Profound Medical Corp. announced on October 14, 2026, that it presented five abstracts at the 15th Interventional MRI (iMRI) Symposium in Boston, Massachusetts. These presentations focus on the TULSA Procedure, performed using the TULSA-PRO system, and cover real-world clinical experience, randomized trial results, and technical feasibility on different MRI platforms.
The company highlighted three key dimensions of the TULSA Procedure's progress: real-world validation, clinical differentiation, and platform expansion potential.
One abstract analyzed data from the Mayo Clinic in Florida, reporting on 58 patients treated with TULSA-PRO over up to 4.5 years. The study found that 100% of patients achieved pad-free continence, 94% achieved leak-free continence, and 87.5% of men preserved erections sufficient for penetration beyond 12 months. Serious adverse events were uncommon, with no strictures or fistulas reported.
A separate prospective study from Mayo Clinic Rochester evaluated 41 patients. Mean prostate-specific antigen (PSA) levels declined from 7.7 ng/mL at baseline to approximately 2.3–2.6 ng/mL at one year, representing a sustained reduction of approximately 62%–66%. Biochemical recurrence was reported in 22% of patients.
The CARE Registry analysis involved 197 patients across five centers with a median follow-up of 24 months. The study demonstrated that more extensive ablation was associated with deeper PSA reductions, with a median nadir of 0.23 ng/mL following whole-gland treatment compared to 0.60 ng/mL after subtotal treatment and 1.10 ng/mL after focal treatment.
The CAPTAIN randomized controlled trial compared the TULSA Procedure to robotic radical prostatectomy in patients with localized intermediate-risk prostate cancer. At six months, whole-gland TULSA demonstrated statistically superior preservation of erectile function and pad-free continence compared to robotic RP, with a risk ratio of 2.1 (p=0.004). Hospitalizations for complications were also lower with TULSA (0.7%) than with robotic RP (6.3%).
Additionally, Profound reported on the technical validation of the TULSA Procedure on the Siemens 0.55T Free.Max MRI platform. The evaluation incorporated new three-dimensional thermometry protocols that improved temperature-measurement precision by 40% compared to conventional approaches. The technical feasibility study noted that prostate anatomy remained clearly visible and simulated treatments demonstrated targeting accuracy of 1.0 ± 0.9 mm.