Core Insights - Profound Medical Corp. has achieved a significant milestone with the completion of its 500th Sonalleve Procedure at PRO FAMILIA Specialist Hospital in Poland, reflecting the growing adoption of non-surgical treatment options for uterine conditions [1][2] - The Sonalleve technology offers a non-invasive alternative for treating uterine fibroids and adenomyosis, providing targeted relief without incisions, blood loss, or the need for overnight hospital stays [1][2] - The company is also focused on the commercialization of TULSA-PRO, which is designed for prostate disease treatment, emphasizing its unique ability to minimize side effects associated with traditional surgical methods [3][5] Company Overview - Profound Medical Corp. is a commercial-stage medical device company that specializes in AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [4] - The company is actively commercializing two main products: TULSA-PRO for prostate conditions and Sonalleve for gynecologic disorders, both of which utilize advanced imaging and therapeutic technologies [5][7] Product Details - Sonalleve has been operational in Europe, China, and Southeast Asia, with over 4,000 women treated for uterine conditions, demonstrating effective pain and symptom relief while preserving fertility [2][3] - TULSA-PRO employs real-time MRI guidance and is designed to treat a wide range of prostate diseases, ensuring preservation of urinary continence and sexual function [5][6] - Both Sonalleve and TULSA-PRO have received various regulatory approvals, including CE marking and FDA clearance, indicating their compliance with safety and efficacy standards [6][7]

Core Insights - Mount Sinai Hospital has successfully treated its first prostate cancer patient using the TULSA-PRO system, marking a significant advancement in prostate care with AI-powered, MRI-guided therapy [1][4] Group 1: TULSA Procedure Overview - The TULSA Procedure™ utilizes robotically controlled directional ultrasound to heat prostate tissue to 'kill temperature' (55-57°C), while protecting surrounding nerves, resulting in no procedural blood loss and a quicker recovery [2][9] - This procedure is designed to treat a range of prostate diseases, including prostate cancer and benign prostatic hyperplasia (BPH), with minimal side effects such as urinary incontinence and erectile dysfunction [2][8] Group 2: Collaboration and Leadership - Mount Sinai is the first health system in the New York Metro Area to offer the TULSA Procedure, establishing itself as a leader in robotic surgical care [4] - The collaboration between the Department of Urology and the Department of Interventional Radiology at Mount Sinai aims to pave the way for future studies and guidelines in prostate cancer and BPH treatment using TULSA-PRO [5] Group 3: Technology and Market Potential - TULSA-PRO combines real-time MRI, AI-enhanced planning, and temperature feedback control, positioning it as a potential mainstream treatment for various prostate conditions [8] - The procedure is CE marked, Health Canada approved, and 510(k) cleared by the U.S. FDA, indicating its regulatory compliance and market readiness [9]

Core Insights - Profound Medical Corp. has successfully increased its TULSA-PRO installed base to 78 systems by the end of 2025, surpassing its target of 75 installations [1] - The qualified sales pipeline for TULSA-PRO has expanded to 97 new systems, indicating strong market interest and potential for future sales [2] - The CEO of Profound Medical anticipates that the growing installed base will lead to higher patient treatment rates and an increase in high-margin recurring revenue, driven by the TULSA Procedure's effectiveness in treating a wide range of prostate diseases while preserving patient functions [3] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing and marketing AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [4] - The TULSA-PRO system utilizes advanced technology, including real-time MRI, AI-enhanced planning, and temperature feedback control, to provide precise treatment for various prostate conditions [5] - Profound is also commercializing Sonalleve, a therapeutic platform approved for treating uterine fibroids and other conditions, and is exploring additional treatment markets for this technology [6]

