Record Revenue and Quarterly Sales
Reported record fourth-quarter sales of approximately $1.3 million and record full-year revenue from sales of $3.4 million for the twelve months ended December 31, 2025.
U.S. FDA Clearance for ProSense
ProSense received U.S. FDA marketing authorization (October 2025) for treatment of low-risk breast cancer in women age 70+ and patients not suitable for surgery — positioning ProSense as the first and only FDA-cleared medical device for breast cancer cryoablation in the U.S.
Major Medical Society Endorsement
American Society of Breast Surgeons (ASBRS) 2026 guidance now recommends cryoablation as an option for selected biologically low-risk early-stage breast cancer, a validation expected to catalyze adoption and support reimbursement expansion.
Growing U.S. Commercial Momentum and Pipeline
Company reports a growing pipeline of customers converting to signed contracts, deliveries and installations (examples include Fuel Imaging and Thomas Hospital), and expects an increase in system sales and installations starting in Q2 2026 with continued growth thereafter.
Post-Marketing Study (PMS) Planning and Enrollment Targets
FDA requires 30 hybrid PMS sites; majority of the 30 sites have been identified. Onboarding expected in the next 3–6 months with all 30 opened by end of next year; patient enrollment slated to commence late summer with a target of 20% enrollment by this time next year.
Existing Reimbursement and Potential Upside
Procedures currently covered by an existing CPT facility payment of about $4,000. Company has applied for transitional pass-through payment that could add up to $900 per procedure by early 2027, and plans to file for CPT1 physician reimbursement in Q2 2026 (target effective early 2028).
Global Regulatory and Clinical Expansion
Submitted Class III amended application to Health Canada for expanded indication (treatment of early-stage low-risk invasive breast cancer in patients aged 60+); working with Terumo in Japan (PMDA consultation completed with positive outcomes) and seeing increased international demand and adoption following U.S. FDA clearance.
Strong Scientific and Awareness Momentum
Record number of peer-reviewed publications and presentations in 2025 (60 principal investigators at 10 conferences) with ongoing independent studies (SIXT in Brazil, PRECISE in Italy) and active social media promotion to boost patient recruitment and professional awareness.
Commercial Team Expansion
Plan to triple the U.S. commercial team by the end of 2026 to address rising demand (targeted ~3x growth in sales headcount).