FDA's Breakthrough Device Designation Program allows for priority review of the Phagenyx® System
MANCHESTER, England, Jan. 14, 2020 /PRNewswire/ -- Phagenesis Ltd., a pioneering leader in the treatment of dysphagia, is pleased to announce 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 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 randomised controlled study, published in Lancet Neurology in 2018, demonstrated that tracheotomised 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."
* Phagenyx® is CE marked in Europe. In the United States, Phagenyx® is currently not available for sales.
Phagenyx® is an innovative product using pharyngeal electrical stimulation (PES) to deliver a patient optimised train of electrical stimuli to the throat (oropharynx). 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.
Phagenesis® was formed in 2007 to translate the research of Prof. Hamdy from the University of Manchester, UK, into an effective technology for standard clinical practice in hospitals. It has developed the only treatment for neurogenic dysphagia that treats the cause of dysphagia using PES. More information: http://www.phagenesis.com.
About Nestlé Health Science
Nestlé Health Science, a wholly-owned subsidiary of Nestlé headquartered in Epalinges, Switzerland, is a health-science company engaged in advancing the role of nutritional therapy to change the course of health for consumers, patients and partners in healthcare. More information: http://www.nestlehealthscience.com.
Glossary of terms
Dysphagia = difficulty in swallowing
Neurogenic dysphagia = dysphagia arising from the disruption of any of the neurological systems or processes involved in the execution of a coordinated safe swallow
Tracheotomy cannula = a tube that is inserted in the opening of the trachea (windpipe) to facilitate mechanical ventilation
Decannulation = Removal of the tracheotomy cannula
PHAST-TRAC = PHAryngeal electrical STimulation for early decannulation in TRACheotomised patients with neurogenic dysphagia after stroke (PHAST-TRAC): a prospective, single-blinded, randomised trial
This news release may contain forward-looking statements based on current assumptions and forecasts made by Nestlé Health Science and Phagenesis management. Various known and unknown risks, uncertainties and other factors could lead to differences between the actual, future results, financial situation, development or performance of the company and the estimates given here. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
- Dziewas R. et al. Lancet Neurol 2018; Published Online August 28, 2018.