Drug free, non-invasive device offers new treatment option.
CARLSBAD, Calif. -- December 14, 1999. Woodside Biomedical, Inc. has received United States Food and Drug Administration (FDA) clearance to market its ReliefBand Device as a new drug-free, non-invasive prescription treatment for reducing post-operative nausea when used as an adjunct to anti-emetics, announced Greg Gruzdowich, Woodside's president and CEO.
The ReliefBand is the first commercially available electronic device to achieve FDA clearance for post-operative nausea. Approximately 16 million people undergo surgery in the U.S. each year. Of that number, almost half suffer some degree on nausea, despite the use of pharmaceuticals.
The FDA clearance was based on a 220 patient, multi-site, randomized, placebo controlled clinical trial sponsored by Woodside. The study demonstrated statistically significant relief of nausea following laporoscopic cholecystectomy, a surgical procedure that commonly causes nausea. The Department of Anesthesiology and Pain Management at the University of Texas/Southwestern Medical Center in Dallas was the lead site in the trial. Anesthesiology departments from Mount Sinai Medical Center, New York City, Wake Forrest University Medical Center, Winston-Salem, NC, and University of Southern California Medical Center, Los Angeles, CA also participated.
"The use of the ReliefBand as an adjunctive therapy to treat post-operative nausea fills a long-standing gap in patient care," said Dr. Paul White, Ph.D, M.D., Professor of Anesthesiology and Department Chair at the University of Texas/Southwestern Medical Center, and the lead investigator for the multi-center study of the ReliefBand in the post-operative environment. "Many of the commonly used anti-emetic drugs work very well for treating post-operative vomiting and retching, but are not as effective in reducing nausea. The ReliefBand was found to have significant anti-nausea activity. It's addition to treatment protocols addresses this need and will help improve patient care."
With this FDA clearance, the ReliefBand Device indications expand to treat nausea and / or vomiting from a variety of causes. In October of 1998 the ReliefBand Device received FDA clearance by prescription for the treatment of nausea and vomiting due to chemotherapy, and pregnancy and motion sickness. In February of 1999, a version of the device was cleared for over-the-counter (OTC), non-prescription sale for the treatment of motion sickness.
"You can think of the ReliefBand Device as the first "broad-spectrum" anti-nausea treatment; capable of treating nausea due to a variety of causes" said Gruzdowich. "The RELIEFBAND device';s versatility is illustrated when compared to anti-nausea and vomiting pharmaceuticals; none of which are routinely used for indications as diverse as motion sickness to chemotherapy." he added.
About the ReliefBand
The ReliefBand Device uses gentle electrical signals to stimulate nerves in the wrist. This wrist stimulation, according to the theory of action proposed by some researchers, causes natural nerve impulses to travel up the arm into the spinal cord and brain. It is thought that these natural nerve impulses interfere with the nausea messages going to the stomach. The ReliefBand is easy-to-use, doesn't cause drug-drug interactions, doesn';t cause drowsiness and the effects last as long as it is worn. Also, because it's drug-free, it has no drug like side effects.
Currently, the prescription ReliefBand Device is in use in hundreds of oncology, obstetric offices, and hospitals nationwide. The OTC version available for motion sickness is available via select Internet drug stores such as www.drugstore.com, www.cvs.com, and www.aeromedix.com.
The ReliefBand Device model WB-2, a disposable device with a 48 hour battery life has been designed by Woodside for the post-operative market. The device will be available through selected wholesalers and direct from Woodside Biomedical by calling 888-297-9728.
About Woodside Biomedical
Woodside Biomedical develops, manufactures, and markets therapeutic medical devices for the treatment of nausea and vomiting. The privately owned, ventured-financed company has raised approximately million from top-tier investors such as Mayfield Fund, Menlo Ventures, Enterprise Partners, and Kingsbury Associates. Additional information about the company and the ReliefBand Device can be obtained from Woodside';s Web site at www.reliefband.com.
Except for the historical information contained herein, this news release contains forward-looking statements that involve risks and uncertainties, including, but not limited to, risks and uncertainties associated with market acceptance of the ReliefBand Device, whether the company will be successful in raising additional funds, the risk that sales of the ReliefBand Device will not increase to target levels, and the effectiveness and marketability of medical products, as well as other risks.
ReliefBand is a registered trademark of Woodside Biomedical, Inc.
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