Therapy Areas: Devices
Phagenesis wins FDA breakthrough device designation for Phagenyx System to treat dysphagia
15 January 2020 -

Neurogenic dysphagia company Phagenesis Ltd reported on Tuesday the receipt of the Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its Phagenyx System to help patients restore neurological swallowing control through Pharyngeal Electrical Stimulation.

Under the US FDA programme, the company will receive priority review and interactive communication during the Phagenyx De Novo review phase.

The company said the Phagenyx System is a novel neurostimulation device that helps to restore neurological swallowing control through Pharyngeal Electrical Stimulation. A result of more that 20 years of research, the treatment restores safe swallowing by inducing and accelerating the re-organisation of the parts of the brain responsible for swallow coordination and control.

According to the company, the Phagenyx System treats the cause of dysphagia. In tracheotomised patients weaned from mechanical ventilation, severe dysphagia (difficulty in swallowing) with related insufficient airway protection is the primary reason why decannulation cannot be performed. The PHAST-TRAC1 randomised controlled study demonstrated that tracheotomised patients treated with the Phagenyx System were five times more likely to be safely decannulated when compared with untreated control patients.