CardioComm Solutions Secures New Health Canada Device Clearance and Exclusive Canadian Sales Rights for US Medical ECG Device Manufacturer
Device certification to meet underserviced Canadian market needs for long-term, remote ECG recording and ECG management software solutions.
Toronto, Ontario--(Newsfile Corp. - October 28, 2019) - CardioComm Solutions, Inc. (TSXV: EKG) ("CardioComm" or the "Company"), a global 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 physcian 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 the 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 ardioComm 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.
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 MDSAP certification, is HIPAA compliant and holds clearances from the European Union (CE Mark), the USA (FDA) and Canada (Health Canada).
As leading global manufacturers, Datrix believes in creating the most reliable products for the top companies and is committed to designing, crafting and assembling the best devices on the market. Datrix has strategic relationships with ISO 13485 registered CM's in Asia to help provide the best possible manufacturing solutions. Datrix was established in 1988 and was incorporated in 1996. In 2017 Datrix was established as an LLC.
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.
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