Affluent Medical: H1 2025 RESULTS: Affluent Medical took major new and transformative steps during the first half of 2025

DJ Affluent Medical: H1 2025 RESULTS: Affluent Medical took major new and transformative steps during the first half of 2025

Affluent Medical 
Affluent Medical: H1 2025 RESULTS: Affluent Medical took major new and transformative steps during the first half of 
2025 
30-Sep-2025 / 18:10 CET/CEST 
Dissemination of a French Regulatory News, transmitted by EQS Group. 
The issuer is solely responsible for the content of this announcement. 
 
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H1 2025 RESULTS: 
Affluent Medical took major new and transformative 
 
steps during the first half of 2025 

 -- Success of the pilot phase of the clinical trial on Artus and start of the pivotal phase; 
 -- US regulatory trajectory on Kalios confirmed with the FDA; 
 -- Continuation of the pilot phase of the clinical trial on Epygon and promising results on hemodynamic properties; 
 -- Medical expertise enhanced with the recruitment of two strategic medical directors - cardiologist Prof. Howard 
  Herrmann and urologist Prof. Nicolas Barry Delongchamp; 
 -- Extension of the horizon of the cash position to end-2025 thanks to the support of historical shareholders. 
  
 
Aix-en-Provence, 30 September 2025 - 5.45 p.m. CEST - Affluent Medical (ISIN: FR0013333077 - ticker: AFME - 
"Affluent"), a French clinical-stage medical technology company specialised in the international development and 
industrialisation of innovative implantable medical devices, is today publishing its 2025 first-half results and 
providing an update on recent clinical, regulatory and financial milestones. 

Sébastien Ladet, Chief Executive Officer of Affluent Medical, said: 
 
"This first half of 2025 marks several important milestones for Affluent Medical. With the completion of the pilot 
phase of the clinical trial and launch of the pivotal phase for Artus, ongoing interaction with the FDA on the 
regulatory trajectory for Kalios in the US and the first hemodynamic results of Epygon, we have reached major 
milestones that bring our three medical devices closer to market launch. 
 
Our mission is clear: to transform disruptive innovations into concrete solutions to meet two major health challenges, 
mitral valve insufficiency and urinary incontinence, two pathologies that affect several million patients worldwide and 
for which no satisfactory therapeutic solution has been found to date. Backed by a strengthened Board of Directors and 
the renewed commitment of our shareholders, we are moving decisively towards the marketing phase, confident in our 
ability to create sustainable value for patients, physicians and our partners." 

NEW MAJOR AND TRANSFORMATIVE STEPS TAKEN IN THE FIRST HALF OF 2025 

The first half of 2025 saw Affluent Medical reach a turning point in the execution of its roadmap. The robustness of 
its clinical portfolio was confirmed with critical milestones reached on its three leading medical devices, while its 
governance was strengthened and financial visibility secured. 

ARTUS URINARY SPHINCTER: completion of the pilot phase and launch of the pivotal phase in Europe 
 
Artus is the first artificial urinary sphincter for the treatment of moderate to severe urinary incontinence that can 
be activated by the patient using a simple remote control. Urinary incontinence is a major public health problem for 
over 400 million people worldwide for which there has been no breakthrough in the last 40 years. Patients suffer a 
reduced quality of life associated with the psychological disorders related to the disease. 
 
The first half of 2025 marked a turning point for Artus. 
 
In January 2025, Affluent Medical announced the completion of the pilot phase of the European multicentre clinical 
trial in humans with the success of the tenth minimally invasive implantation of the urinary sphincter. 
 
In April 2025, Affluent Medical announced that it had made progress towards launch of SPHINX, the clinical trial on 
implantation in women. This study, which is expected to be launched across Europe during the second half of 2025, will 
assess the safety profile and performance of the Artus artificial urinary sphincter in female patients at major medical 
centres in France and Europe. This is an important step in expanding the range of treatment options available to women 
with stress urinary incontinence (SUI). 
 
A first implantation of the Artus device in a female anatomical model was successfully performed by Professor Véronique 
Phé, a leading European urologist at the Tenon Hospital in Paris, to assess the implantation process in women. Using 
the Da Vinci robotic laparoscopy system, it has been confirmed that the device can be implanted with precision and 
ease, demonstrating that it is perfectly suited for minimally invasive surgery. 
 
