IceCure Receives FDA Approval for ProSense® Post-Market Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 18 hours ago
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Should l Buy ICCM?
Source: PRnewswire
- FDA Study Approval: IceCure's ProSense® has received FDA approval for a post-market study following its marketing authorization in 2025, with patient enrollment expected to begin in the second half of 2026, aiming to recruit at least 80 patients in the first year and approximately 400 patients across 30 clinical sites within 36 months, thereby providing a new treatment option for low-risk breast cancer patients.
- Commercial Expansion Opportunity: Participating clinical sites will not only enroll patients but also serve as active commercial sites offering ProSense® cryoablation to patients outside the study, which will support IceCure's commercial expansion and enhance market penetration.
- Reimbursement Mechanism Support: Study procedures are eligible for reimbursement under the established CPT Category III code, providing approximately $4,000 for facility fees, which offers potential reimbursement support for IceCure's study procedures and is expected to facilitate further development in the breast cancer treatment sector.
- Expert Collaboration: IceCure is collaborating with leading experts in breast cancer treatment, Dr. Robert Ward and Dr. Nathalie Johnson, who will serve as Co-Principal Investigators of the study, enhancing the study's credibility and clinical acceptance, further driving market recognition of ProSense®.
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Analyst Views on ICCM
Wall Street analysts forecast ICCM stock price to rise
1 Analyst Rating
1 Buy
0 Hold
0 Sell
Moderate Buy
Current: 0.615
Low
3.00
Averages
3.00
High
3.00
Current: 0.615
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.
IceCure Receives FDA Approval for ProSense® Post-Market Study
- FDA Study Approval: IceCure's ProSense® has received FDA approval for a post-market study following its marketing authorization in 2025, with patient enrollment expected to begin in the second half of 2026, aiming to recruit at least 80 patients in the first year and approximately 400 patients across 30 clinical sites within 36 months, thereby providing a new treatment option for low-risk breast cancer patients.
- Commercial Expansion Opportunity: Participating clinical sites will not only enroll patients but also serve as active commercial sites offering ProSense® cryoablation to patients outside the study, which will support IceCure's commercial expansion and enhance market penetration.
- Reimbursement Mechanism Support: Study procedures are eligible for reimbursement under the established CPT Category III code, providing approximately $4,000 for facility fees, which offers potential reimbursement support for IceCure's study procedures and is expected to facilitate further development in the breast cancer treatment sector.
- Expert Collaboration: IceCure is collaborating with leading experts in breast cancer treatment, Dr. Robert Ward and Dr. Nathalie Johnson, who will serve as Co-Principal Investigators of the study, enhancing the study's credibility and clinical acceptance, further driving market recognition of ProSense®.
See More
IceCure Receives FDA Approval for New Study
- FDA Study Approval: IceCure Medical Ltd. announced that its ProSense cryoablation system has received FDA approval for a post-marketing study named 'ChoICE', aimed at evaluating its use in low-risk breast cancer patients, marking a significant advancement in the company's treatment offerings.
- Market Authorization Milestone: In October 2025, the FDA granted full marketing authorization for the ProSense cryoablation system, making it the first cryoablation device approved for breast cancer treatment in the U.S., highlighting the technology's market potential.
- Research Goals and Impact: The newly approved ChoICE study will collect real-world data on safety and effectiveness in U.S. patients, focusing on women with low-risk breast cancer, aiming to demonstrate that cryoablation can be a reliable, less invasive treatment option compared to traditional surgery.
- Patient-Friendly Treatment: The ProSense cryoablation technology uses extreme cold to freeze and destroy cancerous tissue without surgical removal, performed as an outpatient procedure under local anesthesia, significantly reducing hospitalization and recovery times while enhancing patient treatment experiences.
See More
IceCure Medical to Announce 2025 Financial Results
- Financial Results Announcement: IceCure Medical plans to release its financial and operational results for the year ended December 31, 2025, before the Nasdaq opens on March 17, 2026, which is expected to provide investors with critical performance data to assess the company's growth.
- Conference Call Details: The company will hold a conference call at 11:00 a.m. EDT on the same day to discuss the financial results and other corporate developments, enhancing communication with investors and improving market transparency.
- Technological Background: IceCure focuses on developing liquid nitrogen-based cryoablation technology aimed at providing safe and effective treatment options for tumors such as breast, kidney, bone, and lung cancer, showcasing its innovative capabilities in tumor treatment.
- Market Outlook: With the increasing demand for minimally invasive procedures, the global marketing of IceCure's ProSense® system will help the company capture a larger share in the competitive medical device market.
