Profound Medical Corp. announced that it has received 510(k) clearance from the U.S. Food and Drug Administration ("FDA") for the Company's second TULSA-AI module, Contouring Assistant, for use in conjunction with its TULSA-PRO system. The Transurethral Ultrasound Ablation ("TULSA") procedure has the potential of becoming a mainstream treatment modality across the entire prostate disease spectrum; ranging from low-, intermediate-, or high-risk prostate cancer; to hybrid patients suffering from both prostate cancer and benign prostatic hyperplasia ("BPH"); to men with BPH only; and also, to patients requiring salvage therapy for radio-recurrent localized prostate cancer.

TULSA employs real-time MR guidance for pixel-by-pixel precision to preserve prostate disease patients' urinary continence and sexual function while killing the targeted prostate tissue via a precise sound absorption technology that gently heats it to kill temperature (55-57degC). Virtually all prostate shapes and sizes can be safely, effectively, and efficiently treated with TULSA. There is no bleeding associated with the procedure; no hospital stay is required; and most TULSA patients report quick recovery to their normal routine.

Recognizing TULSA is being used by urologists to treat an unrivalled variety of prostate cancer and/or BPH patients, Profound is developing a novel set of software modules under the 'TULSA-AI' brand to work in conjunction with TULSA-PRO to provide ®? further customizability, ease of use, speed of treatment and higher confidence in clinical outcomes. Contouring Assistant, Profound's second FDA-cleared TULSA-AI module.