The US Food and Drug Administration (FDA) has granted a De Novo request for Phagenesis’ Phagenyx neurostimulation system to treat a type of dysphagia.

Dysphagia is broadly characterised as difficulty in swallowing, and neurogenic dysphagia is caused due to disruption of the neurological systems.

Injury to the central nervous system (CNS) is the most common cause of neurogenic dysphagia. Neurogenic dysphagia is also caused by damage to the peripheral nervous system.

Phagenyx is an advanced therapy system that targets neurological components of swallowing coordination, to treat neurogenic dysphagia.

The system leverages pharyngeal electrical stimulation (PES) to restore swallowing control in patients with severe dysphagia, after a stroke.

The treatment using Phagenyx showed superior results when delivered at the earliest stages after injury to enhance neurorehabilitation and restore swallowing control, said the company.

Phagenesis chief executive officer Reinhard Krickl said: “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.

“We are pleased with the 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 has received the US FDA Breakthrough Device designation, which indicates that the device addresses unmet needs in dysphagia care.

It is currently being commercialised in Europe and is developed in several randomised controlled trials (RCT) and large-scale real-world registries.

The US-based medical device maker is planning to commercialise the device in the US.

Stony Brook Southampton Hospital speech language pathology and swallowing services department head Marta Kazandjian said: “Dysphagia affects millions of people worldwide and many do not receive the desired outcome with currently available treatments.

The University of California, San Francisco (UCSF) professor of neurology Wade Smith said: “There is limited awareness of the significance of dysphagia in the critical care setting following prolonged mechanical ventilation or tracheostomy.

“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.”