News
![Approval of the Registration Document](https://www.affluentmedical.com/wp-content/uploads/2021/07/visuels_news_finance_generique3.jpg)
Approval of the Registration Document
AFFLUENT MEDICAL announces the approval of its Registration Document by the French Financial Markets Authority (Autorité des marchés financiers – AMF) as part of its proposed IPO on the Euronext Paris regulated market
Affluent Medical, a French medtech specialising in the international development and industrial scale-up of innovative medical prostheses, at a clinical stage, to treat urinary incontinence and mitral cardiac insufficiency, announces today the approval of its Registration Document by the AMF under number I.21-007 on 12 April 2021.
The approval of this Registration Document is the first step in Affluent Medical’s proposed IPO on the Euronext Paris regulated market, subject to market conditions and the approval by the AMF of the Prospectus relating to the operation.
![Affluent Medical announces 15.8m€ in new financing and strengthening of its board of Directors](https://www.affluentmedical.com/wp-content/uploads/2021/03/post01.jpg)
Affluent Medical announces 15.8m€ in new financing and strengthening of its board of Directors
The Private Placement Financing was taken out for gross proceeds of €10.3 million, €8 million via convertible bonds (of which €4 million were received in December 2019).
Affluent Medical has been granted two “PGE” (government-backed) loans for a total of €2.2 million from the banks Société Générale and BNP PARIBAS as part of public measures to mitigate the economic impact of the Coronavirus. The two loans are interest free and repayable either after one year or over a period of up to five years.
Joining the board are Jean-François Le Bigot and Benoît Adelus.
![Affluent Medical announces the launch of MINERVA First-In-Human clinical study for EPYGON](https://www.affluentmedical.com/wp-content/uploads/2021/03/post2.jpg)
Affluent Medical announces the launch of MINERVA First-In-Human clinical study for EPYGON
Epygon is the first transcatheter mitral valve designed to restore the physiological blood flow vortex and treat left ventricle disease, in particular in so-called “functional” patients.
No mitral valve prosthesis currently on the market or in development was designed to restore the vortex.
The unique concept and design of the Epygon valve is expected to achieve high procedural success, restore left ventricle physiological flow, and offer excellent performance in terms of the absence of thrombus formation and LVOT obstruction, while eventually also alleviating left ventricular effort.
![Affluent Medical announces first patient implanted in OPTIMISE II pivotal clinical study for KALIOS, the minimally invasive mitral valve repair ring](https://www.affluentmedical.com/wp-content/uploads/2021/03/post3.jpg)
Affluent Medical announces first patient implanted in OPTIMISE II pivotal clinical study for KALIOS, the minimally invasive mitral valve repair ring
- KALIOS is the first fully adjustable mitral valve repair ring, designated for the percutaneous treatment of both residual and recurrent Mitral Regurgitation (MR).
- First patient implanted in Vienna General Hospital (AKH)
- Obtention of regulatory approval to start patient enrollment in 2 European countries already : Austria (Vienna) and Italy (Florence)
- Affluent Medical plans on launching the device ni Europe by the end of 2021, subject to CE Marking
![Affluent Medical strengthens its executive team](https://www.affluentmedical.com/wp-content/uploads/2021/03/post4.jpg)
Affluent Medical strengthens its executive team
Michel Finance is appointed CEO.
Executive team is strengthened with the appointment of:
Daniele Zanotti (the former CEO) as Chief Technology and Innovation Officer leading technology developments and the execution of programs,
Professor François Laborde as Chief Clinical and Scientific Affairs Officer,
Marianna Luppi as Regulatory Affairs Director,
Brian Burg as Cardiovascular Program Director.
![Affluent Medical releases impressive results from SCOPE 1 clinical trial validating efficacy of KARDIOZIS technology](https://www.affluentmedical.com/wp-content/uploads/2021/03/post5.jpg)
Affluent Medical releases impressive results from SCOPE 1 clinical trial validating efficacy of KARDIOZIS technology
- Outstanding results from SCOPE 1 randomized, controlled, multicentric clinical trial, proving the efficacy of treating life-threatening Abdominal Aortic Aneurysm (AAA), by thrombogenic fibers embolization of the aneurysm sac when performing an EndoVascular Aneurysm Repair (EVAR).
- No complications related to thrombogenic fibers embolization were observed.
- Rate of repeat surgery and endoleaks was significantly reduced in the Study group Vs Control Group from 78% to 47% at 24 months (p= 0.003).
- A significant reduction of aneurysm volume of 55% was observed in patients in the Study Group Vs Control Group at 24 months (p=0.001).
Impressive validation of the proprietary KARDIOZIS one-step technology under development, with thrombogenic fibers pre-linked to prosthesis and so introducing a quantum leap innovation in the treatment of abdominal aortic aneurysm, which affects 5 to 10% of men from age 65 to 80.