The landscape of breast cancer treatment is undergoing a historic evolution. For the first time in decades, a new local therapy option has received FDA marketing authorization for early-stage, low-risk breast cancer. IceCure Medical’s ProSense cryoablation system now offers eligible women a minimally invasive, nonsurgical alternative to lumpectomy. For women aged seventy and older with small, hormone-sensitive tumors, this means something once unimaginable: the possibility of eliminating cancer without removing breast tissue.
The authorization marks a milestone not only for IceCure but for patients and clinicians seeking effective treatments that preserve quality of life. According to Eyal Shamir, CEO of IceCure, “Women in America aged 70 or older with low-risk, early-stage breast cancer now have the option of a minimally invasive technique that provides safe and effective care option to a standard lumpectomy, along with outstanding cosmetic outcomes and patient satisfaction.”
Paired with adjuvant endocrine therapy, ProSense is now the first and only medical device approved by the FDA for the local treatment of breast cancer. The decision follows impressive clinical evidence, including a five-year recurrence rate of only 3.1 percent in the pivotal ICE3 study.
Seen from both industry and clinical perspectives, this development signals meaningful change for women facing low-risk breast cancer. Shamir describes the opportunity it creates for minimally invasive care, while Michael S. Sabel, MD, FACS, the William W. Coon Collegiate Professor of Surgical Oncology at Michigan Medicine, discusses its impact on patients he treats with cryoablation.
A New Era in Minimally Invasive Breast Cancer Treatment
Cryoablation itself is not new. For years, clinicians have used freezing technologies to treat tumors in the liver, kidneys, lungs, and other organs. What makes ProSense unique is its ability to deliver extreme cold using liquid nitrogen rather than argon gas, enabling broader access and simpler workflow in office-based settings.
Shamir explains, “In contrast to cryoablation systems utilizing argon gas, liquid nitrogen does not necessitate gas lines, on-site technical personnel, or dedicated safety rooms for storage and operation. This allows procedures to be conducted within outpatient clinics and physicians’ offices, thereby increasing accessibility and cost-effectiveness.”
This simplicity reflects IceCure’s larger mission. “At IceCure, we are driven by a bold vision to revolutionize breast care, delivering hope and healing through our advanced, minimally invasive cryoablation technology,” Shamir says. “Our mission goes far beyond simply destroying cancer. We are dedicated to giving women the freedom to choose treatments that honor their strength, restore their confidence, and safeguard their quality of life.”
How ProSense Cryoablation Works
For patients, the experience is dramatically different from traditional surgery. Instead of an operating room, hospital stay, general anesthesia, or weeks of recovery, ProSense is completed in under an hour and requires only local anesthesia.
Shamir describes the process clearly: “During the ProSense cryoablation procedure, a doctor injects local anesthesia and uses ultrasound imaging to guide a small cryoprobe, a thin hollow needle, into the breast tumor. Once the cryoprobe is placed, liquid nitrogen creates extremely cold temperatures (as low as minus 170 degrees C) which destroys the breast tumor by creating an ice ball around the targeted tissue.”
Once frozen, the tumor tissue is gradually reabsorbed by the body over time. The surrounding breast tissue remains intact, which helps maintain natural shape and sensation.
Recovery is typically fast and painless. Patients often return to normal activity within twenty-four hours. The procedure’s minimal scarring, lack of sedation, and preservation of breast tissue create a drastically improved patient experience compared to conventional lumpectomy.
Clinical Evidence Behind the Approval
The FDA marketing authorization is rooted in a robust body of clinical evidence. The cornerstone is IceCure’s ICE3 trial, the largest liquid nitrogen cryoablation study ever conducted for breast cancer.
With 194 participants aged sixty and older, ICE3 demonstrated a low 3.1 percent recurrence rate when cryoablation was paired with endocrine therapy. Shamir explains, “ICE3’s patient selection criteria focused on patients with a mean age of 74.9 years with low-risk tumors, which are less likely to recur, and the patients who followed treatment with adjuvant endocrine therapy had a local recurrence rate of 3.1 percent.”
According to the study author Dr. Richard Fine, these results are consistent with outcomes seen in surgical standard of care. “At the 5-year follow-up, we observed local control similar to surgical standard of care,” Shamir notes.
IceCure will conduct a post-market surveillance study involving approximately four hundred patients across thirty sites. The goal is to “gain deeper insights into real-world safety, effectiveness, and patient outcomes associated with ProSense cryoablation,” says Shamir. He adds that the study will help refine clinical protocols and potentially support future regulatory expansions.
A Changing Standard of Care for Older Women
For decades, lumpectomy followed by radiation has been the mainstay of treatment for early-stage breast cancer. Yet research increasingly shows that women over seventy with certain small, hormone-sensitive tumors often do well with much less aggressive approaches.
