– CAPTAIN is the first randomized controlled trial ever comparing a new technology to the standard of care of robotic radical prostatectomy to successfully recruit to target –
TORONTO, Dec. 04, 2025 (GLOBE NEWSWIRE) — Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, is pleased to announce that Pejman Ghanouni, MD, PhD, Associate Professor in the Department of Radiology, Division of Body MRI at Stanford University School of Medicine, has received the Cum Laude award for his presentation titled “CAPTAIN Randomized Controlled Trial of MRI-Guided Transurethral Ultrasound Ablation (TULSA) Versus Robotic Radical Prostatectomy” at the 2025 Radiological Society of North America (“RSNA”) Annual Meeting, which just concluded today in Chicago.
RSNA recognizes outstanding education exhibits at its annual meeting with awards of Magna Cum Laude, Cum Laude and Certificate of Merit. Awards are based on review by subspecialty panels within the RSNA Education Exhibits Awards Committee. Dr. Ghanouni’s poster presentation was one (1) of only six (6) that received Cum Laude Awards at RSNA 2025, representing the top 5% of the scientific posters presented at the meeting.
“We would like to congratulate Dr. Ghanouni on receiving the prestigious Cum Laude award from RSNA, a significant professional achievement, as well as a testament to the fact that CAPTAIN enlisted some of the nation’s best academic physicians, which was critical for successful randomization,” said Profound CEO and Chairman, Arun Menawat. “To put the perioperative data that Dr. Ghanouni presented into context, robotic RP patients take almost three weeks of recovery on average to feel like TULSA Procedure patients do the very next day after their procedure. To put it another way, the TULSA Procedure is giving more than two weeks back to the patient. We have always known that the TULSA Procedure has no blood loss and no overnight stay with an improved post-treatment patient experience. Now, it is proven with head-to-head Level 1 data. Importantly, these are some of the same metrics that drove patient demand and initial adoption of the surgical robot for prostate cancer many years ago.”
Profound would also like to congratulate Satoru Takahashi, MD, PhD, of Takatsuki General Hospital in Japan, for receiving a Certificate of Merit award from RSNA for his presentation titled “TULSA for Prostate Cancer: MRI-based Pre-treatment Planning and Post-Treatment Assessment – an Emerging Alternative in the Focal Therapy Spectrum.”
The TULSA Procedure is a significant advancement in prostate care. Instead of surgery or radiation, treatment is performed inside an MRI suite using robotically controlled, directional ultrasound to precisely ablate prostate tissue while protecting surrounding structures. TULSA-PRO is the only AI-powered, MRI-guided robotic system for prostate therapy, enabling real-time MRI thermography and autonomous temperature control. This allows physicians to see, monitor and adjust treatment throughout the procedure — delivering personalized therapy with exceptional precision.
About CAPTAIN
CAPTAIN is a prospective, multi-center randomized controlled trial aimed at comparing the safety and efficacy of the TULSA Procedure™ (performed with the TULSA-PRO® system) with Robotic Radical Prostatectomy (“RP”) in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer. Starting in 2022, CAPTAIN patients were recruited at 20 sites in the United States, two in Canada and one in Europe. As of January 2025, 210 patients were randomized (69% TULSA, 31% RP) in this post-market study, and the last patient treatment occurred in August 2025. Baseline patient characteristics are balanced for TULSA vs RP, with median (IQR) age 63 (58-68) vs. 64 (59-68) years, proportions with PSA ≤10ng/mL 77% vs. 74%, and 23% vs 26% with PSA>10ng/mL. Proportions of TULSA vs. RP patients with GG2/3 disease were 76%/24% vs. 74%/26%. All patients were EPIC pad-free at baseline.
About Profound Medical Corp.
Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue.
Profound is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. The TULSA Procedure™, performed using the TULSA-PRO system, has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia (“BPH”); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer. The TULSA Procedure employs real-time MR guidance for precision to preserve patients’ urinary continence and sexual function, while killing the targeted prostate tissue via precise sound absorption technology that gently heats it to 55-57°C. TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine. TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration (“FDA”).
Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. Sonalleve has also been approved by the China National Medical Products Administration for the non-invasive treatment of uterine fibroids and has FDA approval under a Humanitarian Device Exemption for the treatment of osteoid osteoma. Profound is in the early stages of exploring additional potential treatment markets for Sonalleve where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.
Forward-Looking Statements
This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, any express or implied statements or guidance regarding current or future financial performance; the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, BPH, uterine fibroids, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma; and the success of Profound’s commercialization strategy and activities for TULSA-PRO®. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “is expected”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Profound, including risks regarding the medical device industry, regulatory approvals, reimbursement, economic factors, the equity markets generally and risks associated with growth and competition, statements and projections regarding financial guidance and goals and the attainment of such goals may differ from actual results based on market factors and Profound’s ability to execute its operational and budget plans; and actual financial results may not be consistent with expectations, including that revenue, operating expenses and cash usage may not be within management’s expected ranges. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Other factors and risks that may cause actual results to differ materially from those set out in the forward-looking statements are described in Profound’s Annual Report on Form 10-K and other filings made with U.S. and Canadian securities regulators, available at www.sedarplus.ca and www.sec.gov. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.
For further information, please contact:
Stephen Kilmer
Investor Relations
[email protected]
T: 647.872.4849
Susan Thomas
Public Relations
[email protected]
T: 619.540.9195
