TORONTO, ONTARIO - CardioComm Solutions, Inc. (TSX VENTURE:EKG) ("CardioComm Solutions" or the "Company") today announced that it has completed a HeartCheck(TM) and SMART Monitoring distribution and co-marketing agreement ("Agreement") with Reka Health, Inc. (REKA), a US based company. REKA will promote sales of the HeartCheck(TM) PEN through their own, proprietary international distribution channels, including US-based accountable care organization ("ACO") patient portals.
The Agreement confirms CardioComm Solutions will integrate the REKA E100, a Smartphone connected, handheld, single lead, 30 second ECG cardiac event monitor with CardioComm Solutions' patent-pending SMART Monitoring ECG service to support physician prescribed use of the REKA E100. In return, REKA will co-promote the HeartCheck(TM) PEN ECG as their over-the-counter ("OTC") solution for ECG self-monitoring. Both companies will share in the SMART Monitoring service revenue where REKA has managed the sale of either the HeartCheck(TM) PEN or the REKA E100. Additionally, CardioComm Solutions plans to expand their HeartCheck(TM) OTC 510K clearance from the Food and Drug Administration ("FDA") to include the REKA E100. CardioComm Solutions will benefit with a share of the revenue from the sale of each REKA device and REKA will benefit from ECG reading service revenue derived through the SMART Monitoring ECG service.
"Introducing new ECG monitoring devices that use a Smartphone to transmit data, rather than an internet connected computer, will allow us to access a larger SMART Monitoring ECG service market. By working with groups such as REKA, we can realize increased use of the ECG service through their developed sales channels and benefit from a device royalty for each SMART Monitoring compatible REKA E100 that is sold globally. Further, we aim to incorporate the REKA E100 under our own HeartCheck(TM) OTC clearance to benefit from the Smartphone dependent OTC market for ECG screening and monitoring," said Simi Grosman, member of the Company's Board of Directors.
The Companies will pair their respective technologies where the REKA Smartphone application and HIPPA compliant cloud-based platform (REKA Cloud) will direct all HeartCheck(TM) enabled REKA E100 devices to transmit recorded ECGs into the CardioComm Solutions SMART Monitoring environment. The REKA Smartphone App is compatible with AndroidTM OS and iOS(R) Smartphones. From there, customers will be able to receive ECG reports through the CardioComm Solutions GEMS Home and/or through the REKA Cloud. CardioComm Solutions holds a unique market distinction of having independent Class II medical device FDA clearances on their ECG viewing and reporting software technology used within the SMART Monitoring ECG service. Such clearances to view and report ECGs, regardless of the device used to record and transmit the ECG file, is important in enabling physicians to confidently render reliable ECG interpretations. Such clearances will strengthen both Companyies efforts to access markets such as the veterans' administration-based ACO patient portals, which are now interested in providing both prescribed and OTC access to ECG monitoring services to their patients.
"CardioComm Solutions has been evaluating several different devices for integration into the SMART Monitoring ECG service. Devices of highest interest are those that are already available on the market with prescription use FDA clearance, can be manufactured in high volumes and can communicate through cellular technologies by pairing with a Smartphone or with their own internal GSM capabilities. Such device manufacturers will provide the hardware platform while CardioComm Solutions will provide the OTC clearance under the HeartCheckTM brand for North American sales and the SMART Monitoring ECG software platform for ECG reading services globally," said Etienne Grima, Chief Executive Officer for CardioComm Solutions.
About CardioComm Solutions
CardioComm Solutions' patented and proprietary technology is used in products for recording, viewing, analyzing and storing electrocardiograms (ECGs) 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. The Company has earned the ISO 13485 certification, is HPB approved, HIPAA compliant, and has received FDA market clearance for its software devices. CardioComm Solutions is headquartered in Toronto, Ontario, Canada, with offices in Victoria, B.C.
FOR FURTHER INFORMATION PLEASE CONTACT:
Etienne Grima, Chief Executive Officer
1-877-977-9425 x 227
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: specifically consider risks discussed under the heading "Risk Factors" in the Company's Annual Information Form, available at www.sedar.com; not to place undue reliance on forward-looking statements and forward-looking information; be aware the Company does not assume any obligation to update the forward-looking statements and forward-looking information contained in this Annual Information Form other than as required by applicable laws, including without limitation Section 5.8(2) of National Instrument 51-102 (Continuous Disclosure Obligations).
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