ResApp to take part in German digital health program, secures TGA approval

ResApp ASX RAP respiratory disease TGA approval paediatric treatments
ResApp has joined the Startup Creasphere Digital Health Program in Munich where it will participate in developing a new health-focused product using its proprietary technology.

Digital health company ResApp Health (ASX: RAP) has been given an operational boost by a German health program backed by pharmaceutical giants Roche and Sanofi, while also securing Therapeutic Goods Administration approval for its respiratory diagnostic technology in paediatrics.

Earlier today, ResApp said it had been selected to join the Startup Creasphere Digital Health Program in Munich – a 12-week “accelerator” program that’s set to commence later this month.

Powered by Plug and Play, an “innovation platform” that supports start-ups, and which currently has over 750 portfolio companies under its wing, Startup Creasphere was established in 2018 to become the first health-focused accelerator in Munich.

As an organisation, Plug and Play works in 26 different locations globally and says it can enable innovative commercial ideas to “expand into new markets faster than ever before”.

Most of the company’s work is currently with US-based companies (around 72%) with 562 companies “accelerated” in 2018.

By participating in the Startup Creasphere Digital Health program, ResApp hopes to gain exposure to a range of stakeholders, developers and other companies that could potentially lead to synergies, and ultimately, improve the company’s market traction with its proprietary technology.

ResApp’s primary focus of development is its smartphone app that can diagnose respiratory disease.

The program will see ResApp working with subject matter experts and mentors from the consumer healthcare business unit of Sanofi to explore opportunities to co-create consumer health-focused respiratory disease products.

The program is not commercially-binding which means neither ResApp nor Sanofi have committed to any obligations regarding any products that may be created as a result of the program. ResApp has also stated that it will retain all intellectual property developed over the 12-week period.

“We are very excited to participate in the Startup Creasphere program to build and pilot a consumer health-focused product using our novel respiratory diagnostic algorithms,” said Tony Keating, chief executive officer and managing director of ResApp.

“Collaborating with the consumer healthcare business unit of Sanofi during the program provides ResApp with an outstanding opportunity to explore the direct-to-consumer market alongside global industry leaders,” he added.

Smartphone diagnosis

One innovation that is expected to be developed first and foremost by ResApp is its ResAppDx-EU smartphone-based diagnostic test for acute paediatric respiratory disease.

The technology received Australian TGA approval as a Class 2a medical device earlier this week, with the test now listed on the Australian Register of Therapeutic Goods (ARTG).

The smartphone application can be used by clinicians to accurately diagnose lower respiratory tract disease, croup, pneumonia, asthma, reactive airway disease and bronchiolitis in infants and children.

The software uses machine learning algorithms that analyse a patient’s cough sounds to diagnose disease with enough accuracy to be classed as a professional healthcare device that can be relied upon by doctors.

In relation to sleep apnoea, ResApp’s algorithms correctly identified patients with obstructive sleep apnoea with a sensitivity of 85%, 83% and 83%, respectively.

ResApp says that ResAppDx-EU is a software-only solution that runs on a smartphone and does not require any additional hardware or accessories.

Furthermore, ResAppDx-EU recently received CE Mark approval in the European Union for both adult and paediatric use and is currently pending De Novo classification for paediatric use in the US.

One of the likely next developments is an adult certification which will mean ResApp having to file a follow-on TGA submission for adult use, a move that will be “made shortly”, according to ResApp.

ResApp’s share price lifted almost 8% to $0.29 in early morning trade.

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