Profound Medical Receives FDA Clearance for TULSA-PRO®

Profound Medical (TSX:PRN, OTCQX:PRFMF) has announced it has received 510(k) clearance from the US Food and Drug Administration to market TULSA_PRO for abalation of prostate tissue.

As quoted in the press release:

TULSA-PRO® is a transurethral prostate tissue ablation system that combines real-time Magnetic Resonance Imaging (“MRI”) with robotically-driven directional thermal ultrasound and closed-loop temperature feedback control software to deliver predictable physician prescribed ablation of whole-gland or partial prostate tissue. The TULSA-PRO® system is designed to provide customizable and predictable, incision-free and radiation-free prostate ablation while actively protecting the urethra and rectum with water cooling to preserve men’s functional abilities.

The FDA’s clearance of TULSA-PRO® was based on the Company’s TACT pivotal clinical trial, which met all of its primary and secondary efficacy and safety endpoints. TACT enrolled 115 patients across the United States, Canada and Europe with biopsy-proven, organ-confined prostate cancer (67% and 33% of subjects had NCCN intermediate and low risk disease, respectively). All patients received primary treatment of whole-gland prostate ablation with sparing of the urethra and urinary sphincter. TACT demonstrated that the TULSA-PRO® provides safe and effective prostate tissue ablation, with minimal adverse events, significant prostate volume and PSA reduction, and low rates of residual prostate disease. The favorable safety profile offered by the TULSA-PRO contrasts with radical prostatectomy and radiation therapy that can leave many men with permanent erectile dysfunction, urinary incontinence and bowel dysfunction. The TACT study also demonstrated a favorable risk-benefit profile in the context of other ablative approaches, including whole-gland HIFU and cryotherapy.

The FDA label for TULSA-PRO® will allow U.S. surgeons to perform prostate tissue ablation procedures indiscriminate of tissue type, including malignant and benign.

Click here to read the full press release.