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Biofrontera Inc. Announces Notice of Allowance for U.S. Method-of-Use Patent on PDT-lamp

WOBURN, Mass., Dec. 08, 2021 (GLOBE NEWSWIRE) — Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for Biofrontera Pharma GmbH’s U.S. patent number 17/215,785 (‘785 patent), titled “Illumination device for photodynamic therapy, method for treating a skin disease and method for operating an illumination device,” which protects a number of innovations relating to the RhodoLED XL lamp.

“This is a patent covered by the exclusive license of Biofrontera Inc. to sell Ameluz and the RhodoLED lamp series in the USA. It furthers Biofrontera’s commitment to patient safety, enhances our lead product’s competitive position and strengthens the intellectual property portfolio around our lead product Ameluz in combination with the FDA-approved RhodoLED XL lamp. The technical improvements claimed in the patent allow for greater standardization and procedural compliance for photodynamic therapy (PDT) with the combination product. As previously announced, in 2022, within the framework of our License and Supply Agreement, Biofrontera Bioscience GmbH plans to start a Phase 3 trial for the treatment of actinic keratoses on the face and scalp with three tubes of Ameluz and the RhodoLED XL lamp,” stated Erica Monaco, Chief Executive Officer of Biofrontera Inc.

The ‘785 patent describes specific features of the LED arrays of the five panels constituting the lamp head of RhodoLED XL. These features provide optimized homogenous illumination by an improved spatial arrangement. The patent further describes the implementation of a distance sensor in each panel that improves device positioning. The sensors are connected to visual feedback mechanisms that support the operator in properly positioning the five panels at the recommended treatment distance. This increases standardization of the illumination, while facilitating handling of the lamp for the treating physician.

The ‘785 patent constitutes a continuation-in-part of U.S. patent number 17/071,496, and thus claims the same priority date of October 15, 2020. The continuation-in-part was filed as a fast-track application on March 29, 2021 and the allowance was granted in less than nine months. A worldwide patent application based on this invention and claiming the same priority date has also been filed (PCT/EP2021/078045).

About Biofrontera Inc.

Biofrontera Inc. is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products for the treatment of dermatological conditions. With a focus on the fields of photodynamic therapy (PDT) and topical antibiotics, Biofrontera currently commercializes the FDA-approved flagship drug Ameluz® in the United States. When used in combination with PDT and Biofrontera’s RhodoLED® lamp series, Ameluz®-PDT is indicated for the treatment of actinic keratoses, one of the most common precancerous skin conditions. Biofrontera also commercializes Xepi®, an FDA-approved drug for the treatment of impetigo. In collaboration with dermatologists, Biofrontera is fully committed to advancing treatment options and patient care. For more information, visit www.biofrontera-us.com.

Forward-Looking Statements

Certain statements in this press release may constitute “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the financial impact and benefits of the Company’s recent initial public offering and private placement, the clinical developments involving the Company’s licenses products and any other statements about future Expectations, prospects, estimates and other matters that are dependent on future events or developments. Statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “likely,” “will,” “would,” “could,” “should,” “continue,” and similar expressions constitute forward-looking statements. We have based these forward-looking statements on our current expectations and projections about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed in, or implied by, the forward-looking statements we make. These risks and uncertainties, many of which are beyond our control, including, but not limited to, the impact of extraordinary external events, such as the current COVID-19 pandemic; any changes in the Company’s relationship with its licensors; the outcome of the Company’s litigation with DUSA Pharmaceuticals, Inc.; the Company’s ability to achieve and sustain profitability; whether the current disruptions in the supply chain will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes to the coverage, reimbursement and pricing for procedures using the Company’s licensed products; the uncertainties inherent in the initiation and conduct of clinical trials; availability and timing of data from clinical trials; whether results of early clinical trials or trials in different disease indications will be indicative of the results of ongoing or future trials; whether results of the studies described above will be indicative of results for any future clinical trials and studies of Ameluz® in combination with BF-RhodoLED® ; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz® in combination with BF-RhodoLED® is consistent with the Company’s expectations; whether the Company will be able to successfully transition to a public company operating independently of Biofrontera AG; the Company’s ability to retain and hire key personnel; the sufficiency of cash resources and need for additional financing and other factors that may be disclosed in the Company’s filings with the SEC, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law.


Biofrontera Inc.
Pamela Keck
+1 781 486 1539

LHA Investor Relations
Tirth T. Patel
+1 212 201 6614

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