Monday February 11, 5:58 pm Eastern Time - SOURCE: MicroLight Corporation of America

MicroLight Announces F.D.A. Clears `Cold Laser' for Non-Surgical Treatment of Carpal Tunnel Syndrome

HOUSTON--(BUSINESS WIRE)--Feb. 11, 2002--MicroLight Corporation of America announces receipt of market clearance from the Food and Drug Administration for the company's ML830 "Cold Laser" for use in the non-surgical treatment and management of carpal tunnel syndrome or "CTS."

"CTS sufferers are now free to seek relief from hand and wrist pain through a new non-invasive form of therapy before resorting to surgery," stated Mike Barbour, president of MicroLight Corporation of America. "FDA market clearance for the ML830 resulted from working with FDA examiners over the past ten years to ensure continuing compliance with the law," says Barbour. He estimates that more than $4 million was spent in this effort. "Our ML830 successfully performed in several double blind studies and in many clinical trials where some rather substantial parties were involved, including Baylor College of Medicine and General Motors," he added.

"We are pleased that the FDA market clearance allows commercialization of this important "cold" laser technology," stated Fred A. Simpson, MicroLight's executive vice president. MicroLight Corporation of America is seeking strategic partnerships to manufacture and market the ML830's CTS application and to develop other clinical uses for the ML830. "The ML830 has potential for other soft tissue applications," says Simpson.

Carpal Tunnel Syndrome is the number one repetitive stress injury in America today and is a leading cause of worker lost time and disability. More than one million Americans acquire CTS symptoms each year, and over 200,000 surgical procedures are performed in the treatment of CTS at an annual cost of over $10 billion. Private insurance companies and governmental health plans bear most of that cost.

Although CTS can begin suddenly, its onset is usually gradual. If not treated, CTS may lead to reduced hand function with possible permanent nerve and muscle damage. With early diagnosis and treatment, however, complete recovery usually occurs. Anything that causes swelling of the synovium that surrounds wrist tendons, or produces repeated pressure on the median nerve, can lead to CTS or make it worse if the condition already exists.

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