Cryoablation of Breast Cancer

10/10/2025

Dr. Dennis Holmes, internationally recognized breast surgeon and cryoablation expert, was recently interviewed on The Moss Report Podcast to discuss cryoablation and other breakthrough innovations in breast cancer treatment.

👉 Watch the full interview to hear Dr. Holmes’ insights on the future of minimally invasive cancer care.

Breast surgeon Dr. Dennis R. Holmes joins The Moss Report to discuss cryoablation, a minimally invasive technique that freezes tumors as an alternative to surgery and radiation.

10/05/2025

FDA Approves ProSense Cryoprobe for Breast Cancer Cryoablation

By now, many of you have heard that the FDA has approved the use of the ProSense (IceCure) cryoprobe for the treatment of breast cancer with cryoablation. This approval applies specifically to women aged 70 years and older with low-risk, hormone-sensitive, HER2/neu-negative invasive ductal carcinoma measuring 1.5 cm or less.

While this represents a major milestone, it is only the beginning of the process of achieving full Medicare and commercial insurance coverage for breast cancer cryoablation. Here’s what you need to know about the FDA approval and what comes next:

1. Post-Market Study Requirement

The FDA approval is contingent upon IceCure conducting a post-market study of 400 additional patients to gather more data on the safety and effectiveness of cryoablation in the approved patient population. This study is expected to begin next year and take 2–3 years to complete. I will be participating in this study.

2. Current Medicare Coverage

In the meantime, Medicare will continue to reimburse the “technical” cost (approximately $3,800 of Billing CPT Code 0581T) for breast cryoablation procedures performed in hospitals and hospital-owned clinics.

This coverage:
• Does not yet apply to cryoablation performed in outpatient clinics or private offices.
• Covers only the hospital cost for cryoablation equipment and supplies.
• Does not cover the physician’s professional fee for the procedure.

As a result, many hospitals or cryoablation providers might still find it financially challenging to offer cryoablation without separate payment for professional services. Furthermore, this is a Medicare-only payment decision; other insurers will make their own determinations regarding CPT Code 0581T.

3. Determining Professional Fees

During the post-market study period, data will be collected to estimate the average physician work-effort involved in:
• Prepping patients for cryoablation
• Performing the cryoablation procedure
• Managing patients during the first 3 months post-procedure
• Related overhead and malpractice insurance cost

These factors will be used to establish an appropriate professional fee (physician payment). This data collection process will take several years and may also result in an increase to the equipment and supply (“technical”) reimbursement.

4. Toward a Unified Billing Code

Once steps 1–3 have been completed (estimated 3–5 years), it is anticipated that a new billing CPT code will be released that includes both the professional and technical components and associated costs. This code should apply to breast cryoablation procedures performed in both hospital and office settings, and is expected to be covered by Medicare as well as commercial insurers. It is likely that the indication will remain restricted to women aged 70 years and older with low-risk, hormone-sensitive, HER2/neu-negative invasive ductal carcinoma measuring 1.5 cm or less until further studies are conducted evaluating younger patients or different types of breast cancer.

Bottom line: This FDA approval is a critical first step toward making breast cancer cryoablation widely accessible and reimbursable. Continued data collection will drive broader coverage and payment for both the technical and professional components.

Hopefully that’s all clear. If not, feel free to ask for clarification.
www.cryoablation.com

09/06/2025

Hi Everyone, Check out my recent interview on the Know Better Do Better Podcast.

Freeze Away Breast Cancer

[https://youtube.com/shorts/y1jietz-3S4?si=8MifH5MQLF-1o27C](https://youtube.com/shorts/y1jietz-3S4?si=8MifH5MQLF-1o27C)

05/06/2025

I’m pleased to share the video of my recent lecture at the American Society ofBreast Surgeons' annual meeting. The presentation discussed the final results ofthe FROST Cryoablation Clinical Trial which evaluated the effectiveness and safetyof cryoablation or tumor freezing for Stage I breast cancer in women age 50 andolder.

