Biofrontera Inc. Announces 100 RhodoLED® XL Machines Now Placed in US Market
Biofrontera Inc. (BFRI) announced the successful placement of its 100th RhodoLED® XL Lamp in the US market since its commercial launch in June 2024. The device, FDA-approved in 2022 for use with Ameluz® gel for photodynamic therapy (PDT) of actinic keratoses, has seen rapid adoption with more than 10% of Ameluz-using offices installing the system.
The RhodoLED XL features more LED panels than its predecessor BF-RhodoLED, enabling treatment of larger surface areas in a single session. Dr. Aaron Hoover of Front Range Dermatology highlighted the lamp's design, maneuverability, and enhanced patient throughput. Following FDA approval in October 2024, physicians can now use up to 3 tubes of Ameluz® in one treatment, maximizing the benefits of the larger illumination area.
Biofrontera Inc. (BFRI) ha annunciato il posizionamento con successo della sua 100ª lampada RhodoLED® XL nel mercato statunitense dalla sua introduzione commerciale nel giugno 2024. Il dispositivo, approvato dalla FDA nel 2022 per l'uso con il gel Ameluz® per la terapia fotodinamica (PDT) delle cheratosi attiniche, ha visto un'adozione rapida con oltre il 10% degli studi che utilizzano Ameluz® che hanno installato il sistema.
Il RhodoLED XL presenta più pannelli LED rispetto al suo predecessore BF-RhodoLED, consentendo il trattamento di aree più ampie in una sola sessione. Il Dr. Aaron Hoover della Front Range Dermatology ha evidenziato il design della lampada, la manovrabilità e l'aumento del numero di pazienti trattati. Dopo l'approvazione della FDA nell'ottobre 2024, i medici possono ora utilizzare fino a 3 tubi di Ameluz® in un trattamento, massimizzando i benefici dell'area di illuminazione più ampia.
Biofrontera Inc. (BFRI) anunció la colocación exitosa de su lámpara RhodoLED® XL número 100 en el mercado estadounidense desde su lanzamiento comercial en junio de 2024. El dispositivo, aprobado por la FDA en 2022 para su uso con el gel Ameluz® para la terapia fotodinámica (PDT) de queratosis actínica, ha visto una adopción rápida, con más del 10% de las oficinas que utilizan Ameluz® instalando el sistema.
La RhodoLED XL cuenta con más paneles LED que su predecesora BF-RhodoLED, lo que permite tratar áreas de superficie más grandes en una sola sesión. El Dr. Aaron Hoover de Front Range Dermatology destacó el diseño de la lámpara, su maniobrabilidad y un mayor flujo de pacientes. Tras la aprobación de la FDA en octubre de 2024, los médicos ahora pueden usar hasta 3 tubos de Ameluz® en un tratamiento, maximizando los beneficios de la mayor área de iluminación.
Biofrontera Inc. (BFRI)는 2024년 6월 상업 출시 이후 미국 시장에서 100번째 RhodoLED® XL 램프의 성공적인 배치를 발표했습니다. 이 장치는 2022년에 FDA 승인을 받았으며, Ameluz® 젤과 함께 사용하여 광역동 치료(PDT)를 통해 각질형성선종을 치료하는 데 사용됩니다. Ameluz®를 사용하는 병원 중 10% 이상이 이 시스템을 설치하며 빠른 채택을 보였습니다.
RhodoLED XL은 이전 모델인 BF-RhodoLED보다 LED 패널이 더 많아 단일 세션에서 더 넓은 표면적을 치료할 수 있습니다. Front Range Dermatology의 Aaron Hoover 박사는 램프의 디자인, 조작 용이성 및 환자 처리량이 향상된 점을 강조했습니다. 2024년 10월 FDA 승인을 받으면서 의사들은 이제 한 번의 치료에서 최대 3개의 Ameluz® 튜브를 사용할 수 있어 더 넓은 조명 영역의 이점을 극대화할 수 있습니다.
