BBS-Bioactive Bone Substitutes: The Notified Body has approved the Company’s quality system

BBS-Bioactive Bone Substitutes Plc, press release, 25 November 2023 at 11.00 a.m.

BBS-Bioactive Bone Substitutes Plc ("BBS") has received confirmation from the Notified Body that the Company's quality system has received final approval and the official quality certificate has been delivered to the company.

BBS previously announced (Company announcement on 2 November 2023) that the approval was expected to be received during November.

"With the expected approval of the quality system granted, we can once again mark one important step with regard to the CE marking process completed. The final stage of the process has begun," says CEO Juliusz Rakowski.

After the approval of the quality system, the CE marking of the Company's first product, ARTEBONE® Paste, only requires final product approval, which is already at the last stages of the process, and the consultation of the Finnish Medicines Agency (Fimea) which, according to the Notified Body’s notification on 2 November, was to start in November. The consultation with Fimea is part of the official CE marking process and, according to the company's estimate, will take 3-7 months.

The Company's guidance on the overall schedule for the CE marking remains unchanged. The Company continues to expect the authorities' decision on the approval of the CE marking application for its first product during the second quarter of 2024.

For more information, please contact:

Juliusz Rakowski, CEO
+358 50 448 5132

BBS in brief

BBS -Bioactive Bone Substitutes Plc is a orthobiology company that started its operations in 2003. We have developed a new product for the treatment of complex bone fractures and bone healing issues. Our goal is to provide next-generation medical products for the treatment of bone injuries in orthopedic surgery. In the pharmaceutical industry, the development and research work require perseverance and courage to innovate. We have a track record of over 20 years in this field. Our company is characterized by expertise, innovation, and dedicated employees who are passionate about their work. Our first developed product, ARTEBONE® Paste, is in the final stages of the CE marking process to enable its commercialization in the EU market. We are based in Oulu with a medical manufacturing facility in Reisjärvi, holding a manufacturing license. The company's headquarters are in Oulu, and we employ over 20 people.

BBS has been listed on Nasdaq First North Growth Market Finland since February 2018.

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