Planned launch will increase market access for device sales and ECG services globally.
TORONTO, ONTARIO – CardioComm Solutions, Inc. (TSX VENTURE:EKG) (“CardioComm Solutions” or the “Company”) a global medical provider of electrocardiogram (“ECG”) acquisition and management software, announced today that it will introduce a Bluetooth HeartCheck™ PEN for wireless connectivity to Android and Apple Smartphones by Q1 2016. CardioComm Solutions is the first company to bring ECGs to the North American consumer and over-the-counter markets.
The Company has completed the development and testing of a pre-production version of the Bluetooth HeartCheck™ ECG PEN and a Smartphone application that will wirelessly connect the Bluetooth ECG PEN to the Company’s SMART Monitoring ECG service. With the review of FDA and Health Canada requirements completed and confirming a Bluetooth enabled version of the HeartCheck™ ECG PEN can be sold under the Company’s current and existing medical device approvals, the release of the wireless version of the HeartCheck™ ECG PEN can occur with material time and cost savings. The Bluetooth HeartCheck™ ECG PEN model will retain the same form factor and use-advantages as the current ECG PEN version. It will allow ECGs to be viewed on the device while heart rhythm recordings are taken and for the storage and replaying of up to 20 ECGs. In addition to wireless communication, the Company will maintain the device’s USB connectivity to a Windows-based PC which is critical where cellular coverage may be unreliable.
The ability to connect to Smartphones will provide CardioComm Solutions access to an expansive mobile health consumer market not previously marketed to. Two advantages and major product differentiators of the Bluetooth HeartCheck™ ECG PEN versus other Smartphone-connected ECG monitoring devices are:
- Use of the device is not dependent on a Smartphone: ECG recordings by other devices are not possible if they are not physically near the Smartphone, if the phone is out of power or if cellular reception is not available; and
- No physician prescription is required as a condition to be able to see an ECG report.
By developing their own Smartphone Application and tying to the Company’s proprietary SMART Monitoring ECG services solutions, CardioComm Solutions is now able to introduce other devices under the HeartCheck™ brand for the medical, sport and consumer wireless wearable sensor markets. With the ability to leverage FDA, Health Canada, Chinese FDA, Australian TGA and European CE Mark software clearances/approvals, this would remove a need for such device manufacturers to develop their own costly software solutions and provide them a faster go to market opportunity.
The HeartCheck™ ECG PEN is the first ECG displaying medical device approved by Health Canada and cleared by the FDA for OTC sales and represents the newest medical device approved for every day home-use in the past 30 years. The current model of the device connects via a USB cable to the Windows-based GEMS™ Home software for the transfer and management of recorded ECGs. GEMS™ Home also allows for the ECG to be reviewed by the Company’s SMART Monitoring ECG service for a fee. The response time for an ECG reading is within 30 minutes 24/7/365.
The Company has recently reported the introduction of the HeartCheck™ ECG PEN into the Canadian retail pharmacy market within select Shoppers Drug Mart, Rexall and independent pharmacies. The Company has also announced it will be seeking sales opportunities in US retail pharmacies within 2015. Introduction of the Bluetooth HeartCheck™ ECG PEN by Q1 2016 will benefit from the anticipated development of these sales channels.
CardioComm Solutions will provide further updates on the Bluetooth HeartCheck™ Program at the www.theheartcheck.com website.
