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ICCM Shares Rise as FDA Clears ProSense for Breast Cancer Treatment
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Key Takeaways
ICCM gains FDA authorization to market ProSense for low-risk breast cancer in U.S. women aged 70 .
The approval, backed by ICE3 trial data, validates ICCM's ProSense as a minimally invasive alternative.
ICCM's clearance opens U.S. sales, strengthens market edge, and supports faster revenue and adoption growth.
IceCure Medical (ICCM - Free Report) recently received FDA marketing authorization for its ProSense cryoablation system, marking the first approval for a minimally invasive treatment of low-risk breast cancer in women aged 70 and above. The clearance positions ProSense as a potential alternative to lumpectomy, offering a simpler, outpatient procedure with faster recovery and fewer complications.
This milestone not only opens commercial opportunities in the United States but also validates IceCure’s leadership in cryoablation technology. With growing physician enthusiasm and an established reimbursement pathway, the company is well-positioned to accelerate adoption and strengthen its foothold in the global oncology care market.
Likely Trend of the ICCM Stock Following the News
Following the announcement, shares of the company have risen 12% in the after-market session on Friday. However, in the year-to-date period, ICCM’s shares have lost 12.4% against the industry’s 5.2% growth. The S&P 500 gained 15.2% in the same time frame.
The FDA marketing authorization for ProSense significantly boosts IceCure’s commercial outlook by unlocking access to the U.S. breast cancer treatment market. This approval establishes a strong competitive moat, as rivals now face higher clinical data requirements for entry. With initial reimbursement already in place and plans for broader coverage ahead, IceCure is poised to accelerate revenue growth, strengthen U.S. market penetration, and drive long-term value creation through increased physician adoption and expanding indications across oncology.
Meanwhile, ICCM currently has a market capitalization of $66.2 million. The company expects an earnings growth of 26.7% in 2025.
Image Source: Zacks Investment Research
More on the News
The FDA’s marketing authorization allows ICCM to immediately commence commercial sales of its ProSense cryoablation system in the United States for the treatment of low-risk breast cancer in women aged 70 and above. The approval follows a successful De Novo application and applies to a specific patient population, those with biologically low-risk tumors measuring up to 1.5 cm who are also receiving adjuvant endocrine therapy. Importantly, the indication includes patients who are not suitable candidates for surgery, expanding treatment options for a group that previously relied solely on surgical procedures such as lumpectomy.
This authorization was supported by robust clinical data from IceCure’s ICE3 trial, the largest multi-center study ever conducted for liquid-nitrogen-based cryoablation in early-stage breast cancer. The results demonstrated outcomes comparable to those of traditional surgical removal in terms of recurrence-free rates and safety, while offering the benefits of a quicker, minimally invasive, outpatient procedure. Following FDA feedback, IceCure is likely to conduct a post-market study involving around 400 patients across 30 sites in the United States to further validate long-term efficacy. These same sites will also serve as commercial centers, enabling an efficient and simultaneous rollout.
The FDA’s decision also gives IceCure a significant competitive edge by establishing higher entry barriers for rivals; any future applicants seeking clearance for similar breast cryoablation systems will be required to submit five years of follow-up data. Alongside this exclusivity, ProSense currently benefits from a CPT III reimbursement code that covers $3,800 of facility costs, with the potential for expanded coverage as adoption increases. Combined with growing physician interest and strong clinical backing, this regulatory win positions IceCure for faster U.S. market penetration, strengthened brand credibility and a pathway toward significant revenue growth.
Favorable Industry Prospects for ICCM
Per a report by Verified Market Reports, the global cryoablation for cancer market size was valued at $3.5 billion in 2024 and is projected to register a CAGR of 6.1% from 2026 to 2033, reaching $5.8 billion by 2033.
The cryoablation market is experiencing strong growth, fueled by the rising incidence of cancer, an aging population and innovations in cryotherapy. A major driver of this expansion is the increasing adoption of cryoablation for smaller tumors, as it offers fewer side effects compared to traditional treatments.
ICCM’s Zacks Rank & Stocks to Consider
ICCM carries a Zacks Rank #4 (Sell) at present.
Some better-ranked stocks in the broader medical space are West Pharmaceutical Services, Inc. (WST - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Envista (NVST - Free Report) .
West Pharmaceutical reported second-quarter 2025 adjusted earnings per share (EPS) of $1.84, which beat the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the consensus estimate by 5.4%. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 16.8%.
Medpace Holdings, sporting a Zacks Rank of 1, reported second-quarter 2025 EPS of $3.10, which beat the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%.
Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 13.9%.
Envista reported second-quarter 2025 adjusted EPS of 26 cents, which beat the Zacks Consensus Estimate by 8.3%. Revenues of $682 million surpassed the Zacks Consensus Estimate by 6.3%. It currently carries a Zacks Rank #2 (Buy).
Envista has a long-term estimated growth rate of 16.8%. NVST’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 16.50%.
