FOR: CARDIOCOMM SOLUTIONS, INC.
TSX VENTURE SYMBOL: EKG
May 8, 2018
TORONTO, ONTARIO - CardioComm Solutions, Inc. ("CardioComm" or the "Company") (TSX VENTURE:EKG) a leading global provider of consumer heart monitoring and electrocardiogram ("ECG") acquisition and management software solutions, has initiated the application process to the USA Food and Drug Administration ("FDA") for premarket notification 510(K), Class II medical device clearance of the Company's newest consumer-based and HeartCheck™ branded, hand-held heart rhythm monitor.
Preparations for the FDA pre-market notification application follows 16 months of stringent ISO 13485:2016 compliant product development and compatibility testing of this and several other Bluetooth ECG devices with CardioComm's GEMS™ (Global ECG Management System) Win and GlobalCardio™ ECG management software platforms. The HeartCheck™ branded device name will be disclosed following submission of the FDA application, which will happen within the month of May. The Company expects to announce the progress on the release of other devices to the market as compliance testing is completed.
The FDA premarket notification 510(K) application will also include CardioCommís downloadable GEMS™ Mobile App. The Company has confirmed that GEMS™ Mobile enables any HeartCheck™ branded or HeartCheck™ compatible Bluetooth device to be connected to iOS and Android Smart devices. The GEMS™ Mobile App will be available for download on Appleís iTunes and on Google Play.
The GEMS™ Mobile App has been designed by CardioComm and is based directly on the Company's already FDA cleared and Health Canada approved GEMS™ software. GEMS™ Mobile allows ECG's to be transmitted to Smart devices for post-event or real-time/continuous cardiac monitoring following which GEMS™ Mobile will save the recorded ECG's and transfer them to the Company's cloud-based SMART Monitoring ECG reading service when convenient or as required. Once uploaded, ECGs can be reviewed and reported by physicians and feedback provided to the consumer, or patient, based on the ECG review findings. The workflow for unlocking and viewing the ECG waveform following physician review will follow that of the Company's FDA cleared HeartCheck™ ECG PEN and GEMS™ Home software.
CardioComm is the first company in Canada and the USA to have received Class II medical device clearances for personal ECG monitoring devices under an OTC clearance. Since then several competitor products have come to market using CardioComm's FDA approved device as the predicate technology for gaining their approvals. Imitated but not replicated, CardioComm's differentiator is its 20 years of experience as a trusted ECG management and device connectivity solutions provider to the medical industry. With over one hundred customers from the medical markets licensing software from CardioComm's family of GEMS™ technologies, CardioComm represents a medical company that brings credible and reliable health monitoring solutions to the consumer markets, versus companies that have developed as consumer device providers who are now trying to move into the medical space.
An FDA premarket notification 510(K) Class II medical device clearance for prescription sales is also being sought for the new HeartCheck™ device. Class II medical device clearances for Canadian and European Union markets will be sought in Q4 2018.
The Company confirms that it will continue to emphasize its recognized leadership as a software innovator in providing high impact medical software engineering solutions while working to broaden consumer access to a larger range of wireless, easy-to-use and innovative consumer and medical-wellness products. The introduction of device and software interpretive algorithms is also a priority for the Company as this will support its plans to soon bring other credible and affordable wearable and handheld, single and multi-lead ECG devices to the OTC and Rx markets, including some devices with multiple vital signs monitoring capabilities.
To learn more about the CardioComm' products and for further updates regarding HeartCheck™ ECG device integrations please see the Company's websites at www.cardiocommsolutions.com and www.theheartcheck.com
CardioComm Solution's patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms for diagnosis and management of cardiac patients. CardioComm Solutions is cleared by the FDA for the sales of a consumer based HeartCheckTM PEN handheld EKG device and home version of its proprietary GEMSTM Home software. Products are sold worldwide through a combination of an external distribution networks 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 and devices. CardioComm Solutions, Inc. is headquartered in Toronto, Canada.
INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
This release may contain certain forward-looking statements and forward looking information 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. Such statements and information reflect managementís current beliefs and are based on information currently available to management. By their nature, forward-looking statements and forward-looking information 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 and forward-looking information.
In evaluating these statements, readers should not place undue reliance on forward-looking statements and forward-looking information. The Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this release other than as required by applicable laws, including without limitation, Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.