Xilas Medical, Inc. Receives 510k Clearance from FDA for its TempTouch Home Temperature Monitoring Device

SAN ANTONIO--(BUSINESS WIRE)--March 30, 2005--Xilas Medical, Inc. today announced that its TempTouch(R) home infrared temperature probe has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). As a result, the TempTouch is now commercially available in the United States.

The TempTouch is an infrared thermometer intended for the intermittent measurement and monitoring of human skin surface temperature in the home or clinic for use with people of all ages. The monitoring device is a portable, non-invasive tool, which diabetic patients use daily at home to monitor foot temperature fluctuations, which are indicative of pending foot problems. In diabetes, patient involvement to identify early warning signs of the disease process is imperative to reduce the incidence of complications and prevent morbidity. For people with this chronic disease, foot ulcers are one of the most common precursors to diabetes-related amputations.

“By preventing foot ulcers, we can prevent diabetes-related amputations which is a significant development for the millions of people who have diabetes”

"By preventing foot ulcers, we can prevent diabetes-related amputations which is a significant development for the millions of people who have diabetes," said Don Lawson, CEO of Xilas Medical, Inc. "More than 6 percent of Americans are diabetic, and many of them have a loss of sensation in their feet, which makes it difficult for them to feel inflammation or the beginnings of an ulcer. TempTouch(R) is a way for them to easily test for potential problems, and take action to prevent complications. Now that the TempTouch(R) is commercially available, millions of diabetic patients will be able to benefit from this product and improve their quality of life."

The TempTouch was clinically tested in two trials sponsored by the National Institutes of Health (NIH), and the studies found a ten-fold reduction in foot ulcers for people using the device. As a result of these trials, the TempTouch has been proven to significantly reduce diabetic foot ulcers by providing patients with an early warning of inflammation, which occurs before an ulcer actually breaks the surface of the skin. Once the inflammation has been detected, patients in the trials were able to reduce activity levels to avoid more serious problems such as ulceration.

About Xilas Medical, Inc.

Xilas Medical, Inc. develops patented medical devices, which are founded on evidence-based medicine and clinically proven to reduce foot amputations in diabetic patients. Xilas' friction reduction, nerve damage assessment, and temperature management products dramatically decrease health care costs by preventing acute problems and providing patients and doctors with an early warning system of potential foot-related complications. Studies show that Xilas products have an unusually high level of compliance among diabetic patients and that using the Xilas TempTouch(R) reduces the chances of foot amputation by up to 85 percent. By focusing on prevention, Xilas is bringing about social change in the management of diabetes. For more information, please visit www.xilas.com.

Reader Contact Information

Xilas Medical, Inc.; 12665 Silicon Drive; San Antonio, TX; 78249; Tel: [phone]; www.xilas.com.

TempTouch is a registered trademark of Xilas Medical, Inc.

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