SpineOvations began a clinical study of DiscSeal percutaneous injection for the treatment of low back pain. The pilot human clinical study will enroll 6 to 10 patients at two clinical sites in Australia, with a primary purpose of assessing product safety over the study duration. Data from this pilot study are intended to support larger registration studies in the EU and U.S., the latter either independently or with a large life science partner.
DiscSeal viscous material is delivered via a simple percutaneous injection under local anesthesia. The proprietary formulation of biocompatible synthetic microspheres and a hyaluronic carrier is specifically designed for disc augmentation, minimizing the progression of internal disc disruption and disc degeneration disease.
In preclinical studies, DiscSeal injection was well tolerated and remained in the injected disc without extrusion, and the intervertebral disc maintained its anatomically ideal thickness.