News

• 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

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.

• 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.

• Positive results from the first clinical study on 3 patients implanted between May and September 2018

• The implant technique, via laparoscopy and open surgery, was validated, surgical safety was also verified

• Implantable in about 20 minutes with minimally invasive surgery, ARTUS is the first electronically activated artificial sphincter to treat stress urinary incontinence

• Affluent Medical is planning a market launch of ARTUS in Europe at the end of 2021, subject to regulatory approvals

Affluent Medical announces today the positive conclusion of its OPTIMISE first clinical study for KALIOS, its adjustable mitral repair device. KALIOS has been implanted in five patients between January and May of the current year by Prof. Martin Andreas, Principal Investigator of this feasibility study, at the Vienna General Hospital (AKH). The first results of the study show that the primary endpoint has been attained, proving the surgical safety of KALIOS.