BFRI

Biofrontera Inc. is a specialty pharmaceutical company focused on dermatology, specifically commercializing products for the treatment of actinic keratoses (AK) and other skin cancers. Headquartered in Wakefield, Massachusetts, Biofrontera operates as the U.S. subsidiary of Biofrontera AG (Germany) and holds exclusive rights to commercialize the company's proprietary products in the United States. The company's lead product is Ameluz (aminolevulinic acid hydrochloride) gel, used in combination with photodynamic therapy (PDT) for the treatment of actinic keratoses. Ameluz is applied topically to actinic keratoses lesions and then activated by illumination with a specific wavelength of light (red light or daylight), triggering a photochemical reaction that selectively destroys abnormal cells while sparing healthy tissue. This photodynamic therapy approach offers advantages over traditional treatments including high lesion clearance rates, excellent cosmetic outcomes, and the ability to treat large areas or multiple lesions simultaneously. Biofrontera markets the BF-RhodoLED lamp, a medical device specifically designed for use with Ameluz, providing optimal light exposure for PDT treatments. Actinic keratoses are precancerous skin lesions caused by cumulative sun exposure, affecting millions of Americans and representing a significant risk factor for squamous cell carcinoma. Biofrontera's commercial strategy includes building a specialized dermatology sales force, educating physicians about PDT benefits, securing insurance reimbursement, and expanding the product's use in dermatology practices. The company faces competition from other AK treatment modalities including topical chemotherapies, cryotherapy, and surgical procedures. Biofrontera's success depends on driving adoption of PDT with Ameluz, demonstrating superior clinical and cosmetic outcomes, navigating reimbursement dynamics, and potentially expanding into additional dermatological indications.