Key Study Findings:

1. With an overall 5-year local recurrence rate of 3.6% , cryoablation is aseffective as lumpectomy.
2. 97.5% of participants safely avoided lymph node surgery.
3. Side effects of cryoablation and radiation were mostly mild. There were noserious side effects.
4. There were no breast cancer related deaths or distant recurrences.
5. Anti-estrogen therapy is important for reducing recurrence after cryoablation,just as for lumpectomy.
6. Radiotherapy is helpful in reducing the risk of recurrence in women under 70,similar to lumpectomy.

https://www.youtube.com/watch?v=34hmIDlb4yA

In addition to acknowledging these excellent results, I want to express my deepgratitude to the women from across the U.S. who proudly participated in the FROSTtrial. Your involvement has paved the way for broader acceptance of cryoablationand will help countless women avoid the side effects of breast and lymph nodesurgery. Thanks to your contribution, more women will have access to care thatpreserves physical comfort, enhances sexual health, and improves satisfaction withbreast appearance.If you or someone you know has been diagnosed with early-stage breastcancer and wants to avoid breast or lymph node surgery, ask your doctorabout cryoablation.

Best regards,
Dennis R. Holmes, MD, FACS
Study Principal Investigator

I’m pleased to share the video of my recent lecture at the American Society of Breast Surgeons' annual meeting. The presentation discussed the final results ...

04/22/2025

Chris Wark Interviews Dr. Holmes:

Cryoablation is a procedure that freezes and destroys breast tumors that is less expensive and less invasive than a lumpectomy.

04/14/2025

A few months ago, I shared an early teaser about the long-term outcomes from the FROST cryoablation clinical trial—a study I launched in 2016 and have led as principal investigator ever since.

I’m excited to announce that the full results are finally in—and they are truly impressive.

In recognition of these findings, I’ve been invited to present the results in just two weeks at the upcoming annual meeting of the American Society of Breast Surgeons in Las Vegas, where more than 2,000 breast surgeons from around the world will be in attendance. The official trial manuscript will be submitted at that time and is expected to be published later this summer.

While I’m unable to release the full results publicly until after the Las Vegas meeting, I’m happy to share an updated teaser regarding the use of cryoablation in women aged 50 and older with estrogen-sensitive, stage I tumors (≤2.0 cm):

1. Cryoablation is as safe and effective as lumpectomy.

2. Lymph node biopsy is not needed for most women treated with cryoablation.

3. Survival after cryoablation is equivalent to survival after lumpectomy.

4. Anti-estrogen therapy plays a critical role in reducing recurrence after cryoablation.

In addition to being inspired by these results, I am especially grateful to the women from across the country who participated in this landmark study. The FROST trial will undoubtedly help open the door to broader adoption of cryoablation, sparing many women the side effects of breast and lymph node surgery. This means more women can look forward to improved physical well-being, enhanced sexual health, and greater satisfaction with their breast appearance.

Be on the lookout for a follow-up newsletter in a few weeks, where I’ll share the full results of the FROST trial along with a copy of my official presentation slides.

Continuing to lead the way in cryoablation treatment, research, and innovation.

Dennis R. Holmes, MD

Performed by Dr. Dennis Holmes in Los Angeles, CA. Get a free case review today. Qualified patients may benefit from cryoablation, a minimally invasive, effective outpatient treatment performed under local anesthesia with fewer side effects and a faster recovery than breast surgery.

12/27/2024

https://conta.cc/3VXgyLY

Email from Dennis R. Holmes, MD, FACS     L.A. Breast Chronicles December 24, 2024 By Dennis R. Holmes, MD, F.A.C.S. Update on Cryoablation As An Alternative To Breast Cancer Surgery The ICE3 Trial

12/17/2024

Circulating Tumor DNA (ctDNA) Testing Opportunity
Many women have shown interest in having circulating tumor DNA (ctDNA) measured before and after undergoing cryoablation.

