Breakthrough device designation was granted to the next-generation cryoablation technology ProSense for use in patients with T1 invasive breast cancer as well as in patients not suitable for surgical alternatives for the treatment of their tumors. The technology uses liquid nitrogen–based cryoablation for a minimally invasive destruction of tumor cells. This designation from the FDA will allow for an accelerated review and feedback from the agency through the development process to commercialization. Treating breast cancer with the combination of cryoablation and immune checkpoint inhibition is an appealing strategy owing to the synergistic mechanisms of these therapies. Cryoablation enhances tumor immunogenicity, which may facilitate response to immunotherapy, while immune checkpoint blockade may allow the body to mount a robust response to tumor-specific antigens released by cryoablation. Cryoablation is a well-tolerated outpatient procedure that has been used to treat metastatic sites as well as small breast cancers in patients who are considered poor candidates for surgery. Recent studies suggest that cell disruption caused by cryoablation may increase the expression and immunogenicity of tumor neoantigens, which could enhance the ability of the immune system to recognize and attack cancer cells at both local and distant sites. To discuss how we can help you, please contact us for an appointment: (347) 506-2344.