• 13 June 2012
    Kuros reports success in its European Clinical Study with KUR-023, its novel dural sealant product candidate

    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 KUR-023, its novel dural sealant product candidate, successfully sealed intra-operative CSF leakage in all evaluable patients.

    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 sutured incisions through the dura mater following cranial surgery. It is intended to be used as an adjunct to normal closure techniques such as suturing.

    The trial was a European, single arm, multi-center study in which 41 patients were treated. The primary endpoint was the prevention of intra-operative leakage. The secondary endpoints related to safety and further effectiveness assessments. In all evaluable patients a single application of KUR-023 was sufficient to seal the intra-operative leakage. The safety and further effectiveness assessments were equally positive.

    Dr. Virginia Jamieson, Chief Medical Officer of Kuros commented: “These results in combination with positive feedback from the neurosurgeons are highly encouraging. Achieving water-tight closure of the dura following cranial surgery is important to both surgeons and patients, and KUR-023 has demonstrated its ability to meet this need.”

    KUR-023 is delivered from a double barrelled syringe with a mixing spray tip. The product candidate is delivered as a spray which arrives on the dura as a liquid, conforms to the surface, and polymerises within seconds to form a gel. The gel adheres to the dural surface and is expected to 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 and his group. 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: “The results from this study have demonstrated that KUR-023 is a highly effective dural sealant. We now look forward to progressing this product to market in the EU.”