A medical technology company developing bone implants BBS-Bioactive Bone Substitutes made a loss in the second half of last year.
The operating loss increased to 1.4 million euros in July–December. The company had no turnover yet.
For the whole year, the company’s result was 3.1 million euros below zero.
In the comparison period a year ago, the company made an operating loss of 1.3 million euros, and there was no turnover. The only analysis house following the company, Inderes, estimates that the operating loss swelled to 1.6 million euros in the first half of the year.
The company’s cash and cash equivalents at the end of the year were 1.52 million euros.
The future of the company’s business depends on a possible sales license and growth financing. It has been waiting for a response to the CE marking application for Artebone Paste in Europe filed last spring. Inderes has estimated that the decision could be announced in the summer or autumn of this year.
Based on a survey conducted for the supervisory authority published by Medtech Europe, average application processing times increased in 2022. Therefore, the company now estimates that, based on currently available information, getting the final CE marking application approved by the end of March is unlikely. The company is waiting for the authorities’ decision on approving the application during 2023. The product’s commercialization measures will be started at the end of 2023.
Regarding the registration application, the company says that the first inspection visit by the authority related to the certification of the quality system was successfully completed at the end of November. Only minor measures were needed to correct the issues raised in the inspection report. Quality system certification is part of Artebone Paste’s CE marking process. The second inspection visit is scheduled for the beginning of March.
In its future outlook, the company says that no turnover is expected to be generated during 2023.
The company says it will continue the application for additional funding.
“The company’s financing is currently secured until around July-August, and the management is able to influence the adequacy of funds with its decisions. We are currently holding discussions about additional funding to secure the continuation of development work and the start of commercial operations during the congested approval process”, comments the CEO Ilkka Kangasniemi in the results bulletin.
It was already expected that the company would need additional financing this year. The previous share issue was organized last summer.