Low Cost Carbon Dioxide-Based Cryoablation for Breast Cancer Treatment in Low Resource Settings

PROJECT SUMMARY/ABSTRACT As the most commonly diagnosed cancer in women, breast cancer represents a significant global health challenge, particularly in Low- and Middle-Income Countries (LMICs), where survival rates are significantly lower compared to High-Income Countries. Kubanda Cryotherapy has developed an innovative, low-cost cryotherapy device that utilizes carbon dioxide as a cryogen, addressing the urgent need for accessible breast cancer treatment in these regions by providing an affordable and effective point-of-care device for use in resource-limited settings. This project aims to complete clinical readiness activities in preparation for implementation in low-resource settings, aligning with NIH/NCI’s special interest and directly addressing the goals of NOT-CA-21-062 in bringing minimally-invasive cryotherapy to LMICs. Our Phase I work successfully demonstrated efficacious treatment outcomes when compared to a commercially available argon system and the added benefits of slower cryotherapy. In the Phase II proposal, we will first submit for FDA clearance. Testing will involve validating the device’s substantial equivalence to our predicate through rigorous benchtop testing under GLP conditions following cGMP conversions, as well as the standard safety, biocompatibility, and usability studies for FDA submission. We will then develop and complete a pilot educational training program in Nairobi, Kenya. The training pilot program will involve the development of an LMIC-compatible echogenic phantom, which will be used to evaluate care provider efficacy in placing and monitoring the device using ultrasound visualization in phantom. Lastly, we will prepare an evidence-generation framework for post-market surveillance to support adoption by local payees. Key informant interviews will be conducted to develop a comprehensive Health and Economic Outcomes data collection plan, which will support scaled dissemination, reimbursement by government and insurance funds, and device adoption by a qualified in-country scaling partner. The ultimate goal is to offer an effective, affordable, and easily operable treatment option for breast cancer, significantly improving the healthcare outcomes for women in LMICs while reducing global health disparities.