Profound Medical Launches AI-Powered BPH Module and Expands Global Reach Through Strategic Partnerships
核心洞察
Profound Medical announced the launch of its TULSA-AI Volume Reduction module for treating benign prostatic hyperplasia (搜索) (BPH (搜索)) at the RSNA meeting, following a successful pilot trial earlier this year.
The AI-powered module streamlines workflow and reduces procedure times, potentially tripling Profound's total available market to approximately 600,000 patients annually.
The company secured exclusive distribution agreements with Al Faisaliah Medical Systems (搜索) in Saudi Arabia and Getz Healthcare (搜索) in Australia and New Zealand to expand global access to TULSA-PRO (搜索) technology.
Profound Medical Corp. (搜索) has announced the launch of its TULSA-AI Volume Reduction module for treating benign prostatic hyperplasia (搜索) (BPH (搜索)) at the Radiological Society of North America (RSNA) meeting in Chicago, marking a significant advancement in the company's AI-powered, MRI-guided therapy platform. The launch follows a successful pilot trial conducted earlier this year and represents a major expansion of the TULSA-PRO (搜索) system's capabilities.
AI-Enhanced BPH Treatment Module
The TULSA-AI Volume Reduction module addresses the treatment of BPH (搜索), a non-cancerous enlargement of the prostate (搜索) gland that affects men as they age and often impedes urine flow while creating significant lower urinary tract symptoms. Current BPH treatment with transurethral resection of the prostate (TURP) has remained largely unchanged over the past 100 years, with many alternative methods investigated to improve patient experience and reduce complications such as bleeding, erectile dysfunction, loss of ejaculation, and extended hospital stays.
"We're confident to launch the TULSA-AI Volume Reduction module for BPH (搜索), following a successful pilot trial earlier this year," said Profound CEO and Chairman Arun Menawat. "The use of AI to streamline the workflow and reduce procedure times is a significant advance that makes using TULSA-PRO (搜索) for treating enlarged prostate (搜索) just as efficient as other modern procedures, but with the advanced benefits of precision and customization to any prostate shape or size."
The AI-powered module enables physicians to efficiently stack multiple prostate (搜索) cases in one day using the same device hardware, clinical support staff, and reimbursement codes. According to Menawat, the reduced procedure times are expected to increase adoption of the TULSA Procedure and triple Profound's total available market in prostate disease to approximately 600,000 patients annually.
Technology Platform and Clinical Benefits
The TULSA Procedure, performed using Profound's TULSA-PRO (搜索) system, represents the only incision-free procedure for prostate cancer (搜索), BPH (搜索), and patients with both conditions. The technology combines real-time MRI, AI-enhanced planning, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control.
The procedure employs real-time MR guidance for precision to preserve patients' urinary continence and sexual function while killing targeted prostate (搜索) 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, with virtually all prostate shapes and sizes treatable safely, effectively, and efficiently.
Clinical advantages include no bleeding associated with the procedure, no required hospital stay, and most TULSA patients reporting quick recovery to their normal routine. Real-world data demonstrates significantly reduced risk of loss of sexual function and incontinence, while CAPTAIN perioperative data shows the TULSA Procedure's superiority to Robotic Prostatectomy in blood loss, length of stay, post-operative pain, and recovery time.
Global Expansion Through Strategic Partnerships
Profound Medical has secured exclusive distribution agreements to expand global access to its technologies. The company partnered with Al Faisaliah Medical Systems (搜索) Co. (FMS), a subsidiary of Al Faisaliah Group, for exclusive distribution of both TULSA-PRO (搜索) and Sonalleve (搜索) technologies in Saudi Arabia, the largest healthcare market in the Middle East. All required regulatory approvals to import and sell Profound's technologies in Saudi Arabia are already in place.
"We're honored to partner for the distribution of both TULSA-PRO (搜索) and Sonalleve (搜索) with FMS, one of the leading medical device distributors in the Kingdom of Saudi Arabia," commented Menawat. "Successfully marketing and distributing our incision-free therapies for the ablation of diseased tissue requires a deep understanding of regional market dynamics and the specific needs of local clinicians and patients."
Additionally, Profound announced an exclusive distribution agreement with Getz Healthcare (搜索) for TULSA-PRO (搜索) in Australia and New Zealand. "Our exclusive partnership with Profound Medical marks a significant step in advancing precision prostate (搜索) care across Australia and New Zealand," commented Getz Healthcare ANZ Managing Director Derek Foltin.
Clinical Data and Market Position
To date, more than 4,000 men have undergone the TULSA Procedure, and as of October 2025, Profound's TULSA-PRO (搜索) installed base stood at 67 systems. The technology is CE marked, Health Canada approved, and 510(k) cleared by the U.S. Food and Drug Administration.
In late 2024, the U.S. Centers for Medicare & Medicaid Services issued its outpatient prospective payment system final rule for three new CPT Category 1 codes covering the TULSA procedure, which became effective January 1, 2025. TULSA reimbursement was established at Urology Level 7 Ambulatory Payment Classification.
The company will present new TULSA-PRO (搜索) clinical data at both RSNA and the Society for Urologic Oncology meetings, including presentations on the CAPTAIN randomized controlled trial comparing MRI-guided transurethral ultrasound ablation versus robotic radical prostatectomy, and single-center outcomes in 160 patients with organ-confined prostate cancer (搜索).
Broader Technology Portfolio
Beyond TULSA-PRO (搜索), Profound commercializes Sonalleve (搜索), an innovative therapeutic platform CE marked for treating uterine fibroids (搜索), adenomyosis (搜索), pain palliation of bone metastases, desmoid tumors, and osteoid osteoma. There are currently ten Sonalleve devices operational in parts of Europe, China, and Southeast Asia, where over 4,000 women have been treated for adenomyosis and uterine fibroids. Treatment with Sonalleve has demonstrated pain and symptom relief without affecting ovarian reserve, with reports of women preserving their fertility.