Four Year Follow-Up Data from Profound Medical’s TACT Pivotal Clinical Trial Confirm Durable ...
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, announced that updated results from the TACT (TULSA-PRO® Ablation Clinical Trial) pivotal study were presented for the first time this past weekend, on Saturday, September 24, 2022, by Laurence Klotz, M.D., FRCSC, CM, Professor of Surgery, University of Toronto and Sunnybrook Chair of Prostate Cancer Research, at the FOCAL 2022 Conference held in Los Angeles, CA
TORONTO, Sept. 26, 2022 (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, announced that updated results from the TACT (TULSA-PRO® Ablation Clinical Trial) pivotal study were presented for the first time this past weekend, on Saturday, September 24, 2022, by Laurence Klotz, M.D., FRCSC, CM, Professor of Surgery, University of Toronto and Sunnybrook Chair of Prostate Cancer Research, at the FOCAL 2022 Conference held in Los Angeles, CA.
TACT, a prospective, open-label, single-arm pivotal clinical study of whole-gland ablation, enrolled 115 patients with biopsy-proven, organ-confined prostate cancer, with the majority having intermediate risk disease. TACT demonstrated that the TULSA-PRO® provides safe and effective prostate tissue ablation, with minimal adverse events, significant prostate volume and prostate-specific antigen (PSA) reduction, and low rates of residual prostate disease. The study was used to support Profound’s application to the U.S. Food and Drug Administration for 510(k) clearance to market TULSA-PRO® in the United States, which was granted by the Agency in August 2019.
In the presentation entitled “MRI-Guided Transurethral Ultrasound Ablation (TULSA): Not Just Another Focal Therapy,” Dr. Klotz reported that four-year follow-up data from the TACT clinical study continue to demonstrate durable and stable safety and efficacy outcomes.
The primary efficacy endpoint of TACT was PSA reduction at one year, which decreased 95% to a nadir of 0.34 ng/ml from a median pre-treatment baseline value of 6.3 ng/ml. By four years, the median PSA nadir further reduced to 0.28 ng/ml. PSA reduction was durable over the extended follow-up period, from 0.53 ng/ml at one year to 0.86 ng/ml at four years. The primary safety endpoint of TACT was the frequency and severity of adverse events graded according to the Common Terminology Criteria for Adverse Events (CTCAE). Following treatment with TULSA-PRO®, there were no Grade 4 or higher adverse events, no rectal fistula or injury, and no intraprocedural complications. With four-year follow-up, there were no new device or treatment related adverse events.
