BBS-Bioactive Bone Substitutes – Inside information: The final report of the second audit received from the Notified Body, CE marking process may continue and CE marking approval continues to be expected during 2023

BBS-Bioactive Bone Substitutes, Company announcement, Insider information, 27 March 2023 at 7:20 p.m. EEST

BBS-Bioactive Bone Substitutes – Inside information: The final report of the second audit received from the Notified Body, CE marking process may continue and CE marking approval continues to be expected during 2023

The Notified Body has completed its second audit. The audit was carried out during 10-13 March 2023, the audit report was received on 20 March 2023, and today on 27 March 2023 the last meeting related to the audit was held with the authorities.

The second audit was related to the approval process of BBS-Bone Substitutes Plc’s quality system, which is part of the CE marking process for the company's first product (ARTEBONE® Paste -bone filler). During the second audit, the Notified Body inspected more closely detailed product documentation and the production processes.

According to the final audit report, certain additional measures are required from the company, and the company has committed to complete these by 1 September 2023. After this, the approval of the quality system is expected to be ready. CE marking is still expected to be obtained during 2023.

"Overall, we are satisfied with the results of the two audits, as we have now received information from the authorities about the non-conformities and are confident that we will be able to correct them. Also importantly, the supplementary measures required for the quality system approval will not slow down other ongoing related approval processes. The next important milestone will be to get a decision on the product classification, the processing of which has now been accelerated according to the authorities, even though they continue to have challenges with resourcing", says Ilkka Kangasniemi, CEO of BBS.

Previous disclosures related to the CE marking application:

• 30 December 2023 – BBS-Bioactive Bone Substitutes Plc - Insider information: BBS updates estimate of the CE marking approval schedule of ARTEBONE® Paste
• 18 November 2022 – BBS-Bioactive Bone Substitutes – 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

The CE marking process includes two main streams: approval of the quality system and product approval.  Obtaining product approval requires cooperation between the Notified Body and the Medicines Agency handling the matter.

For more information:

Ilkka Kangasniemi, CEO,
tel. +358 40 708 0307, e-mail: [email protected]

Certified Advisor:
Nordic Certified Adviser AB, tel. +46 70 551 67 29, [email protected]

BBS in brief

BBS-Bioactive Bone Substitutes Plc is a Finnish orthobiology company whose core competence is the development, commercialization and manufacture of easy-to-use bone implants that promote bone formation and healing. Bone substitutes, i.e. implants, are intended for the treatment of various bone damage, bone healing problems and bone diseases instead of autologous and bank bone grafts. BBS aims to become one of the leading players in the field of bioactive implants intended for bone healing problems. The company's head office is located in Oulu, and it employs 20 people.

BBS was founded in 2003, and the company has been listed on Nasdaq First North Growth Market Finland since February 2018.