SOURCE: Event Cardio Group Inc

Event Cardio Group Inc

December 09, 2015 16:15 ET

Event Cardio Group Crosses Major Hurdle

Completion of NowCardio Field Audit

NEW YORK, NY--(Marketwired - Dec 9, 2015) - Event Cardio Group, Inc. (OTCQB: ECGI), a medical device company, is pleased to announce that its Ambulatory Arrhythmia Monitoring System, NowCardio™, has successfully completed its stage 2 audit of compliance to Canadian Medical Devices Conformity Assessment System (CMDCAS). The audit was conducted by a recognized registrar, BSI Group, and is a significant milestone towards both Health Canada and FDA certification. NowCardio™ is on track to receive regulatory certification and approvals by Health Canada in Q1 of 2016, and by FDA early in Q2 of 2016.

On November 26 and 27, 2015, Contex International Technologies (Canada) Inc., the engineering firm engaged by Event Cardio Group, Inc., to develop its NowCardio® heart monitor, completed a Stage 2 Audit, last of a series of audits, conducted by the registrar BSI Group Canada Inc. No non-conformances were noted in the audit, and the Company anticipates that Contex will receive ISO 9001 and ISO 13485/CMDCAS Certificates in the coming weeks. These certificates are required to apply to Health Canada for certification of the NowCardio® System as a Class II Medical Device, and furthermore, to license manufacturing and distribution within Canada. In addition to obtaining the ISO/CMDCAS Certificates, Contex must also submit the NowCardio® device to an outside lab for regulatory testing. NowCardio® has already passed interim testing of development prototypes at the lab.

The Company expects that Contex will receive the ISO/CMDCAS Certificates by the end of the year at which time it will make the submission to Health Canada. The Company currently anticipates that it will receive the necessary approvals and be authorized to sell NowCardio® in Canada in early February 2016.

About Event Cardio Group, Inc.

Event Cardio Group, Inc. is a developer of medical diagnostic detection equipment focused on detection and preventative treatment of high-risk diseases. The Company's core products are Now Cardio™, an advanced cardiac monitor which offers dual-functionality including both holter monitoring and event recording simultaneously, and its FDA approved BreastCare DTS™ breast cancer detection device. For more information on the Company please visit www.eventcardiogroup.com.

Statements in this release may be regarded, in certain instances, as "forward-looking statements" pursuant to certain sections of the Securities Act 1933 and the Securities Exchange Act 1934, respectively. "Forward-looking statements" are based on expectations, estimates and projections at the time the statements are made, and involve risks and uncertainties, which could cause actual results or events to differ materially from those currently anticipated, including, but not limited to delays, difficulties, changed strategies, or unanticipated factors or circumstances affecting Event Cardio Group, Inc. and its business. There can be no assurance that such forward-looking statements will ever prove to be accurate and readers should not place undue reliance on any such forward-looking statements contained herein. Event Cardio Group, Inc. will not republish revised forward-looking statements to reflect events or circumstances after the date hereof to reflect the occurrence of unanticipated events.

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