The CEO of a Sudbury medical technology company said it's about a year away from taking its transformative home blood-testing kit to the market.
Jeff Sutton, one of the founders of Verv Technologies, expects their blood analyzer device, dubbed Vi, to be in small batch production in early 2023 before it’s finally introduced to consumers later in the year.
“We’re opening up a new market and the market is enormous,” said Sutton.
The 11-employee startup is in the early phases of presenting its technology before the Food and Drug Administration in the U.S., their targeted market.
The company recently secured $3.8 million in capital from Randox Laboratories of the United Kingdom to help them navigate the final stretch of their path toward commercialization.
Sutton said the investment allows them to take their innovative product to an advanced stage where it’s ready for regulatory approval and then manufacturing.
“We were looking for money to take us to the next level,” said Sutton. “That’s where Randox comes in.”
Northern Ireland-headquartered Randox is a global health-care solutions leader in the in vitro diagnostics space, meaning the kind of tests that use blood or tissue samples to detect disease, other conditions or for self-monitoring one’s overall health.
The investment money arrived about a month ago, Sutton said. Earlier this year, he flew to Dublin to make his presentation to Randox.
Founded in 2012, Verv is a growing company occupying space at the Health Sciences North Research Institute on Walford Road in the city’s south end.
They’ve designed a technology for the “fit-bit generation,” inventing a method and device that, with a finger prick of blood, separates the plasma from whole blood, and conducts an analysis of the different biomarkers in the blood to deliver the result to your smartphone within 15 minutes.
“It’s monitoring your health while you’re healthy," said Sutton.
More than just delivering an immediate result in a number, the beauty of the device is that it allows the user to monitor trends and normal ranges of their blood chemistry over a period of time. By managing your own health, it also lessens people’s interaction with an already stressed health-care system, he said.
Sutton, with a background in applied physics, hatched the idea years ago while visiting his father, who was taking a glucometer test to check his diabetes. He forged a partnership with two biochemist colleagues and formed Verv to provide this service to consumers.
There are two components to the Vi system: the small analyzer device and the disposable tests chips, the latter in which they would install tests for cholesterol, vitamin levels, and hormones, for starters. The consumer would buy the chip with the tests that are of interest to them.
Sutton said their patent-pending analyzer device is registered in Canada, the U.S., China, India and Europe.
Now, well past the prototype stage, the technology is moving to the final design-engineering phase to come up with a version they can present to the regulatory approvals bodies and present to consumers.
Raising seed money over the years for product development through the usual family-and-friends track and interested local investors hasn’t been a problem, Sutton said, since many people have realized its value from the conceptual stage.
Funding organizations have also chipped in.
The Sudbury Catalyst Fund provided $250,000, the National Research Council of Canada came up with $140,000, and the Northern Ontario Heritage Fund injected Verv with $500,000.
But the company needed significant funding from a multinational like Randox to go through the very extensive and expensive FDA and Health Canada certification process as well as select an engineering firm to make the final design version of the analyzer device.
With the FDA, Sutton said, they are in pre-submission stage for their cholesterol test.
"Every test we put on our device has to go through the FDA process," he said. "There are a number of different classifications for both the device and the type of test."
Verv’s four founders remain majority owners, Sutton said. Randox is considered a significant investor; its owner, noted Irish biochemist Dr. Peter Fitzgerald, gets a seat on the board.
Ideally, Sutton said, they’d like to manufacture the device in Sudbury. It would involve establishing an automated assembly line.
“I’m a Northern Ontario boy,” said Sutton, “and I do not like to see our kids have to move away to get high-tech jobs.”
But in the next breath, he mentions they’ve had great working relationship with a component supplier in China.
"The business environment is different," he said. “I can get things done in China and shipped to me faster than I can here.”
Though federal and provincial funding agencies have been “100 per cent supportive” of Verv, Sutton said, the pandemic and curtailed global supply chains have underscored the need for Canada to have vaccine and diagnostic manufacturing capacity.
“We need our own manufacturing, and governments are very attuned to that. As we move forward, we’ll be looking to see if there are opportunities or timely assistance so that we can do manufacturing here.”