Phagenesis Ltd. has announced today that the company has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Phagenyx System. The Phagenyx System is a novel neurostimulation device that helps to restore neurological swallowing control through Pharyngeal Electrical Stimulation.
The FDA Breakthrough Device Program is intended to help patients and health care providers receive more timely access to medical devices that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Under the program, the FDA will provide Phagenesis with priority review and interactive communication during the Phagenyx De Novo review phase.
Reinhard Krickl, CEO of Phagenesis, said: “Receiving Breakthrough Device Designation is a key milestone, validating Phagenyx as a unique solution to accelerate decannulation that addresses a substantial unmet medical need currently causing negative consequences for risk of pneumonia. This will lead to timely and successful rehabilitation, better patient comfort and positively impact on number of days in the hospital, hospital readmissions and the financial cost of care.”
The Phagenyx System treats the cause of dysphagia. In tracheotomised patients weaned from mechanical ventilation, severe dysphagia with related insufficient airway protection is the primary reason why decannulation cannot be performed. The PHAST-TRAC1 randomized controlled study, published in Lancet Neurology in 2018, demonstrated that tracheotomized patients treated with the Phagenyx System were 5 times more likely to be safely decannulated when compared with untreated control patients.
Greg Behar, CEO of Nestlé Health Science, commented: “Nestle Health Science has been working with Phagenesis for several years in Europe to build the clinical evidence for this treatment and we are excited that the Breakthrough Device Designation will help to accelerate the process of making Phagenyx available to US patients also.”
Note: * Phagenyx® is CE marked in Europe. In the United States, Phagenyx® is currently not available for sales.