BBS-Bioactive Bone Substitutes Plc, Company Release, Inside Information, March 9, 2022 at 3:30 p.m. 

BBS Bioactive Bone Substitutes Plc has filed the CE-marking application of Artebone® bone void filler to the authorities

BBS-Bioactive Bone Substitutes Plc has today on March 9 submitted to the authorities the application for the CE marking of the Artebone® bone filler substitute.

CEO Ilkka Kangasniemi: "I am very pleased that today we have submitted to the authorities the CE marking application for the Artebone® bone void filler. This has been our company's top priority and our employees have worked tremendously to achieve it. Our work will now continue during the approval process as we complete process validations and audits carried out by the authorities. In addition, we will provide answers to any possible additional questions from the authorities."

An approved CE marking is a requirement for beginning the marketing and sales of BSS’s next generation bone substitute.

The notified body processing the application is BSI-NL, which has also been asked to certify the BBS quality system at the same time. The process also includes a consultation of the competent authority on the conformity of the pharmaceutical component of the product. Due to the multistage approval process of the authorities, the company will not at this stage provide an estimate on when it will receive the CE marking.

For more information, please contact:

Ilkka Kangasniemi, CEO, +358 40 7080307,
ilkka.kangasniemi@bbs-artebone.fi

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

DISTRIBUTION:
Nasdaq Helsinki Oy
Nasdaq Stockholm AB
Main media
www.bbs-artebone.fi

This is information that BBS-Bioactive Bone Substitutes Plc is obliged to disclose in accordance with the EU Market Abuse Regulation. The information was submitted for publication through a representative of the afore mentioned contact person on March 9, 2022, at 3:30 p.m. (UTC+2:00).

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. More information: www.bbs-artebone.fi

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