Biofrontera Inc. (BFRI) a annoncé le placement réussi de sa 100ème lampe RhodoLED® XL sur le marché américain depuis son lancement commercial en juin 2024. L'appareil, approuvé par la FDA en 2022 pour une utilisation avec le gel Ameluz® pour la thérapie photodynamique (PDT) des kératoses actiniques, a connu une adoption rapide, plus de 10 % des cabinets utilisant Ameluz® ayant installé le système.
La RhodoLED XL dispose de plus de panneaux LED que son prédécesseur BF-RhodoLED, permettant ainsi le traitement de surfaces plus grandes en une seule séance. Le Dr. Aaron Hoover de Front Range Dermatology a souligné le design de la lampe, sa maniabilité et un meilleur flux de patients. Après l'approbation de la FDA en octobre 2024, les médecins peuvent désormais utiliser jusqu'à 3 tubes d'Ameluz® dans un traitement, maximisant les avantages de la plus grande zone d'illumination.
Biofrontera Inc. (BFRI) gab die erfolgreiche Platzierung ihrer 100. RhodoLED® XL Lampe auf dem US-Markt seit ihrer Markteinführung im Juni 2024 bekannt. Das Gerät, das 2022 von der FDA für die Verwendung mit dem Ameluz® Gel zur photodynamischen Therapie (PDT) von aktinischen Keratosen zugelassen wurde, hat eine rasche Akzeptanz erfahren, denn mehr als 10 % der Büros, die Ameluz® verwenden, haben das System installiert.
Die RhodoLED XL verfügt über mehr LED-Paneele als ihr Vorgänger BF-RhodoLED, was die Behandlung größerer Oberflächen in einer einzelnen Sitzung ermöglicht. Dr. Aaron Hoover von Front Range Dermatology hob das Design der Lampe, die Manövrierbarkeit und die verbesserte Patientenbearbeitung hervor. Nach der FDA-Zulassung im Oktober 2024 können Ärzte nun bis zu 3 Tuben Ameluz® in einer Behandlung verwenden, was die Vorteile des größeren Beleuchtungsbereichs maximiert.
- Rapid market adoption with 100 installations in ~6 months since launch
- 10% penetration rate among existing Ameluz-using offices
- FDA approval for increased Ameluz® usage (up to 3 tubes) per treatment
- Enhanced treatment efficiency with larger surface area coverage
- None.
Insights
The successful placement of 100 RhodoLED XL machines in just six months represents a significant market penetration, particularly given Biofrontera's relatively small market cap of
The dual-unit purchase by a single practice after evaluation period indicates strong clinical validation and return on investment potential. The expanded treatment surface area directly impacts practice economics by increasing patient throughput and potentially reducing treatment time per patient. This operational efficiency could translate to higher adoption rates and increased Ameluz usage per practice.
The rapid market adoption indicates potential revenue acceleration through two key channels:
- Equipment sales revenue from new RhodoLED XL placements
- Recurring revenue from increased Ameluz usage due to larger treatment areas
The testimonial from Dr. Hoover highlighting both clinical and operational benefits provides credible validation of the product's value proposition. The combination of expanded treatment capability and recent FDA approval for increased Ameluz usage per session creates a compelling growth catalyst that could materially impact Biofrontera's financial performance.
- Biofrontera started commercial distribution of the RhodoLED XL in June 2024 and has seen rapid uptake in the US market since launch.
- The RhodoLED XL is approved by the FDA in combination with Ameluz® (aminolevulinic acid hydrochloride) topical gel,
10% for photodynamic therapy (PDT) of actinic keratoses of mild-to-moderate severity on the face and scalp. - Biofrontera’s RhodoLED XL and BF-RhodoLED lamps deliver red light energy using long-lasting light-emitting diode (LED) arrays.
WOBURN, Mass., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic therapy (PDT), today announced that the 100th commercial RhodoLED® XL Lamp has now been installed in the US market.
