The American Stroke Association (ASA) has formally recognised pharyngeal electrical stimulation (PES) as an important tool for post-stroke dysphagia (difficulty swallowing) treatment.
In ASA’s 2026 Guideline for the Early Management of Patients With Acute Ischemic Stroke, the association, which is an offshoot of the American Heart Association (AHA), recommends PES as a “beneficial treatment” in reducing dysphagia’s severity and the risk of aspiration. The guidelines were published on 26 January.
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In patients with severe stroke with dysphagia requiring tracheotomy and mechanical ventilation, ASA’s revised guidelines also stated that treatment with PES following ventilator weaning can prove beneficial in decreasing dysphagia’s severity, reducing aspiration risk, and expediting decannulation.
Phagenesis’ Phagenyx PES system targets the neurological components of swallowing coordination to restore function post-stroke, using a catheter inserted through the nose to deliver low electric currents to the throat nerves.
The UK-based company’s neuromodulation system received de novo clearance from the US Food and Drug Administration (FDA) in October 2022. Phagenyx first gained a European CE mark in 2012 and achieved approval under the European Union’s Medical Device Regulation (EU MDR) in August 2024. The device is the only commercialised PES treatment for patients in the US and EU.
In March 2024, the company raised $42m in a Series D financing round to help commercialisation efforts in the US and deepen market penetration in Europe.
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By GlobalDataPhagenesis CEO Chad Hoskins commented: “The formal inclusion reinforces the value of Phagenyx in improving outcomes for stroke survivors, while also reducing cost and complexity for healthcare providers. We appreciate the AHA’s recognition of dysphagia as a barrier to recovery and PES as a tool to address it.”
Research indicates that 46.6% of patients experience difficulty swallowing after suffering a stroke. While relatively common, the traditional standard of care in addressing the condition primarily focuses on monitoring, rehabilitative therapy, and dietary changes. Additional research has found that up to 50% of individuals still experience dysphagia six months after a stroke, with the condition heightening patients’ risk of pneumonia and death.
In a testimonial for Phagenesis, Dr Alex Choi, professor of neurosurgery and neurology at the University of Texas Health Science Center at Houston, highlighted that despite dysphagia’s prevalence and impact, historically there have been “few meaningful therapeutic interventions” to improve patient outcomes.
Choi said: “The addition of PES to the guidelines signals that we now have a validated therapeutic option that can be integrated into routine stroke care.”
The overall neuromodulation devices market is rapidly advancing, with the treatment modality applicable in addressing other conditions, including incontinence, migraine, and depression.
According to GlobalData analysis, the global neuromodulation devices market is growing at a CAGR of 6.7% and projected to reach a valuation of $12.9bn in 2034, up from $6.35bn in 2024.
