(BFM Stock Exchange) – The French company falls on the Paris Stock Exchange after announcing a gap for obtaining the green light from the American health authority in order to put Eyonis on its artificial intelligence medical imaging software for early detection of lung cancer in the United States. .

Median Technologies accuses this Tuesday, September 23 on the Paris Stock Exchange on Tuesday, September 23. The group specializing in medical imaging fell 8.8% in the early afternoon, weighed down by information contained in its stage on its regulatory advances and its financial situation.

This company founded in 2002 develops new software (regulations considered as medical devices) based on artificial intelligence technologies for the early diagnosis of cancers and metabolic diseases.

And among these software, Median Technologies develops Eyonis LCS which aims to detect and characterize lung cancer. The group hoped to obtain an authorization from the Food and Drug Administration (FDA), the American health authority, during the third quarter for a placing on the American market of its system in the United States.

However, the American health agency has undergone budget cuts from the Trump administration, which led to recent changes within the institution. By ricochet, these upheavals have extended the processing of files for marketing authorization.

Budget cuts at the FDA

From now on, Median Technologies considers that he can obtain a decision on the marketing authorization at the start of the first quarter of 2026. In parallel, the group continues advanced discussions with industrial partners with a view to marketing the system on the American market.

This new regulatory deadline in the United States is now aligned with marketing authorization in Europe, still expected for the first quarter of 2026, specifies TP ICAP Midcap.

Median Technologies had filed in May 2025 in the United States and June 2025 in Europe its requests for marketing for market for Eyonis LCS.

“Our scenario on Eyonis LCS being sufficiently cautious, we do not have to modify our scenario for the division concerned (first turnover expected in the second half of 2026, 2.5 million euros expected over the year)”, adds TP ICAP Midcap.

Financial visibility extended at the end of 2026

During the summer, Median Technologies led a refinancing operation in order to serenely approach this marketing expected next year from the Eyonis LCS system in the United States and Europe.

This refinancing was carried out in two stages in July and August 2025 and allowed the company to secure up to 61.4 million euros thanks to a capital increase and a new financing line of the European Investment Bank (BEI). The company’s cash horizon was thus extended to the fourth quarter of 2026.

For TP ICAP MIDCAP, the group thus has the means to deal with the calendar lag linked to administrative heaviness.

Median Technologies also took stock of its ICRO activity, its imaging service for clinical trials in oncology. The company reports on an increase in the number of tenders it has received in favor of the success of the strategy for repositioning this activity towards major pharmaceutical accounts and CRO (immuno-oncology) CRO.

In recent months, the Chinese Subsidiary of Median Technologies has recorded new orders for an amount of 3.4 million euros with one of the pharmaceutical companies member of the Chinese TOP 3.

Stifel remains confident in the takeover of ICRO from 2026 thanks to the consolidation of its customers among large pharmaceutical companies and global CROs.

“Even if the year promises to be rather stable [pour cette division]we are encouraged by the composition of customers, which leans towards large pharmaceutical companies and global CROs, while contracts with biotechnological companies are declining, “added the design office.

“In our opinion, this progressive development will increase the average turnover per trial due to the greater weighting of phase II and III tests, while larger financial means and more coherent pipelines of large pharmaceutical companies reinforce long -term visibility, as well as brand loyalty”, argues the design office which maintains its recommendation to the purchase, euros against 6.20 euros previously.