ResApp Advances FDA Clinical Trials for Smartphone-Based Respiratory Diagnostic App with IRB Approval from Cleveland Clinic

ResApp is an Australian technology company that develops applications for diagnosing respiratory health based on cough sounds, primarily providing diagnostic assistance to physicians in healthcare institutions. The company is currently conducting three IRB-approved Smartcough-C pediatric clinical trials at Cleveland Clinic and Massachusetts General Hospital, having already received approval for the first trial at Cleveland Clinic. Dr. John Carl, MD, Director of the Center for Pediatric Pulmonary Medicine, will serve as the principal investigator at Cleveland Clinic. A third hospital is expected to join the trials in the near future.

ResApp’s product is an application called ResAppDx, which essentially uses a smartphone’s microphone as a stethoscope to listen to patients’ breathing. Unlike other similar applications, it does not rely on physicians’ auditory assessment for manual interpretation; instead, it employs proprietary machine-learning algorithms to diagnose potential respiratory diseases in patients, such as pneumonia, asthma, bronchiolitis, and chronic obstructive pulmonary disease (COPD). ResApp aims to integrate these algorithms into telemedicine products in the future, enabling their direct use in clinical practice.

As it involves clinical diagnosis, FDA review is required, and the feasibility of medical efficacy must be established through rigorous multi-site double-blind trials. Tony Keating, Managing Director and CEO of ResApp, stated in a press release: “We are delighted to announce that we have received our first Institutional Review Board (IRB) approval for a pivotal pediatric study. Our ultimate goal is to demonstrate the clinical accuracy validation of ResAppDx and improve healthcare outcomes for children worldwide.”

As early as April this year, the company conducted clinical research involving 524 pediatric patients at Joondalup Health Campus (JHC) and Princess Margaret Hospital (PMH) in Perth, Western Australia, achieving an accuracy rate of 89% in both settings. In a smaller trial involving 243 adult patients, the company’s accuracy ranged between 91% and 100%.

Following the receipt of the first Institutional Review Board (IRB) approval from the Cleveland Clinic, the study is expected to be launched in Massachusetts this year as well. It will primarily focus on the diagnosis of pediatric pneumonia, while also evaluating the diagnostic accuracy for conditions including upper respiratory tract infections, labor pain, bronchiolitis, and asthma.

ResApp raised $9.74 million in April this year, with plans to use the funds for the research and development of a smartphone app for diagnosing respiratory diseases. The company has made strategic investments in areas such as telemedicine, clinical diagnosis, consumer-grade device development, pulmonary disease assistance in developing countries, and medical big data.