Phagenesis has secured breakthrough device designation from the US Food and Drug Administration (FDA) for its Phagenyx system.

Phagenyx is a new neurostimulation device developed to advance the removal of the breathing tube by treating neurogenic dysphagia.

Dysphagia may result in complications such as aspiration pneumonia, malnutrition and dehydration.

Phageny uses pharyngeal electrical stimulation to provide an optimised train of electrical stimuli to the patient’s throat

Phagenyx will help restore neurological swallowing control by providing pharyngeal electrical stimulation (PES). Phagenyx uses PES to offer an optimised train of electrical stimuli to the patient’s throat (oropharynx).

As part of the breakthrough device programme, the FDA will offer Phagenesis with priority review and interactive communication during the de novo review phase of the new neurostimulation device.

Phagenesis CEO Reinhard Krickl 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.”

According to the company, the PHAST-TRAC randomised controlled study showed that tracheotomised patients treated with the Phagenyx system were five times more likely to be safely decannulated as compared to untreated control patients.

The company already secured CE mark approval for Phageny to commercialise in Europe. The device is not yet commercially available in the US.

Nestlé Health Science CEO Greg Behar said: “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.”

In September 2016, Nestlé Health Science agreed to acquire Phagenesis for an undisclosed sum.