Profound Medical Receives U.S. FDA 510(k) Clearance for TULSA-PRO®

U.S. Commercial Launch Expected in the 4th Quarter of 2019

TORONTO, Aug. 16, 2019 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX:PRN; OTCQX:PRFMF) (“Profound” or the “Company today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) to market TULSA-PRO® for ablation of prostate tissue.

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.

“We are pleased with the FDA’s expeditious review of our application,” said Arun Menawat, Profound’s CEO. “We believe this, combined with the label that the Agency approved for TULSA-PRO®, serves as a testament to our technology’s strong clinical profile.”

“While we have been conducting a limited commercial launch of TULSA-PRO® in select CE mark jurisdictions over the past few quarters, in many respects, we only just crossed the starting line following the recent reporting of the positive TACT trial clinical results and today’s announcement of FDA 510(k) clearance,” continued Dr. Menawat. “The feedback from physicians using the system in Europe, and from key opinion leaders in the United States who have first-hand experience with the technology as TACT trial investigators, has been very positive, particularly regarding the ease-of-use, efficiency and flexibility based on patient needs; in addition to its excellent patient tolerability and short recovery periods. Given this interest and feedback, we are very much looking forward to working with our strategic partners, Philips and Siemens Healthcare, in concert with our direct sales and marketing teams, to prepare for the U.S. commercial launch of TULSA-PRO® in Q4-2019.”

About Profound Medical Corp.

Profound develops and markets customizable, incision-free therapies for the ablation of diseased tissue.

Profound is commercializing TULSA-PRO®, a novel technology that combines real-time MRI, robotically-driven transurethral ultrasound and closed-loop temperature feedback control. TULSA-PRO® is designed to provide customizable and predictable radiation-free ablation of a surgeon-defined prostate volume while actively protecting the urethra and rectum to help preserve the patient’s natural functional abilities. TULSA-PRO® is demonstrating to be a flexible technology in customizable prostate ablation, including intermediate stage cancer, localized radio-recurrent cancer, retention and hematuria palliation in locally advanced prostate cancer, and the transition zone in large volume benign prostatic hyperplasia (BPH). TULSA-PRO® is CE marked and received 510(k) clearance from the U.S. Food and Drug Administration in August 2019.

Profound is also commercializing Sonalleve®, an innovative therapeutic platform that is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. Sonalleve® has also been approved by the China Food and Drug Administration for the non-invasive treatment of uterine fibroids. The Company is in the early stages of exploring additional potential treatment markets for Sonalleve® where the technology has been shown to have clinical application, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy.

Forward-Looking Statements

This release includes forward-looking statements regarding Profound and its business which may include, but is not limited to, the expectations regarding the efficacy of Profound’s technology in the treatment of prostate cancer, uterine fibroids and palliative pain treatment. Often, but not always, forward-looking statements can be identified by the use of words such as "plans", "is expected", "expects", "scheduled", "intends", "contemplates", "anticipates", "believes", "proposes" or variations (including negative variations) of such words and phrases, or state that certain actions, events or results "may", "could", "would", "might" or "will" be taken, occur or be achieved. Such statements are based on the current expectations of the management of Profound. The forward-looking events and circumstances discussed in this release, may not occur by certain specified dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting the company, including risks regarding the pharmaceutical industry, economic factors, the equity markets generally and risks associated with growth and competition. Although Profound has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Profound undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise, other than as required by law.

For further information, please contact:

Stephen Kilmer
Investor Relations
T: 647.872.4849