Periodic Reporting for period 1 - MiRA (Miniaturised Respiratory Assist to treat acute lung failure patients using a breakthrough hyperbaric technology)
Reporting period: 2024-05-01 to 2025-06-30
Acute lung failure (ALF) is a life-threatening condition in which the lungs can no longer provide sufficient oxygen to the body or remove carbon dioxide effectively. It can result from pneumonia, sepsis, trauma, or viral infections such as COVID-19. Patients with ALF often require intensive care support, and outcomes depend heavily on the ability to manage gas exchange without causing further harm.
For patients who fail non-invasive ventilation, the next available treatment step is typically invasive mechanical ventilation (IMV). While effective in supporting gas exchange, IMV requires intubation, sedation, and often neuromuscular blockade — all of which carry significant risks, including ventilator-associated lung injury, infections, and long-term physical and cognitive impairments. Despite widespread recognition of these complications, no clinically accepted alternatives currently exist for patients who are at risk of being intubated.
The MiRA project addresses this critical treatment gap by developing a novel system for hyperbaric blood oxygenation. Unlike traditional extracorporeal systems, MiRA is designed for earlier intervention and focuses on preserving patient autonomy and lung function. The approach combines a compact console, a high-efficiency artificial lung, and advanced monitoring, into a fully integrated system that integrate seamlessly into the existing infrastructure of intensive care units. By stabilizing gas exchange without the need for intubation, the system aims to prevent further deterioration and reduce the need for invasive ventilation.
Led by HBOX Therapies GmbH, the project brings together expertise in medical device engineering, clinical intensive care, and regulatory strategy. The overall objective is to deliver a safe, effective, and user-friendly system that will improve outcomes for patients with acute respiratory failure and help clinicians intervene before critical thresholds are crossed.
At a broader level, the project supports European healthcare goals to improve patient-centered care, reduce complications associated with highly invasive treatments, and strengthen the resilience of intensive care systems. If successful, MiRA could enable earlier, less invasive treatment of respiratory failure and offer a pathway that reduces clinical burden while supporting recovery.
For patients who fail non-invasive ventilation, the next available treatment step is typically invasive mechanical ventilation (IMV). While effective in supporting gas exchange, IMV requires intubation, sedation, and often neuromuscular blockade — all of which carry significant risks, including ventilator-associated lung injury, infections, and long-term physical and cognitive impairments. Despite widespread recognition of these complications, no clinically accepted alternatives currently exist for patients who are at risk of being intubated.
The MiRA project addresses this critical treatment gap by developing a novel system for hyperbaric blood oxygenation. Unlike traditional extracorporeal systems, MiRA is designed for earlier intervention and focuses on preserving patient autonomy and lung function. The approach combines a compact console, a high-efficiency artificial lung, and advanced monitoring, into a fully integrated system that integrate seamlessly into the existing infrastructure of intensive care units. By stabilizing gas exchange without the need for intubation, the system aims to prevent further deterioration and reduce the need for invasive ventilation.
Led by HBOX Therapies GmbH, the project brings together expertise in medical device engineering, clinical intensive care, and regulatory strategy. The overall objective is to deliver a safe, effective, and user-friendly system that will improve outcomes for patients with acute respiratory failure and help clinicians intervene before critical thresholds are crossed.
At a broader level, the project supports European healthcare goals to improve patient-centered care, reduce complications associated with highly invasive treatments, and strengthen the resilience of intensive care systems. If successful, MiRA could enable earlier, less invasive treatment of respiratory failure and offer a pathway that reduces clinical burden while supporting recovery.
The MiRA project has developed and advanced a system for extracorporeal respiratory support intended for use in awake patients with acute lung failure. The work focuses on translating a laboratory proof-of-concept into a clinically applicable device that meets the safety, performance, and usability requirements for use in intensive care settings.
A key achievement has been the engineering of a high-efficiency artificial lung capable of delivering unrivalled gas transfer performance with minimal resistance. In parallel, a compact control console has been developed to support safe and intuitive system operation in clinical environments. These elements are combined with a single-use cartridge that enables fast and reliable setup, reducing the potential for user error.
The system has undergone extensive in vitro testing, including performance evaluation under clinically relevant flow and pressure conditions and compliance with applicable ISO standards. Usability studies involving intensive care professionals confirmed that the system can be set up and operated efficiently with minimal training. In addition, a pilot production run using injection-molded components has demonstrated that the system can be manufactured to clinical quality standards.
Together, these results form a solid basis for preclinical validation and preparation for First-in-Human studies.
A key achievement has been the engineering of a high-efficiency artificial lung capable of delivering unrivalled gas transfer performance with minimal resistance. In parallel, a compact control console has been developed to support safe and intuitive system operation in clinical environments. These elements are combined with a single-use cartridge that enables fast and reliable setup, reducing the potential for user error.
The system has undergone extensive in vitro testing, including performance evaluation under clinically relevant flow and pressure conditions and compliance with applicable ISO standards. Usability studies involving intensive care professionals confirmed that the system can be set up and operated efficiently with minimal training. In addition, a pilot production run using injection-molded components has demonstrated that the system can be manufactured to clinical quality standards.
Together, these results form a solid basis for preclinical validation and preparation for First-in-Human studies.
The MiRA project addresses a gap in current respiratory support technologies by focusing on ALF patients who are at risk of requiring invasive mechanical ventilation. Existing systems are primarily designed for sedated, intubated patients and aim to fully replace respiratory function. MiRA takes a different approach: stabilising gas exchange early, with the intention of avoiding intubation and sedation altogether.
From a technical perspective, the artificial lung developed within the project combines exceptional gas exchange performance with minimal flow resistance. This enables effective operation across a wide range of flow conditions, supports compatibility with standard centrifugal pumps used in intensive care, and opens the possibility of integrating and improving existing systems for extracorporeal gas exchange.
The MiRA system integrates compact hardware, a single-use cartridge, and an advanced monitoring concept that supports safe and intuitive clinical operation. The control approach is based on pressure and saturation feedback, allowing clinicians to tailor the therapy to the patients’ needs, while ensuring safety.
A hybrid manufacturing concept facilitates scalability, and the system architecture allows for adaptation to use cases beyond its initial application in acute lung failure.
To ensure further uptake and success, the next steps include preclinical and First-in-Human studies to generate the clinical data required for regulatory approval and market access. Additional investment will be needed to expand manufacturing capacity, complete clinical validation, and support early market deployment. Intellectual property protection is already in place, and further development is focused on strengthening the system’s positioning within and beyond its initial application area.
From a technical perspective, the artificial lung developed within the project combines exceptional gas exchange performance with minimal flow resistance. This enables effective operation across a wide range of flow conditions, supports compatibility with standard centrifugal pumps used in intensive care, and opens the possibility of integrating and improving existing systems for extracorporeal gas exchange.
The MiRA system integrates compact hardware, a single-use cartridge, and an advanced monitoring concept that supports safe and intuitive clinical operation. The control approach is based on pressure and saturation feedback, allowing clinicians to tailor the therapy to the patients’ needs, while ensuring safety.
A hybrid manufacturing concept facilitates scalability, and the system architecture allows for adaptation to use cases beyond its initial application in acute lung failure.
To ensure further uptake and success, the next steps include preclinical and First-in-Human studies to generate the clinical data required for regulatory approval and market access. Additional investment will be needed to expand manufacturing capacity, complete clinical validation, and support early market deployment. Intellectual property protection is already in place, and further development is focused on strengthening the system’s positioning within and beyond its initial application area.