TORONTO, ONTARIO – CardioComm Solutions, Inc. (TSX VENTURE: EKG) (“CardioComm” or the “Company”), a leading global medical provider of consumer heart monitoring and electrocardiogram (“ECG”) acquisition and management software solutions, today announced it has entered into an exclusive sales and marketing agreement for the GEMS™ Sirona with California-based Datrix LLC (“Datrix”).
Under the multi-year, renewable agreement, CardioComm assumes the role of exclusive Canadian distributor of the Datrix ECG recorders under the GEMS™ Sirona brand device. The GEMS™ Sirona device is utilized under physician direction as an ambulatory ECG device capable of transmitting ECGs in near real-time when an arrhythmia is detected as well as provide access to long-term, continuous ECG Holter recordings for up to 30 days.
Datrix entered into the agreement with CardioComm in response to new Canadian quality system requirements for medical device manufacturers known as ISO 13485:2016 under the Medical Device Single Audit Plan (“ISO MDSAP”) which will be mandatory for all medical device manufacturers, whether Canadian or not, to hold by January 1, 2020. In addition to the Canadian exclusive distribution rights, CardioComm will also represent Datrix as a preferred ECG hardware/software solutions provider for sales in the US and overseas and will receive fees annually for securing and maintaining the GEMS™ Sirona ISO MDSAP registration and Health Canada medical device licensing.
CardioComm was able to successfully complete several critical milestones leading to their 2019/2020 ISO MDSAP certification. This certification covers a wide range of third party device manufacturers including the Datrix device. The new GEMS™ Sirona has received clearance from Health Canada as a class II medical device. The new Health Canada clearance was confirmed in September 2019 with the new branding for the GEMS™ Sirona under CardioComm finalized in mid-October.
Under the new partnership current Datrix’s Canadian Sirona users will have the continued ability to acquire new devices, now under the GEMS™ Sirona brand, and be able to receive servicing support on existing Sirona device inventories, all managed through CardioComm. It will also open the opportunity for CardioComm to introduce the GEMS™ Sirona to its existing and new customers. CardioComm has GEMS ™ licensing agreements with 13 Canadian hospitals, all which have been introduced to the GEMS™ Sirona device. The majority of these hospitals are reviewing the GEMS™ Sirona as a replacement to devices no longer available to the Canadian markets as of 2019 and the Company confirms that four of these Canadian hospitals have already placed lead orders for the device.
In addition to supporting analogue ECG transmissions, which continues to be utilized in Canada, the GEMS™ Sirona device can connect via Android mobile devices to support wireless remote transmissions of ECG data to healthcare organizations that license CardioComm’s GEMS™ WIN ECG management systems. CardioComm has also engineered connectivity of GEMS™ Sirona to Android and iOS mobile devices through the Company’s newly released GEMS™ Mobile app.
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.
