BBS-Bioactive Bone Substitutes – Inside information: The final report of the additional audit received from the Notified Body

BBS-Bioactive Bone Substitutes Plc, Company announcement, insider information, 31 August 2023 at 1:30 p.m. (EET)

BBS-Bioactive Bone Substitutes – Inside information: The report of the additional audit received from the Notified Body

The CE marking process includes two main streams: approval of the quality system and product approval.

Regarding the approval of the quality system, the Notified Body has now completed the two required audits (in November 2022 and March 2023) and an additional audit on August 29-30, 2023. The authorities delivered their audit report to the company on August 30, 2023.

According to the audit report, the company has successfully completed all the required major additional measures. The company must submit a plan for the completion of the four remaining minor open measures within two weeks, i.e. by 13 September. According to the management's assessment, the open minor measures can be resolved.

BBS will provide an updated schedule for the approval of the quality system following the approval of the plan by the authorities.

Previously published announcements related to the CE marking application

• 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, CE marking process may continue and CE marking approval continues to be expected during 2023
• 30 December 2022 – Insider information: BBS updates 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
  
  

More information:

Ilkka Kangasniemi, CEO,
+358 40 7080307,
[email protected]

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

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