Ongoing impacts of the development of an electrical stimulation treatment for dysphasia (Phagenyx by UoM Spinout Phagenesis)

Narrative

Neurogenic dysphasia is a difficulty in swallowing/inability to swallow safely due to a disruption of neurological systems/processes. It is a dangerous symptom of many neurological diseases such as stroke and traumatic brain injury and a common adverse effect in patients who have had a tracheotomy (incision in the windpipe). It increases the risk of complications and delays recovery. It means patients often need to be fed through a tube and increases the time they spend in hospital. Quality of life is negatively affected.

Phagenyx, developed by Phagenesis Ltd (a University of Manchester Spin out company) uses pharyngeal electrical stimulation (PES) to treat the cause of dysphasia. It delivers electrical stimulation to the pharynx (an area of the throat) and by stimulating areas of the brain involved in swallowing, improves swallowing function.

In November 2020, our research as part of the PHADER trial which took place across 14 centres in the UK, Germany and Austria showed that using Phagenyx in patients with neurogenic dysphagia due to stoke and traumatic brain injury benefitted patient. Patients were able to swallow more safely, have a larger oral diet, remove feeding tubes and be discharged from hospital earlier.

The Phagenyx device is commercially available and in use through the UK and Europe. In February 2020, the German Society for Neurology recommended (PES) to treat dysphagia in tracheotomy stroke patients, citing our research in the PHAST-TRAC trial. In April 2021, scientists in Austria reported successful use of Phagenyx PES treatment to restore safe swallowing in a patient critically ill with Covid-19. In April 2023, the Royal College of Physicians updated their National Clinical Guideline for Stroke for the UK and Ireland, recommending that PES may be considered for patients with tracheostomy and severe dysphagia after stroke to aid decannulation (removal of tracheostomy tube). This recommendation was based on the PHAST-TRAC trial.

In 2022, the US Food and Drug Administration (FDA) approved the use of Phagenyx to restore swallowing control in patients with severe dysphagia following stroke, having granted a Breakthrough device designation in 2020 based on our research. In May 2023, Gaylord Specialty Healthcare, a rehabilitation-focused, non-profit healthcare provider, was the first in the US to adopt the technology and several US hospitals are now evaluating the therapy.

Impact date	1 Aug 2013
Category of impact	Health and wellbeing, Economic
Impact level	Benefit