COMPANY ANNOUNCEMENT Acoustic Severe Asthma Monitor Clinical Trial at Melbourne’s Alfred Hospital HIGHLIGHTS • Pulmosonix Pty Ltd, Australian subsidiary of KarmelSonix, obtains ethics approval for Acoustic Severe Asthma Monitor (ASAM) • ASAM Clinical Trials to commence Q4 2007 at The Alfred Hospital, Melbourne, Australia • Combines the joint Australian and Israeli patented technology owned by KarmelSonix
4th September 2007 : KarmelSonix Ltd (KSX) Melbourne-based subsidiary, PulmoSonix Pty Ltd, is pleased to announce that ethics committee approval has been received to conduct a clinical trial using the Acoustic Severe Asthma Monitor (ASAM) at the Alfred Hospital in Melbourne, Australia.
The technology being developed is funded, in part, by a grant received from VISTECH - the joint technology fund established between the Victorian and Israeli Governments in 2005 to promote, facilitate and support jointly approved science and technology research and development (R&D) projects.
The US$425,000 grant was awarded to PulmoSonix and KarmelSonix Israel, (announced in March 2007) to develop a new medical device combining the previously clinically validated non-invasive acoustic core technologies of both companies.
The novel ASAM technology allows both non-invasive passive and transmissive acoustic technologies to be used side by side to monitor patients with severe asthma.
This first in a series of human trials will be conducted at The Alfred Hospital in Melbourne and will involve up to 30 patients who will be tested using the ASAM across 3 different patient groups.
It is expected that patient enrolment will commence in Q4. Additional clinical evaluation will be undertaken throughout the ASAM development project to further validate the technology and support regulatory approval activities.
The ASAM is part of the overall range of hospital-to-home (H2H™) products and technologies currently being developed by KarmelSonix Ltd. for management of asthma and related respiratory diseases. The first of this product range, the WIM-PC™, is already being deployed commercially in key markets.
KSX Chairman, Mr Peter Marks indicated that the “approval to commence the clinical trial at The Alfred is an important milestone for this project and represents a dynamic product development momentum.
With the vast number of acute hospital admissions seen every year around the world for severe asthma, clinical evaluation of the ASAM underlying technology takes us a step closer to better monitoring and managing acute exacerbations of this chronic disease.” For personal
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