iSonea (ASX: ISN, OTCQX: ISOAY) has begun its first large U.S. post-market study of its WheezoMeter™ monitoring device in paediatric patients with a range of asthma symptom severity.
The study will include patients who are too young to be tested with spirometry, a traditional measuring technique used in older children and adults.
Medical director Jonathan Freudman said the study is an important milestone for the company.
"In the paediatric asthma population, it is challenging to accurately monitor and manage asthma symptoms in patients using conventional techniques," he said.
"The WheezoMeter™ has the potential to meet a critical unmet need for better, easy to use monitoring tools for young asthma patients."
Asthma impacts more than 7 million children in the U.S., and the number of children expected to be diagnosed with this chronic condition continues to increase.
The study is planned for two West Coast locations and iSonea has begun enrolment at the site in Folsom California.
The WheezoMeter™ device is based on iSonea's Acoustic Respiratory Monitoring™ technology platform, which uses acoustic sensors and novel signal processing software to establish the presence, frequency and severity of wheeze.
The portable device records and analyses sounds caused by inflammation or narrowing of the airways, to quantify the rate of wheezing, a hallmark symptom of asthma.
The technology correlates to traditional lung function tests, but is more patient friendly, enabling frequent monitoring in real-life settings.
The device requires no physical exertion and can be used to interpret respiratory symptoms by all asthma patients, including young children or the elderly.
Advance towards commercialisation
iSonea is preparing to roll out a number of its asthma products over the next 24 months after entering its first formal partnership with telecommunications company Qualcomm Life for the development of a mobile asthma monitoring platform.
The new technology will combine iSonea's proprietary Acoustic Respiratory Monitoring (ARM) ™ devices and mobile health asthma management systems with Qualcomm's 2net™ platform.
iSonea will leverage Qualcomm's 2net Hub technology, a plug-and-play connectivity gateway to the cloud-based 2net Platform data server, to collect and transmit patient health data from its asthma monitoring devices.
Importantly, the partnership will also provide iSonea with a larger scale, lower cost platform.
Tapping a US$16b market
In the U.S., healthcare is considered the largest and least tapped market for mobile technology, which is leading to the big IT players like Microsoft, Cisco and Google all seeking out ways to penetrate the market.
The asthma market from a therapy perspective is about US$16 billion annually. Asthma is a widespread and growing condition that affects 300 million people worldwide and represents a major healthcare cost burden.
Australia, in particular, has one of the highest prevalence rates of asthma in the world.