SpineOvations initiated a pilot clinical study of DiscSeal in patients suffering from lumbar spine pain after recently receiving Australian regulatory approval.
The first patient in the study was treated with DiscSeal at Waratah Private Hospital in Sydney.
The study will enroll six to 10 patients suffering from lumbar pain caused by discogenic disease who have not been treated properly by initial medical therapy.
DiscSeal is a viscous material that is injected percutaneously into the intervertebral diseased disc of patients suffering from lumbar pain under local anesthesia. SpineOvations aims to determine DiscSeal's safety and efficacy in reducing the patients' pre-treatment pain levels over a six-month period.
Data from the study will be used to support further studies in Europe and the U.S.