TORONTO, ONTARIO - Established medical electrocardiogram (“EKG”) software and device manufacturer CardioComm Solutions, Inc. (TSX VENTURE:EKG) (“CardioComm Solutions” or the “Company”), today announced its plans to bring to market the HeartCheck™ ECG Card, a small, battery-less, cost effective, medical grade and Smartphone connected ECG device for over-the-counter (“OTC”) consumer and patient use.
The announcement was made following the execution of a product development agreement with the manufacturer of the ECG Card and following the critical step of establishing compatibility between the device, CardioComm Solutions’ Smartphone ECG app and the SMART Monitoring ECG reading service.
Under the agreement, CardioComm Solutions will manage CE, FDA and Health Canada regulatory Class II medical device applications for the HeartCheck™ ECG Card and will hold exclusive sales and marketing rights for the HeartCheck™ branded device globally. CardioComm Solutions is also completing negotiations for a global co-marketing agreement for non-HeartCheck™ ECG branded models of the ECG Card sold by the OEM manufacturer’s own distribution network. The OEM manufacturer’s non-HeartCheck™ ECG branded devices – both current and future - can be connected to SMART Monitoring ECG reading service through a Smartphone app that would be downloaded for a one-time fee. The Company has disclosed that average pricing for the HeartCheck™ ECG Card will be $99 USD. The Company will immediately be applying for CE mark approval and FDA clearance for the HeartCheck™ ECG Card with plans for sales to commence prior to the end of 2016 in Europe.
CardioComm Solutions is the only “total solutions” company when it comes to consumer Medical-Wellness products and ECG monitoring services. The Company owns and holds independent medical device clearances on their GEMS™ ECG management family of software solutions that is proven and credentialed under multi-year licensing agreements with hospitals globally. The Company’s ECG reading services are run through the Company’s GEMS™ based SMART Monitoring system and Tier III managed cloud infrastructure. All ECG transmissions to and from the SMART Monitoring ECG service comply with HIPAA and PPIPA which is an extended benefit to all HeartCheck™ customers gained from the medical industry experience CardioComm Solutions has developed.
Among the unique features of the HeartCheck™ ECG Card is the fact that this Smartphone connected device does not have a battery. Holding the HeartCheck™ ECG card in proximity to a Smartphone will provide it power and connectivity for ECGs to be viewed, recorded and saved to the Smartphone in real time. The device takes its power from the Smartphone, using Near Field Communication (“NFC”) technology which consumes little power compared to Bluetooth. NFC is also useful in crowded locations where Bluetooth devices may have trouble communicating due to interference when several other devices are in close proximity. The NFC technology is also faster and easier to set up than a Bluetooth connection. Bluetooth requires users to manually set up connections to Smartphones however the HeartCheck™ ECG Card will connect automatically in a fraction of a second. ECG viewing and recording length is determined by the user.
The Company’s new GEMS™ Mobile app seamlessly connects with CardioComm Solutions’ SMART Monitoring ECG reading service allowing users access to their ECG recordings as well as physician access to perform ECG reviews at the request of the user. In addition to ECG recordings, the GEMS™ Mobile app will allow users to send quick memos regarding how they were feeling and what they were doing when the ECGs were recorded. CardioComm Solutions is unique in that they provide a total solution to enable HeartCheck™ customers to record their ECG whenever and wherever they wish. This helps customers identify whether they have cardiac arrhythmia conditions that can cause stroke or sudden cardiac death as well as indicate whether their heart rate and rhythm are normal.
Sales of the HeartCheck™ ECG Card will allow the Company to expand and complement its brand presence in markets that have been beyond reach of the HeartCheck™ ECG PEN. These markets are represented by those who prefer using Smartphone connected technologies for health and medical monitoring, looking for easier to use and more affordable devices without compromising reliability of results and protection of their personal information. CardioComm Solutions and its distributors are expecting the HeartCheck™ ECG Card backed by the Company’s total solution will soon become a preferred choice for groups and individuals looking for telemedicine, home, sports, wellness and medical monitoring technologies globally.
CardioComm Solutions has earned the ISO 13485 certification, is HPB approved, HIPAA compliant and holds clearances for the sale of the HeartCheck™ technologies from the European Union (CE Mark), Australia (TGA), the USA (FDA), China (CFDA) and Canada (Health Canada). To learn more about the CardioComm Solutions’ products, please see the Company’s websiteswww.theheartcheck.com and www.cardiocommsolutions.com.