Kuros Biosurgery 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 KUR¬023.
KUR-023, a synthetic hydrogel-based sealant that utilizes Kuros’ synthetic technology is administered as a spray with the aim of ensuring water-tight closure of incisions or tears through the dura mater. It is intended to be used as an adjunct to normal closure techniques such as suturing.
The trial is a 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.
The product 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 easily applied, to swell minimally (addresses a common problem with hydrogels), to dissolve over a period of a few months and to not interfere with the natural healing process.
Kuros’ synthetic technology is based on technology originally developed by professor Jeffrey Hubbell, which uses a cross-linking chemistry which is highly specific, does not generate any heat and is an addition reaction.
Release Date: August 17, 2011
Source: Kuros Biosurgery AG
Filed Under: Drug Discovery