Clinical Study ActivationFDA approval of the ChoICE post-market study design and activation of U.S. clinical sites that function as commercial centers can accelerate patient enrollment and broaden geographic access to ProSense treatments.
Commercial Adoption And ReimbursementInclusion of cryoablation in the American Society of Breast Surgeons guidance, coupled with CPT Category III eligibility and improved facility reimbursement, may encourage more clinics to offer the procedure and boost procedure-related revenue.
Regulatory ExpansionSubmission of a Health Canada application to expand ProSense use for select early-stage breast cancer patients may open the Canadian market and support higher device and consumable sales.