Date: 2011-08-17
Type of information:
phase:
Announcement: completion of patient enrollment
Company: Kuros (Switzerland)
Product: KUR-023
Action mechanism: 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 tears through the dura mater. It is intended to be used as an adjunct to normal closure techniques such as suturing.
Disease: adjunction to normal closure techniques such as suturing
Therapeutic area:
Country:
Trial details: 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.
Latest
news: Kuros Biosurgery 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 KUR¬023.
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.
