Management of BBS-Bioactive Bone Substitutes Plc (”BBS”, ”the Company”) estimates that the Company will receive the CE marking for the ARTEBONE® product designed to heal bone fractures and damages during 2021. The obtaining of the CE marking will be delayed from the previous schedule about 9 months and will cause the additional expenses of approximately EUR 300.000. The Company intends to submit the application for processing in approximately April.
In July 2020 BBS received the draft agreement concerning the implementation of CE marking process of ARTEBONE® from Notified Body (BSI). The Company began preparations to submit CE marking application and documents required by the agreement processing as soon as possible.
At a general level, the Covid-19 pandemic has caused delays and made the operating environment more difficult.
During autumn, the ongoing commissioning of new Medical Device Regulation (MDR) in Europe has highlighted significant number of unfinished documents, quality tests and qualifications of production equipment in the Company. In addition, the Notified Body demands that all documents must be ready for submission at the same time with the CE marking application, whereas according to previous practice, the application could be supplemented during the application process.
Furthermore, the further measurements of the animal experiment required by the authority have had to wait longer than expected (The company announcement 7 August 2020).
The Company has initiated efforts to remedy the situation. The Company has entered into purchasing service agreements with third parties to speed up the production and updating of the necessary documents. In addition, three people have been hired to support the activities of the quality department so far. At a later stage, these individuals move to other positions within the Company.
The product approval schedule has naturally changed. The Company’s current management has assessed a new timetable for obtaining the CE marking. Currently, the Company intends to submit the application for processing in approximately April 2021. Thus, the approval of the CE marking is expected to be completed by the end of 2021, approximately 9 months later than the previously estimated schedule.
The Board's assessment of the factors affecting the timing of the approval process is that the ongoing significant reform of the regulatory process guidelines has caused major changes to the level of documentation requirements. A new quality director was hired for the Company in August, who has begun vigorously supplementing the necessary documents.
According to the CEO's estimate, the additional expenses of the changes will be approximately EUR 300.000. The current management of the Company has formed a new schedule estimate after learning of all the shortcomings.
In Oulu, 11 January 2021
BBS-Bioactive Bone Substitutes Plc
Board of Directors
Jarmo Halonen, Chairman of the Board of Directors
Nasdaq Helsinki Oy
Nasdaq Stockholm AB
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 11 January 2021 at 4:10 pm (UTC+2:00).
BBS – Bioactive Bone Substitutes Plc
BBS-Bioactive Bone Substitutes Plc is a Finnish orthobiologic biotech company. We have developed a new product for healing of difficult bone fractures and for solving the problems in bone healing. Our mission is to offer new generation medicinal products for the orthopedic surgery. The research and development in the field of medicine requires perseverance and courage to develop new things. We have over 20 years of expertise in this. Our operations are characterised by top expertise, innovativeness and dedicated and committed employees. The first product, ARTEBONE® Bone Void Filler, is ready and the application process for the CE marking enabling commercialization is in progress.
More information: www.bbs-artebone.fi.
BBS-Bioactive Bone Substitutes Plc shares are listed on the Nasdaq First North Growth Market Finland and Nasdaq First North Growth Market Sweden. The company’s Certified Adviser is Stockholm Certified Advisers AB, p. +46 70 5516 729, firstname.lastname@example.org