(CercleFinance.com) – Affluent Medical shares jumped Thursday morning on the Paris Stock Exchange following the publication by the manufacturer of medical prostheses of positive clinical results on its mitral annulus.
Positive one-year interim results from the 20-patient Optimise II pivotal study showed that none of the patients had mitral regurgitation greater than two, meeting the study’s pre-specified efficacy endpoint.
‘The safety profile of the study is excellent: no deaths, no myocardial infarctions, no valve thrombosis and no endocarditis have been reported, up to one year’, underlines the medtech in a press release.
However, following the analysis of this data, the company decided to refocus its resources on the American market and to quickly enter into discussions with the Food and Drug Administration (FDA) in the United States.
Due to the increase in regulatory requirements in Europe, Affluent believes that it is likely that the European process will prove more complex and longer than in the United States.
In order to optimize expenses, the European trial was therefore suspended during this strategic reorientation.
Investors were favorable to this strategic reorientation, since the stock rose by more than 70% at the end of the morning, marking by far the largest increase on the Paris market.
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