ResApp Health Acquires CE Mark Certification For World’s First Smartphone-Based Tool For Acute Respiratory Disease

ResApp Health Limited (ASX: RAP), is a prime healthcare company headquartered in Brisbane, Australia that creates clinically validated, regulatory-cleared, smartphone applications based digital tools to diagnose and manage acute respiratory diseases. The company has a tremendous worldwide market with more than 700 million doctor visits per annum for respiratory diseases.

In its latest announcement, ResApp announced that it has acquired CE Mark certification as Class IIa medical device for its first commercial product, ResAppDX-EU, the world’s first smartphone-based test for the diagnosis of acute respiratory diseases in infants and children.

Respiratory Diseases, Traditional diagnosis, and its disadvantages:

Respiratory tract infection is one of the most common acute illnesses, prevalent in infants and children. Based on the site of infection it is divided into two categories; upper respiratory tract infection and lower respiratory tract infection.

Types of Respiratory tract infection ( Source: Company presentation)

Today, the diagnostic method involves the use of stethoscopes, imaging (x-ray, CT), spirometry, blood and/or sputum tests for the identification of respiratory problems. However, these techniques are subjective, expensive, time taking, and inaccurate.

ResAppDX-EU: An instant, easy to use Diagnostic Tool for Respiratory Diseases

ResAppDX-EU is an innovative mobile software-only tool used for the diagnosis of Lower respiratory tract infections in infants and children. It works on the principle of ResApp’s technology which is initially invented by Associate Professor Udantha Abeyratne at The University of Queensland. ResApp’s technology utilizes an artificial intelligence technique and constructs highly precise algorithms to diagnose and evaluate the acuteness of various chronic and acute respiratory diseases like pneumonia, asthma, bronchiolitis and chronic obstructive pulmonary disease (COPD). ResApp is an automated approach, in which the diagnosis is entirely based on the analysis of a patient’s audible sound of the cough, without the need for human interpretation or additional software.

On-the-spot smartphone-based tool for the identification of Respiratory Diseases ( Source: Company’s Presentation

Key features of this instant diagnostic tool include

• differentially diagnosis of respiratory disease,
• use of signatures in cough and breathing sounds,
• ability to comprehend new diseases from the new clinical dataset,
• use of additional accessories eliminated.

Significance of CE Mark certification

The CE Mark signifies that ResAppDX-EU complies with all the mandatory criteria of European Union’s (EU) regulation to be classified as Class IIa medical device and allowing it to be sold in European Economic Area (EEA).

The authorization of CE Mark for ResAppDX-EU was well backed by collecting and analyzing the data from a clinical study namely Breath-Easy Pediatric clinical study conducted at Joodalup Health Campus, Perth, Australia and Princess Margaret Hospital, Perth Australia. The Breathe Easy study is double-blind, multicentric prospective study that determined the efficacy of this programmed cough-sound centric detection method to identify the common respiratory tract disorders in children. The data was collected and investigated from 585 patients with the age group between 29 days to 12 years. The study revealed spot on identification of common pediatric respiratory disorders in children by using this mechanized cough-sound analysis. The data further indicates that ResAPP’s unique and innovative technology excellently corresponds to the presently used standard-of-care clinical diagnosis. These results are recently been published in Respiratory Research, a peer-reviewed journal. The registration number of this trial is ACTRN12618001521213 and was listed in AU and NZ Clinical Trial Registry on 11^th August 2019.

Australian Double-blind, prospective paediatric clinical study (Source: Company presentation)

The press release of this study by the publishers has gained remarkable media attention in ResApp’s technology and has been covered on national television in Australia and in newspapers in America, Europe, and China.

Tony Keating, CEO and Managing Director of ResApp, appreciated the hard work and dedication shown by the ResApp’s team and believes that CE Mark approval of ResAppDX-EU is the greatest accomplishment so far made by the company. He further states that this novel product, which will be used for the first time by European doctors for the fast and precise diagnosis of acute respiratory diseases in children, has great potential in providing profound advantage in healthcare system. ResApp now plans to quickly implement European Commercialization strategy.

ResApp’s product pipeline

ResApp’s pipeline of products is currently in the expanding phase. Apart from acute respiratory diseases, ResApp’S product pipeline includes smartphone applications for the accurate diagnosis of obstructive sleep apnoea (OSA), chronic obstructive pulmonary disease (COPD) or asthma. The figure below depicts the main projects under ResApp’s product pipeline and their respective stages of development.

ResApp’s Broadening product portfolio (Source: Company presentation)

Potential customers of ResApp’s products

Quarterly Results

On 29^th July 2019, the company released its quarterly report for the final quarter of the financial year. Mr Tony Keating, CEO and Managing Director of ResApp was pleased to share that the company has grown in terms of the commercial opportunity, as the adult pivotal clinical study results were positive which led to both US and European regulatory submissions.

Some highlights of the quarterly report are as follows:

Advancement in regulatory submission: ResApp made significant progress by regulatory submissions in Europe and USA. US FDA submission for De Novo classification of ResAppDX-US was done in April 2019. This submission is presently under review. In Dec 2018, CE Mark European approval was submitted for ResAppDx-EU.

Australian adult pivotal study demonstrated Positive Top-line results: Australian double-blind prospective study conducted in adults received highly accurate positive results. It was found that ResApp’s revolutionary smartphone-based diagnostic technology, could diagnose not only acute respiratory diseases but also accurately diagnosed acute exacerbations in chronic obstructive pulmonary disease (COPD) or asthma patients with long history of this disease. Screening of COPD, in vast population, in extremely accurate manner has also been demonstrated. The data generated by these studies would further help in future CE and TGA approval submissions.

Industry Advisory board was formed: The industry advisory board of ResApp was recently established to provide strategic advice on the commercialization of RessApp’s products for respiratory disease diagnosis and management. For this purpose, renowned leaders in digital health, Naomi Fried, Ph.D., and Joseph C. Kvedar, MD were appointed by ReasApp. This announcement was made by the company in June 2019.

Complimentary hardware devices development: In an announcement on May 2019, the company declared that a consultancy dealing in medical devices based in UK was engaged by ResApp for the development of user-friendly customized hardware and wearable devices ,able to run the machine learning algorithms. The design of a ruggedized handheld Android^TM based device and an easily wearable, unobtrusive small monitor has already initiated and the functional preliminary version of these two devices is anticipated in later this year with a target of CE Mark approval by 2020.

Publication of results from the Australian Paediatric study: The results from Breathe Easy pivotal paediatric clinical study were published in an open-access peer-reviewed medical journal published by BioMed Central having an impact factor 3.829. As per the CEO and Managing Director, Mr Tony Keating this publication marks an important breakthrough in the verification of ResApp’s technology. At the American Thoracic Society international conference 2019 held in May, the results from US-based SMARTCOUGH-C-2 were published.

Robust Balance sheet for the commercialization of ResApp’s products: At the end of the final financial quarter i.e., as of 30^th June 2019, ResApp Health Limited held $5.5 million cash, well-financed for the implementation of company’s clinical and commercialization plans.

Stock performance:

RAP’s stock settled the day’s trading at A$0.200 on 26 August with a market cap of A$158 m. The stock has provided a remarkable YTD return of 81.82% to its investors.

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