Stock Exchange Release April 26th, 2021 at 06.00 pm
Due to delays affecting the application process, the management of BBS-Bioactive Bone Substitutes Plc (“BBS”, “Company”) has changed its estimate regarding the submission date of the ARTEBONE® products CE marking application. The company expects to submit the application during August this year. Earlier, the company had estimated that the application could be submitted during April this year.
The delay is due to equipment, material and service deliveries to Oulu laboratory and Reisjärvi factory being delayed significantly due to the COVID-19 situation. Repairing a detected structural fault in Reisjärvi factory’s clean room has delayed the start of the validation process. In addition, the results from the animal testing have been delayed significantly. We expect to receive the final report during May.
The delays are causing similar delays to the forecast CE marking approval schedule. Notified Bodies’ application processing times have been prolonged due to MDR regulation. It is still unclear to what extent prolongation of processing times may result in a delay in the CE marking approval process. We will communicate this separately when the situation becomes clearer.
CEO Ilkka Kangasniemi:
“Even though we estimate the marking application to be delayed compared with our previous estimate, overall the project has developed positively and in terms of content according to plans.”
In Oulu 26th of April 2021
BBS-Bioactive Bone Substitutes Plc
Board of Directors
For more information:
Jarmo Halonen, Chairman of the Board of Directors
Ilkka Kangasniemi, CEO,
puh. +35840 7080307, e-mail: email@example.com
Liisa Hukka, CFO,
puh. +35840 0611038, e-mail: firstname.lastname@example.org
Nordic Certified Adviser AB, p. +46 70 551 67 29, email@example.com
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 26 April 2021 at 6:00 pm (UTC+2:00).
BBS-Bioactive Bone Substitutes Plc is the health technology company operating since 2003. Before that there was a background of seven years of product development in the University of Oulu. 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 characterized by top expertise, innovativeness and dedicated and committed employees. The ARTEBONE ®product is ready and the application process for the CE-mark has been initiated. BBS is the company having its headquarters in Oulu. We have our own production plant located in Reisjärvi and it is approved by FIMEA. More information: www.bbs-artebone.fi