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Potse

12/26/14 1:17 PM

#9959 RE: Potse #9861

ECGI(.075)...certification status update.....

Yesterday the company started putting up some presentations in the investor relations section of the website. The August 12, 2014 business plan document is of particular interest. At the end of that document is a milestone timeframe for the remainder of 2014 and the first half of 2015. If that timeframe turns out to be reasonably accurate, Event Cardio Group expects to make a 510k application to the FDA sometime in Q1 2015 and officially launch the product in Q2 2015.



With the new website design/update last week, ECGI (formerly SUIP) has included a new certification status update for its Now Cardio product. Based on this December 19 update, it appears that the product is now in the final stages of development. Most of the physical/electronic design work appears to be basically complete, and final software design is being completed.

It looks like they expect to do final testing of Now Cardio in March 2015, and make an application to both the FDA and Health Canada sometime in early Q2. Another interesting bit of information was included in this update: Emergo is now a consultant on the Now Cardio product, so that should significantly improve the chances that Now Cardio will get marketing clearance......

Page 2:

The Now Cardio System is in the final stages of development with final product testing planned for March 2015.



Page 12:

The Now Cardio System is on track to start Health Canada and FDA certification submission in late Q1 or early Q2 of 2015. Emergo, has been retained as consultant for the certification process and has been working with the development to ensure that the process and submission will be successful. Emergo is a leading consultancy with more than 2,500 medical device and IVD clients worldwide. Emergo maintain offices in 25 countries, offering a wide range of compliance and market access services.



http://www.eventcardiogroup.com/products/nowcardio/

http://www.eventcardiogroup.ca/wp-content/uploads/2014/12/CONTEX-NowCardio-Status-Update-December-19-2014.pdf