Years of hustle have finally paid off for Sudbury's IRegained.
The med-tech startup, whose MyHand device helps stroke patients regain hand function, is moving to commercial production, having secured a major distributor, Performance Health, to market, sell and disseminate its product in the U.S.
It's been a long time coming, said Vineet Johnson, a co-founder and the company's president and CEO, for whom MyHand has been a passion project.
“A startup is, basically, you give up everything that you're doing and you have to put your heart and soul into this,” he said in an interview with Northern Ontario Business.
Receiving approval from the U.S. Food and Drug Administration (FDA) in January 2023 gave IRegained the OK it needed to move to the next step of commercialization.
Performance Health is one of the top distributors of medical rehabilitation equipment in the U.S., catering to a roughly 40 per cent share of the market, Johnson said, with a focus on getting devices like his into hospitals and medical clinics across the country.
He expects MyHand will sell for about US$30,000 to US$50,000.
To date, IRegained has secured a number of deals with a variety of Canadian and U.S. hospitals and clinics to use MyHand, but the device has not been widely available.
Landing a "big fish” like Performance Health to take the company to the next level is invaluable, Johnson added.
“For a startup, we don’t have to do sales; we don't have to do marketing — they deal with it,” he said.
“Even if their cut is bigger, the volume of devices they're going to sell is much higher, and your margins go up. So, an investor coming in will come in and go, ‘I like this because this is a business that can sustain itself.’”
Assembly of the device, which has, until now, taken place at IRegained's office and lab space at NORCAT on Maley Drive, will move to a Mississauga manufacturing facility that meets the licensing requirements of Health Canada and the FDA.
As production ramps up, Johnson is hopeful of opening a second facility in Sudbury where he'll add to the existing 15-person complement of staff that's currently comprised of local graduates of Laurentian University and Cambrian College.
They'll need people to look after stocking and shipping product, filling purchase orders, and customer service, “but who, how much and when is hard to predict,” he said.
First, he has to get MyHand to the people who need it most.
A little larger than a desktop printer — on wheels — the device prompts users to do repeated activities, stimulating neuropathways in the brain, and eventually helping stroke patients relearn basic hand function.
The device as it looks today — sleek, sophisticated and portable — has evolved since its early days as a basic box.
It can be wheeled to any spot in a hospital, plugged in, and be ready for a patient to sit and begin treatment. There's even a built-in storage compartment for spare parts so that operators don't have to go hunting for them should a replacement be needed.
“Clinicians have a very busy timeline, and during their timelines, they don't want to sit around spending multiple hours or a lot of time setting things up,” Johnson said.
“The design of the device had everything thought through, and that's why you see what you see."
A lot of the feedback on the device came from stroke patients themselves. Johnson's team has recruited locals to try out the device, with twofold benefit: he gets input on how to make it better, while users get the impact of the treatment.
Inspired by his frustration at the lack of rehabilitation options for patients who have experienced stroke, the first inkling of Johnson's idea surfaced in the early 2000s after graduating high school and embarking on a career in physiotherapy.
He went on to complete a master's degree in neuroscience on stroke recovery, and moved on to a PhD on developing robotic devices for stroke patients. Along the way, Johnson has collaborated with other co-founders, although only one remains involved with the company.
By 2016, IRegained was registered as a company, at least on paper, and the following year, Johnson decided to work on the company's business plan while heading off on a backpacking adventure.
Returning to Canada, he went all in on IRegained, taking two years off to focus solely on developing the company. But they were lean times, said Johnson, who worked evenings as a driver for Uber and Amazon after failing to secure a professional position in his field.
"You would think, if you have four degrees, somebody would give you a job," he said. “It was hard; I couldn't meet my bills."
One time, a kind stranger covered his $2 purchase after all his credit cards were declined at the cash.
As a founder, "you should be willing to do that,” he laughed. “Not many people are idiotic enough to do that.”
But his belief in his work propelled him to carry on.
One in four people above the age of 65 will experience stroke, Johnson said, sometimes even when they don't have lifestyle indicators like a poor diet, being a smoker, or lacking proper sleep.
He marvelled at the idea that, in 2024, you can order food from a smartphone and have it delivered directly to you, but patients who live with the effects of a stroke are left with few viable options for rehabilitation.
And those who lose their range of motion must sometimes rely on other people for basic needs, like dressing in the morning.
For formerly robust, active people who have lived their lives independently, it can be a "disgusting, humiliating, almost dehumanizing" experience, Johnson said.
“Your dignity is lost, and that is all we have in life."
Securing Performance Health is the first stage toward commercial production. Johnson said IRegained is still on the lookout for investors to keep building the company, and eventually, he's looking at expanding MyHand's reach to Southeast Asia, an area of the globe that's home to 3.5 billion people.
But first he has to solidify IRegained's North American reach.
That he's got to this point at all, he said, is thanks to a collection of local funding partners — both public and private — that have supported his efforts along the way.
A celebratory gathering held at NORCAT on July 19 was done, in part, to pay thanks to those parties. Johnson believes the collaborative approach they've taken to helping launch IRegained and other local startups is uniquely Sudburian.
“The fact that all of these people collaborated together to make it happen is phenomenal,” he said. “You won't see that in many parts of the world.”
