Promising results of Phagenyx® treatment in Orally Intubated ICU Patients with Dysphagia

July 2019

Post extubation dysphagia is common (44-56%)and comes with a lot of challenges. It can impact negatively the patient outcomes by causing aspiration pneumonia and delaying the switch to oral feeding. The duration of mechanical ventilation is independently associated with post-extubation dysphagia, which is strongly associated with malnutrition and longer length of stay in hospital in patients with neurological conditions.2 Dysphagia is also an independent predictor for 28-day and 90-day mortality.3

The most recent publication with promising results about Pharyngeal Electrical Stimulation treatment in orally intubated ICU patients with dysphagia was published in Neurocritical Care Journal read more.

References

1.Skoretz SA, Flowers JL, Martino R. The incidence of dysphagia following endotracheal intubation: a systematic review. Chest. 2010;137(3):665–73.

2.Macht M, Wimbish T, Bodine C, et al. ICU-acquired swallowing disorders. Crit Care Med. 2013;41(10):2396–405.

3.Schefold JC, Berger D, Zürcher P, et al. Dysphagia in Mechanically Venti-lated ICU Patients (DYnAMICS): a prospective observational trial. Crit Care Med. 2017;45(12):2061–9.

1st patient recruited and randomised in PhINEST, a new RCT to confirm the positive outcomes of Phagenyx® treatment for patients with Post-Extubation Dysphagia

July 2019

Pharyngeal Electrical Stimulation for the Treatment of Dysphagia After Extubation (The PhINEST Study) is a prospective, multi-site, randomised, sham-controlled, patient-masked, single-blind study. It is designed to assess the effects of Pharyngeal Electrical Stimulation (using the Phagenyx®system) for the treatment of oropharyngeal dysphagia after invasive mechanical ventilation in critically ill intensive care unit adult patients. For more information click here.

The Phagenyx® System was approved for sale in Europe in 2012 and is currently being used to treat patients with neurogenic dysphagia including post-extubation dysphagia.

 

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Multicentre randomised controlled trial confirms the significant benefits of Phagenyx® treatment for tracheostomised stroke patients with dysphagia

September 2018

Manchester, England, 4 September 2018Phagenesis 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 read more.

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 themreceive 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 efficienttreatment 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 groupMoreover, 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 swallowingby ‘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 developedthe only treatmentfor neurogenic dysphagia that treats the cause of dysphagia using PES. More information: 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: 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

 

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 Med2017; 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.

 

 

Forward-Looking Statements: This news release may contain forward-looking statements based on current assumptions and forecasts made by Nestlé Health Science and Phagenesismanagement. 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.

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Patients with Parkinson’s disease needed for swallowing treatments study

August 2018

The University of Manchester in collaboration with Salford Royal Hospital is looking for patients from Greater Manchester with confirmed diagnosis of idiopathic Parkinson’s disease and impaired swallowing.

They will be offered the possibility to participate in a clinical study that investigates the effects of 3 neurorehabilitation techniques in improving swallowing function in Parkinson’s disease.

For details and further information please contact:

Dr Ayodele Sasegbon

Tel: 07944622914

e-mail: ayodele.sasegbon@manchester.ac.uk

Standard transportation costs for the patients will be reimbursed.

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PhEED, a new RCT for post ischemic or hemorrhagic stoke patients with dysphagia has started enrollment in the US and Europe

May 2018

Pharyngeal Electrical Stimulation Evaluation for Dysphagia after Stroke (PhEED) is a prospective multi-centre randomised controlled single-blinded trial with Non-Significant Risk status granted by FDA. If you are a healthcare professional working in an acute rehab center and are interested in being part of PhEED in US, please contact Nadine Juran at nadine.juran@phagenesis.com. For more information click here.

https://www.youtube.com/watch?v=oC62qzYdi7Y?rel=0

PhEED is a research study to test the safety and performance of the Phagenyx System for the treatment of swallowing problems of US patients after stroke. The Phagenyx System is not yet approved for commercial use by the U.S. Food and Drug Administration (FDA) and it is therefore considered an investigational device used only in research.

The Phagenyx System was approved for sale in Europe in 2012 and is currently being used to treat patients with neurogenic dysphagia including post-stroke dysphagia.

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First PHAST-TRAC results were presented at ISC 2018

January 2018

The first results of Pharyngeal Electrical Stimulation for Early Decannulation in Tracheotomised Stroke Patients with Dysphagia (PHAST-TRAC): A Randomised, Single-blind, Pivotal, Superiority Trial were presented by Professor Philip M Bath, University of Nottingham, Nottingham, United Kingdom at International Stroke Conference, Los Angeles, 24-26 January 2018 read more.

Medscape also featured the results of the Phagenesis’ PHAST-TRAC study, based on Prof. Bath ’s presentation on Friday. This is a major achievement for Phagenesis Ltd promoting Phagenyx® internationally read more.

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