IceCure Medical Secures FDA Approval for ProSense® in Low-Risk Breast Cancer, Targeting 200,000 Patients
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 12 2026
0mins
Should l Buy ICCM?
Source: PRnewswire
- FDA Approval Milestone: IceCure received FDA marketing authorization for ProSense® to treat low-risk breast cancer in women aged 70 and above, establishing it as the only on-label solution, which is expected to significantly enhance market acceptance and patient choice.
- Record Sales Performance: In 2025, IceCure achieved approximately $3.4 million in ProSense® sales in North America, marking a historic high that reflects surging market demand following FDA clearance, further solidifying the company's global commercial strategy.
- Increased Scientific Recognition: In 2025, IceCure achieved a record number of peer-reviewed publications and presentations at global conferences covering breast, musculoskeletal, and kidney cancer treatments, enhancing the clinical evidence base for ProSense® and supporting its application in other indications.
- Market Expansion Potential: ProSense® addresses an annual U.S. patient population of approximately 200,000 for breast cancer, particularly targeting 46,400 early-stage, low-risk patients aged 70 and above, indicating substantial market opportunities that are expected to drive future revenue growth and market share enhancement.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy ICCM?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on ICCM
Wall Street analysts forecast ICCM stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for ICCM is 3.00 USD with a low forecast of 3.00 USD and a high forecast of 3.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.551
Low
3.00
Averages
3.00
High
3.00
Current: 0.551
Low
3.00
Averages
3.00
High
3.00
About ICCM
Icecure Medical Ltd is an Israel-based company that is engaged in the healthcare sector. The Company operates as commercial stage medical device company focusing on the research, development and marketing of cryoablation systems, disposables and technologies based on liquid nitrogen, or LN2, for treating tumors. Cryoablation technology is a minimally invasive alternative to surgical intervention, for tumors, including those found in breast, lungs, kidneys, bones and other indications. Company's lead product is ProSense system, a single probe system, but in addition the Company developed an additional multi probe system that is expected to have the ability to freeze several tumors simultaneously or larger tumors, named MultiSense system, which has not yet been commercialized.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cryoablation Technology's Role in Breast Cancer Treatment
- Guideline Update: The American Society of Breast Surgeons (ASBrS) is updating its treatment guidelines for benign and malignant breast tumors to include cryoablation, marking a significant step towards widespread adoption of this technology in breast cancer treatment in the U.S.
- Clinical Evidence Support: The ICE3 trial demonstrated that only 3.1% of patients treated with cryoablation and endocrine therapy experienced local recurrence within five years, showcasing the method's efficacy and safety, potentially establishing it as a new standard of care.
- Significant Market Potential: The ProSense® system targets approximately 200,000 breast cancer patients annually, particularly low-risk patients aged 70 and above, and is expected to accelerate commercial adoption and expand reimbursement coverage, enhancing treatment options for patients.
- Accelerated Industry Recognition: ASBrS will be the first medical society to include cryoablation in its guidelines just three months after FDA approval, likely prompting more surgeons to recommend this minimally invasive treatment, thereby improving patient outcomes.
See More
Cryoablation Technology's Role in Breast Cancer Treatment
- Guideline Update: The American Society of Breast Surgeons (ASBrS) is set to include cryoablation in its updated guidelines, which is expected to encourage more surgeons to recommend this minimally invasive treatment option to suitable patients, thereby enhancing treatment choices for breast cancer.
- Clinical Trial Evidence: The ICE3 trial demonstrated that only 3.1% of patients treated with cryoablation and endocrine therapy experienced local recurrence within five years, indicating that this method offers efficacy and safety comparable to lumpectomy while providing excellent cosmetic results and patient satisfaction.
- Significant Market Potential: The ProSense® system addresses an annual patient population of approximately 200,000 women with breast cancer, particularly benefiting low-risk patients aged 70 and over, and its widespread clinical adoption is anticipated to accelerate commercial uptake and expand reimbursement coverage.
- Distinct Technical Advantages: ProSense® is the first FDA-approved device for treating low-risk breast cancer via cryoablation, which minimizes surgical risks and recovery times, enhancing value for both patients and providers, and facilitating fast, convenient office-based procedures.
See More
IceCure Medical Secures FDA Approval for ProSense® in Low-Risk Breast Cancer, Targeting 200,000 Patients
- FDA Approval Milestone: IceCure received FDA marketing authorization for ProSense® to treat low-risk breast cancer in women aged 70 and above, establishing it as the only on-label solution, which is expected to significantly enhance market acceptance and patient choice.
- Record Sales Performance: In 2025, IceCure achieved approximately $3.4 million in ProSense® sales in North America, marking a historic high that reflects surging market demand following FDA clearance, further solidifying the company's global commercial strategy.
