Affluent Medical shares jumped on Thursday morning on the Paris Bourse following the publication by the medical prostheses manufacturer of positive clinical results for its mitral annulus.

Positive interim results at one year from the pivotal Optimise II study involving 20 patients showed that none of the patients had mitral regurgitation greater than two, thus meeting the study's predefined efficacy criterion.

The safety profile of the study was excellent, with no deaths, no myocardial infarctions, no valvular thrombosis and no endocarditis reported up to one year", says the medtech in a press release.

Following analysis of these data, however, the company has decided to refocus its resources on the US market and to rapidly enter into discussions with the US Food and Drug Administration (FDA).

Due to increasing regulatory requirements in Europe, Affluent believes that the European process is likely to prove more complex and time-consuming than in the US.

In order to optimize expenses, the European trial has therefore been suspended during this strategic reorientation.

Investors reacted favorably to this strategic reorientation, with the share price climbing by over 70% at the end of the morning, marking by far the biggest rise on the Paris market.

Copyright (c) 2023 CercleFinance.com. All rights reserved.