Biofrontera Inc.Announces Notice of Clearance for the United States


WOBURN, Mass., December 8, 2021 (GLOBE NEWSWIRE) – Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the marketing of dermatological products, today announced that the United States Patent and Trademark Office (USPTO) has issued a Notice of Release for U.S. Patent Number 17 / 215,785 (785 patent) by Biofrontera Pharma GmbH, entitled “Illumination photodynamic therapy device, method of treatment of skin disease and method of operation of an illumination device”, which protects a number of innovations relating to the RhodoLED XL lamp .

“This is a patent covered by the exclusive license from Biofrontera Inc. to sell Ameluz and the RhodoLED series of lamps in the United States. It reinforces Biofrontera’s commitment to patient safety, improves the competitive position of our flagship product and strengthens the intellectual property portfolio around our flagship 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 combined product. As previously announced, in 2022, as part of our license and supply agreement, Biofrontera Bioscience GmbH plans to start a Phase 3 trial for the treatment of actinic keratosis of the face and scalp with three tubes of Ameluz and the RhodoLED XL lamp ”, said Erica Monaco, CEO of Biofrontera Inc.

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

The ‘785 patent is a continuation-in-part of U.S. patent number 17 / 071,496, and therefore claims the same priority date of October 15, 2020. The continuation-in-part was filed as an expedited application on March 29, 2020. 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 United States-based biopharmaceutical company that markets a portfolio of pharmaceutical products for the treatment of skin conditions. Focusing on the areas of photodynamic therapy (PDT) and topical antibiotics, Biofrontera is currently marketing the flagship drug Ameluz, approved by the FDA.® in the USA. When used in combination with PDT and RhodoLED from Biofrontera® lamp series, Ameluz®-PDT is indicated for the treatment of actinic keratosis, one of the most common precancerous skin conditions. Biofrontera also markets 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 contained 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, without limitation, statements relating to the financial impact and benefits of the Company’s recent public offering and private placement, clinical developments involving the Company’s licensed products and any other statement regarding future expectations, prospects, estimates and other matters which depend on future events or developments. Statements containing the words “anticipate”, “believe”, “estimate”, “expect”, “intend”, “may”, “plan”, “foresee”, “plan”, “target”, “De d ‘d’ d ‘d’ d ‘d’ d ‘d’ d ‘to plan,”, “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 regarding future events, however, 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 change 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 maintain profitability; whether current supply chain disruptions will impact the Company’s ability to obtain and distribute its licensed products; changes in the practices of healthcare providers, including any changes in coverage, reimbursement and pricing of procedures using the Company’s licensed products; uncertainties inherent in the initiation and conduct of clinical trials; the availability and timing of clinical trial data; whether the results of the first clinical trials or trials in different indications of the disease will be indicative of the results of ongoing or future trials; whether the results of the studies described above will be indicative of the results of future clinical trials and studies of Ameluz® in combination with BF-RhodoLED® ; uncertainties associated with regulatory review of clinical trials and marketing authorization applications; if the market opportunity for Ameluz® in combination with BF-RhodoLED® meets the expectations of the Company; 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 adequacy of cash resources and the need for additional financing and other factors which may be disclosed in the documents filed by the Company with the SEC, which can be obtained on the SEC’s website at www. sec.gov. Readers are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date they are made and reflect management’s current estimates, projections, expectations and beliefs. The Company does not intend to update these forward-looking statements and expressly disclaims any obligation to update the information contained in this press release, except as required by law.

Contacts

Biofrontera Inc.
Pamela Keck
+1 781 486 1539
[email protected]

LHA Investor Relations
Tirth T. Patel
+1 212 201 6614
[email protected]

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