- Increased Scientific Recognition: In 2025, IceCure achieved a record number of peer-reviewed publications and presentations at global conferences covering breast, musculoskeletal, and kidney cancer treatments, enhancing the clinical evidence base for ProSense® and supporting its application in other indications.
- Market Expansion Potential: ProSense® addresses an annual U.S. patient population of approximately 200,000 for breast cancer, particularly targeting 46,400 early-stage, low-risk patients aged 70 and above, indicating substantial market opportunities that are expected to drive future revenue growth and market share enhancement.
See More
IceCure Medical Expects Record Q4 Sales Surge in North America Following FDA Approval
- Sales Growth Expectation: IceCure Medical anticipates a significant increase in fourth-quarter sales in North America, with preliminary data suggesting record levels, reflecting strong market demand for the ProSense® system.
- FDA Authorization Impact: Following the FDA's October 2025 approval of ProSense® for low-risk breast cancer in women aged 70 and above, interest from hospitals and medical institutions has surged, driving rapid growth in the sales pipeline.
- Market Demand Drivers: IceCure's sales team is engaging with an increasing number of hospitals and physicians, particularly orders from globally top-ranked medical institutions, which are expected to further drive market demand and enhance the company's industry influence.
- Increased Media Exposure: ProSense® has received extensive coverage in various mainstream media and healthcare industry publications, enhancing public awareness of non-surgical treatment options, which may boost patient acceptance and demand for the technology.
See More
IceCure Medical Presents Four Studies Supporting Broader Adoption of ProSense® at RSNA 2025
- International Recognition: At RSNA 2025, IceCure Medical had four independent study abstracts accepted, showcasing the effectiveness of ProSense® in 263 patients, further promoting the widespread adoption of this technology in breast cancer treatment.
- Clinical Data Support: One study demonstrated a 100% success rate in treating luminal cancers under 2.5 cm using ultrasound-guided cryoablation, indicating a safe and effective alternative for patients ineligible for surgery.
- Significant Treatment Outcomes: Another study comparing cryoablation combined with hormonal therapy to standalone treatments revealed an impressive 83.3% tumor reduction in the combination group, highlighting the added value of cryoablation.
- Increased Interest Post-FDA Approval: Following the FDA's marketing approval of ProSense® for low-risk breast cancer, IceCure Medical has observed a sustained increase in interest in the technology, indicating significant potential for broader applications in non-surgical treatment options.
See More
IceCure Secures China Patent for Cryogen Flow Control, Enhancing Cryoablation Technology
- Patent Approval: IceCure has received a Notice of Allowance for a patent from the China National Intellectual Property Administration for its cryogen flow control technology related to the next-generation XSense™ cryoablation system, marking a total of 55 patents granted globally, which strengthens its market position.
- Technological Innovation: The new patent enhances the efficacy and tissue safety of cryoablation procedures through precise temperature control, utilizing sensor data to regulate cryogen flow, ensuring the desired temperature is maintained at the distal tip of catheters and probes, significantly improving treatment effectiveness.
- Market Prospects: The ProSense® Cryoablation System has received FDA marketing authorization for the local treatment of low-risk breast cancer, becoming the first medical device approved for women aged 70 and older, which is expected to drive market share growth in this segment.
- Global Expansion: IceCure's innovative technology has not only gained regulatory approval in China but also secured a patent in Japan, with applications pending in the European Union and the U.S., showcasing its potential for global market expansion and strategic significance.
See More
Cryoablation Technology's Role in Breast Cancer Treatment
- Guideline Update: The American Society of Breast Surgeons (ASBrS) is updating its treatment guidelines for benign and malignant breast tumors to include cryoablation, marking a significant step towards widespread adoption of this technology in breast cancer treatment in the U.S.
- Clinical Evidence Support: The ICE3 trial demonstrated that only 3.1% of patients treated with cryoablation and endocrine therapy experienced local recurrence within five years, showcasing the method's efficacy and safety, potentially establishing it as a new standard of care.
- Significant Market Potential: The ProSense® system targets approximately 200,000 breast cancer patients annually, particularly low-risk patients aged 70 and above, and is expected to accelerate commercial adoption and expand reimbursement coverage, enhancing treatment options for patients.
- Accelerated Industry Recognition: ASBrS will be the first medical society to include cryoablation in its guidelines just three months after FDA approval, likely prompting more surgeons to recommend this minimally invasive treatment, thereby improving patient outcomes.
See More
Cryoablation Technology's Role in Breast Cancer Treatment
- Guideline Update: The American Society of Breast Surgeons (ASBrS) is set to include cryoablation in its updated guidelines, which is expected to encourage more surgeons to recommend this minimally invasive treatment option to suitable patients, thereby enhancing treatment choices for breast cancer.
