Affluent Medical achieves the clinical objective of the Dry pilot study in the first two patients with the Artus artificial urinary sphincter.

PRESS RELEASE

Affluent Medical achieves the clinical objective of the Dry pilot study in the first two patients with the Artus artificial urinary sphincter

• Second successful implantation of the innovative Artus medical device in Krakow, Poland
• Successful activation of the Artus device in the first two patients six weeks after surgery
• Artus, an artificial sphincter adapted to the treatment of incontinence in both men and women, addresses a substantial medical need with 400 million patients affected worldwide

Aix-en-Provence, June 18, 2024 – 5:45 PM CEST – Affluent Medical (ISIN: FR0013333077 – Ticker: AFME), a French clinical-phase MedTech company specializing in the international development and industrialization of innovative medical prostheses, is announcing the successful activation of its Artus medical device for the treatment of urinary incontinence in the first two patients as part of the European pilot study, “Dry”.

After the successful implantation of the Artus device in an initial patient in the Czech Republic, as reported last March, the device has been successfully implanted in a 70-year-old man suffering from urinary incontinence in Poland by the urologist Professor Piotr Chlosta, President of the Department of Urology of the Faculty of Medicine of Jagiellonian University in Krakow and Head of the Clinical Department of Urology and Oncology at the University Hospital of Krakow.

This second minimally invasive procedure confirmed the ease with which the Artus device can be prepared and implanted, with a surgery time of 45 minutes.

The two Artus devices were successfully activated six weeks after each surgery. The safety criteria were met and both patients expressed no discomfort using the device. A performance assessment will be carried out in the pivotal phase, the aim being to reduce urinary leakage three months after the activation of the device.

Sébastien Ladet, Affluent Medical CEO declares: “Achieving the objectives of the pilot study on these first two patients is a very encouraging result. It enables us to make further progress in demonstrating the safety of the device, and to gather the first patient feedback. This step enables us to move towards our goal of ten patients in the Dry pilot study by the end of 2024”.

Urinary incontinence is a major public health problem worldwide. The pathology affects men and women alike at different stages of their lives. It is generally more prevalent among women than men, notably among younger patients (aged 25 and over) with disorders resulting from multiple child births or in older patients (40 and over) from prostate or bladder cancer treatments. Urinary incontinence has a major impact on social life and mental health. Many patients develop anxiety and depression disorders, as the pathology remains vastly taboo. According to Optima Insights, the global market for medical devices for the treatment of urinary incontinence (including slings, neurostimulators and artificial sphincters) is expected to reach $4.3 billion by 2027, growing annually 11% between 2019 and 2027.

About Affluent Medical

Affluent Medical is a French MedTech company, founded by Truffle Capital, with the ambition to become a global leader in the treatment of structural heart diseases, which are the world's leading cause of mortality, and urinary incontinence, which currently affects one in four adults.

Affluent Medical develops next-generation, mini-invasive, innovative, adjustable, and biomimetic implants to restore critical physiological functions. The product candidates developed by the Company are currently all in clinical studies.

Subject to raising the necessary funds to finance its strategy and to positive results from ongoing clinical studies, the Company's ambition is to gradually commercialize its products early 2026.

For more information, visit www.affluentmedical.com

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