Affluent Medical: insider trades · France · AMF

About Affluent Medical

Affluent Medical is a French clinical-stage medtech company, historically listed under ticker AFME and ISIN FR0013333077, specializing in the development and industrialization of innovative implantable medical devices. Headquartered in Aix-en-Provence and admitted to trading on Euronext Paris in June 2021, the company was originally backed by Truffle Capital and was founded with the ambition of becoming a global reference in urology and interventional cardiology. Its strategic positioning is built around breakthrough technologies designed to address major unmet medical needs, particularly urinary incontinence and mitral valve disease. In 2026, the company announced a rebranding to Carvolix while keeping the same ISIN, highlighting a broader strategic evolution of its identity and technology platform. Affluent Medical’s business model is centered on a portfolio of advanced devices still in clinical development. Its lead programs include Kalios™, a percutaneously adjustable mitral annuloplasty ring intended to reduce repeat surgery after valve repair; Epygon, a biomimetic mitral valve replacement; and Artus, a robotic-assisted artificial urinary sphincter. These products are designed to mimic human physiology as closely as possible, combining minimally invasive implantation with the potential to improve patient outcomes and simplify procedures for physicians. The group’s historical portfolio has been protected by a broad patent estate, supporting its technological differentiation and long-term value proposition. The company has reached several important industrial and regulatory milestones. In 2024, it signed strategic agreements with Edwards Lifesciences, including an upfront payment of €15 million, an equity investment, and an exclusive purchase option on Kephalios, the subsidiary developing Kalios. These agreements strengthened Affluent Medical’s industrial and financial credibility while preserving key rights over its transcatheter technologies. Clinically, the company continued advancing studies on Kalios, Epygon and Artus, with a particular focus on the U.S. market for structural cardiology and on Europe for the initial commercialization pathway in certain indications. It also reported progress in the clinical assessment of Artus in women, broadening its potential commercial addressable market. Affluent Medical is notable for its international development strategy, targeting Europe, the United States and Asia. It remains a high-R&D, pre-commercial medtech company, but one supported by partnerships, regulatory validation and a gradually strengthening capital markets profile. Its recent trajectory, marked by successive financings, growing market visibility and a more focused portfolio, reinforces its ambition to establish itself as a leading specialist in next-generation medical implants.