Phagenyx® Next Generation Catheter obtains CE Mark

July 2017

Manchester, UK – 21st July 2017 – Phagenesis Ltd, an important leader in the treatment of dysphagia, announced today that Phagenyx® Next Generation catheter got CE Mark for neurogenic dysphagia.

Dysphagia (the inability to swallow safely) is a condition with important prevalence as well as high clinical and health economic burden. Dysphagia occurs in 29-55% of stroke patients1, while 15 million people worldwide suffer a stroke2 every year and is common also in many other diseases.

Dysphagia is a debilitating condition that frequently leads to life-threatening complications, including aspiration pneumonia, malnutrition, dehydration and the surgical implantation of a PEG tube to allow a patient to be fed indefinitely through the abdomen wall. Furthermore, patients with dysphagia experience a dramatic reduction in Quality-of-Life3.

Phagenesis remains committed to transforming the lives of people with dysphagia by launching in 2017 Phagenyx® Next Generation catheter. It is the result of company’s engagement to continuous innovation and product improvement. The dysphagia treatment will be easier with the Phagenyx® Next Generation catheter, which allows an optimal and customized treatment, as well as safe feeding for every patient.

Phagenyx® provides a unique innovative treatment for neurogenic dysphagia that uses Pharyngeal Electrical Stimulation (PES) to restore neurological control and in turn improve the swallow function. Phagenyx® is designed to treat the cause of dysphagia, thereby reducing the risk of complications and associated costs and improving outcomes.

The Phagenyx® treatment system delivers a calibrated electrical signal to the back of the throat (oropharynx) for 10 minutes a day for three consecutive days. This protocol has shown to lead to a clinically and statistically significant improvement in swallowing function in a majority of dysphagia patients.

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

Bibliography

1. Martino R., Foley N., Bhogalet S. et al. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke 2005; 36, 2756–2763.

2.http://www.world-heart-federation.org/cardiovascular-health/stroke/

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

 

 

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The staged acquisition of Phagenesis by Nestlé Health Science will benefit patients with dysphagia

September 2016

Phagenesis

Manchester, England, 1 September 2016 – Nestlé Health Science (NHSc) and Phagenesis announced today that NHSc is entering into a staged, milestone-based acquisition of Phagenesis, a medical device company that has developed a new treatment for dysphagia.

Under the terms of the agreement, NHSc will make an upfront payment, followed by milestone-based funding, while Phagenesis completes the clinical evaluation of Phagenyx®*. The staged acquisition will be based upon successful completion of European and US development programs anticipated by 2019. Financial terms have not been disclosed.

Reinhard Krickl, CEO of Phagenesis, said: “Nestlé Health Science is the leading global player in dysphagia with capabilities and reach to enable Phagenesis to accelerate the development and deployment of Phagenyx® to patients around the world.”

Dysphagia, the inability to swallow safely, is a condition with high prevalence as well as high clinical and health economic burden. Dysphagia occurs in around 29% to 55% of stroke patients1, with 15 million people worldwide suffering a stroke2 every year. It is also a common consequence of numerous other diseases, and is often under-diagnosed in various patient populations, e.g. in the ICU. Dysphagia is a debilitating condition that frequently leads to life-threatening complications, including aspiration pneumonia, malnutrition and dehydration. Furthermore, patients with dysphagia experience a dramatic reduction in Quality-of-Life3.

Oern Stuge, Chairman of Phagenesis, said: “Nestlé Health Science’ investment positions the company well to address this immense unmet medical need.”

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.

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 investment by Nestle Health Science.”

Greg Behar, CEO of Nestlé Health Science, stated: “Dysphagia is a strategic focus for Nestlé Health Science. This innovation can bring a new dimension to swallowing rehabilitation that can be transformational from a patient and healthcare professional perspective.” 

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

Bibliography

1       Martino, R., Foley N., Bhogalet S. et al. Dysphagia after stroke: incidence, diagnosis, and pulmonary complications. Stroke 2005; 36, 2756–2763.

2       http://www.world-heart-federation.org/cardiovascular-health/stroke/

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

 

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Phagenesis begins new RCT

November 2015

Following the successful single centre trial at Münster Phagenesis has started recruiting patients to their multi-centre PHAST TRAC trial.

Update: The recruitment for PHAST TRAC trial has finished.

For more information click here .

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RCT shows PES enables decannulation of patients

October 2015

In a pilot study conducted in Münster PES enhanced remission of dysphagia as assessed with fiberoptic endoscopic evaluation of swallowing (FEES), thereby enabling decannulation in 75% of patients.

This trial is published in Intensive Care Medicine Journal read more.

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Healthy Volunteers needed for new products testing

September 2015

We are looking for healthy people interested in doing research to help us test our new devices for comfort and tolerability before we seek CE mark and launch them commercially.

The study will involve a single 3-hour visit to our research unit where you will be asked to swallow a tube (our new naso-gastric treatment tube) and having some pictures and video recorded of the tube in place.

We are a Manchester based medical device company that have developed a treatment for unsafe swallowing (neurogenic dysphagia) for people with brain injuries such as stroke or diseases such as Parkinson’s. Our treatment stimulates nerves in the throat to trigger the brain’s own repair systems so that swallowing can once again be safe.

For further information please contact:

0161-820-4525           š AHE04@phagenesis.com

Volunteers will be reimbursed for time and inconvenience.

Update: The recruitment for the Healthy Volunteer Study has finished.

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