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Device designed by MCW gastroenterologist keeps reflux in check

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Spring 2013 issue (pdf)

A new medical device designed by Medical College of Wisconsin researchers may alleviate the symptoms of severe acid reflux in patients while they sleep, a concept translated from bench, literally, to bedside.

Named the Reza-Band™, the device is founded on research conducted over 20 years by gastroenterologist Reza Shaker, MD, Fel ’88. Dr. Shaker is the Joseph E. Geenen Professor and Chief of Gastroenterology and Hepatology, Senior Associate Dean for Clinical and Translational Research, Director of the Clinical and Translational Science Institute (CTSI) of Southeast Wisconsin and Director of the Digestive Disease Center at the Medical College of Wisconsin (MCW).

The patent-pending device has been licensed to Wisconsin-based Somna Therapeutics, LLC, for further development and marketing, and clinical trials are underway to gain FDA approval.

Katie Swan of the Clinical and Translational Science Institute of Southeast Wisconsin helps Reza Shaker, MD, Fel ’88, demonstrate how his invention, the Reza-Band™, uses external pressure to prevent the symptoms of extraesophageal reflux disease.

Katie Swan of the Clinical and Translational Science Institute of Southeast Wisconsin helps Reza Shaker, MD, Fel ’88, demonstrate how his invention, the Reza-Band™, uses external pressure to prevent the symptoms of extraesophageal reflux disease.

Fifteen million people in the United States suffer from extraesophageal acid reflux disease (EERD), in which stomach contents are regurgitated beyond the esophagus and into the throat, windpipe and lungs, most often during sleep. The condition can cause chronic cough, asthma, voice disorders, sleep apnea and pneumonia. Current therapies include medication, behavior modification and surgery. The economic health impact in the U.S. is estimated at $54 billion.

A non-invasive solution, the Reza-Band™ has been shown in two preliminary MCW studies to prevent the reflux of stomach contents into the throat. EERD is the result of a dysfunctional upper esophageal sphincter, a muscle that serves as the primary defense against reflux by maintaining a certain level of pressure.

This muscle typically relaxes during sleep, but in patients with EERD, the muscle relaxes too much, allowing regurgitation to enter the throat. The Reza-Band™ is worn around the neck at night and adjusts to apply a slight, external pressure on the upper esophageal sphincter area, just below the Adam’s apple, to compensate for the lack of adequate pressure within the muscle.

“EERD leads to a spectrum of health problems,” Dr. Shaker said. “With the Reza-Band™ these patients can minimize or eliminate their symptoms with the added benefits of improved sleep, lower health care costs and diminishing or avoiding the need for acid-reducing drugs.”

The synergy among partners in the CTSI was an asset in the development of the device and transfer of the technology. The CTSI in 2010 was designated part of a national consortium of 61 top medical research institutions dedicated to accelerating medical advances to improve health through research and education. The CTSI includes the Medical College of Wisconsin, Marquette University, the Milwaukee School of Engineering, the University of Wisconsin-Milwaukee, the BloodCenter of Wisconsin, Children’s Hospital and Health System, Froedtert Hospital and the Clement J. Zablocki VA Medical Center.

MCW’s Office of Technology Development helped match the Reza-Band™ project with investors. Somna Therapeutics was founded in March 2012 in partnership with the Medical College. The company was awarded first prize in the 2012 Wisconsin Governor’s Business Plan Contest, Life Sciences Division, after a six-month judging process that included more than 300 companies across the state.

Following FDA clearance and completion of clinical trials, Somna Therapeutics anticipates the Reza-Band™ may be available to hospitals, physician clinics and home health care agencies by the fall of 2013.

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