This is a topic I am curious about as well. I hypothesize that ctDNA levels may rise temporarily after cryoablation due to the release of DNA from cancer cells destroyed during the procedure. Following this initial increase, I would expect ctDNA levels to gradually decrease until they become undetectable. However, this hypothesis remains unproven.
To explore this further, I have arranged an opportunity for 5 women to have their ctDNA levels measured before and after cryoablation. Each woman would need to undergo a blood draw for ctDNA testing prior to cryoablation, with additional tests conducted at 2 weeks, 1 month, 2 months, and 3 months after the procedure to track how levels change and when they normalize.

Blood draws can be done in any town within the United States. All ctDNA tests for these 5 participants will be provided free of charge. However, the women would still need to pay for the cost of the cryoablation procedure itself.
If you know someone who might be interested in this opportunity, please ask them to contact me at info@cryoablation.com.

Leading the way in breast cancer cryoablation...
Thank you,
Dennis Holmes, MD, FACS

12/17/2024

I just returned from the 4th International Conference on Oncology and Research Treatment in Bangkok, Thailand where I gave the Keynote Lecture on Breast Cancer Cryoablation. I shared the results of the ICE3 trial as well as the preliminary results of two clinical trials that I am conducting for Invasive Breast Cancer and DCIS that will soon be published.
Join us for the upcoming cryoablation webinar in early January for an update on all of these studies. ...Continuing to lead the way in forging a path for cryoablation!
Dennis Holmes

11/09/2024

From the American Society of Breast Surgeons

FDA Panel Recommends to Approve the De Novo Classification Request for the IceCure ProSense™ Cryoablation System

On November 7 the FDA General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee convened to discuss the clinical performance data gathered on the IceCure ProSense™ Cryoablation System. A vote on information relative to the benefits and risks profile for a De Novo Classification Request for the IceCure ProSense™ Cryoablation System for patients with early stage, low risk breast cancer for the treatment of breast cancer with adjuvant endocrine therapy took place.
The ICE3 Study demonstrated that the benefits of cryoablation outweigh risks for the treatment of breast cancer in patients ≥ 60 years of age, with low risk (ER/PR +, HER2-) infiltrating ductal breast cancer, measuring ≤1.5 cm, and clinically lymph node negative¹.
After open public statements from the Sponsor, the FDA and consumers, and after deliberations and summation, the panel voted “yes” to the proposal “Considering the data from the ICE3 trial and reported outcomes in the literature for standard of care, do the benefits of the IceCure Medical, Ltd. ProSense™ Cryoablation System outweigh the risk from the proposed indication for use?” moving the De Novo Classification request for the IceCure ProSense™ Cryoablation System forward.

While the affirmative vote of the panel does not confer final approval of the De Novo Classification request, the panel’s clinical advisement is a critical aspect of the FDA process, deliberation and implementation of the classification and any associated special controls.

Dr. Holmes' Assessment:

This FDA decision gets us quite a bit closer to insurance reimbursement of the procedure since the procedure would no longer be considered "experimental" for patients ≥ 60 years of age, with low risk (ER/PR +, HER2-) infiltrating ductal breast cancer, measuring ≤1.5 cm, and clinically lymph node negative. It's important to note that billing codes for cryoablation still do not have a professional reimbursement value that defines what the provider gets paid for the procedure. This might take a few more years because it's a highly political process all by itself.

However, FDA approval will greatly increase the chances that insurance companies will reimburse patients for all or part of the cost of the procedure.

It is also uncertain how this FDA approval impacts insurance coverage for patients that are younger than 60, have turmors large than 1.5 cm, or have non-ER/PR+, HER2- disease. Based on that FDA recommendation, these cases would still be considered "experimental."

Stay tuned for more...

09/27/2024

I'm excited about my upcoming virtual presentation at the Breast Cancer Symposium-Brazil tomorrow morning. I've been instrumental in expanding access to cryoablation in Brazil through education and training, similar to my efforts in the US and other countries. It's an honor to be part of this symposium once again, along with another that took place in May 2024 and another to take place in November 2024. Stay tuned for the online posting of my lecture.

Educating the world about cryoablation.