as important for efficacy and tissue safety in cryoablation procedures.

Regulatory milestones and indications

IceCure reports several regulatory achievements for ProSense® and its cryoablation systems. In the U.S., the company states that the U.S. Food and Drug Administration (FDA) granted marketing authorization for the ProSense® cryoablation system for the local treatment of low-risk breast cancer in women aged 70 and above with adjuvant endocrine therapy, including patients who are not candidates for breast cancer surgery. The company describes ProSense® as the first and only medical device to receive FDA marketing authorization for the local treatment of breast cancer under this indication.

IceCure also reports that ProSense® and its cryoprobes have received regulatory approval in Switzerland for the treatment of malignant or benign tissue of the breast, lung, liver, kidney, and musculoskeletal (bone), including palliative interventions. The company notes that these indications are the same as those for which ProSense® is approved in the European Union. In Israel, IceCure states that the next-generation XSense™ cryoablation system has received regulatory approval for breast cancer and other indications.

Clinical evidence and medical community engagement

IceCure highlights a growing body of independent clinical data generated by investigators using its cryoablation systems. The company reports that independent studies and peer-reviewed publications have evaluated ProSense® in breast, musculoskeletal, kidney, and lung cancers, as well as in abdominal wall endometriosis. For example, IceCure cites studies indicating successful treatment of non-small cell lung cancer (NSCLC) when its cryoablation system is combined with radiation therapy, and studies reporting substantial pain reduction and high procedural efficacy in abdominal wall endometriosis treated with ProSense®.

The company also notes that ProSense® has been featured in multiple abstracts and presentations at major medical conferences, including the Radiological Society of North America (RSNA) Annual Meeting, the Cardiovascular and Interventional Radiology Society of Europe (CIRSE) Annual Meeting, the European Society of Breast Imaging (EUSOBI) Congress, and the Japanese Breast Cancer Society Conference. According to IceCure, these independent studies and conference presentations cover topics such as ultrasound-guided cryoablation for breast cancer in non-surgical patients, comparisons of cryoablation with hormonal therapy versus hormonal therapy alone, imaging assessment of cryoablation outcomes, and use of cryoablation in specific breast cancer subtypes.

Commercial activity and geographic reach

IceCure states that it is a commercial-stage company with ProSense® systems marketed and sold worldwide for approved indications, including in the U.S., Europe, and Asia. The company reports growing adoption of ProSense® cryoablation for breast cancer in key European markets and describes record sales in Europe associated with increased clinical use. In North America, IceCure has reported record quarterly ProSense® sales following FDA marketing authorization for low-risk breast cancer and notes that ProSense® systems are being sold and installed at new locations, including at highly regarded medical institutions in the United States.

The company also references commercial activities involving distributors, such as a partner in Japan expected to submit regulatory requests for breast cancer indications. IceCure describes engagement with hospitals, clinics, breast surgeons, and interventional radiologists who are evaluating ProSense® and, in some cases, placing orders. The company has also reported that ProSense® has been featured in mainstream media, healthcare trade publications, and consumer healthcare news outlets, which it associates with patient-driven interest in non-surgical treatment options.

Regulatory filings and public company status

IceCure Medical Ltd. is a foreign private issuer that files reports with the U.S. Securities and Exchange Commission (SEC), including current reports on Form 6-K and annual reports on Form 20-F. The company’s Form 6-K filings often incorporate press releases related to regulatory milestones, clinical data, commercial updates, and financial results by reference into its registration statements on Form F-3 and Form S-8.

IceCure has disclosed that its ordinary shares trade on the Nasdaq Capital Market under the symbol "ICCM." In a Form 6-K, the company reported receiving a Nasdaq notice regarding non-compliance with the minimum bid price requirement and outlined the standard grace period and potential extended compliance period under Nasdaq rules. The company stated that the notice had no immediate effect on the listing or trading of its shares and that it intended to monitor the closing bid price and consider options to regain compliance, indicating that continued Nasdaq listing is a priority.

Product portfolio and development

According to IceCure, its product portfolio centers on liquid-nitrogen-based cryoablation systems and associated probes. ProSense® is described as a single-probe LN2-based cryoablation technology used in interventional oncology, particularly for breast cancer, but also for other tumor types where regulatory approvals exist. The company’s next-generation system, XSense™, is referenced as part of its platform evolution, with regulatory and intellectual property milestones reported in several jurisdictions.

