Profound Medical Regains Control of TULSA-PRO, Eyes Canadian Expansion

TORONTO, ON – November 10, 2025

Profound Medical Corp. has announced the regaining of exclusive Canadian distribution rights for its TULSA-PRO prostate treatment system from Knight Therapeutics Inc. This strategic shift gives the medical device company direct control over commercialization in Canada, a move analysts suggest reflects strong confidence in the technology and a commitment to expanding patient access.

A Strategic Repositioning for Growth

For Profound Medical, the decision to reclaim distribution rights marks a significant turning point. Previously, Knight Therapeutics handled commercialization of TULSA-PRO within Canada. The CAD$90,000 (USD$64,000) transaction, coupled with a 5% royalty agreement on Canadian net sales for the next 15 years, demonstrates Profound’s willingness to invest directly in the Canadian market. According to one industry insider, “This isn’t simply about finances; it's about control. Profound clearly believes they can maximize the potential of TULSA-PRO by handling the commercial aspects themselves.”

The move comes as demand for minimally invasive prostate treatment options continues to rise. Traditional treatments, such as radical prostatectomy and radiation therapy, often come with significant side effects and recovery times. TULSA-PRO, with its MRI-guided and AI-powered technology, offers a potentially less invasive alternative, targeting prostate tissue with precision while minimizing damage to surrounding structures.

TULSA-PRO: A Deep Dive into the Technology

TULSA-PRO stands out in the prostate treatment landscape due to its unique technological approach. Unlike conventional methods, it utilizes focused ultrasound energy, guided by real-time MRI imaging, to ablate targeted prostate tissue. This allows physicians to precisely target diseased areas while preserving healthy tissue, potentially reducing the risk of side effects such as urinary incontinence and erectile dysfunction.

The system's AI-powered algorithms enhance precision by continuously monitoring and adjusting the energy delivery based on tissue characteristics and temperature feedback. This level of control is crucial for achieving optimal treatment outcomes and minimizing the risk of complications. Currently, Sunnybrook Health Sciences Centre in Toronto is the sole Canadian provider of the TULSA procedure, having successfully performed over 100 cases. “The technology is impressive, but it's the precision and real-time feedback that really set it apart,” explains a physician familiar with the system.

Navigating the Canadian Healthcare Landscape

Despite the technological advancements, introducing a new medical device into the Canadian healthcare system presents challenges. Access to innovative treatments often depends on securing coverage from provincial health insurance plans. While TULSA-PRO is currently available at Sunnybrook, expanding access to other Canadian provinces requires navigating complex approval processes and demonstrating both clinical effectiveness and cost-effectiveness. Profound Medical is actively pursuing provincial health insurance coverage, planning to support applications with positive data from the ongoing Level I CAPTAIN trial.

The CAPTAIN trial, comparing TULSA-PRO to robotic radical prostatectomy, is expected to yield results in 2026. Positive findings from this trial are anticipated to bolster Profound’s case for provincial coverage and pave the way for wider patient access. One health policy analyst notes, “The evidence base is critical. Provinces need to be convinced that TULSA-PRO offers a significant benefit to patients and represents a good value for the healthcare system.”

Furthermore, the prevalence of prostate cancer and Benign Prostatic Hyperplasia (BPH) in Canada creates a substantial potential market for TULSA-PRO. Statistics Canada data indicates that prostate cancer is the most common cancer among men, with over 30,000 new cases diagnosed annually. BPH, affecting a vast majority of men as they age, also represents a significant clinical need. The combination of these factors, coupled with the increasing demand for minimally invasive procedures, positions TULSA-PRO for continued growth in the Canadian market.

Profound Medical’s commitment to expanding access, combined with the innovative technology behind TULSA-PRO, is poised to make a significant impact on prostate cancer and BPH treatment in Canada. The company’s strategic move to regain control of Canadian distribution rights underscores its long-term commitment to the Canadian healthcare system and its dedication to improving patient outcomes.