Affluent Medical Advances Three Medical Device Programs with Pivotal Trial Launch and FDA Regulatory Progress
核心洞察
Affluent Medical (搜索) completed the pilot phase of its Artus (搜索) artificial urinary sphincter trial and launched the pivotal phase, aiming to validate at least 50% reduction in urinary leakage across European centers.
The FDA validated an accelerated De Novo pathway for Kalios (搜索) mitral ring based on existing European data, potentially avoiding further intervention for 30-40% of patients over five years.
The company's Epygon (搜索) transcatheter mitral valve (搜索) program accelerated with four-fold increased patient recruitment and collaboration with Mayo Clinic to document hemodynamic benefits.
Affluent Medical (搜索) reached critical milestones across its three medical device programs during the first half of 2025, with the French clinical-stage company advancing its artificial urinary sphincter into pivotal trials while securing FDA regulatory pathways for its cardiac devices.
The company completed the pilot phase of its Artus (搜索) artificial urinary sphincter clinical trial in January 2025 after successfully implanting the device in ten patients through minimally invasive procedures. The external Data Monitoring and Safety Board authorized initiation of the pivotal phase in May 2025 following positive safety profile review.
Artus Enters Pivotal Phase Targeting 50% Efficacy Threshold
The pivotal phase of the DRY multicentre study aims to validate Artus (搜索) efficacy in reducing urinary leakage by at least 50%. The trial will enroll dozens of patients across leading urology centers in Italy, Spain, France and Belgium, expanding beyond the pilot study countries.
Artus (搜索) represents the first artificial urinary sphincter that patients can activate using a simple remote control for treating moderate to severe urinary incontinence (搜索). The condition affects over 400 million people worldwide, with CEO Sébastien Ladet noting "no breakthrough in the last 40 years" for this patient population.
The company also advanced toward launching SPHINX, a clinical trial assessing Artus (搜索) in female patients expected to begin across Europe in the second half of 2025. Professor Véronique Phé at Tenon Hospital in Paris successfully performed the first implantation in a female anatomical model using the Da Vinci robotic laparoscopy system, confirming the device's suitability for minimally invasive surgery.
FDA Validates Accelerated Pathway for Kalios Cardiac Device
Affluent Medical (搜索)'s Kalios (搜索) mitral annuloplasty device received FDA validation for an accelerated De Novo procedure pathway based on existing European pivotal study data from Optimise II. The regulatory strategy requires no additional patients, significantly shortening the submission and marketing timeline.
Kalios (搜索) is positioned as the only mitral annuloplasty device adjustable percutaneously by cardiologists to treat residual and recurrent mitral valve insufficiency (搜索) at any time after implantation. The company estimates Kalios could avoid further intervention for 30% to 40% of patients over five years in a market valued at $1.5 billion in the US-Europe region in 2023.
Edwards Lifesciences (搜索), the global leader in structural cardiology, holds an exclusive purchase option for Kalios (搜索), reinforcing the device's strategic positioning in North America. During the first half of 2025, Affluent Medical (搜索) finalized supply chain adaptations to meet FDA requirements.
Epygon Program Accelerates with Mayo Clinic Collaboration
The company's Epygon (搜索) transcatheter mitral valve (搜索) program showed significant momentum with four-fold increased patient recruitment in the first half of 2025. Eleven centers are now active, with five additional centers in Austria, Italy, Germany and Spain under evaluation to expand patient enrollment capacity.
Epygon (搜索) is described as the only biomimetic cardiac mitral valve (搜索) that mimics native mitral valve anatomy and physiological blood flows through transcatheter delivery. The approach avoids invasive open-heart procedures for treating mitral failure (搜索), which affects 2% of the global population—approximately 160 million people—yet less than 4% of severe cases can undergo high-risk open-heart surgery.
A scientific collaboration with Mayo Clinic aims to document the unique hemodynamic benefits of Epygon (搜索)'s asymmetric design. The objective remains finalizing the pilot phase with implantation in ten patients as the device positions for the growing transcatheter mitral valve (搜索) replacement market.
Strategic Appointments and Financial Support
Affluent Medical (搜索) strengthened its leadership with key appointments including Dr. Howard C. Herrmann from University of Pennsylvania as Strategic Medical Director in Structural Cardiology and Prof. Nicolas Barry Delongchamps from Cochin Hospital, Paris as Strategic Medical Director in Urology.
The company raised €5.4 million through convertible bonds fully subscribed by historical shareholders including Truffle Capital (搜索), Financière Memnon, Hayk Holding Sàrl, Mrs Simone Merkle, and Ginko Invest. The funding extends cash runway through end-2025, with 41% allocated to Artus (搜索), 38% to Kalios (搜索) and 21% to Epygon (搜索).
Despite advancing clinical programs, Affluent Medical (搜索) reported a net loss of €9.4 million for the first half of 2025, consistent with the €9.4 million loss in the same period of 2024. The company increased its workforce to an average of 76 employees compared to 66 in the first half of 2024.