See More
IceCure Medical to Announce 2025 Financial Results
- Financial Results Announcement: IceCure Medical plans to release its financial and operational results for the year ended December 31, 2025, before the Nasdaq opens on March 17, 2026, which is expected to provide investors with key performance metrics and future outlook.
- Conference Call Details: The company will hold a conference call at 11:00 a.m. EDT on the same day to discuss the financial results and other corporate developments, enhancing communication with investors and increasing market transparency.
- Technological Background: IceCure focuses on developing liquid nitrogen-based cryoablation technology, offering a safe and effective treatment option for tumors, primarily targeting breast, kidney, bone, and lung cancers, indicating significant market potential.
- Market Strategy: By globally marketing its flagship ProSense® system, IceCure aims to expand its market share in tumor treatment while addressing legal and regulatory challenges to ensure sustained growth.
See More
IceCure's ProSense® Receives ASBrS Endorsement for Low-Risk Breast Cancer
- FDA Approval Impact: IceCure's ProSense® received FDA clearance in October 2025 as the first device for treating low-risk breast cancer in patients aged 70 and above, which is expected to significantly enhance market acceptance and solidify the company's leadership in breast cancer treatment.
- ASBrS Guideline Update: The American Society of Breast Surgeons' updated 2026 Resource Guide recommends cryoablation for low-risk early-stage breast cancer patients, further validating ProSense®'s role in modern breast cancer care and likely accelerating clinical adoption.
- Significant Market Potential: According to the American Cancer Society, ProSense® addresses an annual patient population of approximately 200,000 for breast cryoablation, including about 47,245 low-risk breast cancer patients aged 70 and over, indicating substantial market demand and growth potential.
- Commercial Promotion Outlook: IceCure executives noted that the ASBrS's new guidelines will raise awareness and confidence in cryoablation among patients and surgeons, and combined with the existing CPT III reimbursement code, are expected to accelerate the commercial adoption and increase procedure volumes for ProSense®.
See More
IceCure's ProSense® Gains ASBrS Endorsement for Low-Risk Breast Cancer
- FDA Approval Impact: IceCure's ProSense® received FDA clearance in October 2025 as the first device for treating low-risk breast cancer in patients aged 70 and above, which is expected to significantly enhance market acceptance and patient choice.
- ASBrS Guideline Update: The American Society of Breast Surgeons' updated 2026 Resource Guide recommends cryoablation as a treatment option for low-risk early-stage breast cancer patients, further validating ProSense®'s role in modern breast cancer care.
- Significant Market Potential: According to the American Cancer Society, ProSense® addresses an annual patient population of approximately 200,000 for breast cryoablation, including around 47,245 early-stage, low-risk breast cancer patients aged 70 and over, indicating substantial market demand.
- Accelerated Commercial Promotion: IceCure anticipates that the new ASBrS guidelines will boost awareness and confidence in cryoablation among patients and surgeons, thereby accelerating the commercial adoption and procedure volumes of ProSense®, driving future revenue growth for the company.
See More
IceCure Receives FDA Approval for ProSense® Post-Market Study
- FDA Study Approval: IceCure's ProSense® has received FDA approval for a post-market study following its marketing authorization in 2025, with patient enrollment expected to begin in the second half of 2026, aiming to recruit at least 80 patients in the first year and approximately 400 patients across 30 clinical sites within 36 months, thereby providing a new treatment option for low-risk breast cancer patients.
- Commercial Expansion Opportunity: Participating clinical sites will not only enroll patients but also serve as active commercial sites offering ProSense® cryoablation to patients outside the study, which will support IceCure's commercial expansion and enhance market penetration.
- Reimbursement Mechanism Support: Study procedures are eligible for reimbursement under the established CPT Category III code, providing approximately $4,000 for facility fees, which offers potential reimbursement support for IceCure's study procedures and is expected to facilitate further development in the breast cancer treatment sector.
- Expert Collaboration: IceCure is collaborating with leading experts in breast cancer treatment, Dr. Robert Ward and Dr. Nathalie Johnson, who will serve as Co-Principal Investigators of the study, enhancing the study's credibility and clinical acceptance, further driving market recognition of ProSense®.
See More
IceCure Receives FDA Approval for New Study
- FDA Study Approval: IceCure Medical Ltd. announced that its ProSense cryoablation system has received FDA approval for a post-marketing study named 'ChoICE', aimed at evaluating its use in low-risk breast cancer patients, marking a significant advancement in the company's treatment offerings.
