Phagenesis announced it received FDA de novo clearance for its Phagenyx neurostimulation system.
Manchester, England-based Phagenesis is now planning a targeted launch in the U.S.
The company designed the first-of-its-kind therapy to use pharyngeal electrical stimulation (PES). It aims to restore swallowing control in patients with severe dysphagia post-stroke. The FDA granted Phagenyx breakthrough device designation in January 2020. It is also available in Europe.
“Dysphagia affects millions of people worldwide, and many do not receive the desired outcome with currently available treatments. 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,” said Marta Kazandjian, department head for speech-language pathology and swallowing services at Stony Brook Southampton Hospital.
How Phagenyx works
Phagenyx uses PES to target the neurological components of swallowing coordination. According to a news release, its best results come when delivered at the earliest stages after injury. This enhances neurorehabilitation and restores swallowing control.
According to Dr. Wade Smith, professor of neurology at the University of California, San Francisco (UCSF), dysphagia patients can’t manage their own saliva. This creates a high risk for aspiration, thus jeopardizing patient safety. The potential for Phagenyx to treat patients early in the ICU offers multiple benefits, he said. That includes accelerated recovery, reduced length of hospital stay and the prevention of 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,” said Reinhard Krickl, CEO 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 U.S. who suffer from post-stroke dysphagia and are desperate for a better solution.”