Miniaturised Respiratory Assist to treat acute lung failure patients using a breakthrough hyperbaric technology

Introduction

Acute lung failure (ALF) is the third leading cause of death globally and is characterised by severe respiratory impairment. When non-invasive ventilation (NIV) fails, the treatment escalates to invasive mechanical ventilation (IMV) - the current standard of care for ALF. IMV is highly invasive, with a high risk of complications and an average in-hospital mortality rate of 35%, costing thousands of euros per patient. Hospitals have signalled an unmet need for safe and adequate alternatives to IMV in ALF.

MiRA Therapy

HBOX Therapies GmbH is bringing MiRA (Miniaturised Respiratory Assist) to market: a disruptive and innovative hyperoxygenation therapy that combines unrivalled blood oxygenation and CO2 removal to treat ALF patients while they are awake.

Potential Impact

Such a breakthrough therapy has the potential to be the first treatment option for ALF patients who fail NIV. MiRA therapy has an outstanding cost-effectiveness and improved patient outcomes by avoiding or limiting the need for IMV and further respiratory deterioration in these patients.

Market Opportunity

The growing incidence and prevalence of respiratory diseases causing ALF suggests that there are up to 6 million ALF patients who could benefit from MiRA every year, representing a market potential of €10.4 billion per year.

Technology Overview

Behind MiRA, there is our extracorporeal hyperbaric blood oxygenation (HBOX) technology - 2 patents protect the technology and the approach. HBOX has been validated in animal trials (TRL 5) and we now need to:

1. Finalise the integrated system for improved safety and efficacy.
2. Complete clinical studies.
3. Obtain MDR/CE certification for the MiRA medical device to commence commercialisation.

Future Expectations

We expect the results of the MiRA project to accelerate the market entry of HBOX and to serve as a platform technology for additional clinical applications in the future. The EIC support will be key for our company to establish itself as a leading company in the respiratory industry.