News

• 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.

AFFLUENT MEDICAL hosted a Key Opinion Leader event Wednesday, May 23, 2018 on New Generation Technologies for Minimally Invasive Surgery of the Mitral Valve and Abdominal Aorta.
Key opinion leaders (KOLs) present were Professor Christian Latrémouille (Georges Pompidou European Hospital) and Professor Stéphan Haulon (Université Paris Sud) who discussed novel surgical technologies for the treatment of mitral valve regurgitation and abdominal aortic aneurysm.

AFFLUENT MEDICAL’s CEO Daniele Zanotti and Chief Medical Officer Dr. Marcio Scorsin also provided an overview of the Company’s cardiovascular franchise, including the Epygon transcatheter mitral valve implant (TMVI); the Kalios adjustable mitral valve repair device; and Kardiozis endo-prosthesis for treating the abdominal aortic aneurysm aimed at the prevention of endoleaks.

AFFLUENT MEDICAL announces that it has received the approval from the Czech Republic regulatory authority to start ‘first in man’ preclinical study with ARTUS.

ARTUS is the first electronically activated sphincter to treat urinary incontinence. One in 4 adults suffers from stress-induced urinary incontinence, with a high prevalence among women.

ARTUS is the first artificial urinary sphincter intended for both men and women. Fully invisible and easy to use via remote control, ARTUS is inserted in about 30 minutes by minimally invasive surgery. It aims at becoming the next standard of care for this disease with adverse impacts on the patients’ quality of life. The market launch of ARTUS, currently in clinical development, is planned in 2021 in Europe. The global urology market is expected to reach $7 billion by 2020, with a potential 26% annual growth between 2017-2020.

AFFLUENT MEDICAL announces that it has successfully implanted at the Vienna General Hospital, Austria, the first adjustable Kalios ring, intended to restore the normal functioning of the mitral valve with closing defects in some patients.

KALIOS is the first fully adjustable mitral valve repair device, designed to effectively meet the needs of patients with mitral insufficiency, which affects 1% of the world’s population.

KALIOS can treat both residual postoperative leaks and chronic mitral insufficiency. The size and shape of the implant can be adjusted percutaneously multiple times in the months/years following the surgery, offering patients a personalized surgical treatment. The European launch of this device, currently in human clinical trial in Europe, is scheduled for the end of 2020. It targets a global market expected to reach $3.5 billion by 2022 and growing at a rate of 35% per year between 2017-2022.