Core Insights - Profound Medical Corp. reported a significant revenue growth of 82% in Q1 2025 compared to Q1 2024, reaching approximately $2.6 million [5][6] - The company continues to expand its market presence with its TULSA technology, which is positioned uniquely in the prostate disease treatment market [3][4] - Gross margin improved to 71% in Q1 2025, up from 60% in the same period last year, attributed to higher manufacturing efficiency [7] Business Highlights - The revenue growth trajectory aligns with internal expectations, and the AUA 2025 meeting was successful for the company [3] - TULSA's economic proposition is enhanced by new Urology APC Level 7 codes, which offer higher reimbursement rates compared to competitors [3] - The company plans to roll out the TULSA-AI module for benign prostatic hyperplasia (BPH) and the TULSA+ total interventional-MRI solution in the second half of 2025 [3] Financial Performance - Q1 2025 revenue was approximately $2.6 million, with $1.8 million from recurring non-capital revenue and $820,000 from one-time capital equipment sales [6] - Operating expenses increased to approximately $13.0 million in Q1 2025, up from $8.7 million in the prior year, primarily due to expansion efforts [8] - The net loss for Q1 2025 was approximately $10.7 million, or $0.36 per share, compared to a net loss of $6.6 million, or $0.27 per share, in Q1 2024 [9] Market and Product Development - The TULSA-PRO technology is designed for a wide range of prostate disease treatments, emphasizing its precision and effectiveness [14] - Initial perioperative data from the CAPTAIN randomized trial showed TULSA's advantages over robotic radical prostatectomy, including no blood loss and quicker recovery [4][5] - Profound is also exploring additional markets for its Sonalleve platform, which is approved for treating uterine fibroids and palliative pain [15]

Core Insights - The CAPTAIN trial is the first Level 1 study comparing the TULSA procedure with radical prostatectomy (RP) in men with intermediate-risk prostate cancer, showing TULSA's advantages in safety and patient experience [1][4][7] - Initial perioperative data indicates TULSA has no blood loss, shorter hospital stays, and reduced post-procedure pain compared to RP, leading to quicker recovery [1][5][6] Company Overview - Profound Medical Corp. is a commercial-stage medical device company focused on developing AI-powered, incision-free therapies for tissue ablation [1][8] - The TULSA-PRO system combines real-time MRI, AI-enhanced planning, and ultrasound technology for precise treatment of prostate conditions [9] Clinical Trial Details - The CAPTAIN trial recruited 201 patients across 20 sites in the U.S., Canada, and Europe, with 69% receiving TULSA and 31% RP [3][7] - The primary endpoints include preservation of erectile potency and urinary continence at one year, and freedom from additional treatment or cancer-related death by three years [7] Key Findings - TULSA showed a median blood loss of 0 mL compared to 100 mL for RP, and a median length of stay of 0.29 days versus 1.24 days for RP [5] - Patient-reported outcomes indicated significantly lower pain levels and better quality of life for TULSA patients compared to those undergoing RP [5][6] Market Implications - The positive outcomes from the CAPTAIN trial are expected to drive patient demand and influence insurance coverage policies, as Level 1 trials are considered the gold standard in evidence-based research [6]