Cryoablation cleared for early low-risk breast cancer
2024
Peer-reviewed paper confirms cryoablation triggers a body-wide immune response
21 yrs
Between our first breast cryoablation and that clearance
In plain terms
What this procedure is, without the jargon.
This is our breast-specific version of freezing plus immunotherapy. In October 2025 cryoablation (the ProSense device) was cleared as a surgery alternative for one specific group — early, low-risk, hormone-receptor-positive tumors in women 70 and older. Our procedure both predates and extends beyond that.
Cryoablation destroys the tumor by freezing it through a needle, which can preserve the breast and avoid lumpectomy or mastectomy. Intratumoral immunotherapy is then injected into the frozen tumor through the same access. Freezing ruptures the cancer cells intact, releasing their full set of “fingerprints,” and the injected immunotherapy trains the immune system to recognize them — turning the tumor into a personalized in situ vaccine and aiming for the abscopal effect at untreated sites.
A 2024 peer-reviewed study showing breast cryoablation alone can trigger a body-wide immune response further supports the approach. It is considered for early-stage patients wanting a minimally invasive option, and for triple-negative, HER2-positive, recurrent or metastatic disease progressing on standard therapy.
Breast cryoablation: the tumor is destroyed while the breast itself is preserved.
The treated tumor teaches your immune system to recognize the cancer body-wide.
How it works
The two-part procedure.
Part 1
Cryoablation
Image-guided cryoprobes create a controlled ice ball around the tumor, destroying it while preserving the overlying tissue — which is why many patients can avoid lumpectomy or mastectomy. Multiple freeze-thaw cycles maximize cell death and antigen release.
Part 2
Intratumoral immunotherapy
Through the same procedural access, multi-agent immune cocktails tuned to your tumor’s biology — ER, PR, HER2, Ki-67, BRCA, PD-L1, TROP-2 — are injected directly into the ablation bed.
What makes it different
Beyond the cleared indication.
Standard approaches
Our approach
ProSense cleared indication: ER+/PR+/HER2−, ≤1.5cm, age ≥70, with adjuvant endocrine therapy.
Considered across hormone-receptor and HER2 statusunder clinician review.
Cryoablation alone.
Cryoablation plus multi-agent intratumoral immunotherapythrough the same procedural access.
Local control as the goal.
Local control plus systemic immune activation— the abscopal goal.
One specific patient population.
Considered across early, locally advanced, recurrent and metastatic diseasecase by case.
Why cryoablation for breast.
Cosmetic preservation
The ice ball destroys the tumor while preserving overlying tissue — many patients can avoid lumpectomy or mastectomy entirely.
Broad antigen release
Frozen cells rupture intact, releasing the full protein antigen pool the immune system needs to recognize the cancer.
Two decades of practice
Breast cryoablation here since 2004 — twenty-one years before that device clearance, and combined with immunotherapy since 2014.
Is this right for you
When this procedure is right.
This procedure is considered for:
✓ER+/PR+/HER2− early-stage low-risk disease seeking a minimally invasive alternative to surgery (women ≥70 fit the explicit label; selected younger patients under clinician review)
✓Triple-negative disease seeking immune-active local control beyond IV checkpoint regimens
✓HER2+ disease combining cryoablation with immune amplification alongside HER2-directed therapy
✓Recurrent breast cancer with an accessible local tumor target
✓Oligometastatic breast cancer with limited progressing sites
“We’ve been doing breast cryoablation with intratumoral immunotherapy for over a decade. The 2025 clearance of ProSense and the 2024 paper on cryoablation-induced abscopal effect validate what we’ve been doing. The next horizon is extending the combination across breast cancer biologies.”
— Dr. Jason R. Williams
Track record
Pioneering breast cryoablation.
2003
Early RFA for breast cancer
Among the first office-based radiofrequency approaches.
2004
Early adopter of breast cryoablation
Consistent with the field’s adoption era (Sabel et al. 2004).
2024
Abscopal effect published
Sardela de Miranda et al. demonstrate cryoablation-induced systemic immune response in breast cancer.
Oct 2025
ProSense cleared for breast cryoablation
The first device-specific clearance — 21 years after our first case.
Ready to move forward?
There is more ahead. Take the next step with confidence.
Complimentary evaluation.
Dr. Williams’ team will personally review your case and imaging — no cost, no obligation.
