Affluent Medical : Affluent Medical takes stock of its recent operational advances

PRESS RELEASE

Affluent Medical takes stock of its recent operational advances

Access the replay of the interview with Michel Therin, Chairman of the Board of Directors and Sébastien Ladet, CEO, on Boursorama

Aix-en-Provence, 12 September 2024 – 5:45 pm- Affluent Medical (ISIN: FR0013333077 – ticker: AFME - "Affluent"), a French clinical-stage medical technologies company specialising in the international development and industrialisation of innovative medical devices, today announces its participation in the "Actu Bourse" issue on Boursorama on 12 September 2024.

On this occasion, Michel Therin, Chairman of the Board of Directors and Sébastien Ladet, Chief Executive Officer, reviewed the agreements recently signed with Edwards Lifesciences, the world leader in innovative solutions for cardiovascular diseases.

They presented the latest advances in ongoing clinical studies for the three medical devices:

• The positive feedback from the FDA (Federal Drug Administration) on the US market access strategy for Kalios, the adjustable mitral ring, as a class 2 device, without requesting that additional patients be added to the Optimise II clinical study.
• Validation of the innovative design of the Epygon valve through one of the agreements signed with Edwards Lifesciences and evaluations of the haemodynamic benefit of Epygon with Dr. Sarraf of the Clinical Mayo in the United States. This includes progress in the clinical study with the increase in the number of investigation centres as part of the Minerva study, with currently 11 active centres and 5 awaiting validation.
• The progress of the Dry pilot clinical trial for the Artus device, the first remote-controlled mechanical urinary sphincter with currently 5 patients implanted at the end of August and encouraging initial performance results. The company aims to finalise implantation in 10 patients in the last quarter of 2024.

The company also revealed that it had recently secured €1.1 million in non-dilutive financing, mainly in the form of grants, for the development of its Epygon transcatheter valve.

Lastly, during the interview, it was pointed out that the analysts covering the Affluent Medical share price have all revised their target price upwards, which now stands at an average of €4.04, reflecting their confidence in the company's outlook.

Link to the replay of the issue: https://www.boursorama.com/videos/actualites/affluent-medical-fait-le-point-sur-son-actualite-62729027a80baf20086e01ca1280b4fd

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, one of the world's leading cause of mortality, and urinary incontinence, which currently affects one in four adults.

Affluent Medical develops next-generation, minimally invasive, innovative, adjustable, and biomimetic implants to restore critical physiological functions. The product candidates developed by the Company are all currently in ongoing human 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 in 2026, directly or indirectly.

For more information, visit www.affluentmedical.com

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