Profound Medical (PROF) Stifel 2024 Healthcare Conference summary

Regulatory and reimbursement progress

• CMS granted Level 7 facility payment reimbursement for TULSA-PRO, surpassing competing procedures and removing a major adoption barrier.

• Permanent codes allow use in hospitals, ASCs, imaging centers, and physician offices, with TULSA as the only technology approved across all these settings.

• TULSA's hospital reimbursement is $13,000, higher than robotic prostatectomy, and ASC payment exceeds hospital rates for competing procedures.

• Physician payment is competitive on a per-hour basis due to TULSA's faster procedure time.

• Surgeons can bill flexibly depending on their involvement, supporting adoption in diverse clinical workflows.

Technology innovation and clinical evidence

• TULSA is a minimally invasive, MRI-guided, AI-driven prostate ablation with no incision, radiation, or blood loss.

• AI-based treatment planning, approved since May 2024, streamlines workflow and enables more patients to be treated daily.

• Over 67 peer-reviewed publications and 200+ conference presentations support its efficacy across prostate cancer and BPH.

• Clinical data show high continence (97%) and low severe erectile dysfunction (0%) rates, with durable outcomes.

• Flexibility allows treatment of a wide range of prostate sizes and disease types, including hybrid and high-risk cases.

Market opportunity and business model

• Addressable market includes 300,000 prostate cancer patients, with potential to treat at least 200,000 annually at $8,000 per patient.

• BPH segment, especially severe cases, could triple the total addressable market to 400,000 patients.

• Over 3,000 patients treated in 50+ hospitals, with strong cash-pay adoption prior to reimbursement.

• Surgeons value the ability to customize ablation extent, supporting both whole-gland and focal treatments.

• Software modules like Thermal Boost enhance margin control and are used in over 50% of cases.