New BPH module and clinical data reinforce the TULSA Procedure™’s versatility in prostate disease, superior patient benefits, and potential for mainstream adoptionTORONTO, Nov. 28, 2025 (GLOBE NEWSWIRE) -- 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 the upcoming launch of its TULSA-AI® Volume Reduction module ...

Core Insights - Profound Medical Corp. reported a record revenue growth of 87% year-over-year, reaching $5.3 million in Q3 2025, driven by increased demand for its TULSA-PRO technology [2][4] - The gross margin improved significantly by 1,119 basis points to 74.3% in Q3 2025, attributed to enhanced manufacturing efficiency [2][5] - The company is expanding its sales pipeline and installed base for TULSA-PRO, with expectations to reach at least 75 installations by year-end [2][3] Business Highlights - Revenue for Q3 2025 was $5.3 million, with $4.1 million from recurring non-capital revenue and $1.2 million from one-time capital equipment sales, marking an 87% increase from $2.8 million in Q3 2024 [4] - The TULSA-PRO installed base increased to 70 systems, with a growing sales pipeline of 93 new systems in various stages of the sales process [2][3] - The TULSA Procedure was utilized for a diverse range of prostate disease patients, with 79% treated for prostate cancer only [2] Financial Performance - Operating expenses for Q3 2025 totaled approximately $12.8 million, up from $10.8 million in the prior year, primarily due to increased headcount and sales force [6] - The net loss for Q3 2025 was approximately $8.0 million, or $0.26 per share, showing a 15% improvement from a net loss of $9.4 million, or $0.38 per share, in Q3 2024 [7] - As of September 30, 2025, the company had cash reserves of approximately $24.8 million [8] Strategic Developments - In September 2025, Profound launched the TULSA-PROgram in collaboration with Texas Prostate and Dallas Medical Center to enhance access to advanced prostate treatments [2] - The company regained exclusive distribution rights for TULSA-PRO in Canada and entered into a distribution agreement for its technologies in Saudi Arabia [2][3] - A strategic distribution agreement was also established with Getz Healthcare to introduce TULSA-PRO in Australia and New Zealand [3]

Core Insights - Profound Medical Corp has entered into an exclusive distribution and supply agreement for its TULSA-PRO system with Getz Healthcare in Australia and New Zealand, marking a significant step in advancing precision prostate care in these regions [1][3] Company Overview - Profound Medical Corp is a commercial-stage medical device company that develops and markets AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [6][8] - The TULSA-PRO system is the only AI-powered, MR-guided robotic system for prostate therapy, allowing real-time MRI thermography and autonomous temperature control [2][7] Product Details - The TULSA Procedure is a significant advancement in prostate care, utilizing robotically controlled, directional ultrasound to precisely ablate prostate tissue while protecting surrounding structures [2][7] - The procedure is incision- and radiation-free, performed in a single session, and has shown to preserve patients' urinary continence and sexual function [7][8] - TULSA-PRO is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA [8] Market Context - Prostate cancer is the most commonly diagnosed cancer in men in Australasia, highlighting the importance of the TULSA-PRO system in addressing this health issue [3] - The partnership with Getz Healthcare aims to expand the reach of TULSA-PRO and explore additional key markets across the Asia Pacific region [3][5] Strategic Initiatives - Profound Medical is deploying its own direct sales team in North America while partnering with strategic distribution partners globally to support business potential [3]