Today, our client, Xilas Medical, Inc. today announced that its telemedicine grant has been approved for Phase II funding from the National Institutes of Health (NIH). The grant is for $880,000 over 24 months and allows Xilas to conduct clinical trials on its TempTouch RM®, an infrared temperature remote monitoring (RM) device for diabetic patients. A Phase I NIH-sponsored trial was completed in late 2003 and proved that the TempTouch RM can be used as an effective tool for capturing the medical data and sending it over a modem.
The TempTouch RM is a device that diabetes patients use at home and stand on like a bathroom scale. It measures foot temperatures and the patient’s weight, loads the data into an on-board computer, and transmits the information via the phone/Internet to the doctor’s office or a central monitoring facility. The daily measurements are monitored for any potential problems. Elevated foot temperatures can be a sign of inflammation and potential ulceration, and a sudden increase in weight is an indication of impending heart problems in diabetic patients with congestive heart failure.
Xilas will run a one-year clinical trial where the TempTouch RM will be placed into the homes of 50 diabetic patients who are at high risk for foot complications. The use of the TempTouch RM in a home setting provides diabetes patients with a way to participate in their own care and prevention and take corrective action before problems spiral beyond control and high medical costs become unavoidable. Xilas has been issued two U.S. patents on the TempTouch RM. To date, the Company has received a total of $3.6 million from the NIH for product testing and clinical trials on its family of products. Xilas has also received two 510(k) approvals from the Food and Drug Administration and has begun marketing its products.