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.

 

More information:

Irina Manoliu

PHAGENESIS LIMITED

Tel: +44 (0) 161 820 9562

Mobile: +44 (0) 7508 265 151

Website: www.phagenesis.com

 

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.

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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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Phagenesis has successfully reached the first of two milestones in its staged acquisition agreement with Nestlé Health Science

October 2017

Phagenesis

Manchester, 4 October 2017 – Phagenesis announced today that by completing a key clinical study in Europe it has reached the first milestone in its staged acquisition agreement with Nestlé Health Science (NHSc). Under the terms of the agreement, Nestlé Health Science has acquired an additional stake in Phagenesis.

Reinhard Krickl, CEO of Phagenesis, said: “We are very happy to have successfully closed a key clinical study demonstrating the clinical benefit of Phagenyx®* for the treatment of post-stroke dysphagia amongst tracheostomized patients. We are looking forward to having the study results published early 2018.” 

Phagenesis is a medical device company that has developed a new treatment for dysphagia, the inability to swallow safely. Dysphagia is a condition with high prevalence as well as high clinical and health economic burden. It is a debilitating condition, which frequently leads to life-threatening complications, including aspiration pneumonia, malnutrition and dehydration. Furthermore, patients with dysphagia experience a dramatic reduction in Quality-of-Life1.

Oern Stuge, Chairman of Phagenesis, stated: “Nestlé Health Science’s increasing stake in Phagenesis will continue to foster a strong collaboration between Phagenesis and NHSc, allowing Phagenesis to accelerate its clinical programs demonstrating the benefit of Phagenyx® for this significant unmet medical need.” 

Gunnar Weikert, Director of Phagenesis and Founder of Inventages Venture Capital commented: “As a long-term investor in Phagenesis we are pleased about this significant achievement and look forward to working more closely with NHSc.

Currently, the management of neurogenic dysphagia is complex. Available options can improve the status and the symptoms, but few are treating the cause. Phagenesis has developed Phagenyx®, a novel medical device designed to restore the neurological control of swallowing. Phagenyx® is based on ground-breaking research that establishes a mechanism of action of delivering Pharyngeal Electrical Stimulation (PES) to treat the neurological cause of dysphagia.

_________                                                                                                                                            * Phagenyx® system is CE marked and is available for sale only in the European Economic Area and Switzerland.

Glossary of terms 

Dysphagia [dis-fa´jah] = difficulty in swallowing, also known as aphagia.

Neurogenic dysphagia = neurological oropharyngeal dysphagia is a difficulty in swallowing, caused by several neurological conditions such as stroke.

Bibliography

1 Marik P et al. Aspiration Pneumonia and Dysphagia in the Elderly. Chest 2003.124;328-336.

For more information, please contact:                                                                       

Irina Manoliu, MD, MSc, CMM Global Marketing Manager

PHAGENESIS LIMITED 

Address: Unit 18, Enterprise House, Manchester Science Park, Manchester, M15 6SE

Tel: +44 (0) 161 820 9562; Mobile: +44 (0) 7508 265 151; Fax: +44 (0) 161 820 4529

Website: www.phagenesis.com

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. These factors include those discussed in Nestlé Health Science’ and Phagenesis’ public reports. 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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Phagenyx® Next Generation Catheter is launched at 7th ESSD Congress and World Dysphagia Summit, 18-23 September 2017

September 2017

Barcelona, Spain – 21st September 2017 – Phagenesis announced today the official launch of the Phagenyx® Next Generation catheter, the result of company’s engagement to continuous innovation and product improvement.

The participants at 7th ESSD Congress and World Dysphagia Summit, Barcelona, 18-23 September 2017 will have the chance to see and test the new product at Phagenesis stand. The Phagenyx® Next Generation catheter allows an optimal and customised treatment, as well as safe feeding for every patient.

Phagenyx® is an evidence based innovative treatment targeting the cause of neurogenic dysphagia. It uses Pharyngeal Electrical Stimulation (PES) to restore neurological control of swallowing, thus reducing the risk of complications and associated costs and improving patient’s outcomes.

The Phagenyx® system delivers a calibrated electrical signal to the back of the throat (oropharynx) for 10 minutes a day for three consecutive days. Randomised controlled trials have shown that this protocol leads to a clinically and statistically significant improvement in swallowing function in the majority of patients with neurogenic dysphagia.

The treatment is based on over 20 years of research and development led by Professor Shaheen Hamdy at the University of Manchester, UK.

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