Ann: Personal Wheezometer receives regulatory app, page-3

re: Ann: Personal Wheezometer receives regula... SIGNIFICANT NEWS HERE.....BIG $$ TO BUY IN AGAIN....


“Wheeze Rate – A New Paradigm in Asthma Management”

“Wheeze Rate – A New Paradigm in Asthma Management”

KarmelSonix Ltd. (KSX)
Suite 2, 1233 High Street
PulmoSonix Pty, Ltd.
336A Glenhuntly Road
KarmelSonix (Israel) Ltd.

16 Palyam Avenue
Armadale VIC 3143 Australia Elsternwick VIC 3185 Australia Haifa, Israel


COMPANY ANNOUNCEMENT
Personal Wheezometer™ receives regulatory approval in European Union.


• Receipt of CE mark enables KSX European Union sales of Personal WheezometerTM to commence

• Australian TGA approval process to commence on back of CE approval being received


• Major company milestone achieved ahead of schedule
13th January 2009 : The Directors of KarmelSonix Ltd (KSX or the Company) are pleased to announce that the Personal Wheezometer™ - the flagship product of the Company has passed the European Union regulatory audit process – the CE Audit.


The receipt of European regulatory approval means that KarmelSonix is now able to sell the Personal Wheezometer™ throughout the countries of the European Union.
Additionally, this enables the Company to immediately commence the process to obtain Australian approval from the TGA.

As previously mentioned, the Company is currently seeking to raise additional funds to enable the putting in place of a production line and marketing channels for sales in Europe.

Commenting on the achievement of this milestone, KSX Chairman Peter Marks stated: “The achievement of the European regulatory approval process was identified by the Directors as a significant Company milestone and an essential element in its product development rollout plans.

The fact that this milestone has been obtained under difficult financial conditions and ahead of schedule is a testament to the dedication of the team involved in the development of the Personal Wheezometer™ product.”

The ability to now capitalize on this achievement is conditional on receipt of additional funds.

The Company's management and Board are actively engaged in sourcing additional funds from potential investors keen to the see the Personal Wheezometer™ brought to market over the coming months.


KarmelSonix Ltd.
focuses on supplying innovative non-invasive acoustic tools for disease management of asthma and related pulmonary disorders.

Asthma affects 6-16% of the population in developed countries with a cost exceeding $US15 billion in the US alone.

Acoustic Asthma Management is a breakthrough in monitoring of the asthmatic patient of all ages, including the very young, very old and others who cannot perform currently available tests.

The technology that comes from extensive R&D and clinical validation in the US, Israel and Australia, facilitate continuous monitoring of patients at home, in the ICU and even during sleep.

The company is focused on early commercialization of its products with special emphasis on the European and North American markets