Multicentre Randomised Controlled Trial Confirms the Significant Benefits of Phagenyx® Treatment for Tracheostomised Stroke Patients With Dysphagia

MANCHESTER, England, September 4, 2018 /PRNewswire/ --

Phagenesis Ltd, a pioneering leader in the treatment of dysphagia, is pleased to announce today the publication of its most recent randomised controlled trial (PHAST-TRAC) in the journal Lancet Neurology.

Reinhard Krickl, CEO of Phagenesis, said: "The publication of the excellent PHAST-TRAC results in such a well-positioned peer-reviewed journal is a big achievement for Phagenesis. It emphasises the high clinical relevance of the benefits of Phagenyx treatment as demonstrated in the trial, addressing a genuine unmet medical need."

Around 12.5% of all stroke patients admitted to hospitals undergo mechanical ventilation and 16.3% of them receive a tracheostomy.^[1] Safe removal of the tracheostomy cannula is a major goal in the rehabilitation of tracheostomised patients to reduce the risk of respiratory complications, death and duration of hospitalisation.^[1]-[3] However, swallowing problems substantially delay the removal of the tube after breathing has stabilised.^[2],[4]-[5]

Oern Stuge, MD, Chairman of Phagenesis, stated: "These patients don't have access to an efficient treatment that addresses the underlying neurological cause of dysphagia. With the company's technology, we can help many patients by improving their outcomes whilst reducing the risks and costs that come with this condition."

The PHAST-TRAC results confirm that tracheostomised stroke patients with swallowing problems can benefit from treatment with Pharyngeal Electrical Stimulation (PES), a novel therapy based on ground-breaking research. Tracheostomy decannulation (removal of cannula) was achieved safely in 49% of patients from the PES group vs 9% in the control group. Moreover, patients who responded to PES treatment had an average reduction in hospital length of stay of 22 days.^[6]

"In addition to these obvious benefits, we are pleased to observe in PHAST-TRAC no serious adverse events related to the PES treatment. Thus, PES represents a real treatment option for these critically ill patients," reports the principal investigator of PHAST-TRAC, Prof. Rainer Dziewas from the Department of Neurology at the University Hospital Münster.

The Phagenyx^® system developed by Phagenesis, is an innovative medical device that uses PES to restore the neurological control of swallowing in patients with post-stroke dysphagia. By completing this key clinical study in Europe, Phagenesis has reached the first milestone in its staged acquisition agreement with Nestlé Health Science (NHSc).

Greg Behar, CEO of Nestlé Health Science, commented: "NHSc's collaboration with Phagenesis enabled the clinical development and availability of Phagenyx for swallowing rehabilitation. The completion of the PHAST-TRAC trial is a great advancement in dysphagia management. Phagenyx treatment facilitates a faster and safer swallowing recovery for patients, while also considerably reducing hospital costs."

* 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 (PES) that delivers a train of electrical stimuli, optimised for each patient, to the patient's throat (oropharynx). A result of more that 20 years of research, the treatment restores the neurological control of swallowing by 'kick-starting' the re-organisation of the brain.

About Phagenesis^®
Phagenesis^® was formed in 2007 to translate the research of Prof. Hamdy from the University of Manchester, UK, into a non-invasive 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.

About Nestlé Health Science 
Nestlé Health Science, a wholly-owned subsidiary of Nestlé headquartered in Epalinges, Switzerland, is a health-science company engaged in advancing the role of nutritional therapy to change the course of health for consumers, patients and partners in healthcare. More information: http://www.nestlehealthscience.com.

Glossary of terms
Dysphagia = difficulty in swallowing 
Neurogenic (neurological oropharyngeal) dysphagia = dysphagia caused by neurological conditions (e.g.stroke) 
Tracheostomised = patients where a tracheotomy was performed
Tracheostomy = opening in the trachea done through an incision in the windpipe (tracheotomy) to relieve an obstruction to breathing 
Tracheostomy cannula = a tube that is inserted in the opening of the trachea so that the hole is unable to close 
PHAST-TRAC = PHAryngeal electrical STimulation for early decannulation in TRACheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial

Forward-Looking Statements 
This news release may contain forward-looking statements based on current assumptions and forecasts made by Nestlé Health Science and Phagenesis management. Various known and unknown risks, uncertainties and other factors could lead to differences between the actual, future results, financial situation, development 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.

Bibliography    

1. Lahiri S. et al. Neurocritical Care 2015; 23(1): 28-32.
2. Garuti G. et al. Multidisc Resp Med 2014; 9: 36.
3. Clec'h C. et al. Crit Care Med 2007; 35(1): 132-138.
4. Schefold J.C. et al. Crit Care Med 2017; 45(12): 2061-2069.
5. Bosel J. et al. Curr Treat Options Neurol 2014;16(1): 274.
6. Dziewas R. et al. Lancet Neurol 2018; Published Online August 28, 2018.

http://www.phagenesis.com