Mr. Arun Menawat reports

PROFOUND MEDICAL CONGRATULATES THE BUSCH CENTER FOR ACHIEVING 500TH TULSA PROCEDURE MILESTONE

Profound Medical Corp. today unveiled new, real-world data from the internationally recognized Busch Center. The data -- marking the centre's milestone of 500 completed Tulsa Procedures -- demonstrate the procedure's versatility and success in treating a broad spectrum of prostate diseases, severities and aggressions using a unique incision-free, MRI-guided approach.

"When I first began performing the Tulsa Procedure, I was optimistic but cautious. After about 30 procedures, I was confident enough to offer Tulsa to my patients exclusively," said Dr. Joseph Busch, founder of the Busch Center. "I've had highly successful outcomes, even in the more complicated cases, such as those involving cancer at the prostate apex or calcifications that can make treatment more challenging. Fortunately, I have had many men referred to me by previous patients who had positive results, including good cancer control and no side effects like urinary incontinence and/or erectile dysfunction and I have turned away only a very small number who I have felt would not benefit from undergoing the Tulsa Procedure."

The Tulsa Procedure is used by physicians to treat prostate cancer and benign prostatic hyperplasia (BPH, also known as an enlarged prostate). Among Dr. Busch's cases, about half were for the primary treatment of prostate cancer and one-third were for BPH, either alone or co-occurring with prostate cancer. The remainder were salvage patients previously treated with another therapy, a population with significant unmet need, to which Tulsa's inside-out approach is ideally suited.

Early experience included focal and hemi-gland prostate ablations, but over time the clinical data showed that whole-gland Tulsa provided the best oncological control while maintaining urinary continence and erectile function. As a result, over three-quarters of the cases performed to date at the Busch Center have been for customized ablations covering more than 90 per cent of the prostate volume. While the majority of prostate cancer patients were of intermediate risk -- where often surgery or radiation are considered too much and active surveillance not enough -- more than 15 per cent of men had high-risk disease benefiting from Tulsa's intraoperative MRI guidance to visualize the cancer, real-time thermography for precision control, Tulsa-AI modules like Thermal Boost and the ability to ablate the whole-gland safely and efficiently. Tulsa's flexibility is also evident in the range of prostate volumes treated, with two-thirds over 40 cubic centimetres (cc) -- and even as large as 250 cc -- representing the natural distribution expected in this population.

Dr. Busch and his team have reported successful outcomes -- without life-altering complications -- at multiple specialty society meetings, including a retrospective analysis of 73 patients, salvage treatment of recurrences, dose escalation to MRI visible lesions and outcomes in extra-large prostate greater than 90 cc. Of particular interest are prostate cancer lesions at the extreme apex (where the risk of incontinence is greatest), due to Tulsa's unique combination of urethral cooling and high frequency mode which enables tightly controlled margins. In a retrospective analysis of the Tulsa Procedure in men with prostate cancer abutting or involving the external urinary sphincter, Dr. Busch and his team demonstrated PSA reduction from 6.7 to 0.9 nanograms per millilitre (ng/mL), with no evidence of residual disease in 93 per cent of patients. Despite including up to 50 per cent of the external sphincter in the treatment plan, pad-free continence and erectile function was maintained in 100 per cent and 82 per cent of men, respectively.

"Dr. Busch's experience reflects both his surgical expertise and the flexibility of the Tulsa-PRO technology in addressing a broad spectrum of prostate disease and disease severity," said Arun Menawat, Profound's chief executive officer and chairman. "As real-world experience continues to grow, we're seeing encouraging results in diverse patient populations that point to the Tulsa Procedure as a precise, customizable, next-generation treatment for most men with prostate disease."

The Tulsa Procedure represents a major advancement in prostate care. Unlike traditional treatments that involve surgery, radiation, or lengthy recovery times, the Tulsa Procedure is performed inside an MRI suite using robotically guided, directional ultrasound to precisely ablate targeted prostate tissue -- without harming surrounding structures. The Tulsa-PRO system -- the technology behind the procedure -- is the only AI-powered, MRI-guided robotic system for prostate treatment. Real-time thermography from the MRI allows physicians to visualize and control the prostate therapy throughout the procedure and customize treatment for each patient with unmatched precision.

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, artificial-intelligence-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, 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 through precise sound absorption technology that gently heats it to 55 to 57 C. The Tulsa Procedure 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 the Tulsa Procedure. 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.

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