Market Release of HeartCheck(TM) CardiBeat and GEMS(TM) Mobile Application Set For Early 2019
CardioComm Solutions, Inc. (TSXV: EKG) ("CardioComm" or the "Company"), a leading global provider of
consumer heart monitoring and electrocardiogram ("ECG") acquisition and management software solutions, has completed its
response to the USA Food and Drug Administration ("FDA") for additional information following the Company's filing of its
premarket notification 510(k), Class II medical device clearance application for the HeartCheck™ CardiBeat and GEMS™ Mobile
Application.
The 510(k) application started its 90 day Substantive Review by the FDA on June 8, 2018. The FDA requested additional
information from the Company regarding the device July 27, 2018, which stops the clock on the Substantive Review time line. The
countdown of the 90 days will restart upon the FDA accepting the Company's response to the requested additional information.
The FDA's request for additional information required external and independent third party testing for electromagnetic and
electrostatic discharge compatibility. The FDA also requested data confirming the device's ability to record ECGs of equivalent
clinical quality, as compared to ECGs recorded using conventional ECG electrode patches and ECG cables. CardioComm was provided a
maximum of 180 days to reply to the FDA examiner. While the Company intended to respond to the FDA within 90 days, the requested
testing and documentation through third parties did not allow a response to the FDA to be completed within this time frame. All
device tests have now been passed and results compiled for the reply to the FDA. The Substantive Review clock will restart once the
FDA receives and accepts the Company's reply. Based on the FDA's published timelines, the Company projects a possible completion of
the 510(k) application review by the end of December 2018. The Company notes that the FDA has the ability to request more time to
complete their review at the FDA's discretion.
The HeartCheck™ CardiBeat is the second of several planned Bluetooth-enabled ECG recording devices to be marketed by the
Company. The first was the Bluetooth HeartCheck™ECG PEN. As indicated in the Company's May 22, 2018 press release, the GEMS™ Mobile
Smartphone app will have compatibility with a number of different wireless ECG recording devices, including wireless 12 lead
devices which will have direct applicability to remote patient monitoring and telemedicine markets.
The Company will provide updates on this and future 510(k) applications. To learn more about CardioComm's products and for
further updates regarding HeartCheck™ ECG device integrations please visit the Company's websites at www.cardiocommsolutions.com and www.theheartcheck.com. Refer to the Company's May 22, 2018 press release for further information
respecting the initial FDA filing.
About CardioComm Solutions
CardioComm Solutions' patented and proprietary technology is used in products for recording, viewing, analyzing and storing
electrocardiograms 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. CardioComm Solutions has earned the ISO 13485:2016
certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health
Canada).
FOR FURTHER INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
1-877-977-9425 x227
egrima@cardiocommsolutions.com
investor.relations@cardiocommsolutions.com
Forward-looking statements
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 management's 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.
