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Etienne Grima, CEO of CardioComm Solutions, with the company’s HeartCheck PEN.Peter Power/The Globe and Mail

Etienne Grima, head of CardioComm Solutions Inc., took his heart-monitoring products to a global audience more out of necessity than by choice.

"In Canada, we have a challenge: We have a population that's used to having doctors telling them what to do when they're already sick and they're used to health care being paid for," says Mr. Grima, CardioComm's chief executive officer. "In the United States they're used to paying for things because they don't want to go to the doctor."

The Toronto-area company manufactures both the HeartCheck Handheld electrocardiography (ECG) monitor and the more recent HeartCheck PEN, which, unlike the former, doesn't need a prescription. The company also produces the software to operate both, now selling in 29 countries worldwide, according to the company.

The true turning point for the company was obtaining widespread approval of the PEN, which easily allows health-conscious individuals, or those looking to monitor themselves after a heart attack or stroke, to keep on top of their heart health. Having been approved by Health Canada, the United States Food and Drug Administration, and having received its CE mark, allowing it to be sold in Europe, as well as other approvals in China and Australia, the PEN is North America's only over-the-counter ECG displaying heart health monitor available without prescription, according to the company. It retails for $259 in North America.

"Really, until you get CE, FDA and Health Canada [certification] you can't sell globally because the European Union and the Middle East and India and all those places, they want you to be International Organization for Standardization-certified, which is your CE mark, and they want Health Canada or FDA clearances," he says.

Mr. Grima also feels that more people will eventually start to monitor their health, whether through choice or because in some countries medical professionals are not available around the clock.

"What we wanted to do was come up with a disruptive product in the medical market that gives consumers a chance to monitor themselves," he says.

With 16 years of experience with ECG management products, the company only started selling abroad in 2013, using word of mouth through medical professionals and advertising in trade magazines and professional periodicals to spread the word.

It's been an uphill battle at times – the company says it lost $900,000 last year – but Mr. Grima estimates the company is on course for $2-million in revenue this year. Given people's reliance on mobile technology, he also feels the company's recent innovations are just the tip of the iceberg, and the company is in the early stages of launching a smartphone application.

"Our goal is to expand with Bluetooth [technology], partner with the cellphone carriers, partner with the call centres locally, partner with hospitals that need better access to their patients in a cost-effective manner globally, because Canada is not a big enough market for us," he says.

Markets that he mentions for possible growth include those with widespread populations, crowded doctors' offices and without the resources to buy traditional ECG screening technology.

"We have a lot of interest in India and rural areas where they can't afford $3,000 ECG machines and where the doctor's office uses a cellphone for Internet connection," Mr. Grima says. "They can get a device [like ours] that's maybe $200-$300 and use it on multiple people and transmit that data wirelessly, because everybody's got cellphones, and reliably have that data land in a call centre, wherever it is."

Though the PEN began to retail in Canada, including some Shoppers Drug Mart and Rexall stores, this year, those at the cutting edge of Canadian medical technology say gaining traction here is important to improve its overseas pull.

"It's really hard to scale a health company globally if your home market isn't buying your stuff," says Zayna Khayat, senior adviser for health systems innovation at the MaRS Discovery District innovation hub in Toronto.

She says the magic number for keeping a company on these shores is 10 full-time employees – CardioComm Solutions currently has 10 full-time and six part-time staff members – and reaching that number means that it becomes too complicated to uproot and relocate.

But getting any innovation onto the global stage is a complicated formula that, in Ms. Khayat's opinion, involves a combination of product, market and team. She says that potential on these three fronts is what MaRS looks for in seeking out high-growth Canadian companies to work with – companies that will be future global players.

"For Canadian innovations in health care, it helps a lot if they can leverage the local biomedical infrastructure to give them an unfair home advantage," she says. That means working out all the bugs and finishing all the piloting and validating locally in a highly capital-efficient manner, while also using local customers as a strong reference site.

While she mentions that Canada is among the top three in the world in biomedical infrastructure, the country is lagging near the bottom when it comes to converting that into useful products and services.

"It's not too different of an analogy that we're great at taking wheat and our forestry and all that out of the ground and then someone else takes that and processes it and then we buy it back at a higher price," she says. "That's what we're doing with our biomedical research: We buy back the drugs at a premium instead of building the company here."

Ms. Khayat references Denmark, a country a fraction of the size of Canada, as an example of a nation that is punching above its weight in creating multinational pharmaceutical companies.

"The math doesn't add up," she says, adding that Canada should be producing many more companies than it currently is – companies that could drive our economy, export products globally and leverage our biomedical research assets.

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Study and track financial data on any traded entity: click to open the full quote page. Data updated as of 15/04/24 5:43pm EDT.

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