Cyban’s Non-invasive Brain Monitor Demonstrates It Delivers Equivalent Results To Invasive Brain Monitoring In Australian First Clinical Trial

15 February 2023

Pictured: Dr Barry Dixon, the Principal Investigator of the study and Project Lead of the BMTH-funded project, with the Cyban non-invasive brain monitoring technology in use.

A major milestone in the detection and management of brain injuries has been reached thanks to an Australian first clinical trial by Cyban which has demonstrated the company’s patented technology is able to produce similar results to invasive intracranial pressure monitoring (ICP), offering patients with brain injuries such as traumatic brain injury, stroke and brain bleeds, with a more accessible non-invasive alternative. 

The published study, “Assessment of a Non-Invasive Brain Pulse Monitor to Measure Intra-Cranial Pressure Following Acute Brain Injury” (see link at end of news story), was supported with funding from MTPConnect’s BioMedTech Horizons program.

The trial focused on 12 critically ill patients with an acute brain injury who routinely had invasive ICP monitoring to assess and compare with the non-invasive Cyban brain pulse monitor. The trial revealed similar results between the two methods, opening the possibility for a reliable and non-invasive alternative to ICP monitoring which could be used by a broader patient population to ultimately reduce mortality and long-term disability in brain injury patients.

Technology has potential to detect brain injury earlier

According to ICU physician, and Cyban founder and Chief Scientific Officer, Dr Barry Dixon, the findings highlight the potential for the technology in addressing one of the world’s greatest health issues.

“Through this trial we have been able to demonstrate the possibility of this technology in offering a simple, continuous and safe monitoring alternative of the brain to ultimately assist in providing earlier detection of brain injury or its complications,” Dr Dixon said.

“A major challenge in managing acute brain injury is how to continuously monitor the brain to detect secondary brain injury. Early detection of a complication is vital to reduce death and disability, and historically ICP has been the most reliable monitoring solutions however it is incredibly invasive and complex,” Dr Dixon said.

Cyban technology offers continuous, reliable monitoring

ICP monitoring is expensive and has significant risks due to the surgical procedure required to insert the monitoring probe, including ventricular infection rates of up to 9 per cent and haemorrhage of 22 per cent. Due to the high costs and risks, invasive monitoring is usually reserved for cases of severe brain injury. For most patients, therefore, monitoring is confined to just clinical examination.

Cyban’s technology is a non-invasive brain pulse monitor that uses red light to detect a photoplethysmographic (PPG) signal from the blood vessels on the brain’s surface, to measure both ICP and brain oxygen levels. The research found that the non-invasive brain pulse monitor PPG waveform features are similar to the invasive ICP waveforms, and ICP levels from Cyban’s algorithm correlated with ICP levels that were measured invasively.

Offering a simplified, continuous and reliable non-invasive alternative will not only further advance the treatment of brain injuries, by allowing early detection and accelerated treatment to a greater patient population, it has the potential to significantly reduce hospital costs, reduce patient stays and improve patient outcomes simultaneously.

BMTH funding supported development through the first valley of death

Through MTPConnect’s BioMedTech Horizons (BMTH) program, an initiative of the Australian government's Medical Research Future Fund (MRFF), Cyban was awarded $960,000 in 2020 to develop and demonstrate the efficacy of its novel non-invasive brain pulse oximeter to monitor brain oxygen levels following Traumatic Brain Injury.

Senior Director BioMedTech Horizons program, Dr Gerard Gibbs, says it is exciting to see the positive results from Cyban's first Australian study.

“These results take Cyban a step closer to commercialising its ground-breaking brain monitoring technology and are a great endpoint for this BMTH-funded project. Cyban has proven its non-invasive real-time monitoring technology can give clinicians a readout of brain hypoxia that correlates to the existing highly invasive approach – a significant outcome for both patients and clinicians.

“Cyban's technology will ultimately change how head trauma is treated in intensive care units for better patient outcomes and demonstrates how MRFF programs like BMTH are helping to make a real difference," Dr Gibbs said.

A copy of the published study can be found here.