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Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) ("Profound" or the "Company"), a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue, announced today that The Hong Center Scottsdale, led by Dr. Y. Mark Hong of Integrative Urology in Phoenix, Arizona, has achieved a world-first milestone: 200 TULSA Procedures™ performed independently by a urologist, without radiologist involvement. This landmark establishes a new model for delivering MRI-guided prostate therapy.
"Dr. Hong's longstanding commitment to innovation and compassion for his patients made him a pioneer in bringing the TULSA Procedure, a clinically proven, advanced prostate disease treatment, to patients," said Profound Medical CEO and Chairman, Arun Menawat. "This 200-procedure milestone is more than a number - it represents the hundreds of men who are now living cancer-free, with preserved quality of life, thanks to his expertise and dedication."
The TULSA Procedure, performed using Profound's TULSA-PRO ® system, is a significant advancement in prostate care. Instead of surgery or radiation, treatment is performed inside an MRI suite using robotically controlled, directional ultrasound to precisely ablate prostate tissue while protecting surrounding structures. TULSA-PRO is the only AI-powered, MR-guided robotic system for prostate therapy, enabling real-time MRI thermography and autonomous temperature control. This allows physicians to see, monitor and adjust treatment throughout the procedure — delivering personalized therapy with exceptional precision. Often, TULSA Procedures have involved collaboration between urologists and radiologists. Dr. Hong's independent workflow proves that a urologist alone can safely execute the full procedure — from image planning to ablation — while achieving excellent outcomes.
Among the earliest adopters of the TULSA Procedure, Dr. Hong built one of the world's first urology-driven practices to offer incision-free prostate care at The Hong Center Scottsdale. Treating patients from Arizona, nationally and internationally, Dr. Hong routinely performs whole-gland, focal, BPH and salvage cases with consistent, high-volume success, achieving exceptional outcomes without procedural blood loss or hospitalization. His experience and expertise have allowed him to treat the most complex of cases with rapid recovery, high cure rates, and preserved urinary and sexual function.
"Having performed hundreds of robotic prostatectomies, I recognized early the potential of the TULSA Procedure to transform prostate cancer treatment," said Dr. Hong. "Since accountability is the most important factor to improving as an independent surgeon, we are proud of refining the TULSA technique over 200 cases to cure cancer while not causing harm. In my view, TULSA represents the future of prostate disease treatment, one that will ultimately replace radical prostatectomy as a first-line option for prostate cancer."
Dr. Hong is one of the world's first board-certified urologists to complete a fellowship in Integrative Medicine. A graduate of Stanford University School of Medicine, Dr. Hong completed his general surgery training at Brigham and Women's Hospital and his urological surgery residency at Harvard Medical School. His research on prostate cancer and the fear of cancer recurrence remains one of the first works of its kind in the published literature. Dr. Hong completed a robotic and minimally invasive surgery fellowship at George Washington University in Washington, D.C. He has published extensively in nearly every international urological journal.
About Profound Medical Corp.
Profound is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, 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. The TULSA Procedure 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, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma. 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, adenomyosis, pain palliation of bone metastases, desmoid tumors and osteoid osteoma; and the success of Profound'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
