Special to Financial Post, May 16, 2017

BresoDX is first device to come out of MaRS’ Excellence in Clinical Innovation Technology Evaluation program

For the first time, Ontarians will be able to use an at-home device to test themselves for sleep apnea, a development facilitated by the innovative MaRS Excite program.

BresoDx, the first device to emerge from MaRS Excite (Excellence in Clinical Innovation Technology Evaluation), is a game-changer. The portable device frees patients from the standard routine for sleep apnea detection: an overnight stay in a sleep lab, during which the individual has dozens of electrodes attached to their head and body, and breath-measuring belts wrapped around their chest and belly.

The Ontario government recently announced that the device will be available later this year for patients to take home from up to 25 clinics across the province.

The new, patient-centred product makes its debut after the Ministry of Health and Long-Term Care (MOHLTC) approached experts at the Toronto Rehabilitation Institute to ask if they could develop an alternative to the expensive and, for patients, inconvenient overnight-diagnosis process. The vast majority of people with sleep apnea remain undiagnosed, which can have dire health consequences. MOHLTC’s demo project will cover patient costs for the Ontario devices*.

MaRS Excite, a program run by Toronto-based MaRS innovation hub, helps health innovators get their product fully evaluated — key to gaining the regulatory approval required to go to market. It also accelerates and lays the groundwork for a new device’s adoption in the provincial health system.
The device will be available later this year for patients to take home from up to 25 clinics across Ontario

Director of research and senior scientist at Toronto Rehab, biomedical engineer Dr. Geoff Fernie is CEO of BresoTec, the company that produces BresoDX. He says the company and its device might well have perished without the program.

“A startup can only make it if it’s got some market, somewhere. If it hasn’t got its home market and it has to wait until it has produced its product and put it on the market and then has to wait another two or three years to get accepted into its home market, it’ll die.”

Shahira Bhimani, the director of MaRS Excite, says the two-year BresoDX demonstration project — in which up to 3,000 Ontarians a year will try out the device — is “a huge win.”

The Excite program is designed to address the peril involved in taking a new device to market without ensuring there’s at least provincial demand for the product, she says. The program aims to “innovate in the direction the health system is going,” Bhimani says.

“The idea of Excite is that we’re bringing every relevant stakeholder to the table and having them work collaboratively to be able get to this end goal of innovation adoption. Oftentimes, whether it’s the payer or hospital or health system or ministry, there’s an arm’s-length distance between themselves and the innovator,” she says.

Respirologist Dr. Douglas Bradley, a University of Toronto medical school professor and head of the Sleep Research Laboratory at Toronto Rehab, is one of the three experts credited with BresoDX’s creation, along with Fernie and Dr. Hisham Alshaer, a physician, biomedical engineer and scientist at Toronto Rehab. Bradley says there’s no doubt that having Excite’s stamp of approval “accelerates our access to the Canadian market.”

Bradley says their mostly plastic device, which requires a memory to record data, is already selling in Canada, the U.K., Turkey and Italy, and he and his co-creators are optimistic about how its adoption in Ontario will spur further market penetration.

“It’s one of the best-validated devices on the market for accurately diagnosing sleep apnea,” says Bradley of BresoDX, which was tested in three separate clinical trials during its Excite incubation. “And it differs from other devices in being much simpler. All you have to do is put the device on with a head strap, pull a tab, push a button and that’s it.” In contrast to BresoDX, virtually all other devices on the market use the same technology as that used in sleep labs, except with fewer electrodes.

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