BBS-Bioactive Bone Substitutes Plc – Insider information: Plan to complete minor open issues approved – the Company updates its outlook on the schedule of the CE marking

BBS-Bioactive Bone Substitutes Plc, Company announcement, Insider information, 13 September 2023 at 4:45 p.m.

BBS-Bioactive Bone Substitutes Plc – Insider information: Plan to complete minor open issues approved – the Company updates its outlook on the schedule of the CE marking

The CE marking process of BBS-Bioactive Bone Substitutes Plc's ("BBS") first product (ARTEBONE® Paste) includes two main streams: approval of the quality system and approval of the product.

Regarding the approval of the quality system, the Notified body has today (September 13, 2023) approved the plan submitted by BBS to complete the required four open minor measures. The measures are estimated to be completed in March-May 2024, after which the quality system may be approved.

Regarding the product approval process, the authorities continue to review the documentation alongside which the consultation of the Medicines Agency will take place. The Finnish Medicine Agency (Fimea) is prepared to initiate the consultation. Once started, the Company expects the consultation to take 3-7 months to be completed.

Due to the updated schedule of the quality system approval, the Company has updated its outlook for the approval of the CE marking.

Ilkka Kangasniemi, CEO:

"The backlog of application processing by the authorities and the additional measures required of BBS during the process have caused delays in the application process. However, we remain satisfied with how the CE marking process has progressed regarding the substance. No significant non-conformities have been discovered during the audits which we have not been able to solve. Now that the schedule has been clarified, the Company has started the preliminary commercialization measures and engaged with potential distributors."

New outlook

• The Company has submitted the CE marking application for its first product (ARTEBONE® Paste) to the notified body on 9 March 2022. The Company expects the authorities’ decision on approving the application during the second quarter of 2024.
• Further measures are required to ensure the sufficiency of the Company's financing to implement the Company’s plans following the expected approval of the CE marking. The Company continues discussions to secure additional funding to enable the continuation of the development work as well as initiating commercial activities.

Previous outlook

• The Company has submitted the CE marking application for its first product (ARTEBONE® Paste) to the notified body on 9 March 2022. The Company expects authorities’ decision on approving the application during 2023.
• Preparations for commercial operations will start towards the end of 2023.
• Further measures are required to ensure the sufficiency of the Company's financing to implement the Company’s plans following the expected approval of the CE marking. The Company continues discussions to secure additional funding to enable the continuation of the development work as well as initiating commercial activities.
  
  

The product's journey towards commercialization

Phase	Action	Status
Product development	Preclinical animal tests	Completed
	Functionality and efficiency tests	Completed
	Clinical test	Completed
CE marking	Submitting the CE application	Completed
	Quality system application	In process
	1st audit	Completed
	2nd audit	Completed
	Additional audit	Completed
	Additional measures	Plan approved
	Product approval	In process
	Product classification	Completed
	Consultation with the Medicines Agency	In preparation
	Production lines and line certification	Mostly completed
	CE marking	Expected in Q2/2024
Commercialization	Preliminary commercialization	In process
	Extensive commercialization	In preparation

Previously published announcements related to the CE marking application

• 31 August 2023: Inside information: The final report of the additional audit received from the Notified Body
• 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, the CE marking process may continue and CE marking approval continues to be expected during 2023
• 30 December 2022 – Insider information: BBS updates the 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

Additional 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