FDA Clearance of the DeltaScan® Brain State Monitor UTRECHT, The Netherlands, March 15, 2023 – Prolira BV, a high-tech company committed to enabling early and effective treatment of patients at…

Mr. Spadafore’s appointment comes at a critical stage for the company as it builds on its success in Europe and prepares for the US market release of its first commercial product, the DeltaScan® Brain State Monitor, for detecting acute brain failure.

Innovative approach to delirium by Santeon nurses Santeon (a group of 7 topclinical hospitals in the Netherlands) introduces a new approach to delirium; it is an innovation led by nurses….

Growth capital investment for Prolira for roll-out of brain state monitoring to hospitals Investors Borski fund, ROM Utrecht Region, Holland Capital, Health Innovations and Oost NL together invest€5 million in…

The companies ORION Pharma and Prolira are excited to announce their sales collaboration agreement that has been signed in June 2021. The agreement includes the Germany-wide promotion of DeltaScan®, a revolutionary medical device that objectively monitors the brain state of patients. Within minutes, the patient’s brain is assessed for signs of illness (acute encephalopathy and delirium). Monitoring the brain state of hospitalized patients is as important as monitoring other vital organs like the heart or the lungs. Until now this was difficult, as usual care only has subjective checklists with limited performance.

UMC Utrecht carried out an investigator initiated large scale validation study for DeltaScan device performance, collecting data from a wide study population of 434 hospitalized patients, spread over 9 Dutch hospitals and 31 departments. The aim of the study was to investigate the diagnostic performance of the DeltaScan, a CE-certified device to detect acute encephalopathy and delirium using a brief electroencephalography (EEG) recording, in patients admitted to Intensive Care (ICU), and elderly patients admitted to wards (non-ICU departments).

With the consortium partners (UMC Utrecht, Charité and UZ Leuven and Key Opinion Leaders Prof Slooter, NL; Prof Spies, DE; Prof Milisen, BE), we set up the international CLEO evaluation study with the purpose to evaluate DeltaScan in daily practice. The intervention phase was severely hampered by the COVID-19 pandemic. Despite the pandemic, that put a tremendous strain on all hospital staff, thousands of nurses and doctors measured thousands of patients with DeltaScan.

We are proud to announce that the intended use for DeltaScan® has been expanded to include the indication acute encephalopathy, in addition to the existing indication delirium. Encephalopathy means “disease of the brain” and acute encephalopathy is a sudden disturbance and change of (the condition of) the brain that can only be diagnosed on the basis of EEG.

We are proud to announce that Prolira is one of the first medical device companies in the world, to be certified according to the new EU MDR.

Article in New York Times (may 2020): Scores of physicians from around the world report a rise in delirium of up to 70% because of Covid-19, says Dr Inouye (USA). It is occurring in both younger and older patients.

St Antonius hospital is one of the first users of DeltaScan, the objective EEG based device to detect & monitor for delirium. They strive to continuously improve delirium care, as it is a common complication. The longer delirium lasts, the worse the patient outcome.