Phagenesis^®
Phagenyx® – A Paradigm Shift in The Management of Swallowing Problems for ICU Patients

What are the fundamental requirements to sustain human life? Breathing is certainly number one, but a close number two is eating and drinking safely. Imagine, then, if every swallow is a struggle. Food and drink or even your own saliva stubbornly stay in your mouth and won’t clear from your throat, or worse, you fear if you try to swallow, the food and drink will choke you and stop that life supporting breath. Imagine being told you can’t safely eat normal foods again. No more family meals or refreshing cold drinks, no more trips to a restaurant or raising a glass in celebration.

Each year, millions of patients are faced with this reality after experiencing brain injuries or prolonged mechanical ventilation. The act of swallowing, which we take for granted, involves a complex orchestration of nerves and muscles that collectively ensure food, drink, or salivary secretions can be managed without interfering with the airway. Disruption to the neurological components of this orchestra results in neurogenic dysphagia, an uncoordinated and unsafe swallow. Patients with neurogenic dysphagia don’t just suffer from a profound drop in quality of life, they have consistently poorer health outcomes in the short, medium, and long term. One example is increased risk of pneumonia due to food, drink or salivary secretions entering the airway. This problem impacts providers too, in expensive and resource constrained care settings like the ICU, where dysphagia can be overlooked or misunderstood. These patients stay in the ICU longer and consume increased levels of precious one-toone care which quickly adds costs to the provider. For these patients the ICU can become a prison cell without a key.

Traditional dysphagia therapies don’t directly target the underlying neurological components of neurogenic dysphagia. They rely on swallowing exercises to try to rebuild muscle activity and strength with the hope that the neurological control of swallowing will spontaneously return over time. Phagenesis Limited, based in Manchester in the UK, takes a very different approach to treating neurogenic dysphagia. Leveraging 25 years of scientific and clinical research, they’ve developed a solution, Phagenyx^®, to address the root of the problem. They believe the solution is to restore the neurological systems that control swallowing function, not treat the symptoms, and to treat patients early in their care journey, in the ICU, to maximize the clinical and economic impact for patients and providers. Phagenyx^® has a substantial and growing portfolio of clinical and health resource utilization evidence that supports this position and many examples of delivering life changing outcomes for patients with severe dysphagia.

One such patient was Anna, a sixty-two-year-old who suffered a severe stroke, requiring a tracheostomy (surgery to place a tube in the neck to access the airway) for mechanical ventilation, or assistance with breathing, and airway protection. After nine days, Anna was weaned from the ventilator but could not have the tracheostomy tube removed due to severe persistent dysphagia with poor salivary secretion management. Up to this point, Anna had been hospitalised for 12 days. She was unable to eat by mouth requiring a feeding tube for nutrition and hydration delivery and required regular secretion suctioning and care by nursing staff.

After another 10 days the severity of Anna’s dysphagia was still preventing safe removal of the tracheostomy tube. The prospect of being discharged with a long-term life changing disability upset Anna and she worried about returning to life without many of the things she had previously taken for granted. At this point, she was recruited into the PHAST-TRAC study, a Phagenesis sponsored randomised controlled trial.

After three days of Phagenyx^® treatment, Anna showed a profound improvement in secretion management and swallowing safety allowing the tracheostomy tube to be removed, and Anna returned to normal eating and drinking. Four days after receiving Phagenyx^® treatment and after 26 total days in the ICU, Anna was discharged. Overall, PHAST-TRAC showed a statistically significant 22-day average length of stay reduction between Phagenyx^® responders and Phagenyx^® non-responders.

PHAST-TRAC and many other Phagenyx^® studies demonstrate that most profoundly unwell patients respond quickly, positively, and significantly to Phagenyx^® treatment. Providers benefit too with a game changing reduction in ICU and hospital lengths of stay, a reduction in their overall cost of care, and improved patient outcomes.

