Leverkusen (pta024/22.10.2021/15:55) - Leverkusen, Germany, October 22, 2021 - Biofrontera AG (NASDAQ: BFRA; Frankfurt Stock Exchange: B8F) (the "Company"), an international biopharmaceutical company, today announced the approval of the new red-light source for photodynamic therapy (PDT), the BF-RhodoLED® XL, by the U.S. Food and Drug Administration (FDA). In accordance with FDA requirements, the approval was granted as a combination approval with our prescription drug Ameluz®, same as the approval with the predecessor model BF-RhodoLED®.
The new, larger BF-RhodoLED® XL was approved in combination with Ameluz® for the treatment of mild and moderate actinic keratoses on the face and scalp, which corresponds to the current approval of Ameluz®. The new PDT lamp enables the illumination of larger areas, enabling the simultaneous treatment of several actinic keratoses distant from each other.
Ahead of the approval by the FDA, the new lamp was protected by several patent applications, which, due to the specifics of the FDA's combination approval, will also contribute to the protection of the prescription drug Ameluz® in the US-market once the patents are granted.
The treatment parameters of the new BF-RhodoLED® XL, such as light dose, illumination time and wavelength of light are identical to the predecessor model BF-RhodoLED®. In order to meet the FDA's strict requirements for the manufacture of a class III medical device, production of the new lamp has, similar to the older model, been established at the Company's headquarters in Leverkusen. At present, there are no plans to market the new BF-RhodoLED® XL in Europe. The BF-RhodoLED® model will continue to be offered in all our markets.
Biofrontera AG, Hemmelrather Weg 201, 51377 Leverkusen
Tel: +49 (0214) 87 63 2 0, Fax: +49 (0214) 87 63 290
Hemmelrather Weg 201
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