Woodside Biomedical's ReliefBand Device Receives FDA Clearance for Non-Prescription Sales in...

Business Editors and Health/Medical Writers

CARLSBAD, Calif.--(BW HealthWire)--March 25, 2002

Woodside Biomedical, makers of the ReliefBand(R) Device, a patented, revolutionary drug-free way to combat morning sickness announced today that it has received 510(k) clearance from the Food and Drug Administration (FDA) to market the device without a prescription to pregnant women for relief of mild to moderate nausea and vomiting associated with pregnancy.

Previously the device was available by prescription only.

The ReliefBand(R) Device sold over-the-counter (OTC) for pregnancy will be technically identical to the product currently being sold for OTC motion sickness. New packaging and labeling consistent with the new clearance is being designed and the company plans to have retail distribution and promotion in place by fall 2002.

Morning sickness affects 50-70% of the four million pregnancies occurring in the U.S. each year. Currently, there are no other treatments with FDA clearance or approval specific to morning sickness, and physicians rely primarily on diet changes, small frequent meals, and supplements such as ginger ale for treatment.

"Pregnant women will have direct access to an important new product for relief of mild to moderate morning sickness," stated Greg Gruzdowich, president and CEO of Woodside.

Woodside Biomedical has four FDA clearances for the ReliefBand(R) Device. Over-the-counter indications include motion sickness in addition to the new pregnancy clearance. Woodside Biomedical also offers a higher-strength prescription-only version of the ReliefBand(R) Device for treatment of chemotherapy-induced nausea and vomiting, post-operative nausea as an adjunct to anti-emetics, and nausea and vomiting associated with pregnancy requiring a physician's attention.

The ReliefBand(R) Device is a remarkable, non-invasive watch-like device worn on the underside of the wrist. A unique benefit of this non-invasive treatment is that there are no drug-like side effects or drug interactions and it does not cause drowsiness or other side effects that are common with most nausea medications.

The ReliefBand(R) Device uses gentle electronic signals to stimulate nerves in the wrist, which, according to researchers, causes natural nerve impulses to travel up the arm into the spinal cord and brain. The user is able to control the sophisticated electronic pulses and may experience results within minutes of utilizing the device, which means the product can be used before or after symptoms start. Research has shown that these natural nerve impulses restore the stomach to normal operation and offer quick relief.

Woodside Biomedical Inc., based in Carlsbad, is on the forefront of developing technology-based, drug-free, non-invasive medical devices designed to provide therapeutic effects. Woodside is a privately owned, venture-financed company. Additional information about Woodside Biomedical, the ReliefBand(R) Device and retail availability 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(R) Device, whether the company will be successful in financing its business needs, the risk that sales of the ReliefBand(R) Device will not increase to target levels, and the effectiveness and marketability of medical products, as well as other risks.