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ICCM Shares Rise as FDA Clears ProSense for Breast Cancer Treatment
Key Takeaways
IceCure Medical (ICCM - Free Report) recently received FDA marketing authorization for its ProSense cryoablation system, marking the first approval for a minimally invasive treatment of low-risk breast cancer in women aged 70 and above. The clearance positions ProSense as a potential alternative to lumpectomy, offering a simpler, outpatient procedure with faster recovery and fewer complications.
This milestone not only opens commercial opportunities in the United States but also validates IceCure’s leadership in cryoablation technology. With growing physician enthusiasm and an established reimbursement pathway, the company is well-positioned to accelerate adoption and strengthen its foothold in the global oncology care market.
Likely Trend of the ICCM Stock Following the News
Following the announcement, shares of the company have risen 12% in the after-market session on Friday. However, in the year-to-date period, ICCM’s shares have lost 12.4% against the industry’s 5.2% growth. The S&P 500 gained 15.2% in the same time frame.
The FDA marketing authorization for ProSense significantly boosts IceCure’s commercial outlook by unlocking access to the U.S. breast cancer treatment market. This approval establishes a strong competitive moat, as rivals now face higher clinical data requirements for entry. With initial reimbursement already in place and plans for broader coverage ahead, IceCure is poised to accelerate revenue growth, strengthen U.S. market penetration, and drive long-term value creation through increased physician adoption and expanding indications across oncology.
Meanwhile, ICCM currently has a market capitalization of $66.2 million. The company expects an earnings growth of 26.7% in 2025.
Image Source: Zacks Investment Research
More on the News
The FDA’s marketing authorization allows ICCM to immediately commence commercial sales of its ProSense cryoablation system in the United States for the treatment of low-risk breast cancer in women aged 70 and above. The approval follows a successful De Novo application and applies to a specific patient population, those with biologically low-risk tumors measuring up to 1.5 cm who are also receiving adjuvant endocrine therapy. Importantly, the indication includes patients who are not suitable candidates for surgery, expanding treatment options for a group that previously relied solely on surgical procedures such as lumpectomy.
This authorization was supported by robust clinical data from IceCure’s ICE3 trial, the largest multi-center study ever conducted for liquid-nitrogen-based cryoablation in early-stage breast cancer. The results demonstrated outcomes comparable to those of traditional surgical removal in terms of recurrence-free rates and safety, while offering the benefits of a quicker, minimally invasive, outpatient procedure. Following FDA feedback, IceCure is likely to conduct a post-market study involving around 400 patients across 30 sites in the United States to further validate long-term efficacy. These same sites will also serve as commercial centers, enabling an efficient and simultaneous rollout.
The FDA’s decision also gives IceCure a significant competitive edge by establishing higher entry barriers for rivals; any future applicants seeking clearance for similar breast cryoablation systems will be required to submit five years of follow-up data. Alongside this exclusivity, ProSense currently benefits from a CPT III reimbursement code that covers $3,800 of facility costs, with the potential for expanded coverage as adoption increases. Combined with growing physician interest and strong clinical backing, this regulatory win positions IceCure for faster U.S. market penetration, strengthened brand credibility and a pathway toward significant revenue growth.
Favorable Industry Prospects for ICCM
Per a report by Verified Market Reports, the global cryoablation for cancer market size was valued at $3.5 billion in 2024 and is projected to register a CAGR of 6.1% from 2026 to 2033, reaching $5.8 billion by 2033.
The cryoablation market is experiencing strong growth, fueled by the rising incidence of cancer, an aging population and innovations in cryotherapy. A major driver of this expansion is the increasing adoption of cryoablation for smaller tumors, as it offers fewer side effects compared to traditional treatments.
ICCM’s Zacks Rank & Stocks to Consider
ICCM carries a Zacks Rank #4 (Sell) at present.
Some better-ranked stocks in the broader medical space are West Pharmaceutical Services, Inc. (WST - Free Report) , Medpace Holdings, Inc. (MEDP - Free Report) and Envista (NVST - Free Report) .
West Pharmaceutical reported second-quarter 2025 adjusted earnings per share (EPS) of $1.84, which beat the Zacks Consensus Estimate by 21.9%. Revenues of $766.5 million surpassed the consensus estimate by 5.4%. It currently sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
West Pharmaceutical has a long-term estimated growth rate of 8.5%. WST’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 16.8%.
Medpace Holdings, sporting a Zacks Rank of 1, reported second-quarter 2025 EPS of $3.10, which beat the Zacks Consensus Estimate by 3.3%. Revenues of $603.3 million outpaced the consensus mark by 11.5%.
Medpace Holdings has a long-term estimated growth rate of 11.4%. MEDP’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 13.9%.
Envista reported second-quarter 2025 adjusted EPS of 26 cents, which beat the Zacks Consensus Estimate by 8.3%. Revenues of $682 million surpassed the Zacks Consensus Estimate by 6.3%. It currently carries a Zacks Rank #2 (Buy).
Envista has a long-term estimated growth rate of 16.8%. NVST’s earnings surpassed estimates in each of the trailing four quarters, with an average surprise of 16.50%.