Mr. Etienne Grima reports

HEALTH CANADA APPROVES THE HEARTCHECK ECG PEN FOR OVER-THE-COUNTER SALES

CardioComm Solutions Inc. has received clearance from Health Canada for the sales and marketing of its HeartCheck ECG (electrocardiogram) Pen to both consumers and patients under physician prescription.

The Health Canada licence (89624) was granted Sept. 6, 2012. The HeartCheck ECG Pen was first cleared for sale in the United States by the Food and Drug Administration (K111159) as the HeartCheck Pen hand-held ECG with GEMS Home. The Health Canada approval now completes the ability for CardioComm Solutions to market its HeartCheck brand of hand-held ECG devices across North America. GEMS Home, the free downloadable, software designed by the company to provide a personal heart rhythm/ECG health record on a person's home computer, also provides connectivity between the HeartCheck Pen readings and CardioComm Solutions' ECG co-ordinating centre known as C4. GEMS Home use is approved by Health Canada under the company's existing GlobalCardio and GEMS clearances.

The initial application to secure a Health Canada approval for a new medical device licence for a private label medical device product was made July 23, 2012, for the prescription version of the HeartCheck Pen. The company recently completed language translation to meet Health Canada requirements for consumer product sales through the assistance of Lionbridge Technologies Inc., a global leading provider of translation, development and testing solutions, and the company was able to modify the original Health Canada application to include the over-the-counter version of the HeartCheck Pen.

"I believe that securing two regulatory clearances from the FDA and three new Health Canada medical licences within a 10-month period highlights our commitment to quality and points directly to CardioComm Solutions' strength as a leader in cardiac communications. All clearances were secured with only a short delay from the date of submission, with this final pair occurring in less than two months and today's fall in line with CardioComm Solutions' co-ordinated North American launch strategy for sale of both the locked (unlockable) and unlocked (ECG displaying) versions of the HeartCheck ECG Pen services," said Etienne Grima, chief executive officer of the company.

"We are very pleased with the news of these final approvals, and acknowledge the efforts of our staff in both the Toronto, Ont., and Victoria, B.C., offices. We have gone on record stating that CardioComm Solutions is committed to establishing a successful and innovative line of connected health products to enable consumers and patients to put their heart health into their own hands, and enable easier and more cost-effective telemedicine and remote monitoring solutions for prescribed services as well as for self-monitoring initiatives. I could not be more encouraged to believe in the achievement of this goal after seeing today's news," said Dr. Anatoly Langer, chairman of the board of directors for CardioComm Solutions.

"CardioComm Solutions' strength is our software solutions. We are a cardiac communications solutions company, and we ensure ECG recording device integration with our GEMS and GlobalCardio products is complete. This is the case whether it is for 12-lead ECG devices, event loop recorders or hand-held consumer-based ECG devices for use in clinic or under remote monitoring and telemedicine applications," said Mr. Grima.

"Our plans remain on track for the North American launch of the HeartCheck Pen and Smart Monitoring service, as well as for the development of a global distribution network. Expansion into multiple biometric monitoring markets is also within the company's product development schedule for 2012/2013, and we look forward to expanding our cardiac communications solutions reputation into the arena of biometric communications solutions," added Simi Grosman, member of the board of directors for CardioComm Solutions.

For more information on the HeartCheck brand of products, and associated remote and home-based ECG services, please go to the HeartCheck website.

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