Pupiloscope, a Neuro-Critical Care Device, Enabling Quantitative, Real-Time, Pupillary Monitoring and Assessment of Patients with Neurotrauma and Head Injuries.

Project Information

PUPILOSCOPE

Grant agreement ID: 811499

DOI

10.3030/811499

Project closed

EC signature date 12 May 2018

Start date 1 June 2018

End date 30 September 2021

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 1 250 911,25

EU contribution

€ 875 637,88

Coordinated by

VIVO SMART MEDICAL DEVICES LTD
United Kingdom

Periodic Reporting for period 3 - PUPILOSCOPE (Pupiloscope, a Neuro-Critical Care Device, Enabling Quantitative, Real-Time, Pupillary Monitoring and Assessment of Patients with Neurotrauma and Head Injuries.)

Reporting period: 2020-10-01 to 2021-09-30

Summary of the context and overall objectives of the project

An estimated 42 million people Worldwide suffer a Head Injury (2.5 million in the EU) that can lead to Mild or Traumatic Brain Injury (TBI). It is a major cause of death and disability, especially in young people, impacting victims and relatives, with significant costs to society, estimated at €33 Billion per annum in Europe alone.

Emergency Care is critical in the process of treating patients with head injuries and to also prevent secondary injury to the brain.

The overall project objectives are:
1. Enable Pupiloscope® to assess patients with potentially life-threatening head injuries. ViVO's engineers and technical team is collaborating with Emergency Care based clinicians, who identified the unmet clinical need.

2. The Pupiloscope device is now being progressed to prove, and evidence, effective use in Emergency care monitoring. This will be supported with health economic assessment that will support adoption to the EU and International Emergency Care markets.

3. The Pupiloscope will positively impact clinical pathways as well as patient outcomes. It is quick, simple, and easy to use by Doctors, Nurses and Paramedics of all skill levels.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The work performed from the beginning of the project includes the following:

Clinical reviews - This has defined the final performance requirements so that the Pupiloscope can be used across emergency healthcare as a new innovative medical device.

Technology development - This has included developing the patented technology, software and electronics to be an accurate point of care device.

Usability design - This has included ergonomic design studies, user interface design, product concept development and clinical product design.

Engineering development - This has included CAD mechanical design drawings, electronics design and imaging sensors and processing design.

Design for manufacture - This has included creating production engineering documentation, functional performance criteria and technical specifications to enable mass production of the device.

Regulatory requirements - This has included ISO 13485:2016 quality management system approval and a regulatory roadmap that will enable final testing for CE approval.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The state of the art will be the development of Pupiloscope which will then be a clinically tested CE Marked medical device. This will have the following impacts:

1. Improved patient outcomes - Enabling rapid assessment of patients with head injuries will improve patient outcomes and impact the socio-economic factors for healthcare and state.

2. Clinical need - An increasing trauma population creates a significant and growing demand; the number of clinicians, hospitals and emergency departments triaging and assessing this volume of patients requiring neuro monitoring creates the unmet clinical need which the Pupiloscope will address.

3. Healthcare impact - Pupiloscope will positively impact healthcare systems in the following ways 1. Improve Clinical pathways. 2. Improve Patient outcomes. 3. Enable Productivity efficiencies. 4. Improve efficiencies the emergency care departments.

Pupiloscope Prototype exhibited at Trauma Care

Trauma Care exhibition logo