Phagenesis Ltd has announced that the U.S. Food and Drug Administration (FDA) has granted a De Novo request for the Phagenyx® Neurostimulation System, a first-of-its-kind therapy that uses pharyngeal electrical stimulation to restore swallowing control in patients with severe dysphagia post stroke. The company is now preparing a targeted launch in the U.S.

Dysphagia is defined broadly as difficulty swallowing and when it occurs from a disruption of the neurological systems, it is called neurogenic dysphagia. The most common cause of neurogenic dysphagia is injury to the central nervous system (CNS) due to stroke or traumatic brain injury. Neurogenic dysphagia is also caused by damage to the peripheral nervous system, due to prolonged mechanical ventilation or tracheostomy. In a worst-case scenario, severe dysphagia can result from both CNS injury and prolonged mechanical ventilation or tracheostomy.

Dysphagia affects millions of people worldwide and many do not receive the desired outcome with currently available treatments,” commented Marta Kazandjian, MA CCC-SLP BCS-S, F-ASHA and Department Head for Speech Language Pathology and Swallowing Services at Stony Brook Southampton Hospital. “Adding an innovative therapy like Phagenyx has the potential to accelerate results and may allow the patient to spend fewer days in the hospital, which would significantly improve quality of care and patient experience.”

The Phagenyx System treats neurogenic dysphagia using pharyngeal electrical stimulation (PES) targeting the neurological components of swallowing coordination. Phagenyx therapy has demonstrated best results when delivered at the earliest stages after injury to enhance neurorehabilitation and restore swallowing control.

“There is limited awareness of the significance of dysphagia in the critical care setting following prolonged mechanical ventilation or tracheostomy”, says Dr. Wade Smith, Professor of Neurology at the University of California, San Francisco (UCSF). “Such patients cannot manage their own saliva, creating a high risk for aspiration and their safety. Phagenyx has the potential to treat patients early in the ICU which has been shown to accelerate recovery, reduce hospital length of stay and prevent downstream complications.”

“The Phagenyx System is a next-generation therapy for neurogenic dysphagia that has been shown to deliver significant benefits in swallowing safety and swallowing efficiency, which have the potential to translate into substantial health economic benefits due to accelerated patient recovery,” commented Reinhard Krickl, Chief Executive Officer of Phagenesis. “We are pleased with FDA’s decision to grant our de novo request and are eager to bring this new technology to the millions of patients in the US who suffer from post-stroke dysphagia and are desperate for a better solution.”

The Phagenyx System is designated a Breakthrough Device by the FDA which reflects clear unmet needs in current dysphagia care. Phagenyx is commercially available in Europe and is supported by numerous randomized controlled trials and larger-scale real world registries.1-4

About Phagenesis

Phagenesis® Ltd, is a private healthtech company offering an innovative treatment for neurogenic dysphagia using pharyngeal electrical stimulation, PES. The Phagenyx® Neurostimulation System is the result of years of rigorous scientific research, initiated by Professor Shaheen Hamdy from the University of Manchester, and has been featured in numerous clinical publications. For additional information, visit phagenesis.com.

1.Dziewas R. et al. Lancet Neurol 2018; 17: 849–59.

2.Suntrup S. et al. Intensive Care Med 2015; 41:1629–1637.

3.Koestenberger M. et al. Neurocritical Care 2019; 32: 532-538.

4.Bath P.M. et al. 2020. EClinical Medicine 2020.