Aegirbio prepares for launch, but postpones launch for up to a few weeks

As previously disclosed, Aegirbio has an ongoing clinical study in Liverpool. The study continues, but as the number of patients at the hospital has decreased sharply, it will now be expanded to an additional hospital as well. As a consequence, the completion of the study will be delayed for up to a few weeks. The signals are encouraging and the test will in all probability be approved. In the light of the prevailing situation, we have chosen to expand the scope of the study to include operation as well. This entails that we will be able to offer the test for home use in addition to selling to professional operators. This will not happen at the first stage of the process, however.

As we await approval, we are focusing on preparing the Company for the upcoming launch. We have as part of this effort started the process of signing agreements with European distributors and preparing an aggressive release plan for the United States. Moreover, we are scaling up production and contracting third-party providers to meet the market demand that we have identified. This relates in particular to the launch of the product for home use.

Our hope is to be able to start selling within a week’s or a few weeks’ time. The CE marking process and the authorization process with the FDA are well underway, and as soon as Aegirbio has received sufficient data from the clinical studies, the Company will start marketing the product. 

“Very annoying to fumble near the goal line and having to postpone the launch of sales; we have a product that both we and our distributors have a lot of confidence in, but we have to reach the right number of patients before we can finalize the CE marking and the FDA process. Nevertheless, we are very happy to see that demand is growing day by day, and we believe that we will be able to sign agreements with several strong distributors connected to the health care system, pharmacies and retail,” says CEO Martin Linde.