Largest real-world study of Phagenyx® demonstrates significant benefits of treatment in patients with unsafe swallowing (neurogenic dysphagia) resulting from multiple causes

MANCHESTER, England, Nov. 11, 2020 /PRNewswire/ -- Phagenesis Ltd, a leading innovator in the treatment of dysphagia, is pleased to announce today the publication of the largest and most complex study on Pharyngeal Electrical Stimulation (PES) (PHADER) in the journal EClinicalMedicine-The Lancet.

“This largest ever study of PES recruited 255 patients from 14 different centres in Austria, Germany and the UK, with five different neurological conditions. The findings show that PES is a potential game changer for patients with severe swallowing problems – dysphagia – who previously were at high risk of complications including pneumonia,” reports the co-lead investigator of PHADER, Professor Philip Bath from University of Nottingham.

Neurogenic dysphagia affects up to 78% of stroke patients^[1], up to 90% of traumatic brain injury patients^[2], 50-83% of tracheotomised patients^[3] and up to 62% of orally intubated mechanically ventilated patients^[4]. Dysphagia delays patient recovery and is known to increase the risk of complications such as aspiration pneumonia (2-4.5 times higher risk), reintubation (2-4 times higher risk) and ICU readmission^[4],[5],[6] resulting in up to 13 times higher mortality^[5],[6],[7]. Dysphagic patients commonly need special tube feeding and have increased risk of malnutrition and dehydration. It also reduces the quality of life and more than doubles the length of time patients stay in hospital after leaving the ICU^[6],[8] placing higher demands on healthcare systems.

Reinhard Krickl, Phagenesis CEO, says: “Dysphagia is a frequent complication and may be life-threatening. PHADER not only confirms the significant clinical benefit of Phagenyx^® treatment on post-stroke dysphagia as published in previous studies but also demonstrates that patients suffering from dysphagia after traumatic brain injury or after prolonged mechanical ventilation equally benefit from this novel treatment.”

Professor Shaheen Hamdy from The University of Manchester and co-lead Investigator continues: “These data are exciting in that Phagenyx^® treatment can be successfully applied in a number of conditions associated with dysphagia and raises additional hope that after mechanical ventilation, dysphagic critically ill COVID-19 patients could recover faster; as seen from recent reports in 2 European hospitals. Given the current global pandemic, this approach may help free up expensive ICU resources.”

PHADER demonstrates that patients with dysphagia due to stroke, traumatic brain injury or following mechanical ventilation and tracheotomy can benefit from treatment with PES, delivered using Phagenyx^®. In all patient subgroups, Phagenyx® treatment was significantly associated with improvement of dysphagia and reduced aspiration risk. Patients had a safer swallow, progressed to greater oral diet, had their feeding tube removed and could be discharged from the hospital. Overall, user experience was positive and no treatment-related serious adverse events were reported.^[9]

Professor Rainer Dziewas from the University of Münster and co-lead Investigator says: “These results are fascinating since most patients were treated in a chronic state of illness, where it is usually extremely difficult to achieve any treatment success. PHADER clearly suggests that PES may help even in this notoriously difficult situation. However, it is important to mention that patients with dysphagia should be treated as early as possible for best outcomes.”

The Phagenyx^® system developed by Phagenesis Ltd, is an innovative medical device that uses PES to treat the cause of dysphagia by restoring the neurological control of swallowing in patients with dysphagia.

* Phagenyx^® is CE marked in Europe. In the United States, Phagenyx^® is currently not available for sales.

About Phagenyx^®

Phagenyx^® is an innovative product using pharyngeal electrical stimulation to deliver a patient optimised train of electrical stimuli to the throat (oropharynx). A result of more that 20 years of research, the treatment can restore safe swallowing by inducing and accelerating the re-organisation of brain areas responsible for swallow coordination and control, and by driving local changes in the peripheral sensory architecture.

About Phagenesis^®

Phagenesis^® was formed in 2007 to translate the research of Professor Shaheen Hamdy (University of Manchester, UK), into an effective technology for standard clinical practice in hospitals. It has developed the only treatment for neurogenic dysphagia that treats the cause of dysphagia using PES. More information: http://www.phagenesis.com.

Glossary of terms

Dysphagia = difficulty in swallowing
Neurogenic dysphagia = dysphagia arising from disruption of any neurological systems or processes involved in executing a coordinated safe swallow
PHADER = PHAryngeal electrical stimulation for treatment of neurogenic Dysphagia: a European Registry (PHADER)

Bibliography

1. Cohen D et al. Int J Stroke 2016; 11:399-411.
2. Terre R. et al. Brain Inj 2007; 21(13-14):1411-1417.
3. Garuti G et al. Multidisc Resp Med 2014; 9:36.
4. Skoretz SA et al. Chest 2010; 137(3):665-673.
5. Zuercher P. et al. Critical Care 2019; 23:103.
6. Macht M et al. Critical Care 2011; 15: R231.
7. Schefold J. et al. Crit Care Med 2017; 45(12),2061-2069.
8. Clec’h C. et al. Crit Care Med 2007; 35(1):132-138.
9. Bath P.M. et al. EClinical Medicine 2020.

This news release may contain forward-looking statements based on current assumptions and forecasts made by Phagenesis. Various known and unknown risks, uncertainties and other factors could lead to differences between the actual, future results, financial situation or performance of the company and the estimates given here. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

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