Patient recruitment complete in Kuros' KUR-023 dural sealant European clinical trial

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 Officer of Kuros, commented: "Kuros is pleased to have completed recruitment of this study and is especially pleased to have achieved this ahead of schedule.  KUR-023 is the first product based on our synthetic technology to have entered into clinical studies and we look forward to reporting the results of this study in the near future."