Median Technologies business update following successful financing

Press release – For immediate release – 05:45 pm CEST

Median Technologies business update following successful financing

• Cash runway extended until at least Q4 2026 and potentially well beyond
• eyonis® LCS commercial launch preparations underway in the U.S.
• eyonis® LCS subject to advanced negotiations for U.S. commercialization partners
• Reviews ongoing for market authorization of eyonis® LCS in both U.S. and Europe
• Strong momentum in the strategic repositioning of the iCRO business servicing major pharmaceutical companies and global CROs

Median Technologies (FR0011049824, ALMDT, PEA-PME scheme eligible, “Median” or the “Company”), manufacturer of eyonis®, a suite of artificial intelligence (AI) powered Software as a Medical Device (SaMD) to aid cancer diagnosis, and a globally leading provider of AI-based image analyses and central imaging services for oncology drug developers, provides a business update following the successful completion of the financing carried out in July and August 2025.

CEO statement

“Thanks to the financial visibility gained from our recent successful financing, we are fully equipped to deliver on our growth strategy with our cash runway now extending until at least Q4 2026, and potentially much further. This takes us well past expected decisions on authorization, and subsequent commercialization, of eyonis® LCS in both the U.S. and Europe,” said Fredrik Brag, CEO and Founder of Median Technologies.

“We have initiated commercial launch preparations for our Software as a Medical Device, eyonis® LCS, in the United States, where it continues to progress toward FDA 510(k) clearance in this complex regulatory environment. Recent changes within the FDA are driving a longer review period for our submission — in line with delays currently being observed across the biopharmaceutical and medtech industries — with a final response from the FDA expected in early Q1 2026. Our discussions with the leading industrial partners for eyonis® LCS commercialization in the U.S. are intensifying and are expected to move towards an agreement in parallel with market clearance.”

Brag added: “Alongside Median’s regulatory and commercial progress on eyonis® LCS, there is significant momentum in iCRO’s repositioning strategy toward major pharmaceutical companies and global CROs. This is being driven by strong partnerships with leading industry players and an increasingly differentiated imaging services offering.”

Cash runway extended through at least Q4 2026

The Company’s refinancing operations, completed in two phases in July and August 2025, have secured up to €61.4 million. This includes a gross capital increase of €23.9 million including the issuance premium, through the issuance of ABSA (ordinary shares with warrants), announced on August 1, 2025, and a new financing facility from the European Investment Bank (EIB) of up to €37.5 million, signed and announced on July 11, 2025.

As a result of these transactions, the Company’s cash runway has been extended through Q4 2026 — and potentially well beyond, assuming the full exercise of the 14,424,541 share warrants (BSA) subscribed during the capital increase. Their full exercise would represent an additional cash inflow of €51.7 million.

The drawdown of the first €19 million tranche from the new European Investment Bank (EIB) financing facility is imminent.

Finally, the first €4 million tranche from the €10 million equity financing line subscribed with IRIS in January 2025 —intended as bridge financing—has been repaid up to 96%. Median has suspended drawdowns of the remaining tranches from this financing line, until further notice.

eyonis® LCS: Commercial launch preparations underway in the U.S., advanced discussions with major industry players for distribution, regulatory pathway progressing

In preparation for launch upon clearance, a comprehensive mapping of all medical institutions involved in lung cancer screening has been completed, enabling precise segmentation of key accounts based on their profiles. A multi-phase, regionally tailored commercial strategy has been defined to address these segments in a sequenced manner. All sales aids and training tools have been developed.

Negotiations with potential commercial partners for the U.S. market launch of eyonis® LCS are progressing and are expected to move towards an agreement in parallel with market authorization.  

Median’s already strong network of key opinion leaders in radiology, pulmonology, and thoracic oncology continues to expand through numerous site visits and ongoing engagement with relevant medical societies. In particular, Median met with the international lung cancer screening medical community during the annual World Conference on Lung Cancer (WCLC), organized by the International Association for the Study of Lung Cancer (IASLC), held from September 6 to 9, 2025, in Barcelona, Spain. These meetings further increased visibility for eyonis® LCS among future users and enabled continued discussions with healthcare institutions regarding the health-economic studies that will be launched following market authorization in the United States and subsequently in Europe. In addition, awareness efforts among patient advocacy groups are gaining momentum.

The Company submitted market authorization applications for eyonis® LCS in the United States and Europe in May and June 2025, respectively. The Company received a request for additional information from the FDA on July 12, and from the notified body for CE marking on August 08, 2025.

Due to decreased FDA staffing, the Company anticipates a longer review period for the regulatory decision regarding eyonis® LCS 510(k) clearance. This is consistent with similar delays currently affecting biopharmaceutical and medtech companies seeking market authorization for their products. As a result, the Company now expects a decision on U.S. clearance early Q1 2026.

The regulatory review process for obtaining CE marking for eyonis® LCS is progressing. In Europe—where the target population for lung cancer screening is estimated at 20 million people—Croatia, Poland, and the Czech Republic have already implemented national screening programs based on low-dose computed tomography (LDCT). In Germany, the launch of a national lung cancer screening program is scheduled for April 2026, while other countries, such as France, have initiated promising pilot programs.

iCRO: Global key account strategy execution with a differentiated service offering

The Company’s strategy to target major pharmaceutical groups and global CROs is delivering results. Over the first nine months of the year, this success has translated into an increase in the number of requests for proposal received by Median, along with a 30% growth in their cumulative value. Following the announcement in May 2024 of a preferred supplier agreement with a second top 3 global oncology pharmaceutical company, Median is in advanced discussions with other top 10 global pharma groups for new preferred supplier agreements.

In recent months, the Company’s Chinese subsidiary has secured new orders totaling €3.4 million from one of the top 3 pharmaceutical companies in China. As of today, Median manages half of the newly launched oncology clinical trials for this pharmaceutical group. China continues to play a central role in the Company’s iCRO strategy, serving as a key growth driver and strategic market for long-term success. Recent studies[1] show that in 2024, new oncology clinical trials initiated by China-based companies accounted for 39% of all global new oncology trials — surpassing those initiated by U.S. companies (32%) and European companies (20%) in 2024.

To meet evolving market expectations, the iCRO division has launched a new service offering dedicated to imaging in clinical trials for radiopharmaceutical therapies — a rapidly growing trend in oncology drug development. This highly differentiated offering is generating strong traction and is already contributing to the expansion of the Company’s order backlog.

Next financial communication on October 23, 2025, after market close:

H1 2025 financial results

Disclaimer

The 510(k) for eyonis® LCS is currently under review by FDA; the device is not yet for sale in the United States.

Forward-Looking Statements

This press release contains forward-looking statements. These statements are not historical facts. They include projections and estimates, as well as the assumptions on which these are based, statements concerning projects, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, or future performance.

These forward-looking statements can often be identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates” or “plans” and any other similar expressions. Although Median’s management believes that these forward-looking statements are reasonable, investors are cautioned that forward-looking statements are subject to numerous risks and uncertainties, many of which are difficult to predict and generally beyond the control of Median Technologies, that could cause actual results and events to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements.

All forward-looking statements in this press release are based on information available to Median Technologies as of the date of the press release.  Median Technologies does not undertake to update any forward-looking information or statements, subject to applicable regulations, in particular Articles 223-1 et seq. of the General Regulation of the French Autorité des Marchés Financiers.

[1] Source : Global Oncology Trends 2025 (May 2025) – IQVIA Institute for Human Data Science