ECGI Holdings Inc (ECGI)

[Potse]

ECGI...Health Canada clearance, FDA timeline.....

Things might get a bit interesting from this point forward following the most recent corporate developments. Now that ECGI has regained marketing rights to NowCardio in all countries/markets, Canadian regulatory application/approval should have a more positive direct impact on the company/stock.

The financing this past week was done at significant premiums to the current price ($1M at 10 cents and $375K at 15 cents, with 25-cent warrants). Also very interesting to note that it appears these latest warrant packages do not have any cashless exercise provisions in the agreement. All things considered, this looks like a pretty favorable development for current ECGI shareholders.

Based on yesterday's press release, it appears that ECGI has hired a new public relations firm (Dian Griesel International). So there will likely be an increased level of media awareness of the company at some point.

I picked up some more shares last week at 6 cents following the disclosure that NowCardio had received marketing clearance from Health Canada. It looks like the application went pretty smoothly through the Canadian regulatory process. That should bode well for a relatively quick/clean path through the FDA 510(k)
application process.

According to today's press release ECGI plans to submit the FDA application in late July. If that guidance date is met, ECGI would probably receive marketing clearance from the FDA sometime around October/November of this year.....

NCMC, a FDA-registered independent diagnostic testing facility (IDTF), has been providing cardiac diagnostic services since 1986. It provides a range of cardiac monitoring modalities including Mobile Cardiac Telemetry (MCT), wireless and trans-telephonic cardiac event monitoring (CEM), 24/48-hour digital Holter monitoring with data transmission to NCMC, 24-hour ABP monitoring, full time and off-hours monitoring, and triage. The facility can receive any number of patient calls simultaneously, with patients receiving immediate, one-on-one service every time they call. NCMC will be used by EventCardio to introduce its NowCardio™ heart monitoring system in the U.S. upon clearance by the FDA and will serve as the Company’s U.S. data monitoring center. EventCardio intends to submit its 510(k) application for NowCardio in late July. NowCardio has already been cleared for sale by Health Canada as a Class 2 Medical Device.

EventCardio plans to retain all NCMC staff, consisting of 10 staff members and 19 sales representatives in 15 states. The company plans on expanding its sales force to 25 states by the end of 2016 and all 50 states by the end of 2017. NCMC will be the U.S. headquarters for Now Cardio.

https://www.sec.gov/Archives/edgar/data/1394130/000072174816001424/ecgi8k070716ex99_1.htm

Today's announcement regarding the planned acquisition of the US-based data monitoring center next week, and the planned expansion of the sales force, should result in NowCardio gaining some traction in the US marketplace.