BBS-Bioactive Bone Substitutes Plc, Company announcement, Insider information, 13 September 2023 at 4:45 p.m.
BBS-Bioactive Bone Substitutes Plc – Insider information: Plan to complete minor open issues approved – the Company updates its outlook on the schedule of the CE marking
The CE marking process of BBS-Bioactive Bone Substitutes Plc's ("BBS") first product (ARTEBONE® Paste) includes two main streams: approval of the quality system and approval of the product.
Regarding the approval of the quality system, the Notified body has today (September 13, 2023) approved the plan submitted by BBS to complete the required four open minor measures. The measures are estimated to be completed in March-May 2024, after which the quality system may be approved.
Regarding the product approval process, the authorities continue to review the documentation alongside which the consultation of the Medicines Agency will take place. The Finnish Medicine Agency (Fimea) is prepared to initiate the consultation. Once started, the Company expects the consultation to take 3-7 months to be completed.
Due to the updated schedule of the quality system approval, the Company has updated its outlook for the approval of the CE marking.
Ilkka Kangasniemi, CEO:
"The backlog of application processing by the authorities and the additional measures required of BBS during the process have caused delays in the application process. However, we remain satisfied with how the CE marking process has progressed regarding the substance. No significant non-conformities have been discovered during the audits which we have not been able to solve. Now that the schedule has been clarified, the Company has started the preliminary commercialization measures and engaged with potential distributors."
The product's journey towards commercialization
|Product development||Preclinical animal tests||Completed|
|Functionality and efficiency tests||Completed|
|CE marking||Submitting the CE application||Completed|
|Quality system application||In process|
|Additional measures||Plan approved|
|Product approval||In process|
|Consultation with the Medicines Agency||In preparation|
|Production lines and line certification||Mostly completed|
|CE marking||Expected in Q2/2024|
|Commercialization||Preliminary commercialization||In process|
|Extensive commercialization||In preparation|
Previously published announcements related to the CE marking application
Ilkka Kangasniemi, CEO,
+358 40 7080307,
Nordic Certified Adviser AB,
+46 70 551 67 29,
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 developed product, ARTEBONE®, is in the final stages of product development, and we are seeking the CE marking 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 20 people.
BBS has been listed on Nasdaq First North Growth Market Finland since February 2018.
More information: www.bbs-artebone.fi