Cryoablation of Breast Cancer

06/11/2026

New Cryoablation Clinical Trial Opening in July 2026

Dr. Holmes is pleased to announce the upcoming opening of the ChoICE Trial, a multicenter study evaluating cryoablation for the treatment of early-stage breast cancer in women age 70 and older.
The ChoICE Trial is a follow-up study to the landmark ICE3 Trial, which contributed to FDA approval of a breast cancer cryoablation device for selected patients with early-stage breast cancer. As a condition of FDA approval, IceCure Medical is conducting this 400-patient post-market study to further evaluate the safety and effectiveness of breast cancer cryoablation.

The ChoICE Trial will be open to women who meet the following criteria:

-70 years of age or older
-Diagnosis of invasive ductal carcinoma (IDC) by core needle biopsy
-A single site of disease
-Tumor size equal to or less than 1.5 cm in greatest diameter as measured by breast ultrasound
-Estrogen receptor positive (ER+)
-Progesterone receptor positive (PR+)
-HER2 negative (HER2-)
-Favorable (low-risk) tumor biology

The cost of the cryoablation procedure will be billed to insurance or Medicare when coverage is available. For eligible patients whose insurance does not cover the procedure, treatment may be provided at no cost through the study.

Dr. Holmes is pleased to serve as the only participating investigators on the West Coast.

In addition to participating in the ChoICE Trial, Dr. Holmes continues to offer cryoablation to appropriate patients outside of the study.
For more information about the ChoICE Trial or breast cancer cryoablation, contact us at [email protected].

Call now to connect with business.

06/11/2026

New Cryoablation Clinical Trial Opening in July 2026

Dr. Holmes is pleased to announce the upcoming opening of the ChoICE Trial, a multicenter study evaluating cryoablation for the treatment of early-stage breast cancer in women age 70 and older.
The ChoICE Trial is a follow-up study to the landmark ICE3 Trial, which contributed to FDA approval of a breast cancer cryoablation device for selected patients with early-stage breast cancer. As a condition of FDA approval, IceCure Medical is conducting this 400-patient post-market study to further evaluate the safety and effectiveness of breast cancer cryoablation.

The ChoICE Trial will be open to women who meet the following criteria:

-70 years of age or older
-Diagnosis of invasive ductal carcinoma (IDC) by core needle biopsy
-A single site of disease
-Tumor size equal to or less than 1.5 cm in greatest diameter as measured by breast ultrasound
-Estrogen receptor positive (ER+)
-Progesterone receptor positive (PR+)
-HER2 negative (HER2-)
-Favorable (low-risk) tumor biology

The cost of the cryoablation procedure will be billed to insurance or Medicare when coverage is available. For eligible patients whose insurance does not cover the procedure, treatment may be provided at no cost through the study.

Dr. Holmes is pleased to serve as the only participating investigators on the West Coast.

In addition to participating in the ChoICE Trial, Dr. Holmes continues to offer cryoablation to appropriate patients outside of the study.
For more information about the ChoICE Trial or breast cancer cryoablation, contact us at [email protected].

01/17/2026

Hot off the press!! The FROST Trial Publication-the clinical trial that I led evaluating the effectiveness of breast cancer cryoablation for early stage breast cancer. Dennis Holmes, MD, FACS

Background Cryoablation is emerging as a minimally invasive alternative to lumpectomy for select women with early-stage breast cancer. The FROST trial (NCT01992250) was a prospective, phase 2 multicenter study evaluating the outcome of cryoablation in the management of stage I, hormone receptor-posi...

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