In May 2025, the external Data Monitoring and Safety Board (DSMB) authorised the initiation of the pivotal phase of the 
DRY multicentre study following the positive review of the safety profile of the pilot clinical phase. The pivotal 
phase aims to validate the efficacy of Artus in reducing urinary leakage by at least 50% and will enrol dozens of 
patients in leading urology centres in Italy, Spain, France and Belgium, in addition to countries already approved for 
the pilot study. 

KALIOSTM MITRAL RING: acceleration of the regulatory trajectory for marketing in the US 
 
KaliosTM is the only mitral annuloplasty device that can be adjusted percutaneously by a cardiologist to treat both 
residual and recurrent mitral valve insufficiency, at any time after implantation, repeatedly and at beating heart, 
thus avoiding repeat open-heart surgery. 
 
Affluent Medical believes that KaliosTM would avoid further intervention for potentially 30% to 40% of patients over a 
five-year horizon. The overall market for mitral valve repair surgery was estimated to be worth USD1.5 billion in the 
US-Europe region in 2023, growing at 3.5% per year.  
 
In 2024, a key regulatory milestone was reached for KaliosTM: the Food and Drug Administration (FDA) validated a 
strategy of accelerated access to the US market via a De Novo procedure based on existing data from the European 
pivotal study, Optimise II. No additional patients will be required, which significantly shortens the Company's 
submission and marketing process. 
 
Combined with the exclusive purchase option granted to Edwards Lifesciences, the global leader in structural 
cardiology, this advance reinforces the potential of Kalios and strengthens its strategic positioning in the 
strategically important North American market.   
 
During the first half of the year, the Company finalised work on adapting the supply chain to the requirements of the 
FDA, notably with the selection and commissioning of suppliers. 
 
The objective remains to be able to file for market access based on the current clinical data, followed by marketing, 
based on the decisions of its partner Edwards Lifesciences. 

EPYGON MITRAL VALVE: acceleration of the clinical programme 
 
Epygon is the only biomimetic cardiac mitral valve, mimicking the anatomy of the native mitral valve and physiological 
blood flows, implantable via transcatheter delivery. This transcatheter approach avoids an invasive open-heart 
procedure and associated complications in treating mitral failure. 
 
This serious and potentially fatal disease affects 2% of the world's population, around 160 million people. However, 
less than 4% of patients with a severe form can have open-heart surgery, which poses a high risk of death and 
hospitalisation. 
 
In 2024, the clinical programme was accelerated, with a four-fold increase in patient recruitment in the first half of 
the year and the gradual opening of new European centres. Eleven centres are now active, and five more - in Austria, 
Italy, Germany and Spain - are being evaluated to further expand the ability to include new patients in the study. The 
objective is to finalise the pilot phase with implantation in ten patients. 
 
This clinical programme is also being supported by a high-level scientific collaboration with the Mayo Clinic (USA), 
which aims to document the unique hemodynamic benefits of Epygon's asymmetric design. These advances confirm the 
positioning of this device in the growing market for transcatheter mitral valve replacement (TMVI), in which Epygon is 
expected to emerge as a standard solution. 

Strengthened governance and medical expertise 
 
Affluent Medical has strengthened its organisation to prepare for the transition to the marketing phase. In February 
2025, Liane Teplitsky, CEO of Artedrone and a recognised expert in the MedTech sector, joined the Board of Directors. 
 
Then, in March 2025, three key appointments were made in medical and clinical expertise: 
 
 -- Dr. Howard C. Herrmann (University of Pennsylvania), Strategic Medical Director in Structural Cardiology, 
 -- Prof. Nicolas Barry Delongchamps (Cochin Hospital, Paris), Strategic Medical Director in Urology, and 
 -- Federica Azzimonti, Director of Clinical Operations, an expert in international trials. 
These appointments give the Company leading governance and expertise to bring its medical devices to the market. 

Extended financial visibility thanks to the support of historical shareholders 
 
In June, Affluent Medical raised EUR5.4 million via a convertible bond issue that was fully subscribed by its historical 
shareholders: Truffle Capital, Financière Memnon, Hayk Holding Sàrl, Mrs Simone Merkle, and Ginko Invest. 
 
This transaction extends the horizon of the cash position until the end of the 2025 financial year, making it possible 
to finance the next stages of value creation on its three programmes: 41% of the funds are allocated to Artus, 38% to 
Kalios and 21% to Epygon. 
 
The renewal of this support illustrates the shareholders' confidence in the Company's strategy and in its ability to 
transform its clinical advances into market opportunities. 

H1 2025 FINANCIAL RESULTS 

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