BIOCARE SYSTEMS' CONSUMER-MARKET PAIN RELIEF DEVICE GETS FDA CLEARANCE

LED Infrared Low Level Light Therapy device offers alternative to lasers

DENVER (January 10, 2005) - BioCare Systems, Inc., today announced it received 510(k) clearance from the FDA to market its PremIR818 Infrared Therapy device for the temporary relief/reduction of minor pain or discomfort associated with muscles including neck and back pain caused by muscle tension, joints, arthritis, sprains and strains. Designed specifically for the consumer market, the device is expected to be available in Spring 2005.

Infrared Low Level Light Therapy (LLLT) refers to the use of light in the infrared spectrum to elicit beneficial biological responses. LLLT works by stimulating natural biological processes in the area where the light is applied. Referred to as "photobiomodulation" and "photobiostimulation," this process promotes the body's own natural healing and tissue immune responses. In the clinical setting, Low Level Light Therapy has proven effective for many conditions to increase the speed, quality and tensile strength of tissue repair; give pain relief; resolve inflammation; and improve function of damaged neurological tissue.

PremIR818 BioCare's working name for the company's patented technology LED (light emitting diode) device that delivers infrared light to users without the expense or possible hazards invoked when lasers are used to relieve pain.

"BioCare has improved upon the proven technology of the science of photobiomodulation and developed a medical device for the consumer market using light emitting diodes (LEDs) in place of laser technology," said Sherry Fox, BioCare's president and CEO. "LED light is safer, less expensive and often as effective as the more highly complex technology used in clinical settings."

BioCare's patented emitter technology uniquely addresses issues of treatment modality, power deposition rate, optimal source wavelength, dosage duration and specific indication parameters. The LED wavelength falls within the optimal range for absorption of light by oxygenated hemoglobin to promote maximal photobiostimulatory effects while still allowing adequate tissue penetration. At the same time, this wavelength is poorly absorbed by water, resulting in little direct heating of tissue, and therefore, minimal risk of heat-induced tissue damage.

Researchers are currently investigating additional Low Level Light Therapy applications for cosmetic treatment, spinal cord injuries, Parkinson disease, strokes, brain tumors and tissue, muscle and organ regeneration as well as healing wounds, ophthalmic applications, diabetic neuropathy and erectile dysfunction.

About BioCare Systems, Inc.
Located in Denver, Colorado, BioCare Systems, Inc. (BioCare) develops and markets innovative, practical, non-invasive Low Level Light Therapy (LLLT) medical devices - FDA cleared to temporarily relieve pain for the widest range of indications - to consumers and to medical professionals whose patients want to maintain active lifestyles. BioCare is a leader in consumer LED Low Level Light Therapy through the application of sound science, marketplace knowledge, and the ability to mainstream complex clinical technology into affordable, effective, portable and easy-to-use products. For more information, visit www.biocaresystems.com or contact Sherry Fox, (303) 796-7043.

Contact

Sherry Fox
BioCare Systems, Inc.
(303) 796-7043
 
Bob Wolper
The Wolper Group
(303) 707-1021