Profound Medical to present TULSA-PRO 3-year outcomes and BPH subgroup analysis


Three-year clinical outcomes and a subgroup analysis of benign prostatic hyperplasia (BPH) patients enrolled in Profound Medical’s (TSX:PRN; OTCQX:PRFMF) earlier Phase 1 safety and feasibility study of TULSA-PRO will be presented at the German Society For Urology Congress on Sept. 27 in Dresden.

Profound’s TULSA-PRO is a therapeutics platform that provides the precision of real-time magnetic resonance imaging combined with the safety and ablation power of directional and focused ultrasound technology for the incision-free ablation of diseased tissue.

BPH is a non-cancerous enlargement of the prostate gland due to an overgrowth of prostate cells and is a common condition in older men, often impeding the flow of urine and creating significant lower urinary tract symptoms (LUTS). Current surgical treatment for BPH can result in potential complications.

As part of a presentation, Dr. Jurgen Futterer will report on an analysis of LUTS in a subgroup of nine patients in the Phase 1 study who had at least moderately symptomatic BPH, based on International Prostate Symptoms Score (IPSS), in addition to their cancer at baseline.

At 12 months after TULSA-PRO treatment, patients’ IPSS improved by similar levels reached with modern surgical therapies and IPSS quality of life improved, with 8-of-9 patients, or 89%, saying they were “pleased” or “delighted."

In addition, all nine patients had full urinary continence at six and 12 months. Erectile function was stable as was the proportion of patients with erections sufficient for penetration at 12 months.

“As with localized prostate cancer, TULSA-PRO may present a promising modality for treatment of BPH, as it enables incision-free and targeted ablation of excessive prostate tissue by providing real-time MRI visualization as well as millimeter precision,” Profound CEO, Arun Menawat, said in a statement.

“The enhanced precision, the ability to personalize the treatment to the patient’s anatomy, and the promise of providing a one-time, minimally-invasive solution is now leading to expanded clinical use of TULSA-PRO in prostate care to include BPH by clinicians in Europe that are gaining early experiences with this technology for the ablation of localized prostate cancer,” he added.

Dr. Menawat also said the company expects that when full results from the ongoing TACT study in the U.S. are available, “they will help pave the path for the successful commercialization of TULSA-PRO in the U.S. and further drive clinical adoption of the technology in Europe.”

Michelle Carr