Phagenesis Launches Phagenyx Neurostimulation System in the U.S.

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Oct 10, 2022, 02:00 ET

MANCHESTER, England, Oct. 10, 2022 /PRNewswire/ — Phagenesis Ltd, today 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.