Announcement • Jun 10
Intrasense and Guerbet Obtain PMDA Certification In Japan For DUOnco Pancreas AI Software Intrasense and Guerbet announced that DUOnco Pancreas has obtained PMDA certification in Japan under certification number 308AGBZI00003000 (Class II, Classification: Program 1 Disease Diagnostic Program, Program for X-ray imaging diagnostic device workstations (JMDN code: 40935012)). With this certification, DUOnco Pancreas becomes to our knowledge the first AI software focused on the pancreas to be certified in Japan. Pancreatic cancer remains one of the deadliest malignancies worldwide and represents a particularly important healthcare challenge in Japan. In 2022, 510,992 new cases and 467,409 deaths were estimated worldwide, including 47,627 new cases and 43,265 deaths in Japan. Surgery remains the only potentially curative treatment, but it is generally possible only when the disease is identified at an early stage. Early pancreatic cancer often causes few or no specific symptoms, and lesions can be difficult to identify on CT because of their small size and limited contrast. Because many patients are diagnosed after progression, fewer than 20% are eligible for surgery. Prior studies have also reported that 42% of pancreatic cancers smaller than 2 cm were missed on CT, underlining the need for tools that may help radiologists identify subtle findings earlier. Published data including a recent project led by Guerbet’s research team in collaboration with researchers from the University of Copenhagen, suggest that characteristic CT findings of pancreatic cancers are visible as early as 36 months before diagnosis, indicating an opportunity for earlier detection. DUOnco Pancreas is an AI-based image analysis software designed to assist radiologists in the evaluation of contrast-enhanced CT examinations by highlighting regions of interest in the pancreas. The software is intended to support the detection of regions of interest in the pancreas, the measurement of these areas and the main pancreatic duct maximal size. DUOnco Pancreas is designed to support radiologists in their routine reading workflow. It is not an automated diagnostic system and does not replace physician review, interpretation, or diagnosis. In Japan, Intrasense and Guerbet intend to work closely with local imaging IT partners to integrate DUOnco Pancreas as tightly as possible into radiologists’ existing reading environments, especially through collaboration with PACS vendors and other established system providers. This strategy is intended to provide the best possible user experience by enabling radiologists to access the software within their habitual viewer and routine workflow, while limiting disruption and facilitating adoption in daily practice. This certification in Japan is part of a broader effort by Guerbet and Intrasense to evaluate the clinical value of pancreas-focused AI through research collaborations in Japan and Europe. Among these initiatives is the research collaboration with Kyushu University Hospital, announced by Guerbet in April 2025, to assess the performance of DUOnco Pancreas using a substantial dataset including a majority of Japanese patients and cases of early pancreatic cancer. The certification in Japan builds on the CE marking already obtained in Europe in 2025 for DUOnco Pancreas, which represented a key milestone in the DUOnco roadmap co-developed by Intrasense and Guerbet. The product also received “Breakthrough Device designation” from the FDA in the United States in 2025 which does not represent marketing approval, reflecting its potential to address a global unmet need in medical imaging. Announcement • Apr 27
Intrasense S.A., Annual General Meeting, Jun 02, 2026 Intrasense S.A., Annual General Meeting, Jun 02, 2026. Location: 11 rue galilee, paris France New Risk • Apr 27
New major risk - Share price stability The company's share price has been highly volatile over the past 3 months. It is more volatile than 90% of French stocks, typically moving 10% a week. This is considered a major risk. Share price volatility increases the risk of potential losses in the short-term as the stock tends to have larger drops in price more frequently than other stocks. It may also indicate the stock is highly sensitive to market conditions or economic conditions rather than being sensitive to its own business performance, which may also be inconsistent. Currently, the following risks have been identified for the company: Major Risks Share price has been highly volatile over the past 3 months (10% average weekly change). Negative equity (-€1.2m). Earnings have declined by 37% per year over the past 5 years. Minor Risks Latest financial reports are more than 6 months old (reported June 2025 fiscal period end). Revenue is less than US$5m (€2.6m revenue, or US$3.1m). Market cap is less than US$100m (€11.8m market cap, or US$13.8m). 
