Dr. Arun Menawat reports

INITIAL PERIOPERATIVE DATA FROM CAPTAIN RANDOMIZED TRIAL DEMONSTRATE MRI-GUIDED TULSA PROVIDES STATISTICALLY SIGNIFICANT IMPROVEMENT OF POST-OPERATIVE EXPERIENCE VS. ROBOTIC RADICAL PROSTATECTOMY

Profound Medical Corp. has released the initial perioperative data from the level 1 postmarket 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 groups 2 and 3 (GG2/3)) prostate cancer.

The positive perioperative results were presented yesterday by Dr. Xiaosong Meng, MD, PhD, an assistant professor in the Department of Urology at UT Southwestern Medical Center, at the American Urological Association (AUA) annual meeting.

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, 201 patients were randomized and, to date, 194 have been treated or scheduled for treatment (69 per cent Tulsa, 31 per cent RP). Baseline patient characteristics are balanced for Tulsa versus RP, with median (IQR) age 63 (58 to 68) versus 64 (59 to 68) years, proportions with PSA of 10 nanograms per millilitre (ng/mL). Proportions of Tulsa versus RP patients with GG2/3 disease were 76 per cent/24 per cent versus 74 per cent/26 per cent. All patients were EPIC pad-free at baseline.

Dr. Meng's AUA presentation highlighted that Tulsa provided statistically significant improvement in all assessed perioperative measures:

• Blood loss: Tulsa median zero (IQR zero to zero) mL versus RP 100 (100 to 200) mL, p less than 0.001;
• Length of stay: Tulsa median 0.29 (IQR 0.27 to 0.32) days versus RP 1.24 (1.12 to 1.36) days, p less than 0.001;
• NRS (numeric rating scale) pain: significantly lower postoperative pain after Tulsa procedure versus RP through to posttreatment day 6, p less than 0.05;
• Patient-reported health-related QOL: significantly higher overall health on the EQ-5D-5L 0-100 VAS (visual analogue scale) after Tulsa versus RP for all 30 days measured after treatment, p less than 0.05;
• During the first month posttreatment, significantly fewer Tulsa patients reported experiencing extreme problems or inability with mobility (0 per cent for Tulsa versus 12 per cent for RP, p equal to 0.001), self-care (3 per cent for Tulsa versus 17 per cent for RP, p equal to 0.005) and usual activities (17 per cent for Tulsa versus 40 per cent for RP, p equal to 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 enrolment. 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 posttreatment patient experience compared to robotic prostatectomy."

"Zero blood loss and nearly a full 24 hours less at the hospital or clinic. Dramatic reduction in postprocedure pain and significant improvement with patient mobility, self-care and ability to perform usual activities," said Dr. Arun Menawat, Profound's chief executive officer and chairman. "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."

About Captain

Captain (a comparison of Tulsa procedure versus radical prostatectomy in participants with localized prostate cancer) is a prospective, multicentre randomized controlled trial aimed at comparing the safety and efficacy of the Tulsa procedure (performed with the Tulsa-Pro system) with RP in men with organ-confined, intermediate-risk, Gleason Score 7 (GG2/3) prostate cancer. The goal of Captain is to demonstrate that the efficacy of the Tulsa procedure is not inferior to RP, while demonstrating superior quality of life outcomes. The primary safety end point is the proportion of patients who preserve both erectile potency and urinary continence at one year after treatment. The primary efficacy end point is the proportion of patients who are free from any additional treatment for prostate cancer, free of metastases or prostate-cancer-related death by three years after treatment. Secondary end points include comparison of rates of complications, cost-effectiveness, as well as histologic and biochemical failure.

About Profound Medical Corp.

Profound is a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing Tulsa-Pro, a technology that combines real-time MRI (magnetic resonance imaging), 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 (magnetic resonance) 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 C to 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 and palliative pain treatment of bone metastases. 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. The company 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.

We seek Safe Harbor.