Core Insights - Profound Medical Corp. has achieved a significant milestone with the launch of its TULSA-PRO system at The Johns Hopkins Hospital, marking the beginning of non-clinical-trial treatments for prostate cancer using this advanced technology [1][3] Company Overview - Profound Medical 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] Technology and Procedure - The TULSA Procedure™ utilizes robotically controlled directional ultrasound to treat prostate cancer and benign prostatic hyperplasia (BPH) by heating prostate tissue to 'kill temperature' (55-57°C) while preserving surrounding nerves [2][5] - Real-time MRI thermography allows for continuous visualization and temperature adjustments during the procedure, resulting in no procedural blood loss, no overnight hospital stay, and a quicker recovery for patients [2][5] Clinical Development and Approval - Johns Hopkins University played a crucial role in the clinical development of TULSA-PRO, participating in pivotal clinical trials that led to FDA clearance and further studies to validate its efficacy [3] - TULSA-PRO is CE marked, Health Canada approved, and has received 510(k) clearance from the U.S. FDA, indicating its regulatory compliance and readiness for commercialization [5] Market Potential - The TULSA Procedure has the potential to become a mainstream treatment for a wide range of prostate conditions, including low-, intermediate-, and high-risk prostate cancer, as well as BPH and salvage therapy for radio-recurrent localized prostate cancer [5]