Toronto, Canada - CardioComm Solutions, Inc. (TSX-V:EKG) ("CardioComm Solutions" or the "Company"), a global medical provider of electrocardiogram ("ECG") acquisition and management software solutions, announced it shall be providing HeartCheckTM SMART Monitoring ECG services at no cost effective December 10, 2013 for its USA based customers who have been provided a HeartCheckTM device under a physician prescription.
The Food and Drug Administration ("FDA") cleared both the over-the-counter ("OTC") and prescription use of the handheld HeartCheckTM ECG devices and associated GEMS Home software in use by CardioComm Solutions. The Company remains the only organization that is permitted to show ECG waveforms to consumers without a prior physician prescription. While the Company has developed a business from the OTC sales of the HeartCheckTM PEN ECG device, they also hold a May 17, 2012, FDA clearance for the prescribed use of the HeartCheckTM PEN. Over the subsequent 12 months the Company established a software service infrastructure with SunGard to accommodate global expandability of the now patent-pending SMART Monitoring ECG reading service. This service infrastructure is adherent to personal and health information protection requirements and maintains ISO, FDA, Health Canada and CE Mark standards to ensure protection of the Class II and Class I classifications for CardioComm Solutions' software and devices.
"We have been steadily building our SMART Monitoring capabilities and use cases for the HeartCheckTM devices. In April 2013 we established a rapid, 30 minute on average ECG reading service for ECGs submitted through GEMS Home. Last month we released GEMS Home 1.2 that allows both the HeartCheckTM PEN and the HeartCheckTM ECG monitors to interact with our SMART Monitoring ECG service. With these latest milestones completed, we are now able to expand use of our HeartCheckTM devices so that our American customers with a physician prescription for arrhythmia surveillance will be able to receive up to three ECG interpretations in one day at no cost. After submitting a third ECG in a 24 hour period, the usual pay-as-you go model will apply as is currently in place for OTC consumer driven sales of the HeartCheckTM PEN device," said Etienne Grima, Chief Executive Officer of CardioComm Solutions.
"What this announcement means is that another barrier has been removed to enable more people who would benefit from extended ECG monitoring periods or prolonged arrhythmia surveillance to now have access to the ECG monitoring they need. Everyone becomes at a higher risk for arrhythmias, such as atrial fibrillation ("AF"), as they age and those with hypertension, diabetes and prior cardiac issues are at highest risk," said Tony Spires, Chief Executive Officer of Humble, Texas based SPI Scanning LLC ("SPI"). "We have been very impressed with the performance of the SMART Monitoring service from CardioComm Solutions and look forward to working with them in support this newest offering." CardioComm Solutions announced their strategic relationship with SPI in an April 24, 2013 press release.
CardioComm Solutions will continue to introduce new enhancements into its GEMS Home solution and SMART Monitoring ECG services throughout the coming year. "We intend to continue to update our customers and shareholders as new programs and partnerships are announced. With respect to the free ECG readings, we will make available the required information and prescription form directly from our website at www.theheartcheck.com. We are also examining the expansion of no-cost, prescription driven ECG readings into Canada," said Simi Grosman, member of the Board of Directors for CardioComm Solutions.
About CardioComm Solutions
CardioComm Solutions' patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms (ECGs) for diagnosis and management of cardiac patients. Products are sold worldwide through a combination of an external distribution network and a North American-based sales team. The Company has earned the ISO 13485 certification, is HPB approved, HIPAA compliant, and has received FDA market clearance for its software devices. CardioComm Solutions, Inc. is headquartered in Toronto, Canada, with offices in Victoria, B.C.
For Further Information On Cardiocomm Solutions Please Contact:
Etienne Grima, Chief Executive Officer
This release may contain certain forward-looking statements with respect to the financial condition, results of operations and business of CardioComm Solutions and certain of the plans and objectives of CardioComm Solutions with respect to these items. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements.
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