The HeartCheck PEN ECG device is the first to utilize the patent pending SMART Monitoring technologies to enable/unlock a consumer medical devices to record, display, transmit and receive bio-signals and images.
TORONTO, ONTARIO -May 9, 2013. CardioComm Solutions, Inc. (TSX VENTURE:EKG) (“CardioComm Solutions” or the “Company”), a global medical provider of electrocardiogram (“ECG”) acquisition and management software solutions, today confirmed it has filed for U.S. and Canadian patents for use of their proprietary technologies in the automated, software enabled and server based unlocking of over-the-counter (“OTC”), consumer based, bio-monitoring devices. Under the U.S and Canadian patents, filed on May 6, 2013 and May 8, 2013 respectively, the Company will be permitted to apply the statement “Patent Pending SMART Monitoring Technologies” in its corporate materials until the application process has been completed.
The patent pending SMART Monitoring technologies are intended to enable, or unlock, personal health monitoring devices that display bio-sign wave forms and images and can be used for remote access interpretation. Until now such devices were available only under physician prescription.
In 2012, the Company announced their FDA clearance for the HeartCheck PEN ECG device, the first OTC consumer product capable of taking and displaying an ECG without the existence of a patient-physician relationship. The clearance also included GEMS Home, a consumer heart rhythm management solution based on CardioComm Solutions’ proprietary Global ECG management and diagnostic (“GEMS”) and GlobalCardio software. Both GEMS and GlobalCardio have been in use globally under physician prescription for the diagnosis of ECG abnormalities for several years. The solution involves a system of server-based validations where consumer and HeartCheck PEN device authentications permit ECG recordings to be taken from the HeartCheck PEN and viewed by a qualified healthcare professional or physician for diagnostic purposes. The system, named SMART Monitoring, ensures the interpreted results are then returned to the registered consumer in compliance with all privacy and personal information protection regulations and laws. In May 2013, CardioComm Solutions announced completion of their infrastructure to ensure a 30 minute ECG interpretation service in support of their HeartCheck PEN sales and SMART Monitoring service.
The patent application scope covers more than ECG based technologies. “We are committed to capitalizing on our ongoing product development and software innovations. Accordingly, these patent applications are intended to extend to any bio-sign image management solution involving consumer based, home or remote access monitoring medical devices that are capable of recording, displaying and/or transmitting a biometric measure or image,” said Etienne Grima, Chief Executive Officer of the Company. “As we ready for news of our FDA clearance for GUAVA II, we are preparing for expansion of our SMART Monitoring technologies to include multiple bio-signs. Our GEMS and GlobalCardio software are cleared as a Class I and II medical products globally and contain drives to support devices from different manufacturers. With the addition of GUAVA II, which will have interpretation capabilities, we will maintain our device agnostic approach while expanding our reach into the growing disease prevention and home health care markets by adopting a disease agnostic SMART Monitoring solution,” added Grima.
The CardioComm Solutions’ patent applications have multiple claims involving the unlocking of an OTC product for bio-sign viewing and receipt of interpretive reports, under the control of a combination of device-unique and user-unique identifiers, cross matched on a robust and centralized monitoring server system. Through the use of these specific protocols confirming receipt and viewing of medical reports by physicians and consumers, the equivalent of a doctor-patient relationship is established. Once established, the monitoring server will update the device record of the bio-signal recorder to indicate that it is eligible for bio-sign signal viewing (unlocking).
The Company reports that results from the HeartCheck PEN, ECG-based SMART Monitoring solution and service are excellent. Consumer feedback has shown this is a needed product. Customer testimonials can be reviewed on the CardioComm Solutions website at www.theheartcheck.com.
“We are looking forward to the 2013 calendar year as our ECG SMART Monitoring services continue to expand and as we plan for additional SMART Monitoring revenue generating opportunities from new consumer ECG recording devices and new biomarker measuring products such as pulse oxymetry, blood pressure and blood glucose,” said Simi Grosman, member of the Board of Directors for the Company. “These patent applications, and the ability to state Patent Pending in our literature, will allow CardioComm Solutions a less encumbered expansion into the available North American markets.”
