Profound Medical (PROF) 43rd Annual J.P. Morgan Healthcare Conference 2025 summary

Key product, technology, and clinical advancements

• Commercialized MRI-guided, AI-enhanced TULSA treatment for prostate cancer and BPH, with over 3,000 patients treated at more than 50 U.S. sites and strong clinical evidence from 67+ publications and 200+ conference presentations.

• AI assistant FDA cleared in May 2024, enabling precise, autonomous procedures with real-time imaging, temperature mapping, and new features like Thermal Boost for reliable capsule-edge treatment.

• Clinical data shows minimal side effects, no blood loss, rapid recovery, and most patients returning home the same day.

• TULSA demonstrates high efficacy and safety for both whole gland and focal ablation, with near elimination of incontinence and very low rates of severe erectile dysfunction over five-to-seven-year outcomes.

• CAPTAIN trial, a randomized study comparing TULSA to prostatectomy, has completed recruitment with perioperative results expected April 2025.

Market access, opportunity, and reimbursement

• U.S. annual addressable market is estimated at 200,000 prostate cancer and 400,000 BPH/hybrid cases, with a combined TAM of $4.8 billion.

• CMS reimbursement established in January 2024, with rates higher than other prostate procedures; new permanent AMA CPT codes effective January 2025 at Urology Level 7.

• Hospital outpatient payment is $12,992 and ASC payment is $10,728, with ASC rates exceeding hospital rates for prostatectomy.

• Three CPT codes allow flexible physician collaboration models, supporting adoption in hospitals, ASCs, imaging centers, and physician offices.

• Transition from cash-pay to reimbursement model, supported by a growing sales team and top-tier hospital adoption, is expected to drive high double-digit revenue growth.

Industry partnerships and pipeline

• Siemens partnership enables bundled TULSA Plus solution with a new, more accessible MRI system, launching in 2025 and reducing infrastructure costs.

• Pipeline includes FDA HDE-approved pediatric product, ongoing phase 1 pancreatic cancer trial with initial data expected by end of 2024, and research-funded trials for combination therapies in metastatic cancer.

• Regulatory-cleared products for adenomyosis and uterine fibroids are commercialized in Asia and parts of Europe, with U.S. expansion planned in the next 12–18 months.

• AI module for BPH treatment is design complete and expected to commercialize by summer 2024, with broader commercialization planned for H2 2025.

• Long-term vision is to become a platform company addressing major diseases in both men and women.