Skip to main content

BBS-Bioactive Bone Substitutes Plc: New Schedule Estimate for the CE Marking of Company’s ARTEBONE® Product

Written by Customer Service on . Posted in Public Companies.

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 2021BBS-Bioactive Bone Substitutes Plc
Board of Directors
More information:
Jarmo Halonen, Chairman of the Board of Directors
jarmo.halonen@bbs-artebone.fi

Distribution:
Nasdaq Helsinki Oy
Nasdaq Stockholm AB
Main Media
www.bbs-artebone.fiThis 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 PlcBBS-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, info@certifiedadviser.se

Disclaimer & Cookie Notice

Welcome to GOLDEA services for Professionals

Before you continue, please confirm the following:

Professional advisers only

I am a professional adviser and would like to visit the GOLDEA CAPITAL for Professionals website.

Important Notice for Investors:

The services and products offered by Goldalea Capital Ltd. are intended exclusively for professional market participants as defined by applicable laws and regulations. This typically includes institutional investors, qualified investors, and high-net-worth individuals who have sufficient knowledge, experience, resources, and independence to assess the risks of trading on their own.

No Investment Advice:

The information, analyses, and market data provided are for general information purposes only and do not constitute individual investment advice. They should not be construed as a basis for investment decisions and do not take into account the specific investment objectives, financial situation, or individual needs of any recipient.

High Risks:

Trading in financial instruments is associated with significant risks and may result in the complete loss of the invested capital. Goldalea Capital Ltd. accepts no liability for losses incurred as a result of the use of the information provided or the execution of transactions.

Sole Responsibility:

The decision to invest or not to invest is solely the responsibility of the investor. Investors should obtain comprehensive information about the risks involved before making any investment decision and, if necessary, seek independent advice.

No Guarantees:

Goldalea Capital Ltd. makes no warranties or representations as to the accuracy, completeness, or timeliness of the information provided. Markets are subject to constant change, and past performance is not a reliable indicator of future results.

Regional Restrictions:

The services offered by Goldalea Capital Ltd. may not be available to all persons or in all countries. It is the responsibility of the investor to ensure that they are authorized to use the services offered.

Please note: This disclaimer is for general information purposes only and does not replace individual legal or tax advice.