Kalios, Kephalios’ device, has just been implanted in a patient.

Kephalios, innovative medtech startup

Kephalios, a medtech startup company, which was supported in its Aix-en-Provence setup by Provence Promotion in 2014, is embarking on a new crucial stage in the development of its innovative mitral ring. This device, called Kalios, has just been implanted in a patient for the first time and will be evaluated for several months before its initial results are shared. We bring you the latest news on this ambitious medical device which could well revolutionize the lives of almost four million patients affected by this heart condition worldwide.

On January 18, 2018, Kephalios announced it had implanted its Kalios mitral ring in its first human patient. This operation, which took place at the Vienna General Hospital (AKH) in Austria, successfully used an implantation technique inspired by the Carpentier method using a balloon catheter. Four other patients will soon be implanted, taking part in the “Optimise” clinical trial, whose initial results are expected in Q2 2018.

The novelty of Kalios is its ability to be gradually adjusted several times within months following the surgery with minimally-invasive interventions, to achieve currently unrivaled adjustment precision. It will bring a reduction in operating risks with results that could prove to be invaluable for both functional mitral regurgitation (MR) and post-operative residual MR.

KEPHALIOSKephalios’ CEO Daniele Zanotti, who in 2014 chose to develop its activities in the south of France in Aix-en-Provence, works with experts and international specialists in biotechnologies and heart disease. Co-founded in 2011 by investment fund Truffle Capital and inventors Piergiorgio Tozzi and Daniel Hayoz, the startup now employs six people with complementary profiles and plans to hire three more people soon.

Kephalios holds ambitions for the future

After dedicating two years to in-vivo tests on animals, the team’s ambition for 2018 is to prove the feasibility and safety of the Kalios device on humans. The initial tests now underway are decisive and all efforts will be focused on the analyses of the medical outcomes.

While the objective is to ultimately obtain the necessary marketing authorizations for Kalios, Kephalios is also becoming highly involved in the French cardiovascular industry.  The startup, which leads the MIVANA consortium supported by private funds and Bpifrance, nurtures a collaborative dynamic with strong ambitions for the future with the PSPC project (R&D growth-generating project for competitiveness).

Drawing on the innovations of Epygon, the scientific progress of technical textile specialist MDB Texinov, and the new materials expertise of the Institut Français du Textile et de l’Habillement (IFTH), the objective of this five-year partnership is to speed up the research and manufacture of these new medical devices at a competitive cost and with unprecedented quality levels. The MIVANA consortium has planned to invest close to 30 million euros, including 8.6 million euros funded through the Programme d’Investissements d’Avenir [Investments for the Future Program] (PIA).


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