Digital health innovator ResApp Health (ASX: RAP) has received a significant boost courtesy of European regulatory approval for its first commercial product, ResAppDx-EU.
The smartphone app has received CE Mark certification as a Class 2a medical device thereby validating and securing its future marketability as a diagnostic test for acute paediatric respiratory disease.
Obtaining CE Mark certification means that ResAppDx-EU has met the essential requirements of all the applicable European regulations as a medical device and allows for the sale of ResAppDx-EU in the European Economic Area (EEA).
According to ResApp, its product can have far-reaching benefits in the healthcare system and will serve as a springboard for the company to move ahead with its European commercialisation strategy.
Furthermore, by acquiring European certification, ResApp’s technology now has added momentum and stature to acquire further regulatory submissions in Australia, Canada and Singapore.
The US market is also on the horizon following a De Novo classification request to the US Food and Drug Administration (FDA) in April this year. The application is still “pending review” with a final confirmation expected in the foreseeable future.
First breath in the EU market
ResAppDx-EU is a “software-only solution” that can accurately diagnose lower respiratory tract disease, croup, pneumonia, asthma/reactive airway disease and bronchiolitis by using machine learning algorithms that analyse a patient’s cough sounds to make a diagnosis.
One of its most important features is the lack of invasiveness and making existing diagnostic aids such as stethoscopes, imaging, blood and sputum tests largely redundant.
In order to ensure competency and efficacy, ResApp conducted a series of studies and to obtain the CE Mark, the company carried out a “Breath Easy paediatric clinical study”.
Breath Easy was a double-blind, prospective trial which evaluated the efficacy of ResApp’s algorithms in diagnosing acute respiratory disease in children.
The study collected data from 585 patients and demonstrated that ResApp’s algorithms had “excellent agreement with a clinical diagnosis”. Results from the study were recently published in the peer-reviewed journal Respiratory Research.
In a separate pivotal study on adults, ResApp’s software “achieved greater than 86% positive and negative per cent agreement for lower respiratory tract disease and pneumonia compared with clinical diagnosis”.
The pivotal study also demonstrated that ResApp’s algorithms accurately identified acute exacerbations in patients with a history of chronic obstructive pulmonary disease (COPD) or asthma and were able to accurately screen for COPD.
“This is our biggest achievement yet and results from many years of hard work by our dedicated team,” said Mr Tony Keating, chief executive officer and managing director of ResApp.
“For the first time clinicians in Europe will have access to a rapid and accurate diagnostic test for the most commonly seen acute respiratory conditions in children,” Mr Keating added.
From software to hardware
In addition to strong progress as a software-only product, earlier this year ResApp unveiled plans to capture a slice of the hardware market.
In May, ResApp confirmed it had engaged a UK-based medical device consultancy to develop customised hardware and wearable devices capable of running ResApp’s machine learning algorithms.
For the time being, the UK consultancy is developing two devices: a handheld unit and a small, unobtrusive wearable monitor with functional prototypes expected later this calendar year and CE Mark approval targeted for 2020.
With CE Mark now acquired and other regulatory certifications expected in the near future, ResApp said that potential customers of its products include healthcare providers in telehealth, emergency department, urgent care and primary care settings as well as humanitarian organisations in the developing world.
This morning’s European market approval helped ResApp’s shares rise by almost 40% up to $0.21.