IceCure also emphasizes ongoing clinical and post-market activities. For example, the company has described a planned post-market study protocol for ProSense® in the U.S. involving multiple sites and patients, to run in parallel with commercial rollout under the authorized breast cancer indication. The company notes that existing reimbursement codes may be used to support claims and reimbursement for study procedures and that it expects further publications from independent studies of ProSense® worldwide.

Industry context based on company statements

Within the surgical and medical instrument manufacturing sector, IceCure characterizes its technology as part of minimally invasive interventional oncology and tumor management. The company repeatedly describes its cryoablation systems as providing an option to surgical tumor removal, with potential benefits such as shorter procedures, reduced pain, and fewer complications relative to surgery, based on reported clinical experience and independent studies. IceCure’s communications emphasize the role of cryoablation in what it terms "de-escalation" of breast cancer care, referencing clinical trials and conference presentations that explore cryoablation as an alternative to more invasive surgical approaches in selected patient populations.

FAQs about IceCure Medical Ltd. (ICCM)

• What does IceCure Medical Ltd. do?
  IceCure Medical develops and markets liquid-nitrogen-based cryoablation therapy systems that destroy benign and cancerous tumors by freezing them. The company describes its technology as a minimally invasive option to surgical tumor removal, with primary focus areas including breast, kidney, bone, and lung cancer.
• What is the ProSense® Cryoablation System?
  ProSense® is IceCure’s flagship cryoablation system. It is a minimally invasive cryosurgical tool that uses liquid nitrogen to create large lethal zones for tumor destruction in benign and malignant lesions, including in the breast, kidney, lung, and liver. The company states that ProSense® is marketed and sold worldwide for indications cleared and approved to date.
• For which breast cancer indication has ProSense® received FDA marketing authorization?
  IceCure reports that the FDA granted marketing authorization for ProSense® for the local treatment of low-risk breast cancer with adjuvant endocrine therapy in women aged 70 and above, including patients who are not suitable for surgical alternatives for breast cancer treatment. The company describes ProSense® as the first and only medical device to receive FDA marketing authorization for the local treatment of breast cancer under this indication.
• In which regions is ProSense® approved or marketed?
  According to IceCure, ProSense® is marketed and sold worldwide for indications cleared and approved to date, including in the U.S., Europe, and Asia. The company also reports regulatory approval in Switzerland for the treatment of malignant or benign tissue of the breast, lung, liver, kidney, and musculoskeletal (bone), including palliative interventions.
• What is XSense™?
  XSense™ is described by IceCure as its next-generation liquid-nitrogen-based cryoablation system. The company reports regulatory approval for XSense™ in Israel for breast cancer and other indications and notes that patents related to XSense™ and its probes, including cryogen flow control technology, have been granted or allowed in certain jurisdictions.
• How does IceCure describe the benefits of its cryoablation systems?
  IceCure states that its cryoablation systems provide a minimally invasive option to destroy tumors by freezing them, with potential benefits such as accelerated recovery, reduced pain, and lower surgical risks and complications. The company also notes that ProSense®’s design and use of liquid nitrogen allow for office-based procedures for breast tumors in appropriate settings.
• What types of clinical evidence support IceCure’s technology?
  The company cites multiple independent studies and peer-reviewed publications involving ProSense® and its cryoablation system in indications such as breast cancer, lung cancer, kidney cancer, musculoskeletal tumors, and abdominal wall endometriosis. IceCure reports that these studies have been presented at major conferences, including RSNA, CIRSE, EUSOBI, and the Japanese Breast Cancer Society Conference.
• Is IceCure Medical Ltd. publicly traded?
  Yes. IceCure states that its ordinary shares trade on the Nasdaq Capital Market under the ticker symbol "ICCM." As a foreign private issuer, the company files reports with the U.S. Securities and Exchange Commission, including Form 6-K current reports and Form 20-F annual reports.
• Has IceCure disclosed any Nasdaq listing compliance issues?
  In a Form 6-K, IceCure reported receiving a notice from Nasdaq indicating that the company was not in compliance with the minimum bid price requirement for continued listing. The company stated that it was granted a 180-day period to regain compliance, that the notice had no immediate effect on its listing, and that it intended to monitor the closing bid price and consider options to cure the deficiency.
• What tumor types does IceCure focus on?
  IceCure states that its primary focus areas are breast, kidney, bone, and lung cancer. The company also reports use of its cryoablation system in other indications, such as liver lesions and abdominal wall endometriosis, where regulatory approvals or clinical studies support such use.