PES Inclusion in AHA/ASA Stroke Guidelines Opens a New Tool Earlier in Post-Stroke Care: Q&A with Chad Hoskins

The American Heart Association/American Stroke Association (AHA/ASA) recently updated its guidelines to include pharyngal electrical stimulation (PES) as a therapy for patients suffering from post-stroke dysphagia.

Pharmaceutical Executive spoke with Chad Hoskins, CEO of Phagenesis, about the updated guidelines and how it might impact patients. Phagenesis developed a commercially available system named the Phagenyx System that delivers PES for patients.

According to Hoskins, there is strong evidence that shows that PES improves swallowing function by driving changes in the brain. Due to the way that the therapy is delivered, patients have the option of receiving during the initial hospital stay or during the rehabilitation period, depending on their needs and the severity of the problem.

Pharmaceutical Executive: How does PES’ new classification change how neurologists and rehabilitation teams think about PES as a treatment option?
Chad Hoskins: Historically, providers have had relatively few options to actively treat dysphagia early after stroke. Much of the focus has been on identifying the problem, managing aspiration risk, and modifying or restricting oral intake. Swallowing rehabilitation is important and can be effective, but it often requires active participation that severely impaired patients may not be able to provide.

PES, which can only be delivered through our product Phagenyx, being included in both the acute stroke and rehabilitation guidelines gives neurologists, speech-language pathologists, and rehabilitation teams a stronger basis for incorporating an active intervention earlier into the care pathway. The recommendations cover a broad stroke population, including patients with and without a tracheostomy, across acute care and rehabilitation.

For us, the significance is giving providers a new tool supported by the guidelines, including earlier in care when conventional therapy can be harder to administer. That gives teams an opportunity to address swallowing recovery sooner and help patients progress in their overall recovery.

PE: What does that body of evidence for PES actually show in terms of clinical outcomes, and what are the remaining questions it hasn’t yet answered?
Hoskins: The evidence is one of the strongest parts of this story. Across more than 30 publications and eight randomized studies, we’ve built a compelling chain of evidence—from mechanism of action to clinical outcomes. We’ve shown how stimulation drives changes in the brain, how those changes improve swallowing function, and how that translates into patient recovery.

Clinically, I’d focus on two things: protecting the airway and getting patients back to eating and drinking. Controlled studies have shown reduced aspiration and improved readiness to remove a tracheostomy. Randomized data have also shown a return to oral diet roughly six days faster and about half the feeding-tube dependence at discharge. These findings come from different studies, with some also demonstrating shorter ICU or hospital stays.

The next phase is about building on that foundation: defining who is most likely to respond to therapy, supporting earlier treatment, and demonstrating the value these benefits create for providers. We also see an opportunity to expand the evidence beyond stroke.”

PE: How does PES fit into the existing rehabilitation pathway?
Hoskins: We see PES as an early intervention that supports swallowing recovery alongside conventional therapy. The goal is to help patients regain the ability to swallow so they can participate more fully in rehabilitation and get back to eating and drinking.

That starts with identifying dysphagia, assessing its severity, and determining whether the patient is an appropriate candidate for treatment. Neurologists, speech-language pathologists, rehabilitation physicians, and nursing teams all have a role.

The timing should follow the patient’s clinical needs. For some patients, that means considering PES during the acute hospital stay; for others, during rehabilitation. The guidelines support consideration across those settings. Our job is to make it straightforward for teams to identify appropriate patients and incorporate treatment into their existing care pathway.”

PE: From a payer and market access perspective, how is a Class 2b recommendation likely to affect coverage decisions for PES?
Hoskins: Guideline inclusion strengthens the clinical case in conversations with hospitals and payers. It provides independent recognition of the evidence, although it doesn’t automatically establish coverage or payment.

Our focus is on how improving swallowing function early after stroke can deliver better outcomes for patients while reducing the cost and complexity of care for hospitals. These patients can be incredibly challenging to manage, and swallowing impairment often becomes a barrier to discharge that teams have few options to address.

PES gives hospitals a tool to address airway safety and help patients return to an oral diet faster. That can reduce the need for procedures to place longer-term feeding tubes and help shorten hospital stays. Those are meaningful benefits for patients and a strong basis for demonstrating economic value to hospitals.

The guidelines strengthen that case, and our ongoing work focuses on demonstrating the value of earlier swallowing recovery in routine care.

PE: What are the practical barriers to PES becoming more widely used in post-stroke care?
Hoskins: Given that we’re relatively new in the U.S., the biggest challenge is often just awareness. Many hospitals and clinicians haven’t been aware of the technology or what it can do for patients. Inclusion in the AHA/ASA guidelines has helped broaden that understanding, and as people learn about PES and its potential benefits, we’re seeing a lot of enthusiasm.

Like any new technology in a hospital, there’s a process to integrating it into existing stroke care pathways. That includes defining which patients to treat and when, how to deliver the treatment, and how to evaluate outcomes over time. Those are practical considerations when starting a new program, and our focus is on helping teams make that integration straightforward.