The ongoing clinical study, called the ‘Hylomate Trial’, is a multi-center, confirmatory, single-arm study, with endpoints of safety in combination with cardiac rhythm management devices (pacemakers and defibrillator indications) and performance related to the maintenance of stable interface with the surrounding soft tissues and minimization of fibrotic capsule.
“Safe, effective and easy to use”
"The Hylomate and the technology behind it represent a promising concept of minimizing the negative effects of foreign body reaction to medical implants" said Christoph Starck, Cardiac Surgeon (German Heart Center Berlin) and principal investigator of the Hylomate study. "Based on our initial experience in the clinical trial and the results obtained so far, Hylomate is safe, effective and easy to use".
"The Hylomate is a very interesting envelope. It is very easy to use and potentially very effective in protecting the device from the formation of fibrosis and adhesions. On the basis of what we have observed, we confirm that the study and the envelope are safe and effective." said Giovanni Rovaris, Head of Interventional Electrophysiology (San Gerardo Hospital, Monza, Italy) and Chairman of the Monitoring Board for the Hylomate study.
Aldo Ferrari, Chief Scientific Officer and co-founder of Hylomorph, added: "the complete dataset on the first 10 enrolled patients has shown excellent results. The post implant evolution was monitored at 1, 6, and 12 months, fully confirming the product indication and providing a very encouraging outlook on its efficacy".
Hylomorph, a spin-off of the Swiss Federal Institute of Technology (ETH Zurich), aims at solving post-operative complications in implantable medical devices. The Hylomate product family is based on a proprietary platform technology for the generation of surface micro-engineered biosynthesized cellulose. Hylomate is intended to durably separate body implants from surrounding soft tissues. The Hylomate’s engineered interface is designed to minimize the deposition of fibrotic tissue. Primary market focus is on cardiac rhythm management devices and neurostimulators, in EU and US, for which CE mark and FDA clearance are currently being sought.
(Press release / SK)