ZURICH, August 17, 2011 /PRNewswire/ —
Kuros Biosurgery AG, a biotechnology company focused on the
development of novel biomaterials and bioactive-biomaterial
combination products for trauma, wound and spinal indications,
announced today that it has completed patient recruitment in a
clinical trial investigating the safety and efficacy of KUR-023,
its novel dural sealant product candidate. Kuros intends that this
trial will support CE Marking of KUR023.
KUR-023 is a synthetic hydrogel-based sealant that utilises
Kuros’ synthetic technology. The product candidate is
administered as a spray with the aim of ensuring water-tight
closure of incisions or tearsthrough the dura mater. It is
intended to be used as an adjunct to normal closure techniques such
as suturing.
The trial is a European, single arm, multi-center study in which
41 patients have been treated. The primary endpoint refers to the
prevention of intraoperative leakage with secondary endpoints
related to safety and further effectiveness assessment.
KUR-023 is delivered from a double barrelled syringe with a
mixing spray tip. The product candidate is delivered as a spray
which then arrives on the dura as a liquid, conforms to the
surface, and quickly polymerises. The applied gel is expected
to adhere strongly to the dural surface and be able to withstand
cerebral pressures in excess of those experienced in a patient.
The gel is designed to be easy to apply, to swell minimally
(addresses a common problem with hydrogels), to dissolve over a
period of a few months and not to interfere with the natural
healing process.
Kuros’ synthetic technology is based on technology originally
developed by Prof. Jeffrey Hubbell. The technology uses a
cross-linking chemistry which is highly specific, does not generate
any heat and is an addition reaction, meaning that no chemicals are
released during the polymerisation process.
Didier Cowling, Chief Executive
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