No one looks forward to cancer treatment: the remedy can often seem worse than the disease. With prostate cancer, side effects from currently available treatments can be life-altering, including incontinence, impotence and bowel complications.

So it's likely that a new treatment promising a greatly reduced incidence of side effects would see strong uptake from hospitals and urologists.

This is what Profound Medical Corp is counting on.

Approximately one in eight men will develop prostate cancer in their lifetime, with the risk increasing over the age of 50. Toronto-based Profound Medical is commercializing an innovative and minimally invasive treatment to ablate the prostate gland in these patients. The technology combines real-time magnetic resonance (MR) imaging with transurethral therapeutic, robotically-driven ultrasound and closed-loop thermal feedback control.

Known as TULSA (for transurethral ultrasound ablation), the procedure is designed to ablate cancerous and non-cancerous prostate tissue in a single 40-minute session with precision down to the millimetre. Patients can go home within 24 hours of treatment.

This image shows the heating pattern of the ultrasound transducers.
This image shows the heating pattern of the ultrasound transducers.

Critical early support from Ontario

Profound Medical was established in 2008 as a spin-off out of Sunnybrook Research Institute in Toronto. Working directly alongside Sunnybrook with support from seed investment, a small but determined team devoted long hours to the early stages of research and testing to get the company off the ground.

Steven Plymale, CEO, Profound Medical Corp.
Steven Plymale, CEO, Profound Medical Corp.

Steven Plymale, who became CEO in 2011, says the company had six employees when he joined, and had just achieved $10 million in funding. It now has more than 50 employees and strong financial and strategic support: it raised about $28 million in June 2015, recently went public on the Toronto Venture Exchange, and has signed agreements with Philips and Siemens.

The company is well-funded these days, but it wasn't always so. Plymale notes that if not for early-stage funding provided by the province of Ontario, “the company would not be here today.” “That funding was critical to our growth at that stage,” he recalls.

So was access to reasonably priced testing environments, says Plymale. "We would not have been able to complete the work in a timely fashion without access to the technical resources at some of the Ontario research facilities we relied on," such as York University, where Plymale says "a lot of late-night validation work" was done. Other Ontario institutions that played key roles included the Robarts Research Institute, the University of Guelph, Sunnybrook, and London's Victoria Hospital. "These Ontario institutions were critical partners," says Plymale. "And we're still working with several hospitals throughout the GTA."

All systems go

Today, the company is poised for major growth: having recently completed a phase 1 international safety and feasibility trial, Profound Medical now has the go-ahead to market its device across Europe, and made its first sale (in Spain) just one week after obtaining the necessary approval. It's expected to begin selling in Canada later this year, upon receiving its Health Canada regulatory approval.

The FDA requires a final pivotal trial before the company can launch its product in the U.S. Profound expects to start selling there in 2018 following the outcome of a 110-patient trial in more than 10 institutions in Europe, Canada and the United States. Meanwhile, 12-month outcomes from the phase 1 trial indicate that Profound's technology is both precise and well-tolerated.

Plymale says it's difficult to project the company's growth, but he expects double-digit growth year-over-year soon—or even quarter-over-quarter after Profound launches its device in the U.S in 2018.

Bringing it home

Ironically, while Profound's technology is currently manufactured in the U.S., Plymale says there are plans afoot to "repatriate" the manufacturing to Canada. The company has identified a 38,000 square-foot facility in Mississauga as a potential site. Part of the reason for the move is cost: current exchange rates make it more expensive to manufacture in the U.S. Ontario also offers the lowest business costs in the G7 and a substantial talent pool, with nearly 40,000 STEM graduates every year.

"We think we can do a better job in Ontario," says Plymale. "We'll have tighter control over the resources and the quality of the product. Other medical device manufacturers in the area have done very well by tapping into Ontario's talent, and we hope to be the next big success story there."


June 13, 2016

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