Median: success of pivotal study, market appreciates
(CercleFinance.com) - Median Technologies announced on Monday the successful completion of a pivotal study for its lung cancer screening software, bringing it a step closer to market authorization and boosting its share price.
The Sophia Antipolis-based company reported this morning that eyonis LCS had met its primary endpoint 'in a statistically significant manner' in the final clinical trial required for regulatory submissions.
This AI- and machine-learning-based medical device, which had already met all primary and secondary endpoints in a previous pivotal study, has now successfully completed its clinical validation.
In a press release, Median states that it expects to file for US FDA approval and CE marking for Europe in the second quarter of 2025.
Approval from the US health agency is expected as early as the third quarter of 2025, followed by a commercial launch across the Atlantic.
In terms of commercialization, we recently learned that the company has entered into discussions with US industry leaders for a potential commercial agreement", emphasize analysts at Allinvest Securities.
On the Paris Bourse, Median shares soared on Monday following these announcements, posting a gain of 11.4% around 11:45 a.m.
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