Dr. Sabel sees cryoablation as the logical next step in this de-escalation trend. “Cryoablation is the natural next step in de-escalation, particularly as these patients no longer require lymph node surgery or in many cases radiation therapy,” he says. “The local recurrence rate in the trials has been similar to that of lumpectomy.”
He explains that his team has long used cryoablation for patients who were too high-risk for surgery. Now, the calculus has shifted. “We have been using cryoablation as an alternative to surgery in patients who are high-risk for surgery or would have increased risks for complications. Now we are routinely offering cryoablation to appropriate women as an alternative to surgery.”
At Michigan Medicine, the criteria are straightforward. “Cryoablation is an option for women over the age of 70 who have small (<1.5cm), hormone sensitive, her-2 negative breast cancers,” Dr. Sabel says. His team reviews each case carefully to ensure tumors are not too close to skin or muscle.
Once selected, patients receive a detailed comparison of lumpectomy and cryoablation so they can choose what aligns best with their values and lifestyle.
What the Procedure Looks Like in Practice
Dr. Sabel describes the procedure as simple and efficient. “In the clinic, we make sure the patient is a good candidate for cryoablation and review the pros and cons of both cryoablation and lumpectomy. If the patient desires cryoablation, we perform this in our radiology suite using ultrasound.”
He continues, “The patient is given local anesthesia, but do not require sedation. Using ultrasound, the ProSense probe is placed within the tumor and then the freezing begins. We watch the ice ball develop on ultrasound to confirm the entire tumor, and adequate margins, are obtained.”
Cryoablation involves a freeze, thaw, and refreeze cycle to ensure complete destruction of cancerous tissue. When the process ends, there are no stitches or drains. “The procedure is then complete, a bandaid is placed and the patient can go home,” he says.
Patients tolerate it extremely well. “The patients have been extremely satisfied with cryoablation. It is very well tolerated and very few patients report post-treatment pain that requires anything stronger than Tylenol,” Dr. Sabel notes.
Improving Patient Experience and Quality of Life
One of cryoablation’s biggest advantages is its impact on the patient experience. Traditional lumpectomy involves fasting, anesthesia, surgical margins, recovery rooms, postoperative limitations, and sometimes follow-up surgeries when tissue margins are unclear.
Shamir contrasts the two approaches plainly. “Traditionally, patients undergoing a lumpectomy must fast, have a localization device inserted, receive full anesthesia, go through a 1–2-hour surgical procedure, spend another hour or more in recovery at the hospital, arrange for someone to drive them home, and then recover at home. Additionally, about 14 percent to 20 percent of lumpectomy patients require a second surgery because the margins are unclear.”
By comparison, cryoablation restores normalcy quickly. “With cryoablation, patients can enjoy breakfast as usual, drive themselves to and from their doctor’s office for the procedure, which takes less than an hour, return to their normal daily activities, and retain their breast tissue.”
Dr. Sabel underscores this point. “Patients have been very thankful to have this as an option, particularly if going to the OR would be higher risk.”
Looking Ahead: The Future of Cryoablation in Cancer Care
While ProSense is currently authorized only for women aged seventy and older with low-risk breast cancer, its potential reaches far beyond that demographic. IceCure’s system already holds FDA clearance for several benign and cancerous lesions in the kidney, liver, lung, neurology, and fibroadenoma.
Shamir notes that independent studies worldwide are already exploring expanded indications. Although the company remains focused on its FDA-authorized population, the larger vision is clear: a future where nonsurgical tumor treatment becomes standard for many cancers.
“Our aim is to establish cryoablation as an alternative to lumpectomy in this select population when followed by appropriate adjuvant treatment,” Shamir says. The company’s long-term mission, he emphasizes, is to “champion a world where dignity and possibility thrive.”
IceCure’s ProSense cryoablation system represents something rare in modern oncology: a breakthrough that improves clinical outcomes and patient experience simultaneously. The FDA’s marketing authorization marks a turning point, giving thousands of women each year access to a fast, minimally invasive option that preserves breast tissue, accelerates recovery, and maintains quality of life.
With encouraging clinical results, growing physician adoption, and strong patient satisfaction, cryoablation is poised to shift how clinicians think about early-stage breast cancer in older women. And with continued research, its reach may grow even further.
For now, ProSense offers something powerful: a chance to freeze cancer without freezing life.
For more information about IceCure and the ProSense cryoablation system, visit IceCure at icecure-medical.com and ProSense at icecure-medical.com/products/prosense.
Daniel Casciato is a seasoned healthcare writer, publisher, and product reviewer with two decades of experience. He founded Healthcare Business Today to deliver timely insights on healthcare trends, technology, and innovation. His bylines have appeared in outlets such as Cleveland Clinic’s Health Essentials, MedEsthetics Magazine, EMS World, Pittsburgh Business Times, Post-Gazette, Providence Journal, Western PA Healthcare News, and he has written for clients like the American Heart Association, Google Earth, and Southwest Airlines. Through Healthcare Business Today, Daniel continues to inform and inspire professionals across the healthcare landscape.
