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.
More on the clinical trial in the press release below:
PRESS RELEASE: SEVERNA PARK, Md. — Medical technology company, iSonea Ltd. (ASX: ISN; OTCQX: ISOAY) today announced the launch of a post-market study using iSonea’s WheezoMeter monitoring technology. The goal of the Wheeze Rate Correlation Study is to assess wheeze rate in pediatric patients with a range of asthma symptom severity.
Although the WheezoMeter has been studied previously, this is the first large U.S. study of the WheezoMeter in a pediatric population. The study will include patients who are too young to be tested with spirometry, a traditional measuring technique used in older children and adults. The study is planned for two West Coast locations and has begun enrollment at the site in Folsom, California. The study is registered at clinicaltrials.gov.
iSonea’s WheezoMeter device is based on the company’s Acoustic Respiratory Monitoring™ (ARM) technology platform, which uses acoustic sensors and novel signal processing software to establish the presence, frequency and severity of wheeze. In essence a ‘thermometer’ for wheeze, the portable device records and analyzes 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.
“Asthma impacts more than seven 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,” said Jonathan Freudman, M.D., medical director for iSonea Ltd. “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.”
About iSonea Limited
iSonea Limited (ASX:ISN; OTCQX:ISOAY) is an emerging medical technology company developing innovative, non-invasive devices and mobile health apps to improve the management of chronic, costly respiratory disorders such as asthma and COPD. By leveraging iSonea’s proprietary Acoustic Respiratory Monitoring™ (ARM) technology with its AsthmaSense™ mobile applications, iSonea is turning smartphones into medical devices—enabling anyone, anywhere, at any time to monitor breathing distress symptoms, in order to take action. iSonea’s ARM devices have been cleared for use by the U.S. Food and Drug Administration, the Australian TGA and the European Union CE. For more information, please visit www.iSoneaMed.com.
Certain statements made in this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on iSonea’s current expectations, estimates and projections about the industry in which iSonea operates, and its beliefs and assumptions. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” “guidance” and similar expressions are intended to identify forward-looking statements and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process of developing technology and in the endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties and other factors, some of which are beyond the control of iSonea, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. iSonea cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of iSonea only as of the date of this release. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. iSonea will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.