Neuromodulation breathing tube startup looks to begin first clinical trial

A Case Western Reserve University spinoff developing a neuromodulation device to help patients with breathing tubes to swallow is looking to build a prototype of the device and begin a clinical trial early next year.

The device is intended to replace existing tracheostomy tubes, and works by electrically stimulating a nerve in the neck to activate the vocal cord folds to simulate a swallowing motion.

The company developing the device goes by the temporary title of BEAR, which stands for Biomedical Engineering and Research. The company was previously known by the informal title Swallowing Solutions, but that name was never intended to be the company’s long-term identity, according to Dustin Tyler, an associate professor of biomedical engineering at Case who is leading the research project.

Following strokes or neurodegenerative diseases like Parkinson’s, patients can lose their ability to swallow, so they must be fed and hydrated through feeding tubes. Using an electrical device to stimulate normal swallowing could significantly improve the quality of life for these patients, according to the thinking behind the company.

First, though, the company must complete a prototype of the device and then begin testing it on humans. Plans call for a roughly 30-patient trial to begin early next year and wrap up around the end of the first quarter, Tyler said.

“What we’re going to figure out in the trial is the details of how we can make this system work,” he said.

Key insights the company hopes to glean from the trial include how the device feels to the user, exactly where on patients’ bodies to apply the stimulation and the optimal strength and timing of electricity delivery.

Roughly 700,000 U.S. patients could benefit from the device if it works as the company hopes, Tyler said.

Armed with successful clinical trial results, the company’s next steps would involve obtaining investment funding for further trials aimed at helping secure U.S. Food and Drug Administration approval of the device.

BEAR has received funding for its research and development through Case’s translational research program that’s funded in part by the Wallace H. Coulter Foundation.

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