Profound Medical Announces First-of-its-Kind TULSA-PRO® Installation

TORONTO, April 16, 2019 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX:PRN; OTCQX:PRFMF) (“Profound” or the “Company”), the only company to provide customizable, incision-free therapies which combine real-time Magnetic Resonance imaging (“MRI”), thermal ultrasound and closed-loop temperature feedback control for the radiation-free ablation of diseased tissue, today announced that the first prostate cancer treatment using a first-of-its-kind TULSA-PRO^® installation has been performed in Trier, Germany. The installation combines Profound’s TULSA-PRO^® system with Philips’ newest digital MR solution, the Ingenia Elition.

“We’re honored to collaborate with renowned European radiology and urologic oncology specialists to build the world’s first TULSA-PRO^® / Ingenia Elition installation,” said Arun Menawat, Profound’s CEO. “Treating the first patient using the combination of these innovative systems not only represents a milestone for Profound, but also demonstrates our system’s versatility and synergy with the latest imaging technology. We believe this synergy could maximize the efficiency and precision of ultrasound ablation to treat prostate cancer, and potentially increase the efficacy of treatment while minimizing side effects.”

Prof. Winfried Willinek, Medical Director and Head of Radiology, Neuroradiology, Sonography and Nuclear Medicine at Trier’s Krankenhaus der Barmherzigen Brüder Trier (a Brothers of Mercy hospital), collaborated with Profound and Philips to integrate the TULSA-PRO^® system with the hospital’s new Ingenia Elition.

Commenting on the project, Prof. Willinek said, “This exciting collaboration with Profound and Philips demonstrates the synergy that can result from combining two leading technologies. Positioning our facility as a leader in prostate cancer treatment, the installation enables our physicians to perform highly technical procedures that could significantly improve treatment outcomes.”

Dr. Andreas Neisius, Associate Professor and Head of Urology and the Prostate Cancer Center at the hospital, who led the installation’s first prostate cancer treatment, said, “Low and intermediate-risk prostate cancer patients are typically advised to take a ‘wait and see’ approach as current procedures to treat the malignancy often result in significant side effects. We are encouraged by the potential of our TULSA-PRO^® / Ingenia Elition installation, especially with the successful completion of our first procedure. In addition to addressing the unmet needs of prostate cancer patients, we believe the unit will benefit physicians by enabling efficient ultrasound ablation procedures with high levels of precision.”

Philips debuted the new Philips Ingenia Elition at the European Congress of Radiology in February 2018. This new MRI system offers cutting-edge MR imaging techniques, while setting new standards for clinical research in 3.0T imaging based on new gradient- and RF designs. These fully redesigned gradients combined with Compressed SENSE acceleration technology allow up to 60% higher spatial resolution in the same scan time, revealing more details for greater precision and delivers superb image quality, and performs MRI exams up to 50% faster. This is made possible by new gradient- and RF designs as well as Compressed SENSE.

Commenting on the use of the Ingenia Elition in guiding treatment with the TULSA-PRO^®, Wouter Horck, Product Manager of Philips said, “We’ve been working closely with Profound to commercialize the TULSA-PRO^® and believe that TULSA-PRO^® highly benefits from the Ingenia Elition’s advanced MR imaging innovations that provide great accuracy and performance.”

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 CE marked and commercially launched in key European and other CE mark jurisdictions. 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).

Profound has completed enrollment and 12-month follow-up in a multicenter, prospective clinical trial, TACT, which is expected to support its application to the U.S. Food and Drug Administration for approval to market TULSA-PRO^® in the United States.

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