The RhodoLED XL was approved by the FDA for use in combination with Ameluz® in 2022 and was launched in June of this year. Since then, it has seen rapid adoption by offices who had previously used Ameluz and those who are new to the product, with 100 now being installed since launch. The main difference between the company’s existing BF-RhodoLED lamp and the new RhodoLED XL is the number of LED panels which allows a larger surface area to be illuminated during a single PDT treatment with Ameluz®.
“We are delighted that the RhodoLED XL Lamp has had such an enthusiastic reaction from dermatologists who perform PDT, with more than
After a three-month evaluation of the RhodoLED XL, Dr. Aaron Hoover of Front Range Dermatology, Colorado was so impressed with its performance that his practice decided to purchase not one but two units, including the 100th installed RhodoLED XL lamp. “We were thoroughly impressed by the lamp’s robust yet elegant design, as well as its exceptional maneuverability and adjustability, which made it ideal for Photodynamic Therapy (PDT) treatments in our offices,” Dr. Hoover explained. “The larger illumination area has significantly increased our patient throughput while also enhancing the overall quality of care and patient experience.” Dr. Hoover also noted the high level of satisfaction among both staff and patients with the outcomes of using Ameluz PDT in conjunction with the RhodoLED XL. “Additionally, the Biofrontera team made the purchase and transition to the XL an entirely seamless process for us,” he added.
“We were pleased to receive FDA approval for the use of up to 3 tubes of Ameluz® in one treatment in October of this year” stated Dr Luebbert. “With this capability and the larger illumination area of the RhodoLED XL our physicians can now treat a larger surface area on the face and scalp at one time which is efficient for the office and convenient for their patients” he concluded.
About Actinic Keratosis
AK is the most common pre-cancerous skin lesion caused by chronic sun exposure that may, if left untreated, develop into life-threatening skin cancer called squamous cell carcinoma. AKs typically appear on sun-exposed areas such as the face, bald scalp, arms or the back of the hands. In 2020, approximately 58 million people in the US were affected by AK and 13 million AK treatments were performed.2
1. https://www.skincancer.org/skin-cancer-information/basal-cell-carcinoma/
2. https://www.skincancer.org/skin-cancer-information/actinic-keratosis/
About Biofrontera Inc.
Biofrontera Inc. is a U.S.-based biopharmaceutical company specializing in the treatment of dermatological conditions with a focus on PDT. The Company commercializes the drug-device combination Ameluz® with the RhodoLED® lamp series for PDT of AK, pre-cancerous skin lesions which may progress to invasive skin cancers. The Company performs clinical trials to extend the use of the products to treat non-melanoma skin cancers and moderate severe acne. For more information, visit www.biofrontera-us.com and follow Biofrontera on LinkedIn and Twitter.
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. These statements include, but are not limited to, statements relating to Biofrontera's commercial opportunities and the commercial success of its licensed products. 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, include, but are not limited to: the impact of any extraordinary external events; any changes in the Company’s relationship with its licensors; the ability of the Company’s licensors to fulfill their obligations to the Company in a timely manner; the Company’s ability to achieve and sustain profitability; whether the current global disruptions in supply chains 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 earlier clinical trials or trials of Ameluz ® in combination with BF-RhodoLED and/or RhodoLED XL in different disease indications or product applications will be indicative of the results of ongoing or future trials; uncertainties associated with regulatory review of clinical trials and applications for marketing approvals; whether the market opportunity for Ameluz in combination with BF- RhodoLED and/or RhodoLED XL is consistent with the Company’s expectations; 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 Securities and Exchange Commission (the “SEC”), which can be obtained on the SEC’s 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.
Contact:
Investor Relations
Andrew Barwicki
1-516-662-9461
ir@bfri.com
FAQ
How many RhodoLED XL machines has Biofrontera (BFRI) placed in the US market as of December 2024?
What is the main difference between RhodoLED XL and BF-RhodoLED lamps?
When did Biofrontera (BFRI) receive FDA approval for RhodoLED XL?
How many tubes of Ameluz can now be used in one treatment with RhodoLED XL?
What percentage of Ameluz-using offices have installed RhodoLED XL?
