Unique entrant into the Medical-Wellness and m-Health markets to target the active consumer
TORONTO, ONTARIO – Established medical electrocardiogram (“ECG”) software and device manufacturer CardioComm Solutions, Inc. (TSX VENTURE:EKG) (“CardioComm Solutions” or the “Company”), today unveiled plans to bring to market a wearable product line of Bluetooth connected, ECG chest patches intended for the active consumer. The devices will be branded as the HeartCheck™ ECG Sport and will introduce medical-grade ECG monitoring to the over-the-counter (“OTC”) consumer Medical-Wellness, out-patient hospital and cardiac rehabilitation markets.
The announcement was made following the completion of integration, testing and compatibility assurance of the two-part and three-part versions of the HeartCheck™ Sport patch devices with the CardioComm Solutions’ developed GEMS™ Mobile Smartphone app and connectivity to the Company’s SMART Monitoring ECG reading service. The patch devices will also be compatible with the Company’s hospital based GEMS™ WIN software that is sold globally.
The devices are lightweight and can be worn under clothing discreetly. Using regular disposable ECG adhesive electrodes that snap onto each of the patch modules, the HeartCheck™ ECG Sport is worn against the skin on the chest over the heart region. An advantage of the two-part device is that a lead II rhythm recording can be acquired which is preferred by cardiologists to identify and classify arrhythmias. The three-part device offers simultaneous 3 lead ECG recordings reflective of recordings taken in hospital.
CardioComm Solutions will manage FDA and Health Canada Class II medical device applications for the co-branded HeartCheck™ ECG Sport and will hold exclusive sales and marketing rights within North America. CardioComm Solutions also holds the global co-marketing rights for the devices which will provide new product revenue from 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 patch devices sold.
Connectivity to both the HeartCheck™ ECG Sport devices will be managed by the GEMS™ Mobile app, which is based on the Company’s FDA and Health Canada cleared GEMS™ medical software, allows real-time viewing and simultaneous recording of ECGs on Smartphones. The GEMS™ Mobile app will permit recorded ECGs to be recalled and displayed on the Smartphone and will seamlessly manage connectivity with CardioComm Solutions’ cloud-based SMART Monitoring ECG reading service. The total solution is compliant with HIPAA and PIPEDA, while allowing remote physicians or ECG technicians access to the ECGs should a customer request an ECG interpretation or triage. Whether an ECG reading is requested or not, GEMS™ Mobile users may have access to a standard ECG report that they can share with their health care provider at their own discretion. The GEMS™ Mobile app will also allow users to send quick memos regarding how they were feeling and what they were doing when the ECGs were recorded. This total solution will enable HeartCheck™ ECG Sport 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.
CardioComm Solutions will be providing further updates regarding HeartCheck™ branded ECG recording devices. 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.
