FDA Approval - 510 k - for Biolight


STOCKHOLM, Sweden, Jan. 24, 2002 (PRIMEZONE) -- Biolight:

The company has gained FDA approval - 510(k) - for Physiotherapeutic Care. This approval allows the company to market and sell its equipment (PCD) and treatment programs for prevention and rehabilitation of injuries in the locomotor apparatus (locomotorium) in the American market.

Christer Wallin, President of Biolight International AB, says:

"We are very excited about being able to present the market with an approval regarding the American market. "Wellness" is one of the most rapidly growing industries in the USA, with annual sales amounting to about 200 billion dollars in 2000. Workout and fitness training are dominating features. This results in a great need for efficient methods for the prevention and treatment of injuries, an area where we have extensive and long-standing experience.

Our method - Biolight(r) - is also non-pharmaceutical, non-invasive and without side-effects. A concept that should fit in perfectly with "Wellness".

This spring, the company will carefully map out potential distributors in the USA. A number of tests involving selected customers is already under way."

Facts about Biolight:

Biolight is a Swedish medical technology company, that has developed a unique product for the treatment of damaged cells. The patented product is based on a method that introduces light of a specific wavelength (monochromatic light), pulse frequency and time. The light provides energy to the cell, increases its activities and initiates healing. A cell without sufficient energy is not strong enough to contribute properly to healing.

The method speeds the healing processes and supplements traditional treatment. It contributes to an improved quality of life and reduced treatment expenses. The treatment is non-pharmaceutical (not a drug) and applied externally. It is easy to administer, painless and does not involve any side effects. Today, Biolight is active in treatment of ulcerations, dental care and rehabilitation.

Clinical studies using the same stringent design as for pharmaceutical products, have demonstrated that the Biolight method significantly reduces time to healing for both gingivitis and chronic wounds.

Biolight International AB is a medical technology company that offers its customers, including patients, health care personnel and authorities, various products and services, based on the company's patented method for the use of pulsating, monochromatic light. The company aims to improve the patient's quality of life and significantly reduce healing time as well as treatment expenses. Through systematically performed clinical trials, Biolight is gradually expanding its scientific basis to establish the method within the health care system. In recent years, Biolight has focused on a small number of indication areas grouped around wound healing.

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