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Monday, 07/11/2016 1:47:41 PM

Monday, July 11, 2016 1:47:41 PM

Post# of 15281
ECGI(.058)...acquisition, medical device clearances.....

ECGI's acquisition of a US-based data monitoring center is expected to occur this Friday (as per the 8-K filing).

In addition to the marketing clearance from Health Canada that the company received for its NowCardio product, ECGI is expecting to receive at least two other marketing clearances before the end of 2016 (United States and Europe).......

As part of the Event Cardio-NCMC deal, the center will serve as
the company’s U.S. data monitoring hub. NCMC, an
FDA-registered independent diagnostic testing facility,
already provides ECG support services for physicians, hospitals,
scanning services and home health care agencies. It boasts of
about 900 customers and projects sales of $2.5 million this
year.

To help in this monitoring operation, Event Cardio plans to
use the NCMC, a 30-year-old organization that is located in
Glenelg, Md., “as a vehicle to launch our product,” following
FDA clearance, Bentivoglio told Medical Device Daily. He added
that talks between the two had been ongoing for about six
months. Event Cardio plans to use the facility to monitor data
and detect heart problems in patients performing their day-today
activities.

The company intends to submit its 510(k) application for the
Nowcardio system by the end of July.


Event Cardio plans to keep and enlarge the NCMC staff,
expanding its sales force to 25 states by the end of the year and
all 50 states by the end of 2017. Richard Owsik, president, CEO
and co-founder of NCMC, will stay on board as a consultant.
Joseph Hashim, formerly with NCMC, will become vice
president of sales and marketing at Event Cardio.

Richard Smith, chief technical officer at Event Cardio, told
Medical Device Daily that the company is aiming to move its
remote monitoring model globally, and already has gained
ground in Australia and the Asia-Pacific region. Bentivoglio
added that the company expects the CE mark within 90 days.



http://www.eventcardiogroup.com/wp-content/uploads/2016/07/MDD07082016.pdf

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