TORONTO, Jan. 31, 2018 (GLOBE NEWSWIRE) -- Profound Medical Corp. (TSX-V:PRN) (OTCQX:PRFMF) (“Profound” or the
“Company”), the only company to offer a therapeutic platform that provides the precision of real-time MR imaging combined with the
safety and accuracy of directional (inside-out) and focused (outside-in) ultrasound technology for incision-free ablation of
diseased tissue, today announced the completion of patient enrollment in the TACT (TULSA-PRO® Ablation Clinical Trial)
pivotal study designed to further evaluate the safety and efficacy of TULSA-PRO® to ablate prostate tissue in patients
with localized, organ-confined prostate cancer.
TACT, a prospective, open-label, single-arm pivotal clinical study, has enrolled 110 prostate cancer patients
across 13 research sites in the U.S., Canada and Europe. If successful, TACT is expected to support Profound’s application to the
U.S. Food and Drug Administration (“FDA”) for clearance to market this technology in the United States.
The primary efficacy endpoint of TACT is the proportion of patients achieving a post-treatment prostate-specific
antigen (“PSA”) reduction ≥ 75% of their pre-treatment baseline value. The Company’s pre-established performance goal for the
success proportion is 50% of patients. Based on a preliminary analysis performed by the Company, of the first 63 evaluable
patients, the median PSA reduction to-date is 93%, and 92% (58 out of 63) have achieved the PSA reduction success
proportion.
The primary safety endpoint is the frequency and severity of adverse events, with additional secondary endpoints
focused on quality-of-life side effects commonly associated with current prostate cancer therapies, such as erectile dysfunction
and urinary incontinence. As the standard evaluation period for these side effects is 12 months post-treatment, the sample size of
evaluable patients is not yet large enough to assess.
“It is very exciting the TACT trial has completed accrual in such a timely manner,” said Dr. Scott Eggener,
TACT’s Principal Investigator, Professor of Surgery and Radiology and the Director of the Prostate Cancer Program at the University
of Chicago. “Today, the gap between active surveillance and radical treatments such as surgery and radiation is often too wide for
both clinicians and patients. TULSA-PRO® is a minimally-invasive and image-guided option intending to ablate low and
intermediate risk prostate cancers with the goal of reducing the risk of side-effects commonly associated with other treatments.
There has been a smooth collaboration between the various clinical sites and Profound and we all are looking forward to seeing the
final results.”
“We are pleased patient enrollment has now been completed and look forward to sharing the full clinical results
of this pivotal study with our stakeholders in due time,” commented Arun Menawat, Profound’s CEO. “We expect data from TACT will
help pave the path for the successful commercialization of TULSA-PRO® in the United States and further drive clinical
adoption of the technology in Europe.”
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 clearance 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
