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Press Release

Profound Medical Corp. Announces Expanded Clinical Use of TULSA-PRO® in Prostate Care to Include BPH


Posted on: 06 Nov 17

TORONTO, Nov. 06, 2017 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX-V:PRN) (OTCQX:PRFMF) (“Profound” or the “Company”), the only company to provide a therapeutics platform that provides the precision of real-time MR imaging combined with the safety and ablation power of directional (inside-out) and focused (outside-in) ultrasound technology for the incision-free ablation of diseased tissue, today announced that Benign Prostatic Hyperplasia (“BPH”) treatments utilizing TULSA-PRO® are now being successfully conducted in Germany.

BPH is a non-cancerous enlargement of the prostate gland due to an overgrowth of prostate cells. It is a common condition as men age, often impeding the flow of urine and creating significant urinary symptoms. Current surgical treatment of BPH can result in potential complications such as retrograde ejaculation, erectile dysfunction, significant bleeding, and require long recovery times. Therefore, for several years many alternative treatments have been investigated. 

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. 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 for BPH is now beginning to be embraced by clinicians in Europe that are gaining early experiences with this technology for the treatment of localized prostate cancer.

For example, ALTA Klinik (“ALTA”) in Bielefeld, Germany has begun treating BPH patients with TULSA-PRO® under the supervision of Dr. Agron Lumiani, a leading German radiologist and an early adopter of MRI diagnostics and biopsy for prostate disease.

“Our early clinical experience with TULSA-PRO® for focal therapy in prostate cancer has been very positive,” commented Dr. Lumiani.  “We have been able to achieve precise ablation with the TULSA procedure.  What is truly encouraging is the patient quality of life outcomes in erectile and urinary function.”

Dr. Lumiani continued, “Current surgical treatment of BPH still presents with potential complications and a longer recovery time for patients.  Men are looking for minimally invasive options with this condition.  In our first few BPH patients undergoing treatment with TULSA-PRO®, our procedure goals of reduction of prostate tissue with preservation of peripheral zone and the ejaculatory duct have been successfully achieved. I was pleased to see us being able to treat prostates as large as 122cc.  Early patient follow-ups look promising.”

Dr. Roberto Blanco Sequeiros, Chairman of the Medical Imaging Center at Turku University Hospital (“Turku”) in Finland, who will soon be enrolling the first BPH patient in the centre’s ongoing clinical research with TULSA-PRO®, said, “We are expanding our clinical experience with the TULSA procedure and are keen to assess its potential in both localized prostate cancer and other prostate conditions such as BPH.”  Dr. Peter Boström, a leading European urologist, and the Chief of Department of Urology at Turku added, “With our focal therapy clinical trial with TULSA-PRO®, we are impressed with the ablation precision that the system is demonstrating.  Looking forward to assessing its clinical application in treating large volume prostates with BPH.”

“As is often the case with innovative new medical technology platforms like Profound’s, the targeting of additional unmet needs of patients in various anatomies and disease states will be largely driven by its current clinician users,” stated Arun Menawat, Profound’s CEO.  “We are grateful to our customers like ALTA and Turku for helping to lead the expanded clinical use of the TULSA-PRO® system, offering patients a one-time, precise, minimally invasive alternative to existing prostate care therapies.”

About Profound Medical Corp.

The Profound Medical team is committed to creating the powerful combination of real-time MR-guidance as the imaging platform and ultrasound as the energy source for delivering non-invasive ablative tools to clinicians. These key technology pillars, linked with intelligent software and robotics, have the potential to fulfill unmet needs of patients and clinicians in many anatomies and disease states, including prostate cancer, uterine fibroids, and bone metastases. Our mission is to profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives.

Profound Medical is commercializing a novel technology, TULSA-PRO®, which combines real-time Magnetic Resonance Imaging with transurethral, robotically-driven therapeutic ultrasound and closed-loop thermal feedback control that is designed to provide precise ablation of the prostate while simultaneously protecting critical surrounding anatomy from potential side effects.  TULSA-PRO® is CE marked and Profound Medical is currently conducting a pilot commercial launch of the technology in key European and other CE mark jurisdictions.  The Company is also sponsoring a multicenter, prospective FDA-registered clinical trial, TACT, which, if successful, is expected to support its application to the FDA for approval to market TULSA-PRO® in the United States.

Profound Medical is also commercializing Sonalleve, an innovative therapeutic platform that combines real-time MR imaging and thermometry with thermal ultrasound to enable precise and incision-free ablation of diseased tissue. Sonalleve is CE marked for the treatment of uterine fibroids and palliative pain treatment of bone metastases. The Company is also in the early stages of exploring additional potential treatment markets for Sonalleve, such as non-invasive ablation of abdominal cancers and hyperthermia for cancer therapy, where the technology has been shown to have clinical application.

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.

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange), nor the OTCQX accepts responsibility for the adequacy or accuracy of this release.

For further information, please contact:

Stephen Kilmer
Investor Relations
skilmer@profoundmedical.com
T: 647.872.4849

Or

Rashed Dewan
Vice President, Finance
T: 647-476-1350

GlobeNewswire
globenewswire.com

Last updated on: 06/11/2017

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