Some very positive news Bob.... Niv
FDA Responds to Henley's MicroLight 830(TM) Filing SUGAR LAND, Texas, Feb. 21 /PRNewswire/ -- Henley Healthcare, Inc. (Nasdaq: HENL) today announced that the U.S. Food and Drug Administration (FDA) has responded and has formally accepted the company's pre-market approval application (PMA) for the MicroLight 830(TM) Laser System. The correspondence stated that the FDA has made a threshold determination that the PMA is sufficiently complete to permit a substantive review. The MicroLight 830(TM) Laser System is a hand-held, low-energy (non- surgical) laser primarily designed for the treatment of repetitive stress disorders such as carpal tunnel syndrome. The company has been conducting clinical trials and gathering clinical data on the laser system over the last five years and believes that the most recently submitted clinical data provides sufficient evidence of the laser's efficacy and ability to successfully treat carpal tunnel syndrome. Michael M. Barbour, president and chief executive officer of Henley, stated, "This is a true milestone in the laborious and lengthy approval process we've had to endure. The latest clinical trial data continues to enforce our opinion that the laser system is a benefit to sufferers of carpal tunnel syndrome. With marketing approval, the MicroLight 830(TM) will not only be a health benefit but a significant cost savings to millions of persons experiencing the dreadful and painful condition." Henley Healthcare, Inc., a leader in the growing pain management industry, develops, manufactures and distributes products and related accessories used in the control of acute or chronic pain. The company offers a diversified line of non-invasive physical medicine and rehabilitation products that are used in the treatment of disabilities or injuries with therapeutic exercise and the application of various heat, Fluidotherapy(R), traction, ultrasound or other modalities. Henley Healthcare is also awaiting FDA approval on its MicroLight 830(TM), a hand-held, low-energy (non-surgical) laser for the treatment of repetitive stress disorders such as carpal tunnel syndrome. For additional information on Henley Healthcare, Inc. please visit the company's Web site at www.henleyhealth.com. SOURCE Henley Healthcare, Inc. -0- 02/21/2000
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