October 2018 issue
October 31, 2018 | The emerging market for bioelectronic medicine is being driven in large part by devices and therapies that cardiovascular, circulatory, and inflammatory disorders. But recently, there have been key developments in the market segment for gastrointestinal disorders.
More than 60 million people in the U.S. suffer from disorders in the gastrointestinal tract that could be cured by electrical stimulation, but scientists don’t fully understand the therapy’s effects on a critical organ: the stomach. EndoStim Inc. in Dallas, TX is developing a neurostimulation therapy to treat gastroesophageal reflux disease (GERD) using stimulation of the lower esophageal sphincter muscle.
Last month, MedAutonomic, a bioelectronic medicine startup firm based in Concord, CA and Venice, Italy implanted its brain neuromodulation device, the Phoenix, into the stomach wall of a human through an innovative digestive endoscopic procedure. The Phoenix, powered without a battery, sends signals to the brain to reset an imbalance in the autonomic nervous system with the aim to treat functional diseases such as type-2 diabetes, hypertension, and gastroesophageal reflux disease.
According to MedAutonomic president Valerio Cigaina, who is leading the research, “Our initial results of the first human implant of the Phoenix represent an important milestone for our company. The outpatient procedure using a gastric endoscope has been perfected, and we are able to implant our device without surgery in less than 10 minutes. We are pleased to be the first to insert a diagnostic and/or therapeutic device in the gastric wall in a minimally invasive way, with the device perfectly tolerated over the long term. The Phoenix is sending a signal to the brain, which is confirmed by heart rate variability.”
Earlier this month Purdue University researchers used an MRI to show a play-by-play of how sending an electric impulse to the vagus nerve successfully corrects stomach complications. The technique paves the way for more precise treatment that drugs and dietary changes have not achieved.
“Eventually, by asking a patient to undergo multiple MRI scans with different electrical stimulation settings, we could figure out the best stimulation setting for alleviating that particular patient’s symptoms,” said Kun-Han “Tom” Lu, a Ph.D. student in electrical and computer engineering. The work is published in the journal Neurogastroenterology and Motility.
One important indicator of a digestive disorder is the rate of gastric emptying into the small intestine for the absorption of nutrients. Slow gastric emptying in the disorder gastroparesis, for example, means that stomach muscles aren’t moving properly. Stimulating the vagus nerve would allow doctors to control how fast the stomach empties, effectively curing gastroparesis.
“Some stimulation protocols for the stomach in humans already have FDA approval, but they’ve proved only partially effective,” said Terry Powley, Purdue’s distinguished professor of neuroscience and the director of the SPARC project. As part of the SPARC project, Purdue researchers proposed using MRIs in small animals to get a better view of the effects of vagus nerve stimulation on the stomach.
“MRIs are noninvasive, show tissue contrast well, and make it easier to repeat an experiment for verification,” Lu said.
Lu stimulated the vagus nerve to control the pyloric sphincter in rats, the valve that controls food leaving the stomach and entering the small intestine. He then created 3D reconstructions of MRI images over time. The images showed that stimulation relaxed the pyloric sphincter, speeding up gastric emptying to potentially correct delayed emptying in the case of gastroparesis, or other kinds of gastrointestinal malfunction.
