Ortoma: US market approval for OTS™ Hip - Redeye

Redeye is pleased that Ortoma has received the 510(K) approval from the US FDA regarding the OTS™ Hip. This means the company can market and sell OTS™ Hip in the US, the largest worldwide market for orthopedic surgery equipment. The importance of this approval can not be overstated. We expected this approval during the H1 2024; thus, the approval that arrived in Q1 is positive for our projected US sales timeline towards the end of the year. This confirms the steady progress of the company and that management continues to deliver. This also opens up further partner discussions and substantially drives the commercialisation process forward in the US. Based on this news, we do not change our assumptions as we have penciled in an approval in the H1 of 2024. However, the risk associated with the FDA approval for OTS™ Hip is now removed and increases the likelihood of a positive development in the US towards the end of the year. The customized solutions for the platform require additional market approval. The positive share price reaction this morning is warranted.