- Market Authorization Milestone: In October 2025, the FDA granted full marketing authorization for the ProSense cryoablation system, making it the first cryoablation device approved for breast cancer treatment in the U.S., highlighting the technology's market potential.
- Research Goals and Impact: The newly approved ChoICE study will collect real-world data on safety and effectiveness in U.S. patients, focusing on women with low-risk breast cancer, aiming to demonstrate that cryoablation can be a reliable, less invasive treatment option compared to traditional surgery.
- Patient-Friendly Treatment: The ProSense cryoablation technology uses extreme cold to freeze and destroy cancerous tissue without surgical removal, performed as an outpatient procedure under local anesthesia, significantly reducing hospitalization and recovery times while enhancing patient treatment experiences.
See More
IceCure Medical to Announce 2025 Financial Results
- Financial Results Announcement: IceCure Medical plans to release its financial and operational results for the year ended December 31, 2025, before the Nasdaq opens on March 17, 2026, which is expected to provide investors with critical performance data to assess the company's growth.
- Conference Call Details: The company will hold a conference call at 11:00 a.m. EDT on the same day to discuss the financial results and other corporate developments, enhancing communication with investors and improving market transparency.
- Technological Background: IceCure focuses on developing liquid nitrogen-based cryoablation technology aimed at providing safe and effective treatment options for tumors such as breast, kidney, bone, and lung cancer, showcasing its innovative capabilities in tumor treatment.
- Market Outlook: With the increasing demand for minimally invasive procedures, the global marketing of IceCure's ProSense® system will help the company capture a larger share in the competitive medical device market.
See More
IceCure Medical to Announce 2025 Financial Results
- Financial Results Announcement: IceCure Medical plans to release its financial and operational results for the year ended December 31, 2025, before the Nasdaq opens on March 17, 2026, which is expected to provide investors with key performance metrics and future outlook.
- Conference Call Details: The company will hold a conference call at 11:00 a.m. EDT on the same day to discuss the financial results and other corporate developments, enhancing communication with investors and increasing market transparency.
- Technological Background: IceCure focuses on developing liquid nitrogen-based cryoablation technology, offering a safe and effective treatment option for tumors, primarily targeting breast, kidney, bone, and lung cancers, indicating significant market potential.
- Market Strategy: By globally marketing its flagship ProSense® system, IceCure aims to expand its market share in tumor treatment while addressing legal and regulatory challenges to ensure sustained growth.
See More
IceCure's ProSense® Receives ASBrS Endorsement for Low-Risk Breast Cancer
- FDA Approval Impact: IceCure's ProSense® received FDA clearance in October 2025 as the first device for treating low-risk breast cancer in patients aged 70 and above, which is expected to significantly enhance market acceptance and solidify the company's leadership in breast cancer treatment.
- ASBrS Guideline Update: The American Society of Breast Surgeons' updated 2026 Resource Guide recommends cryoablation for low-risk early-stage breast cancer patients, further validating ProSense®'s role in modern breast cancer care and likely accelerating clinical adoption.
- Significant Market Potential: According to the American Cancer Society, ProSense® addresses an annual patient population of approximately 200,000 for breast cryoablation, including about 47,245 low-risk breast cancer patients aged 70 and over, indicating substantial market demand and growth potential.
- Commercial Promotion Outlook: IceCure executives noted that the ASBrS's new guidelines will raise awareness and confidence in cryoablation among patients and surgeons, and combined with the existing CPT III reimbursement code, are expected to accelerate the commercial adoption and increase procedure volumes for ProSense®.
See More
IceCure's ProSense® Gains ASBrS Endorsement for Low-Risk Breast Cancer
- FDA Approval Impact: IceCure's ProSense® received FDA clearance in October 2025 as the first device for treating low-risk breast cancer in patients aged 70 and above, which is expected to significantly enhance market acceptance and patient choice.
- ASBrS Guideline Update: The American Society of Breast Surgeons' updated 2026 Resource Guide recommends cryoablation as a treatment option for low-risk early-stage breast cancer patients, further validating ProSense®'s role in modern breast cancer care.
- Significant Market Potential: According to the American Cancer Society, ProSense® addresses an annual patient population of approximately 200,000 for breast cryoablation, including around 47,245 early-stage, low-risk breast cancer patients aged 70 and over, indicating substantial market demand.
- Accelerated Commercial Promotion: IceCure anticipates that the new ASBrS guidelines will boost awareness and confidence in cryoablation among patients and surgeons, thereby accelerating the commercial adoption and procedure volumes of ProSense®, driving future revenue growth for the company.
See More
