Shares of CardioComm (TSXV:EKG) were on fire today after the company announced it had cleared an important hurdle in its goal to market a new handheld ECG device called the HeartCheck Pen.
CardioComm received confirmation from the Canadian Medical Devices Conformity Assessment System that it had cleared an ISO (International Organization for Standardization) audit performed by DQS Medizinprodukte GmbH. The purpose of the audit, said management, was to ensure the treatment was safe and effective.
Shares of CardioComm were up 200% today to $.435 as a startling $23.6 million shares changed hands.
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CardioComm, which was founded more than two-decades ago in Victoria and is now headquartered in Toronto, has derived modest revenue from it products to date, which provide a real time means of viewing electrocardiograms online. The company’s customer based includes the Ottawa Heart Institute, Toronto’s St. Michael’s Hospital and Calgary’s Foothills Hospital.
“This is excellent news for CardioComm Solutions,” said Etienne Grima, the company’s CEO, “especially in light of the rally in our stock price and brisk trading. The recent market response provides a clear signal that our shareholders and corporate partners understand the significance of the FDA’s [Food and Drug Administration] permission for CardioComm Solutions to sell the HeartCheck Pen with our GEMSA Home software. The results of this ISO audit demonstrate that what differentiates CardioComm Solutions in the marketplace is our design excellence and compliance pedigree as an ISO-certified, FDA-compliant software engineering and solutions company.”
Recent data suggests CardioComm is hitting its stride at the right time. Dallas based market research firm Markets and Markets says the the global diagnostic ECG market is expected to be worth U.S. $4.1 billion by 2014, inferring an estimated Compound Annual Growth rate of 9.6% from 2009 to 2014. The firm says the growth is being driven by an increasingly aging population an rising incidence of lifestyle diseases.