Profound Medical Corp. Announces Preliminary Fourth Quarter 2017 Revenue and Provides Progress Update on TACT Pivotal Trial Patient Enrollment

TORONTO, Jan. 08, 2018 (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 preliminary unaudited revenue for the fourth quarter of 2017 and provided an update on patient enrollment in the TACT pivotal clinical study. Profound noted that it is providing this information due to the significant lag-term between planned investment community meetings to be held in connection with, among other non-deal investor events, the 36th Annual J.P. Morgan Healthcare Conference in San Francisco, CA, and its expected reporting of final 2017 results in March 2018.

Profound anticipates total revenues for the fourth quarter of 2017 to be approximately $1.9 million, compared to $nil in the fourth quarter of 2016, and reflecting an approximate 30% increase sequentially over the previous quarter. For the full year 2017, the Company anticipates total revenues to be approximately $4.9 million. These figures are preliminary and unaudited, and actual revenues may differ.

Profound also reported that, as of December 31, 2017, the Company-sponsored TACT pivotal clinical study, designed to further evaluate the safety and efficacy of TULSA-PRO® to ablate prostate tissue in patients with localized, organ-confined prostate cancer, had reached 87% (96 out of 110) patient enrollment. With an additional 14 patients still to be treated, Profound expects to complete study enrollment at some point during the month of February 2018.

“As demonstrated by this, our fourth consecutive quarter of sequential revenue increases, we have successfully transitioned from a development-stage company to one focused on growth,” said Arun Menawat, Profound’s CEO.  “The sales traction we are seeing in Europe should bode well for the future when we are able to market both TULSA-PRO® and Sonalleve® in the United States. To that end, we look forward to completing patient enrollment in TACT this quarter and also to updating our stakeholders on our U.S. regulatory strategy for Sonalleve® as the year progresses.”

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 palliative pain treatment of 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. Profound’s anticipated fourth quarter 2017 total revenues are preliminary and subject to change as the Company reviews its financial results as well as those that are audited by its independent auditors. 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
T: 647.872.4849


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