Bonesupport Holding AB CERAMENT G US Market Approval Call Transcript
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Thank you so much, operator, and welcome, everyone, for this beautiful day where Hakan and I are sitting here with a big smile on our face. And what we want to do is to take you through a brief presentation on the news that we have released early this morning, and then open up the line for questions and answers.
We have a presentation that the operator will manage. So if we go to Slide 2, as usual, there are some disclaimers regarding what we will share with you today, and let's immediately jump to Slide #3, please.
So what we released this morning is that CERAMENT G has received market authorization. We received the e-mail notification from FDA sometime after midnight early this morning, and we woke up to this very good news.
It is the first ever antibiotic elution bone graft that has been authorized for the U.S. market. As a matter of fact, it is the first-ever combination product, a combination of device and drug, that has ever been approved through the De Novo process. We
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