News

• 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

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

Carvolix 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.

Carvolix 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.

Carvolix’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.

Carvolix 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.