Profound Medical Congratulates the Busch Center for Achieving 500th TULSA Procedure Milestone
TORONTO, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF, TSX:PRN) ("Profound" or the "Company"), a commercial-stage medical device company that develops and markets customizable, AI-powered, incision-free therapies for the ablation of diseased tissue, today unveiled new, real-world data from the internationally recognized Busch Center. The data — marking the center'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% 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% 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 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 > 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 ng/mL, with no evidence of residual disease in 93% of patients. Despite including up to 50% of the external sphincter in the treatment plan, pad-free continence and erectile function was maintained in 100% and 82% 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 CEO 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, 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 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. 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, palliative pain treatment and osteoid osteoma; and the success of Profound's U.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
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T: 647.872.4849
Susan Thomas
Public Relations
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T: 619.540.9195
