Biofrontera AG receives FDA-approval of the BF-RhodoLED® XL lamp
22 Octobre 2021 - 3:55PM
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
LeverkusenISIN: DE0006046113WKN: 604611
Contact: Biofrontera AGTel: +49 (0214) 87 63 2
0, Fax: +49 (0214) 87 63 290Email: ir@biofrontera.com
Forward-Looking Statements: Certain statements
in this press release are forward-looking within the meaning of the
Private Securities Litigation Reform Act of 1995 regarding the
public offering and the intended use of proceeds from the
offering.These statements may be identified by the use of
forward-looking words such as "anticipate," "believe," "forecast,"
"estimate" and "intend," among others. Such forward-looking
statements are based on the currently held beliefs and assumptions
of the management of Biofrontera AG, which are expressed in good
faith and, in their opinion, reasonable. Forward-looking statements
involve known and unknown risks, uncertainties and other factors,
which may cause the actual results, financial condition,
performance, or achievements of the Company, or industry results,
to differ materially from the results, financial condition,
performance or achievements expressed or implied by such
forward-looking statements. These risks, uncertainties and other
factors are set forth in the annual report on Form 20-F filed with
the SEC, including Item 3.D. "Key Information - Risk Factors," and
in future reports filed with the SEC. Given these risks,
uncertainties and other factors, prospective investors are
cautioned not to place undue reliance on these forward-looking
statements. The Company does not undertake an obligation to update
or revise any forward-looking statement.
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