Core Insights - Profound Medical Corp. announced the superiority of the TULSA Procedure over robotic radical prostatectomy (RP) in terms of primary safety endpoints in the CAPTAIN trial for men with intermediate-risk prostate cancer [1][5] Group 1: CAPTAIN Trial Overview - The CAPTAIN trial exceeded its enrollment target, treating 211 patients across 20 sites in the U.S., two in Canada, and one in Europe by August 2025 [2] - The trial aimed to compare the safety and efficacy of the TULSA Procedure with RP, focusing on preserving erectile function and urinary continence [8] Group 2: Clinical Outcomes - At 6 months post-treatment, 50% of patients preserved both erectile function and urinary continence after TULSA compared to 24% after RP, indicating a statistically significant improvement (p<0.05, risk ratio 2.1) [5] - TULSA preserved pad-free continence in 84% of men, while only 49% achieved this after RP [5] - Patient-reported erectile function was preserved in 56% of TULSA patients compared to 47% after RP [5] Group 3: Perioperative Measures - TULSA demonstrated zero blood loss during the procedure, while RP had an average blood loss of 150 mL (p<0.001) [5] - Patients undergoing TULSA had a shorter recovery time, missing an average of 10 days from work compared to 19 days for RP (p<0.05) [5] - There were significantly fewer serious complications requiring hospitalization after TULSA (0.7%) compared to RP (6.3%) within 90 days (p<0.05) [5] Group 4: Future Implications - The CAPTAIN trial is positioned to potentially establish the TULSA Procedure as a standard of care for prostate cancer treatment, with secondary oncologic outcomes expected later this year [6][8] - The trial's design allows for a rigorous comparison of safety, quality of life, and oncological control between the two treatment modalities [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. has achieved a significant milestone with the TULSA Procedure, marking the first 200 procedures performed independently by a urologist without radiologist involvement, establishing a new model for MRI-guided prostate therapy [1][2][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 [5][6] - The company is commercializing the TULSA-PRO® system, which combines real-time MRI, AI-enhanced planning, and robotically-driven ultrasound for precise prostate treatment [6][7] TULSA Procedure Details - The TULSA Procedure is a clinically proven treatment for prostate disease that utilizes robotically controlled ultrasound to ablate prostate tissue while preserving surrounding structures [2][6] - This procedure is performed in a single session, takes a few hours, and does not require hospitalization, with most patients reporting quick recovery [6][7] - The TULSA Procedure is designed to treat a wide range of prostate conditions, including low-, intermediate-, and high-risk prostate cancer, benign prostatic hyperplasia (BPH), and salvage therapy for radio-recurrent localized prostate cancer [6][8] Clinical Impact - Dr. Y. Mark Hong's independent execution of the TULSA Procedure demonstrates that urologists can safely perform the entire procedure, achieving excellent outcomes without the need for radiologist collaboration [2][3] - The procedure has shown to result in high cure rates, rapid recovery, and preservation of urinary and sexual function, with no procedural blood loss [3][4] Future Outlook - Dr. Hong believes that the TULSA Procedure represents the future of prostate disease treatment and may eventually replace radical prostatectomy as the first-line option for prostate cancer [4]

Core Insights - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, incision-free therapies for tissue ablation [3][4] Company Overview - Profound Medical Corp. is engaged in the commercialization of TULSA-PRO®, a technology that integrates real-time MRI, AI-enhanced planning, and robotically-driven ultrasound for prostate disease treatment [4] - The TULSA Procedure™ is designed to treat various prostate conditions, including low-, intermediate-, and high-risk prostate cancer, benign prostatic hyperplasia (BPH), and salvage therapy for radio-recurrent localized prostate cancer [4] - The TULSA Procedure is characterized as a "one-and-done" treatment, performed in a single session without incisions or radiation, with a typical duration of a few hours [4] - The procedure utilizes precise sound absorption technology to heat targeted prostate tissue to 55-57°C, preserving urinary continence and sexual function [4] - TULSA-PRO has received CE marking, Health Canada approval, and 510(k) clearance from the U.S. FDA [4] Additional Products - Profound is also commercializing Sonalleve®, a therapeutic platform approved for treating uterine fibroids and palliative pain from bone metastases [5] - Sonalleve has received CE marking and approval from the China National Medical Products Administration for non-invasive treatment of uterine fibroids, as well as FDA approval under a Humanitarian Device Exemption for osteoid osteoma treatment [5] - The company is exploring further treatment applications for Sonalleve, including non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy [5] Upcoming Events - Management will present a business update at the Stifel 2025 Healthcare Conference on November 11, 2025, at 1:20 p.m. Eastern Time [1][2]

Core Points - Profound Medical Corp. held its Annual General and Special Meeting of Shareholders, with 20,587,011 common shares represented, accounting for 68.5% of the outstanding shares [1][2] - All matters presented to shareholders were approved by the requisite majority [2] Election of Directors - All six nominees for the board of directors were elected with the following voting results: - Arun Menawat: 11,147,209 votes (94.536% for) [3] - Brian Ellacott: 11,048,084 votes (93.695% for) [3] - Cynthia Lavoie: 11,438,299 votes (97.005% for) [3] - Murielle Lortie: 11,291,509 votes (95.76% for) [3] - Arthur Rosenthal: 10,899,784 votes (92.438% for) [3] - Kris Shah: 11,040,268 votes (93.629% for) [3] Other Matters - Shareholders approved the appointment of PricewaterhouseCoopers LLP as the auditor until the next annual meeting [4] - An ordinary resolution was passed approving all unallocated options under the Company's share option plan [4] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on customizable, incision-free therapies for the ablation of diseased tissue [5] - The company is commercializing TULSA-PRO®, a technology that combines real-time MRI, AI-enhanced planning, and robotically driven ultrasound for prostate disease treatment [6] - TULSA-PRO® is designed to preserve urinary continence and sexual function while effectively treating prostate tissue [6] - Profound is also commercializing Sonalleve®, a platform for treating uterine fibroids and palliative pain from bone metastases, with various regulatory approvals [7]

Core Insights - Profound Medical Corp. is a commercial-stage medical device company focused on customizable, incision-free therapies for ablation of diseased tissue [3] Company Overview - Profound Medical is commercializing TULSA-PRO®, a technology that integrates real-time MRI, robotically-driven transurethral ultrasound, and closed-loop temperature feedback control for prostate disease treatment [4] - The TULSA procedure is designed to treat a range of prostate conditions, including low-, intermediate-, and high-risk prostate cancer, benign prostatic hyperplasia (BPH), and salvage therapy for radio-recurrent localized prostate cancer [4] - TULSA is a single-session procedure that preserves urinary continence and sexual function while effectively targeting prostate tissue through precise heating [4] - Profound is also commercializing Sonalleve®, a therapeutic platform for treating uterine fibroids and palliative pain from bone metastases, with approvals in multiple regions including CE marking and FDA clearance [5] Upcoming Events - Management will present a business update at the 2025 Bloom Burton & Co. Healthcare Investor Conference on May 6, 2025 [1] - The presentation will be available for live broadcast and archived on the company's website [2]