SBIR Phase II: Cryogenic probe development and testing for post-lumpectomy margin ablation treatment

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase II project is a novel minimally invasive thermal therapy for improving post surgical lumpectomy outcomes. In the US, 300,000 new breast cancer cancer diagnoses occur each year with nearly half, or 150,000, undergoing surgical excision of the tumor. These patients are also required to undergo subsequent radiation therapy to decrease the risks of recurrence.

The follow on treatments require multiple follow up visits to hospitals or clinics with specialized equipment and personnel, disproportionately affecting social and economically disadvantaged patients in underserved regions. This initiative aims to provide an adjunctive therapy to be performed by the breast cancer surgeon immediately following a lumpectomy, in order to significantly reduce or eliminate remaining cancerous cells in the surrounding tissue or fluid medium.

The proposed benefits include reducing the rates and severity of side effects of radiation therapy, as well as reducing multiple inclinic follow up visits. The system represents a novel treatment paradigm for breast cancer - the most commonly diagnosed form of cancer in the female population affecting one in eight women, and fifth leading cause of cancer death worldwide with 2.3 million new cases and 685,000 deaths per year.

The potential commercial impact is a new type of cryogenic probe and treatment paradigm for the $7.5B annual breast cancer lumpectompy and invasive treatment market.

This Small Business Innovation Research (SBIR) Phase II project aims to complete engineering and validation activities for a novel minimally invasive cryoablation probe, coupled with an external cryoagent controller, for performing post lumpectomy augmentative therapy. The cryoablation probe will be optimized for procedural and development considerations based on a gel model in order to ensure proper contact with the tumor cavity walls to induce necrosis or apoptosis.

The probe will be developed and integrated within medical device processes and standards including materials selection, product development and manufacturing considerations for human use. The probe will then be integrated into an overall system consisting of an external controller, console and cryoablative fluid supply needed to deliver controlled sub freezing therapy.

The system will then be validated in separate ex vivo tissue experiments followed by in vivo ovine studies to demonstrate system efficacy and safety to initiate human use.

This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.