- Clinical Trial Evidence: The ICE3 trial demonstrated that only 3.1% of patients treated with cryoablation and endocrine therapy experienced local recurrence within five years, indicating that this method offers efficacy and safety comparable to lumpectomy while providing excellent cosmetic results and patient satisfaction.
- Significant Market Potential: The ProSense® system addresses an annual patient population of approximately 200,000 women with breast cancer, particularly benefiting low-risk patients aged 70 and over, and its widespread clinical adoption is anticipated to accelerate commercial uptake and expand reimbursement coverage.
- Distinct Technical Advantages: ProSense® is the first FDA-approved device for treating low-risk breast cancer via cryoablation, which minimizes surgical risks and recovery times, enhancing value for both patients and providers, and facilitating fast, convenient office-based procedures.
See More
IceCure Medical Secures FDA Approval for ProSense® in Low-Risk Breast Cancer, Targeting 200,000 Patients
- FDA Approval Milestone: IceCure received FDA marketing authorization for ProSense® to treat low-risk breast cancer in women aged 70 and above, establishing it as the only on-label solution, which is expected to significantly enhance market acceptance and patient choice.
- Record Sales Performance: In 2025, IceCure achieved approximately $3.4 million in ProSense® sales in North America, marking a historic high that reflects surging market demand following FDA clearance, further solidifying the company's global commercial strategy.
- Increased Scientific Recognition: In 2025, IceCure achieved a record number of peer-reviewed publications and presentations at global conferences covering breast, musculoskeletal, and kidney cancer treatments, enhancing the clinical evidence base for ProSense® and supporting its application in other indications.
- Market Expansion Potential: ProSense® addresses an annual U.S. patient population of approximately 200,000 for breast cancer, particularly targeting 46,400 early-stage, low-risk patients aged 70 and above, indicating substantial market opportunities that are expected to drive future revenue growth and market share enhancement.
See More
IceCure Medical Expects Record Q4 Sales Surge in North America Following FDA Approval
- Sales Growth Expectation: IceCure Medical anticipates a significant increase in fourth-quarter sales in North America, with preliminary data suggesting record levels, reflecting strong market demand for the ProSense® system.
- FDA Authorization Impact: Following the FDA's October 2025 approval of ProSense® for low-risk breast cancer in women aged 70 and above, interest from hospitals and medical institutions has surged, driving rapid growth in the sales pipeline.
- Market Demand Drivers: IceCure's sales team is engaging with an increasing number of hospitals and physicians, particularly orders from globally top-ranked medical institutions, which are expected to further drive market demand and enhance the company's industry influence.
- Increased Media Exposure: ProSense® has received extensive coverage in various mainstream media and healthcare industry publications, enhancing public awareness of non-surgical treatment options, which may boost patient acceptance and demand for the technology.
See More
IceCure Medical Presents Four Studies Supporting Broader Adoption of ProSense® at RSNA 2025
- International Recognition: At RSNA 2025, IceCure Medical had four independent study abstracts accepted, showcasing the effectiveness of ProSense® in 263 patients, further promoting the widespread adoption of this technology in breast cancer treatment.
- Clinical Data Support: One study demonstrated a 100% success rate in treating luminal cancers under 2.5 cm using ultrasound-guided cryoablation, indicating a safe and effective alternative for patients ineligible for surgery.
- Significant Treatment Outcomes: Another study comparing cryoablation combined with hormonal therapy to standalone treatments revealed an impressive 83.3% tumor reduction in the combination group, highlighting the added value of cryoablation.
- Increased Interest Post-FDA Approval: Following the FDA's marketing approval of ProSense® for low-risk breast cancer, IceCure Medical has observed a sustained increase in interest in the technology, indicating significant potential for broader applications in non-surgical treatment options.
See More
IceCure Secures China Patent for Cryogen Flow Control, Enhancing Cryoablation Technology
- Patent Approval: IceCure has received a Notice of Allowance for a patent from the China National Intellectual Property Administration for its cryogen flow control technology related to the next-generation XSense™ cryoablation system, marking a total of 55 patents granted globally, which strengthens its market position.
- Technological Innovation: The new patent enhances the efficacy and tissue safety of cryoablation procedures through precise temperature control, utilizing sensor data to regulate cryogen flow, ensuring the desired temperature is maintained at the distal tip of catheters and probes, significantly improving treatment effectiveness.
- Market Prospects: The ProSense® Cryoablation System has received FDA marketing authorization for the local treatment of low-risk breast cancer, becoming the first medical device approved for women aged 70 and older, which is expected to drive market share growth in this segment.
- Global Expansion: IceCure's innovative technology has not only gained regulatory approval in China but also secured a patent in Japan, with applications pending in the European Union and the U.S., showcasing its potential for global market expansion and strategic significance.
See More
