BBS-Bioactive Bone Substitutes – Insider information: The company provides an update on the CE marking process related to the approval of the quality system – consultation with the Finnish Medicines Agency to begin on 21 November 2023
BBS-Bioactive Bone Substitutes Plc, Company announcement, insider information, 2 November 2023 at 19.30 EET*BBS-Bioactive Bone Substitutes – The company provides an update on the CE marking process related to the approval of the quality system – consultation with the Finnish Medicines Agency to begin on 21 November 2023*
BBS-Bioactive Bone Substitutes Plc ("BBS") has been informed by the Notified Body on 2 November 2023 that the final approval of the quality system is expected within approximately one month, which is earlier than was previously estimated (March-May 2024). In addition, the company has already received the quality system certificate from the authorities for advance commenting.
Following the expected approval of the quality system, the product approval is next, part of which is a consultation with the Finnish Medicines Agency. The Notified body has informed the company on 2 November 2023 that the consultation will begin on 21 November 2023. The consultation with Fimea is part of the official CE marking process and the company expects the consultation to take 3-7 months to be completed.
The company's guidance on the overall schedule for CE marking remains unchanged. The Company expects the authorities’ decision on approving the CE marking application during the second quarter of 2024.
*The product's journey towards commercialization (updated)*
Phase Action Status
Product development
Preclinical animal tests Completed
Functionality and efficiency tests Completed
Clinical test Completed
CE marking
Submitting the CE application Completed
Quality system application (updated) Mostly completed 1^st audit Completed
2^nd audit Completed
Additional audit Completed
Additional measures Plan approved
Product approval In process Product classification Completed Consultation with the Medicines Agency (updated) In process
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*
· 17 September 2023: Insider information: Plan to complete minor open issues approved – the Company updates its outlook on the schedule of the CE marking
· 31 August 2023: Inside information: The final report of the additional audit received from the Notified Body
· 26 May 2023 – Inside information – Positive decision received on the product classification, schedule for the quality system approval to be updated
· 27 March 2023 – Inside information: The final report of the second audit received from the Notified Body, the CE marking process may continue and CE marking approval continues to be expected during 2023
· 30 December 2022 – Insider information: BBS updates the estimate of the CE marking approval schedule of ARTEBONE® Paste
· 18 November 2022 – Inside information: The first audit completed by the Notified Body, CE marking process may continue as planned
· 9 March 2022 – BBS Bioactive Bone Substitutes Plc has filed the CE-marking application of Artebone® bone void filler to the authorities
*Additional information:*
Pekka Jalovaara
Chairman of the Board
+358 50 552 9275
pekka.jalovaara@bbs-artebone.fi
Certified Advisor:
Nordic Certified Adviser AB,
+46 70 551 67 29,
info@certifiedadviser.se
*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