Profound Medical (NASDAQ:PROF; TSX:PRN) announced initial perioperative data from its Level 1 post-market CAPTAIN trial comparing the safety and efficacy of the TULSA procedure with radical prostatectomy (RP) in men with organ-confined, intermediate-risk, Gleason Score 7 (Grade Group 2 and 3) prostate cancer.
Xiaosong Meng, M.D., Ph.D., and assistant professor at the Department of Urology at UT Southwestern Medical Center, presented the positive perioperative results at the American Urological Association (AUA) Annual Meeting on April 28, 2025.
Dr. Meng’s AUA presentation highlighted that TULSA provided statistically significant improvement in all assessed perioperative measures:
- Blood loss: TULSA median 0 (IQR 0-0) mL vs. RP 100 (100-200) mL, p<0.001.
- Length of stay: TULSA median 0.29 (IQR 0.27-0.32) days vs. RP 1.24 (1.12-1.36) days, p<0.001.
- NRS (Numeric Rating Scale) pain: Significantly lower post-operative pain after TULSA procedure vs. RP through to post-treatment day 6, p<0.05.
- Patient-reported health-related QOL:
- Significantly higher overall health on the EQ-5D-5L 0-100 VAS (Visual Analog Scale) after TULSA vs. RP for all 30 days measured after treatment, p<0.05.
- During the first month post-treatment, significantly fewer TULSA patients reported experiencing extreme problems or inability with mobility (0% for TULSA vs. 12% for RP, p=0.001), self-care (3% for TULSA vs. 17% for RP, p=0.005), and usual activities (17% for TULSA vs. 40% for RP, p=0.008).
Dr. Meng commented, “I commend the sponsor and the study investigators for taking on this audacious study, as CAPTAIN is the fist randomized controlled trial comparing a new technology to the standard of robotic radical prostatectomy to successfully recruit to target enrollment. In addition to including some of the most talented and high volume surgeons from academic hospitals and private practice, I believe successful randomization was in large part due to TULSA’s proven safety and efficacy for whole-gland ablation in intermediate-risk prostate cancer patients, which fostered equipoise between both arms. While TULSA already has a well-established body of clinical evidence, it now has hard data that shows quantitatively in a head-to-head fashion significantly superior post-treatment patient experience compared to robotic prostatectomy.”
Lake Street Capital Markets senior research analyst, Ben Haynor, issued a research note today highlighting the initial CAPTAIN data. “These are precisely the perioperative outcomes upon which the CAPTAIN trial just demonstrated clear superiority. As such, we believe this puts TULSA firmly in the conversation to become a mainstream prostate cancer treatment option.”
Mr. Haynor added, “We think the perioperative CAPTAIN data will be well received by commercial payors and expect wide spread reimbursement will be forthcoming before next year is out.”
Additionally in his note, commenting on Profound’s investor event held on the last day of the AUA meeting, Mr. Haynor pointed out, “One of the more important items we took away from the company’s investor day occurred toward the end of the program, when the three surgeons invited by the company began discussing (unprompted) their reduced stress levels when performing TULSA as compared to radical prostatectomy with da Vinci (and these were surgeons who had collectively performed many thousands of RARP procedures, likely over 10K on a collective basis) – not only are there fewer potentially disastrous perioperative issues to worry about, but instead of being fully engaged at a da Vinci console, the surgeon can simply monitor TULSA’s progress on the treatment plan drawn by the surgeon and make any necessary adjustment with cup of coffee in hand—quite a difference.”
Mr. Haynor rates Profound’s stock a ‘buy’ with an $11 price target. The stock closed yesterday at $4.77 on Nasdaq.
In a statement, Arun Menawat, CEO and chairman of Profound, said, “Zero blood loss and nearly a full 24 hours less at the hospital or clinic—dramatic reduction in post procedure pain and significant improvement with patient mobility, self-care, and ability to perform usual activities. When we see the data that says that robotic prostatectomy patients take over two weeks of recovery, on average, to feel like a TULSA patient does the day after their procedure, we can understand how TULSA patients are often out at the restaurant with their families the night of their procedure rather than laying in a hospital bed. This superior patient experience leads to high patient satisfaction and patient demand, which interestingly is the same axis that drove adoption of the surgical robot in its early days.”
Dr. Menawat added, “We believe the CAPTAIN perioperative outcomes are not only central to patient demand, but are also important for insurance companies who consider Level 1 randomized controlled trials the gold standard in evidence-based research for establishing the effectiveness of interventions and making their coverage policies. We look forward to continue reporting CAPTAIN follow-up data, adding to the growing body of clinical evidence that demonstrates the unrivalled precision and flexibility of TULSA with consistent safe and effective outcomes across the full spectrum of prostate disease states.”
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. TULSA 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 FDA.
