iSonea begins recruiting for pediatric asthma trial
iSonea, makers of the WheezoMeter, has begun recruiting for a post-market study of its asthma monitoring device for children under the age of 12 years old. The company aims to determine the device’s ability to accurately assess wheeze rate in a group of pediatric patients. The study is expected to include about 95 participants and will be based in Folsom, California,according to the clinical trial’s listing on clinicaltrials.gov.
iSonea’s core offering today is a medical device called the WheezoMeter, a point of care, handheld device that “analyzes 30 seconds of breath sounds using advanced signal processing algorithms to detect, quantify and objectively document the presence of wheeze and its extent,” according to iSonea’s website. The company is currently seeking an over-the-counter (OTC) status for the WheezoMeter from the FDA. Last month iSonea announced plans to leverage Qualcomm’s 2net platform for home health devices.
“Asthma impacts more than 7 million children in the United States, and the number of children expected to be diagnosed with this chronic condition continues to climb at alarming rates,” Dr. Jonathan Freudman, medical director for iSonea, stated in a company release. “This study is an important milestone for iSonea. In the pediatric asthma population, it is challenging to accurately monitor and manage asthma symptoms in patients using conventional techniques. The WheezoMeter has the potential to meet a critical unmet need for better, easy to use monitoring tools for young asthma patients.”
At the HIMSS event in February, iSonea demonstrated its device as part of the Qualcomm Life booth. While the company’s setup included an image of an iPhone app called Asthma Sense (pictured), the app is not yet available for download from Apple’s AppStore.
In the future, iSonea hopes to become hardware agnostic and create smartphone peripherals that work like its WheezoMeter today. Assuming the FDA grants the Wheezometer OTC status based on the bench validation study the company currently has underway, iSonea CEO Michael Thomas said the company plans to create smartphone-based versions of the medical device for iPhone, Android, and BlackBerry devices. Thomas told a journalist in Australia last year that since there were about half a billion smartphones sold the world over in the past year, and there are expected to be about 1 billion smartphones sold in 2015, the smartphone has become the most efficient way for iSonea to get its technology to the 300 million people worldwide who have asthma.
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