Profound Medical Corp. reported that its CAPTAIN randomized controlled trial met its primary safety endpoint, showing that 50 % of men treated with the TULSA Procedure preserved erectile potency and urinary continence at six months, compared with 24 % of men who underwent robotic radical prostatectomy. The trial enrolled 211 patients across 23 sites—20 in the United States, two in Canada and one in Europe—providing a robust, guideline‑grade evidence base for the TULSA technology.
The functional outcome data reveal that TULSA achieved 84 % pad‑free continence and 56 % erectile function at six months, versus 49 % and 47 % for the surgical arm, respectively. These figures underscore a clear advantage in both continence and potency preservation, while the composite endpoint of erectile potency plus continence—critical for patient quality of life—was more than double the rate seen with standard robotic surgery.
CAPTAIN is a Level 1, post‑market, randomized controlled trial designed to generate guideline‑grade evidence on oncologic control and functional outcomes. By enrolling a diverse patient population and comparing TULSA directly with high‑volume robotic surgeons, the study provides the most rigorous data to date on the safety and efficacy of an incision‑free prostate cancer therapy.
Profound’s management highlighted the clinical and commercial implications of the data. “Dr. Klotz will review the CAPTAIN data and its clinical relevance, and Profound management will discuss the commercial implications of the data and next steps in advancing the TULSA Procedure toward potential inclusion in prostate cancer treatment guidelines,” the company said. The company also noted that the comparative data could influence European clinical guidance and payer assessments, potentially accelerating broader adoption of the incision‑free therapy. If CAPTAIN demonstrates non‑inferiority on oncologic endpoints with measurable advantages in continence and potency preservation, it could fundamentally recalibrate how guideline panels weigh trade‑offs between cure and quality of life in localized disease.
Financially, Profound reported record Q4 2025 revenue of $6.0 million and a full‑year 2025 revenue of $16.1 million, with a gross margin of 71 %. The company posted a net loss of approximately $42.6 million for the year, largely driven by increased operating expenses related to CAPTAIN trial enrollment. The positive functional outcomes are expected to drive broader adoption, enhance payer coverage, and accelerate revenue growth from the flagship prostate therapy.
The CAPTAIN trial results, presented at the 41st Annual European Association of Urology Congress in London on March 13 2026, represent a significant milestone for Profound Medical and position the TULSA Procedure as a compelling minimally invasive alternative to robotic radical prostatectomy. The data support the company’s strategy to expand market share, improve patient outcomes, and ultimately strengthen its commercial trajectory in the prostate cancer treatment space.
The content on EveryTicker is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.