Commercial AdoptionPreliminary U.S. sales and initial commercial traction in the targeted breast cancer indication indicate improving market uptake as commercialization progresses.
Regulatory ApprovalsFDA marketing authorization for ProSense should boost U.S. demand and strengthen international interest by validating the device for early-stage breast cancer treatment.
Reimbursement And Post-market StudySelection of 20 of 30 sites for the post-market study with reimbursable procedures should support broader clinical adoption by ensuring coverage at participating centers.