Texas Prostate and Dallas Medical Center Launch First-of-its-Kind TULSA Program, Expanding Access to Advanced Prostate Treatment

New program delivers TULSA Procedure’s precision treatment - minimal side effects, no overnight hospital stay – to Medicare patients across Texas

TORONTO, Sept. 23, 2025 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company developing AI-powered, incision-free therapies for ablating diseased tissue, announced today the launch of a first-of-its-kind TULSA program by Texas Prostate and Dallas Medical Center to meet the growing demand for advanced prostate treatment — without surgery. Under the program, Texas Prostate will perform TULSA procedures for men with prostate cancer and benign prostatic hyperplasia (“BPH”) in Dallas Medical Center’s state-of-the-art MRI suite, significantly expanding Medicare patient access to the TULSA Procedure™.

“The TULSA procedure is integral to our practice because it offers many men effective prostate treatment without the life-altering side effects of surgery — such as incontinence or erectile dysfunction,” said Dr. James Cochran, founder of Texas Prostate. “With Medicare coverage now available, we’ve been seeking ways to offer more men access to this transformative technology. Working with Dallas Medical Center allows us to do just that.”

In January, 2025 Medicare coverage was granted for the TULSA Procedure performed in Hospital Outpatient, Ambulatory Surgical Center and Private Office/Non-Facility settings, broadening access to the treatment. This collaboration makes the TULSA Procedure available under Medicare coverage, with Texas Prostate now performing TULSA procedures exclusively at Dallas Medical Center. The hospital gains both advanced technology and the Texas Prostate team’s proven expertise in performing TULSA Procedures.

“At Dallas Medical Center, we’re committed to bringing advanced, compassionate care to our patients,” said Ruben Garza, CEO of Dallas Medical Center. “By working with Texas Prostate, patients can be treated with the TULSA-PRO^® system in our state-of-the-art MRI suite — and then return home the same day, with no procedural blood loss, and a significantly lower risk of complications.”

Profound Medical CEO Arun Menawat added, “The versatility of TULSA enables the treatment of a wide variety of prostate disease including whole gland or targeted gland treatments, and we are thrilled to see that this new program will provide access to a wider population of patients. Importantly, it also provides a model for private pay urology practices and Medicare accepting hospitals nationwide seeking to expand access to the TULSA procedure.”

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. It allows physicians to visualize the prostate in real time and customize therapy 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
skilmer@profoundmedical.com
T: 647.872.4849

Susan Thomas
Public Relations
sthomas@profoundmedical.com
T: 619.540.9195

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