This opinion falls within a specific regulatory framework enabling coverage of medical innovations (Article L.162-1-24 of the French Social Security Code), through the RIHN 2.0 scheme (Registry of Innovative Procedures Outside the Standard Reimbursement List).
This is excellent news for both patients and healthcare professionals. This opinion represents a key step toward the long-term recognition of VisioCyt® Bladder, an innovative urine test based on image analysis and artificial intelligence, offering a promising alternative to cystoscopy, an invasive examination routinely used to monitor bladder tumor recurrence.
Exceptional reimbursement is subject to the collection of clinical and medico-economic data and will make it possible to complete the elements required for a full evaluation by the HAS with a view to standard reimbursement (Article L.162-1-7 of the French Social Security Code).
This data collection is based on the NMIBC Registry led by the French Association of Urology (AFU), a prospective, comparative, multicenter study planning to include 2,000 patients with non–muscle-invasive bladder tumors monitored using VisioCyt® Bladder. The study will validate the diagnostic performance of the test under real-life clinical conditions, in particular its sensitivity and negative predictive value, in comparison with cystoscopy.
This HAS opinion now enables the Ministry of Health and Access to Care to review the projected study budget as well as the overall cost of coverage, representing the final step before a definitive decision on reimbursement within the RIHN 2.0 framework.
This decision therefore paves the way for a revolution in the management of bladder tumors by offering patients a less invasive and more comfortable alternative.
VitaDX would like to extend its sincere thanks to its internal teams, whose commitment has been essential. We also express our gratitude to Rweality for its support in preparing the application file, as well as to our investors. Our thanks also go to the urologists and healthcare professionals involved, to the AFU for its scientific support, and of course to the HAS for the trust placed in us.
With this favorable opinion, VitaDX reaffirms its commitment to transforming bladder cancer management through technological innovation. We look forward to continuing this momentum to provide patients with ever more effective and accessible solutions.
About VitaDX International
Founded in 2015, VitaDX develops and markets cancer diagnostic solutions combining image analysis and artificial intelligence applied to cytology through its patented VisioCyt® technology. Its mission is to develop innovative, high-performance solutions with a significant impact on healthcare systems for the benefit of as many patients as possible. After several years of development and a prospective multicenter clinical study, its first solution, VisioCyt® Bladder, CE-marked under IVDR, enables the diagnosis and monitoring of bladder cancer from a simple urine sample. Other devices are currently under development, notably for bladder cancer screening and for thyroid cancer diagnosis.
To learn more about VitaDX and VisioCyt® Bladder:
www.vitadx.com
Press contact:
Lucie Paget – Communication & Marketing – [email protected]
Tel: +33 (0)1 48 87 00 55 / +33 (0)7 67 12 62 78