Profound Medical Corp. — Form 8-K

Profound Medical announced five abstracts at the 15th Interventional MRI Symposium demonstrating: (1) real-world validation from Mayo Clinic Florida (58 patients, up to 4.5 years follow-up; 100% pad-free continence, 87.5% erectile function preservation) and Mayo Clinic Rochester (41 patients; 62–66% PSA reduction); (2) CAPTAIN randomized trial showing whole-gland TULSA superior to robotic prostatectomy at 6 months (2.1x more likely to preserve both erectile function and pad-free continence, p=0.004; 0.7% vs 6.3% hospitalization for complications); (3) CARE Registry analysis of 197 patients across five centers demonstrating flexible treatment planning and PSA response correlation with ablation extent; and (4) technical feasibility of TULSA on Siemens 0.55T Free.Max lower-field MRI platform with 40% improved temperature-measurement precision (±1.1°C baseline uncertainty, 1.0±0.9 mm targeting accuracy). No regulatory clearance, clinical validation, or commercial availability on the Siemens platform has yet been established.