PRESS RELEASE 

Affluent Medical Announces
Participation in Upcoming Scientific Events

Aix-en-Provence, October 8, 2024 – 5:45 p.m. CEST – Affluent Medical (ISIN: FR0013333077 – Ticker: AFME – "Affluent"), a French clinical-stage medical technology company specializing in the international development and industrialization of implantable innovative medical devices, today announced that the company will participate in the following upcoming scientific conferences in the fourth quarter, 2024:

EACTS 2024
38th European Association for Cardio-Thoracic Surgery Annual Meeting
Location: Lisbon, Portugal
Date: 09-12 October 2024
Learn more

ICS 2024
54th International Continence Society Annual Meeting
Location: Madrid, Spain
Date: 23-25 October 2024
Learn more

PCR London Valves
Official Course of the European Association of Percutaneous Cardiovascular Interventions
Location: London, United Kingdom
Date: 24-26 November 2024
Booth: #A2
Learn more

“Affluent Medical is dedicated to pioneering minimally invasive solutions that redefine patient care, enhance lives and address pressing medical needs of more than 600 million individuals worldwide affected with urinary incontinence and mitral insufficiency. In the past year, we have made major steps in the development of our medical devices, notably, our important deal with Edward Lifesciences, the global leader in patient-focused medical innovations for structural heart disease, for our mitral valve technologies, as well as encouraging initial performance results for our artificial sphincter Artus”, explained Sébastien Ladet, CEO of Affluent Medical. “As we progress our programs towards the pivotal and approval stages, we are very much looking forward to meeting with leading experts and companies in their respective fields to discuss latest research, patient needs as well as our programs and partnering opportunities.”

During the events, Affluent will be available to discuss the company’s latest advances in the development of its three innovative medical devices as well as their unique potential:

MITRAL RING KALIOS^TM:

Kalios^TM is the only mitral annuloplasty device that can be simply adjusted percutaneously by a cardiologist to treat both residual or recurrent mitral valve insufficiency, at any time after implantation, repeatedly and with a beating heart, thereby avoiding a repeat open-heart surgery. Affluent Medical believes that Kalios^TM would avoid further intervention for potentially 30% to 40% of patients over a five-year horizon.

Following positive feedback from the FDA in September 2024, Affluent Medical’s objective is to submit a De Novo application with current clinical data at the end of 2025/early 2026, followed by commercial launch, subject to Edwards’ decisions.

MITRAL VALVE EPYGON:

Epygon is the only biomimetic mitral heart valve that mimics the anatomy of the native mitral valve and physiological blood flow, able to be implanted via a transcatheter route. This transcatheter approach avoids an invasive open-heart procedure and associated complications to treat mitral valve insufficiency.

In 2024, the company began a collaboration with Prof. Mohammad Sarraf, MD, interventional cardiologist at the Mayo Clinic in the US, to evaluate the benefits of the biomimetic design of the Epygon valve. This innovative design aims to replicate the anatomy and natural physiology of the native mitral valve to enable patients to recover good cardiac function more quickly.

During the first half of 2024, Affluent Medical accelerated patient evaluations, achieving a fourfold increase in the number of patients included by the end of June 2024 with the goal is to implant up to 10 patients to complete the pilot phase.

URINARY SPHINCTER ARTUS:

Artus is the first artificial urinary sphincter that can be activated by the patient with a simple remote control for the treatment of moderate to severe urinary incontinence. Urinary incontinence is a major public health problem for over 400 million people worldwide without any innovation in the last 40 years, causing patients to suffer a reduced quality of life associated with the psychological disorders related to the disease.

As of mid-September 2024, seven patients had received an implant, representing over half of the planned patients for the pilot phase of the study. The Company plans to implant a total of 10 patients by Q4 2024 and then launch the pivotal phase of the study.

To schedule a meeting during the upcoming conferences, please contact the company at contact@affluentmedical.com.

About Affluent Medical

Affluent Medical is a French medical technologies company, founded by Truffle Capital, that aims to become a global leader in the treatment of structural heart diseases, one of the world's leading causes of mortality, and urinary incontinence, which currently affects one in four adults.

Affluent Medical develops next-generation implants that are minimally invasive, innovative, adjustable and biomimetic, designed to restore essential physiological functions. The candidate products developed by the Company are all undergoing clinical studies in humans.

Subject to raising the funds necessary to finance its strategy and the positive results of ongoing clinical studies, the Company aims to gradually market its products from 2026, directly or indirectly.

For more information, please visit www.affluentmedical.com

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