Mr. Arun Menawat reports

ROBOTIC RADICAL PROSTATECTOMY COMES UP 'SHORT' IN CAPTAIN TRIAL

Profound Medical Corp. has released new data from the Level 1 postmarket Captain randomized controlled trial comparing the Tulsa Procedure with robotic radical prostatectomy in men with organ-confined, intermediate-risk, Gleason Score 7 (grade group 2 and 3) prostate cancer. At one month following the Tulsa Procedure, there was no median change in penile length, compared with a median 0.65-centimetre reduction in penile length after robotic RP.

The new penile length results in favour of the Tulsa Procedure were presented for the first time earlier today by Xiaosong Meng, MD, PhD, an assistant professor in the Department of Urology at UT Southwestern Medical Center at the Society of Robotic Surgery annual meeting held in Fort Lauderdale, Fla.

Dr. Meng's SRS presentation highlighted:

• No median change in penile length at one month after whole-gland Tulsa, compared with a median 0.65-centimetre reduction in penile length after robotic RP;
• A statistically significant between-arm difference in change in penile length estimated from a mixed-effect model (0.42 centimetre, p is less than 0.001);
• Additional quality of life context following Profound's previously announced Captain primary safety end point results, in which Tulsa demonstrated statistically significant superiority over robotic RP in preserving both erectile function and urinary continence at six months.

"Penile length is not something many men feel comfortable talking about, even in the absence of prostate disease," said Arun Menawat, Profound's chief executive officer and chairman. "Because the penis may be deeply tied to their identity, masculinity and/or self-worth, even small amounts of penile shrinkage can cause men a lot of additional worry and distress. This new data points to the greater peace of mind that the Tulsa Procedure can deliver to patients by gently, safely and precisely ablating prostate tissue while actively protecting surrounding structures."

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 robotic RP in men with organ-confined, intermediate-risk, Gleason Score 7 (grade group 2 and 3) prostate cancer. Captain exceeded its enrolment target, treating 211 patients, instead of the initially planned 201 patients, by August, 2025, at 20 sites in the United States, two in Canada and one in Europe. The goal of Captain is to demonstrate that the efficacy of the Tulsa procedure is not inferior to robotic 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 and cost-effectiveness, as well as histologic and biochemical failure.

About Profound Medical Corp.

Profound is a commercial-stage medical device company and an innovator in interventional MRI procedures. The company's flagship platform, Tulsa-Pro, enables MRI-guided, incision-free prostate ablation. Physicians use the Tulsa Procedure to see, ablate and confirm therapy in real time, supporting personalized treatment strategies across the continuum of prostate care -- from whole gland to subtotal, hemi, multifocal and focal treatment. This approach enables individualized care using prostate tissue ablation while minimizing the potential of the side effects that are typically associated with surgery or radiation, such as urinary incontinence and/or erectile dysfunction.

Profound also commercializes Sonalleve, an MRI-guided therapy that provides a non-surgical treatment option for pain palliation of bone metastases, desmoid tumours and osteoid osteoma, as well as for common gynecologic conditions, including uterine fibroids and adenomyosis. Sonalleve delivers targeted therapy with no incisions, no blood loss during the procedure, no overnight hospital stay and faster recovery, and, in gynecologic applications, enables uterine-sparing treatment that may help preserve fertility. Profound is also exploring additional clinical applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia-based cancer therapies.

Profound Medical's technologies are approved across major global markets. Tulsa-Pro is cleared by the Food and Drug Administration in the United States for transurethral ultrasound ablation (Tulsa) of prostate tissue. In addition, Tulsa-Pro is cleared for use in various jurisdictions including Europe, Canada, Saudi Arabia, India, Australia/New Zealand and the United Arab Emirates. Sonalleve is approved by the FDA as HDE in the United States for the treatment of osteoid osteomas in the extremities. Sonalleve is also cleared or approved in the Europe, Canada, China and Saudi Arabia.

Through real-time MRI guidance and data-driven innovation, Profound is advancing the future of MRI-guided therapy -- expanding access to precise, personalized and incision-free treatment options worldwide.

We seek Safe Harbor.