Update on BBS-Bioactive Bone Solutions’ CE marking process


Investor news, 8 November 2022 at 11.45 EET

As part of the on-going CE marking process, BBS-Bone Substitutes Oyj (BBS) has in cooperation with the Notified body scheduled the first audit for 15-18 November 2022, related to the company's first product (ARTEBONE® Paste bone filler).

"In March, the authorities estimated that the approval process will take 8-12 months from the date of submission of the application (9 March 2022), so we are currently proceeding according to the plan and what has previously been communicated," says Ilkka Kangasniemi, CEO of BBS.

The Notified body has been reviewing the documentation provided by the company and will carry out two separate on-location audits to review the company's operations. The second audit is currently scheduled for February 2023. After each audit, the Notified body will deliver an audit report to the company. The company will communicate about the Notified body’s findings separately.

Additional information

Ilkka Kangasniemi, CEO
m. 040 708 0307, e-mail: ilkka.kangasniemi@bbs-artebone.fi

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