BBS-Bioactive Bone Substitutes – Inside information: The first audit completed by the Notified Body, CE marking process may continue as planned

BBS-Bioactive Bone Substitutes Oyj, Company release, Inside Information, 18 November 2022 at 2.30 p.m. EET

The Notified Body has completed its first audit (15-18 November 2022) and has delivered its audit report to the company. The audit was focused on the quality system of BBS-Bioactive Bone Substitutes Oyj (BBS), and it was a part of the CE marking process of the company’s first product (ARTEBONE® Paste bone filler).

During the authorities’ first audit, the Notified Body inspected documentation related to the quality system. No critical non-conformities related to the quality system were reported during the audit and the CE marking approval process may thus proceed as planned.

“We are very pleased with the results of the audit. We have been successful in developing our quality system further, as the audit revealed only minor non-conformities, while no critical ones were observed”, says BBS’s CEO Ilkka Kangasniemi.

The Notified body shall continue to review the documentation provided by the company and the second audit is currently scheduled for February 2023.

For more information:

Ilkka Kangasniemi, CEO,
tel. +358 40 708 0307, e-mail: ilkka.kangasniemi@bbs-artebone.fi 

Certified Advisor:
Nordic Certified Adviser AB, tel. +46 70 551 67 29, info@certifiedadviser.se 

This is information that BBS-Bioactive Bone Substitutes Plc is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on 18 November 2022 at 2:30 pm EET.

BBS in brief

BBS-Bioactive Bone Substitutes is a health technology company that started operations in 2003. We have developed a new product for the treatment of severe bone fractures and lumber problems. Our goal is to provide a new generation of medical products for the treatment of bone damage in orthopaedic surgery. In the pharmaceutical sector, development and research requires perseverance and courage to develop new things. We have evidence of this for over 20 years. Our activities are characterised by top expertise, innovation and employees who are enthusiastic and committed to their work. The ARTEBONE ® in the final stages of product development, and we are looking for a CE marking that enables commercialisation in the EU. We are a company in Oulu with a pharmaceutical factory permit in Reisjärvi.

BBS-Bioactive Bone Substitutes Oyj:n shares are listed in Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden.

More information: www.bbs-artebone.fi