BBS-Bioactive Bone Substitutes Plc – Insider information: BBS updates its action plans

BBS-Bioactive Bone Substitutes Plc updates its action plans in a situation where the processing of the Company's Artebone® Paste product's European application for certification was refused by the Notified Body (BSI).The refusal was based on that the clinical trial conducted by BBS, which was intended to be supplemented by a Post Market Clinical Follow-up study after CE marking approval, was conducted according to MDD rules. The supervisory authority required compliance with the new MDR regulations, which came into effect after the completion of the clinical trial, and which require a larger number of patients to demonstrate statistical evidence. The Company can submit a new CE marking application after increasing the number of patients in accordance with MDR requirements. The Company has made a plan and started preparations for conducting the supplementary clinical trial.

In the current situation, the Board of BBS has also decided to start evaluations to secure the Company's financial situation and operations. The Company has entered into a cooperation agreement with ConAlliance GmbH (https://www.conalliance.com/), which covers all possible options and actions related to the Company's additional financing and strategic industrial cooperation options.