I was one those Blokes so I’ll have a crack for you.For ISN to...

I was one those Blokes so I’ll have a crack for you.

For ISN to justify its current share price it has to sell anywhere from 6000 to 14000 units a month. And that’s to justify the current sp – not any blue sky.

The only way it can do this is in the US and for that you need FDA approval. Everything else, TGA / CE mark, thinking your Coke and buying access to P&G’s mums word of mouth marketing tool, consumer surveys, sporting legends, doctor conferences is just fluff.

So hows the FDA approval process going?

Wheezemeter was the original ISN device. It had FDA approval to be used under a health professional supervision – that is it needed a doctors prescription. It never sold very many units – and the old company tried unsuccessfully for many years to get over the counter status for it.

In Oct 2012 ISN put in a FDA 510 application to gain approval for Sonosentry (the updated Wheezometer) to be sold over the counter. This was rejected.

It then reapplied in the Q2 2013. As it later emerged one essential step for the FDA submission was the completion of a usability study to demonstrate that consumers could effectively use the device without the guidance of healthcare professionals. This was completed in June with 20 consumers.

So if the submission went in say early July - approval should take 90 days all going well – in September. Where is the approval? It’s not mentioned in the September quarterly – but we can note the puff went out of sp around this time.

Its not taking people long to join the dots here. On the 9 September 2013 Mobihealthnews reported as follows:

“iSonea previously released an app, AsthmaSense, that allows users to manually record their symptoms. From its conception, the app was designed to eventually work with AirSonea, which at the time the company said was still awaiting over-the-counter 510(k) FDA clearance.

Neither the clearance nor the product has yet emerged, although the company has been speaking about FDA clearance since 2012, even inking a deal with Qualcomm to be part of its 2net hub. The postmarket clinical trial the company was talking up in March 2012 has been terminated as of last month. The company does hold an FDA clearance for their original non-smartphone connected Wheezometer, but it is only cleared for prescription use.”

The clinical trial was terminated (ie abandoned). Why. Difficulty in recruiting patients is one reason. The second was that the algorithm used in Sonosentry didn’t correlate to what clinicians were doing (the gold standard) or match guidelines.

Now turn to the flagship Airsonea.

In Jan 2013 plan was to start selling Airsonea in the US in Q3 013. In March 2013 the planned Airsonea submission date set as August 2013. In June 2013 the planned Airsonea submission date was Q4 in Calender 2013. In September 2013 the planned Airsonea submission date is now Q2 Calender 2014

What has happened to push the date for Airsonea FDA submission out not one quarter but two quarters?

25 September 013 the FDA released it guidelines for medical apps. There are two paths.

An easy path for apps that pose low risk. An example: Mobile apps that help asthmatics track inhaler usage, asthma episodes experienced, location of user at the time of an attack, or environmental triggers of asthma attacks;

And a hard path for apps that pose a risk to safety if they don’t perform as intended. Examples include mobile apps that use an attachment to the mobile platform to measure blood oxygen saturation for diagnosis of specific disease or condition. Or a mobile apps that use an attachment to the mobile platform to measure blood glucose levels.

So what is Airsonea?. Well the app part is pretty harmless – easy path. But attach the device and it looks analogous to the examples used in the hard path. Trouble is the app is free – it’s the device that earns the money.

And that’s the bit that’s on a hard path getting harder.

On the 234th floor of a New York skyscraper is the short it to zip global hedge fund. Their most experienced trader is a 20 year old with a masters degree in the universe. He puts down his copy of Mobihealthnews. He pulls up a sp graph of ISN. He leans over his trading station – “Hey boss I think I’ve spotted a big bubble in this mHealth app stuff”. His sp target ….. 5cents.

http://mobihealthnews.com/25286/isonea-asthma-monitor-gets-ce-mark-no-fda-yet/

Cant promise a 10 bagger from here - but every bit of downramping helps!

Southoz.