Unique entrant into the OTC wearable Medical-Wellness and m-Health markets to hold Class II medical device and software clearances
TORONTO, ONTARIO – Established medial electrocardiogram (“EKG”) software and device manufacturer CardioComm Solutions, Inc. (TSX VENTURE:EKG) (“CardioComm Solutions” or the “Company”), today unveiled its plans to bring to market the HeartCheck™ EKG Lifeband, a medical-grade EKG and fitness band for over the counter (“OTC”) consumer and patient use.
The announcement was made following execution of a product development agreement with US-based NeuroSky Inc. and following the critical step of establishing EKG compatibility between the NeuroSky device and CardioComm Solutions’ EKG software.
Under the agreement, CardioComm Solutions will manage FDA and Health Canada regulatory Class II medical device applications and will hold exclusive sales and marketing rights for HeartCheck™ EKG Lifeband within North America. CardioComm Solutions and NeuroSky will also both have the right to distribute the EKG band through their own distribution networks in overseas markets. Multiple revenue streams for CardioComm Solutions are expected to be created through direct sales of HeartCheck™ branded devices, a connection fee for OEM device overseas sales and recurrent revenue generated through the SMART Monitoring ECG reading service from all devices sold.
NeuroSky is the designer and manufacturer of the HeartCheck™ EKG Lifeband and the EKG computer chip technology that is used to acquire the EKG signals. The band has sensors placed into a waterproof and stylish sports band, which allows EKGs to be taken simply and discretely by touching a sensor on the band. The HeartCheck™ EKG Lifeband will additionally track wellness measurements such as physical activity, nutrition and sleep cycle that are offered by popular non-medical wellness products manufactured by Fitbit, Apple, Samsung and Microsoft.
Connectivity to Smartphones will be managed via Bluetooth connectivity through an App designed by CardioComm Solutions that is based on the Company’s FDA-cleared GEMS™ software. EKGs will be transmitted to Smartphones for real-time/continuous monitoring or the wearer can record and save EKG recordings directly onto the band that can be moved to a Smartphone for later review when convenient.
The Android and IOS compatible GEMS™ App will seamlessly connect with CardioComm Solutions’ SMART Monitoring EKG reading service and GEMS™ WIN software to allow physician access to EKG reviews. In addition to EKG recordings, the GEMS App will allow users to send quick memos regarding how they were feeling and what they were doing when the EKGs were recorded. The total solution will enable the HeartCheck™ EKG Lifeband wearers to record their EKG whenever and wherever they wish. The SMART Monitoring EKG service will help wearers to identify whether they have cardiac arrhythmia conditions that can cause strokes, sudden cardiac death as well as indicate whether their heart rate and rhythm are normal. As a Medical-Wellness product, the HeartCheck™ EKG Lifeband is also intended to be used by anyone interested in learning more about their heart health.
Adding EKG and cardiac rhythm recording/monitoring to the array of established common-place wellness sensor technologies will provide a differentiating and competitive edge for CardioComm Solutions and device partners such as NeuroSky at a time when consumers are looking for more credible health monitoring solutions. CardioComm Solutions efforts will help consumers benefit from access to credible Medical-Wellness products at a lower cost and at a newer dimension of connectivity as compared to products available from Samsung, Apple, Fitbit, AliveCor and Microsoft.
In addition to the wellness market, the Company is reviewing opportunities with medical organizations for the pre- and post-operative adverse event screening of patients who will undergo cardiac procedures, who have had a stroke, who have had a heart attack or who are living with a heart condition.
CardioComm Solutions will be providing further updates regarding US and Canadian HeartCheck™ EKG Lifeband regulatory clearances. CardioComm Solutions has earned the ISO 13485 certification, is HPB approved, HIPAA compliant and holds clearances for the sale of the HeartCheck™ technologies from the European Union (CE Mark), Australia (TGA), the USA (FDA), China (CFDA) and Canada (Health Canada). To learn more about the CardioComm Solutions’ products, please see the Company’s websites www.theheartcheck.com and www.cardiocommsolutions.com.