For the last ten years, we have continued to develop an ever deeper understanding of the neurological architecture of swallowing control and function

Phagenesis’ mission is to bring this life changing treatment to all patients who need it. The company was started in 2007 by Shaheen Hamdy MB ChB, PhD, FRCP a professor of neurogastroenterology at the University of Manchester. The foundation of the therapy is built on research by Professor Hamdy that, for the first time, mapped the parts of the brain responsible for swallowing control and coordination and showed how these changed over time in patients with brain injury and dysphagia. The team further identified unique neurostimulation conditions that could be applied to the pharynx (throat) to stimulate compensatory reorganisation of the neural pathways to overcome dysphagia related brain changes.

Phagenesis’ north star continues to be a relentless commitment to scientific and clinical evidence-based dysphagia treatments. “For the last ten years, we have continued to develop an ever deeper understanding of the neurological architecture of swallowing control and function,” commented Reinhard Krickl, CEO of Phagenesis. “We work closely with clinical researchers and academic leaders from all over the world who share our vision for effective and timely dysphagia treatments. Our goals are to positively change the lives of patients and provide a powerful tool to healthcare professionals to improve patient outcomes and reduce the health economic burden of dysphagia care.” Clinical data aside, Phagenyx^® also impresses with its intuitive design. “From the outset, we wanted this treatment to be readily integrated into current dysphagia care and complement already available therapies.

We wanted to provide an enabling new tool to the dysphagia care toolbox,” explains Conor Mulrooney, Phagenesis COO.

That design process resulted in Phagenyx^®, a single patient use sterile catheter, and a Base Station, a touchscreen computer that guides the user through treatment optimisation. The catheter delivers both enteral feeding and electrical stimulation functionality with a pair of bipolar ring electrodes integrated at specific points on its outer surface.

Positioning guides ensure the catheter electrodes target specific swallow related sensory receptors in the pharynx. Each treatment begins at the bedside by connecting the catheter to the Base Station and measuring the patients’ sensory capacity. The system then calculates a patient specific therapy profile and then the treatment can begin. Stimulation is only required for 10 minutes per day for 3 to 6 consecutive days. The fixed low frequency (5Hz) stimulation has been shown through brain imaging studies to dramatically excite the swallow centres in the brain and drive therapeutic reorganisation of the damaged areas. In several studies, significant clinical improvements were seen as quickly as 24-72 hours after treatment.

Phagenyx^® is also designed to integrate easily into multidisciplinary care settings like the ICU, with minimal patient involvement. “Many current swallowing therapies require substantial patient involvement and are impractical to deliver early in the care pathway where the need is greatest and the risk to the patient is the highest,” suggests Reinhard. “We have successfully treated patients with locked in syndrome where eye movement was the only form of communication. This capability strongly positions us to deliver the therapy within ICUs and to help patients and the healthcare system at such a critical moment. For patients with dysphagia in the ICU, Phagenyx^® is realistically the only treatment option and may be the key to unlocking the door and giving them their life back.”

Anil Keni, Phagenesis VP of Global Marketing, notes the economic challenges healthcare providers face and believes Phagenyx^® can deliver results. “Phagenyx presents an attractive return on investment. Patients recover faster in the ICU and have a shorter length of stay in hospital overall.

The savings this represents and the increase in capacity provided, mean the costs of Phagenyx can be easily recovered within a single financial year by the hospital.” Reinhard and his team are also very aware that the COVID pandemic has placed enormous pressure on critical care resources and see Phagenyx as a novel solution to help free up bed space and reduce the burden of care in these difficult times.

Where does Phagenesis go from here? “We have a substantial product pipeline that will treat many different patient populations over the next few years. We will continue combining our detailed knowledge of patient and market needs with our commitment to evidence based clinical research to produce world class solutions for dysphagia care,” says Reinhard. “We have the right team in place and a genuine passion in what we are doing.”

Patients and providers across Europe have a new choice in dysphagia therapy and this one’s easy to swallow.