sonosentry and airsonea

SONOSENTRY & AIRSONEA

Just to clear up a misunderstanding that I had in relation to Isonea which has now been clarified:

There are two distinct 510 (k) applications to the FDA being, one for Sonosentry and one for AirSonea.

The main difference is that SONOSENTRY relates to the 2nd generation analog device for people without smart phones.

AIRSONEA relates to the flagship digital wheeze monitor which relates to smartphones and the AsthmaSense Cloud etc.

I note that the Sonosentry application was re-submitted to the FDA in Q4 FY 2013 as per page 6 of Company 2013 annual report. That means it was submitted in May/June over 4 months ago. Allowing 90-120 days plus an additional couple of weeks due to closure of U.S. govt we would expect to have a decision re: SONOSENTRY from the FDA between Nov 1 and Dec 15.

Although ultimately we will be waiting for approval from the FDA for the flagship AIRSONEA wheeze monitor, approval for SONOSENTRY will allow the company to advance work in the U.S. with additional confidence of getting the second FDA approval in early 2014.

People are going to start waking up in the next few weeks that we are not going to have wait until Jan/Feb 2014 for confirmation of a U.S. launch. Upon SONOSENTRY approval from FDA it will be full steam ahead.

The AIRSONEA era has commenced.