Core Viewpoint - Profound Medical Corp. has increased the size of its private placement to raise up to US$6.45 million, accommodating a long-term existing investor [1]. Group 1: Offering Details - The Offering will consist of up to 921,428 common shares priced at US$7.00 per share [1]. - The common shares will be subject to a hold period of four months plus one day from the closing date, which is expected to occur on or prior to December 30, 2025 [2]. Group 2: Use of Proceeds - The net proceeds from the Offering will be utilized for expansion of sales and marketing, working capital, research and development, strategic transactions, and general corporate purposes [2]. Group 3: Company Overview - Profound Medical Corp. is a commercial-stage medical device company that develops AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [4]. - The company is commercializing TULSA-PRO, a technology that combines real-time MRI, AI-enhanced planning, and ultrasound for prostate disease treatment [5]. - Profound is also commercializing Sonalleve, a therapeutic platform for treating uterine fibroids and other conditions, with approvals in multiple jurisdictions [6].

Core Insights - Profound Medical Corp. announced that Dr. Pejman Ghanouni received the Cum Laude award for his presentation on the CAPTAIN trial comparing MRI-guided TULSA Procedure with robotic radical prostatectomy at the RSNA Annual Meeting 2025, highlighting the significance of this recognition in the medical community [1][2][3] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, MRI-guided, incision-free therapies for the ablation of diseased tissue [5][6] - The company is commercializing the TULSA-PRO system, which utilizes real-time MRI and AI-enhanced planning for precise prostate tissue ablation, aiming to become a mainstream treatment for various prostate conditions [6][7] TULSA Procedure Details - The TULSA Procedure is a non-invasive treatment that uses robotically controlled ultrasound to ablate prostate tissue while preserving surrounding structures, offering advantages such as no blood loss, no overnight hospital stay, and quicker recovery times compared to traditional surgical methods [3][7] - The procedure is designed to be performed in a single session, taking a few hours, and is suitable for a wide range of prostate shapes and sizes [7] CAPTAIN Trial Insights - The CAPTAIN trial is a multi-center randomized controlled study comparing the safety and efficacy of the TULSA Procedure with robotic radical prostatectomy in men with organ-confined, intermediate-risk prostate cancer, with 210 patients randomized as of January 2025 [4] - The trial's results indicate that patients undergoing the TULSA Procedure experience significantly shorter recovery times, with many feeling back to normal the day after the procedure, compared to an average of three weeks for robotic surgery patients [3][4] Recognition and Awards - Dr. Ghanouni's presentation was one of only six to receive the Cum Laude award at RSNA 2025, representing the top 5% of scientific posters, underscoring the quality and impact of the research presented [2][3] - Additionally, Dr. Satoru Takahashi received a Certificate of Merit for his work on TULSA, further validating the procedure's emerging role in prostate cancer treatment [3]

Core Insights - Profound Medical Corp. is launching the TULSA-AI Volume Reduction module for treating benign prostatic hyperplasia (BPH) at the RSNA meeting, enhancing the TULSA Procedure's versatility and potential for mainstream adoption [1][4] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on AI-powered, MRI-guided, incision-free therapies for ablation of diseased tissue [9][10] - The TULSA Procedure™ is the only incision-free option for prostate cancer and BPH, utilizing real-time MRI guidance for precision [3][10] Product Details - The TULSA-AI Volume Reduction module allows for efficient stacking of multiple prostate cases in one day, improving workflow and reducing procedure times [3][4] - The TULSA Procedure has shown significantly reduced risks of sexual function loss and incontinence compared to traditional methods, with superior outcomes in blood loss, length of stay, post-operative pain, and recovery time [3][4] Market Potential - The launch of the TULSA-AI module is expected to triple Profound's total available market in prostate disease to approximately 600,000 patients annually [4] - The TULSA Procedure is positioned to become a mainstream treatment across various prostate disease conditions, including low-, intermediate-, and high-risk prostate cancer, as well as BPH [10] Event Participation - Profound Medical will showcase the TULSA-AI Volume Reduction module and present new clinical data at the RSNA and SUO meetings [5][6][7]

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]