For women with breast cancer, a lumpectomy can offer several advantages over a mastectomy, including faster recovery times and less post-operative pain. However, one in four women who undergo the procedure will need a second round of surgery due to lingering cancerous cells.

Perimeter Medical Imaging, a Toronto-based medical device company, aims to change that. After several years of research and clinical trials, the company is ready to commercialize an advanced surgical imaging technology that will allow surgeons, radiologists and pathologists to better assess microscopic tissue structures in real time during surgical procedures. With a lumpectomy, the current gold standard is to wait for the results of post-operative pathology, which can take a week. Perimeter's imaging technique will offer an additional source of in-surgical information to the clinician by providing rapid, automated visualization of near surface tissue structures.

Ensuring cancer has no place to hide

Perimeter's Optical Tissue Imaging System (OTIS™) provides clinicians with a high resolution image of the entire outer layer of tissue removed during surgery. OTIS™ is based on Optical Coherence Tomography (OCT), which is similar to ultrasound imaging but uses light instead of sound. The technology doesn't replace pathology, but enables clinicians to get a comprehensive understanding of the removed tissue within minutes.

The technology's use in breast cancer surgery is just one example of its potential. Perimeter's initial device, the OTIS™ 1.0, is broadly indicated for use as an imaging tool in the evaluation of excised human tissue microstructure. The platform is currently under evaluation by local clinicians for use in a variety of in-surgical tissue assessment applications, pathology planning, and interventional radiology.

OTIS images allow clinicians to visualize sub-surface tissue microstructure.
OTIS images allow clinicians to visualize sub-surface tissue microstructure. OTIS images are available immediately, while the clinical gold standard (conventional histology) is available 24 to 48 hours after specimen excision at the earliest.

The perfect location for financing and talent

Paul Weber, President and CEO of Perimeter
Paul Weber, President and CEO of Perimeter

Now a company of 12, Perimeter had just four employees when it formed in 2013 after acquiring technology that had been incubated in collaboration with Toronto's Princess Margaret Cancer Center. The company's two biggest challenges since its inception have been financing and talent—and its location in Ontario has been beneficial in attracting both.

"There was certainly some advantage in being based in Toronto, close to Bay Street and the finance centre," says Paul Weber, President and CEO of Perimeter, noting how the company managed to raise $5 million in equity financing in summer 2015, in addition to $1.5 million in non-dilutive funding.

In terms of access to critical expertise, Ontario also has a "rich base of engineering and technical talent," adds Weber. That talent base is complemented by a network of supportive programs, which the company leveraged to great advantage. For example, Perimeter was supported by the Health Technology Exchange (HTX), which Weber described as "an incredible program that took a very pragmatic approach to dealing with emerging companies."

The company also benefited from the MaRS Embedded Executive Funding Program, utilizing it multiple times at early stages to tap into senior level talent that it would not otherwise have been able to afford. "We were able to draw on regulatory guidance from an individual with highly relevant experience as we put together our first strategy for FDA clearance," says Weber. "Having that talent was a big driver for us."

Other programs that offered invaluable support to Perimeter at various stages include the Ontario Centres of Excellence, Ontario Bioscience Industry Organization, and the Federal Development Agency for Southern Ontario.

Programs like these, says Weber, are why there is so much innovation in Ontario.

"There is strong support here for early-stage companies to get off the ground. And being able to tap into world-class health institutions adds significant credibility to Ontario-based companies as they try to market on the world scene."

Access to the largest healthcare market in the world

Perimeter received FDA clearance for their platform OTIS™ 1.0 device in May 2016—a game-changer for the firm, which has six U.S. sites ready to participate in adoption studies for the start of 2017 and anticipates its first commercial sales later that year.

"That clearance was based on a huge body of effort that included different phases of product development and clinical testing," says Weber. "We worked through our initial proof of concept device, tested it, and built a robust world-class atlas of images that correlate to the gold standard in pathology images. That was a very big milestone."

The company will transition from business development to a more commercial focus over the balance of 2016, and plans to launch marketing activities near the end of the year. Weber expects Perimeter to expand its employee base to support its full commercial ramp-up. While he believes the U.S. market is well positioned to be the primary target for the company's market entry, he also plans to pursue clearances in Canada and Europe.

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