Profound Medical Receives U.S. FDA 510(k) Clearance for ‘Contouring Assistant’ AI Module that Enables Creation of an Automated TULSA Treatment Plan

– Prostate segmentation using a deep learning convolutional neural network –

– Model uses 24,611,072 parameters extracted from 7,466 training images –

– Validated in standalone and multi-reader, multi-case clinical studies conducted by world-renowned experts –

– Urologists testing this TULSA-AI module improved their segmentation accuracy and were 32% faster in their contours –

TORONTO, May 14, 2024 (GLOBE NEWSWIRE) -- Profound Medical Corp. (NASDAQ:PROF; TSX:PRN) (“Profound” or the “Company”), a commercial-stage medical device company that develops and markets customizable, incision-free therapies for the ablation of diseased tissue, today 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 (55-57°C). TULSA is an incision- and radiation-free “one-and-done” procedure performed in a single session that takes a few hours. 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, is a machine learning-based prostate segmentation tool designed to assist in efficiently delineating the prostate and target ablation volume. This module uses a large database of successful physician-created TULSA treatment designs and recommends a design in a new procedure based upon that knowledge. Moving forward, as the TULSA treatment and outcomes database continues to grow via real-world adoption, and as AI technology evolves, the proposed treatment designs are expected to continue to improve.