Breakthrough for Unique Method in Wound Healing.

Business Editors

STOCKHOLM, Sweden--(BUSINESS WIRE)--June 21, 2001

Biolight has developed a unique method, which reduces the time to healing for chronic wounds.

This has been confirmed through a recent study carried out in Sweden and Denmark. The study shows that the time to healing was reduced by 36%.

The estimated number of chronic wounds, only in Sweden, is currently estimated to about 100,000, a figure which, considering the age structure, is expected to increase.

Today at 12 a.m., the result of the study will be presented by Christer Wallin, the company's president, and Jan-Ake Gustafsson, chairman of Biolight's scientific council at a press conference at Berns in Stockholm.

Christer Wallin, President of Biolight, says: "Decubitus ulcers cause a lot of suffering, especially to elderly patients. The treatment of these wounds results in considerable costs to society every year, and the problem keeps increasing. Biolight can now present a unique method for improving medical care for patients with chronic wounds. The results mean that we will now accelerate the process by selecting a distributor for the business area "Wound Care". I consider the market potential for Biolight within the wound area to be of substantial proportions. We have now shown in quite a number of studies that Biolight(R) is a biologically active method. Apart from the study we have just presented, we have also presented statistically significant results on the growth of fibroblasts (a cell-type) and the treatment of gingivitis (inflammation of the gums) in earlier studies."

Ove Dehlin, professor of geriatrics in Malmo, Sweden, Solve Elmstahl, professor of geriatrics, Malmo, Sweden, and Finn Gottrup, professor of wound healing in Copenhagen, Denmark, who have jointly headed the execution of the clinical phase III studies on decubitus ulcers, have made the following statement:

"Decubitus ulcers is a big problem in medical care, and primarily affect older patients, who already suffer from other complicated illnesses. There hasn't been anything principally new in the treatment of decubitus ulcers in recent years. Biolight(R) is pulsating, monochromatic light, which in pre-human studies has shown interesting biological effects in relation to wound healing. In two double-blind, placebo-controlled studies, we have examined the effects of Biolight(R) on decubitus ulcers, grade 2, in older patients. In the first study, promising but not altogether significant results (p=0.06) were achieved, which is the reason why that study has now been complemented with another study, and the studies have been pooled. The results are satisfactory. Treatment with Biolight(R) made the wounds heal significantly faster compared to placebo (p=0.04). No serious side effects have been observed."

Professor Jan-Ake Gustafsson of the Department of Medical Nutrition and the Department of Biosciences, Novum, the Karolinska Institute, and chairman of Biolight's scientific council, says:

"The healing effect of Biolight(R) in the treatment of decubitus ulcers, is now clearly established through the same stringent criteria as apply to the trial of drugs. Thus, Biolight has taken a definite step from being an alternative medical method into being an allopathic treatment method."

Facts:

The analysis of data from two randomized, double-blind and placebo- controlled phase III studies on the effect of treatment with Biolight(R) on the healing of decubitus ulcers, grade 2, is finalized. The results show a statistically significant difference in effect of 61% 1) (p=0.0394) between patients treated with Biolight(R) compared to placebo- treated patients. The study has been carried out at 9 centres in Sweden and Denmark. The healing of the wounds has the same pattern and speed as in the earlier studies. The result shows that the time to healing after treatment with Biolight(R) was reduced by 36 %. 163 patients (79 Biolight(R), 84 placebo) are included in the analysis.

EXECUTED             Difference  Reduction of
                     in
STUDIES              effect      time to healing     Completed
                     compared    compared
                     to placebo  to control          p-value    in

Fibroblasts (in      83%         -                   p<0.0003   1998
vitro)
Gingivitis, phase    87%         -                   p=0.035    2000
III
Decubitus ulcers,    -           33%                 p=0.013    1997
phase II
Decubitus ulcers,    61%         36%                 p=0.0394   2001
phase III

Biolight International AB is a medical technology company, offering its customers - patients, nursing staff and different authorities - various products and services, based on the company's patented method for the use of pulsating, monochromatic light. In this way, the company wishes to improve the quality of life for the patients and significantly reduce the time to healing as well as the treatment costs. Through systematically executed clinical trials, Biolight is gradually extending its scientific basis to secure the method in the field of health care. During the past few years, Biolight has focused on a small number of indication areas grouped around wound healing.

For further information, please visit Biolight's web site at www.biolight.se The effect is expressed as the difference in reduction of normalized wound area between the groups, measured after 12 weeks of treatment.