DiscSealTM Clinical Development
SpineOvations conducted a prospective, single-arm feasibility clinical study to investigate the safety, tolerability, and exploratory efficacy of DiscSealTM for the treatment of degenerative and diseased Intervertebral Disc (IVD) of the lumbar spine. The primary safety objective was met and final efficacy results showed a clear trend in reduction of low back pain, leg pain and disability. The study enrolled patients with low back pain caused by discogenic disease not responding to first-line medical therapy. The trial, conducted in Australia at two clinical study sites, enrolled 6 subjects who received DiscSealTM treatment with follow-up visits through 180 days from initial treatment.
The primary objective of the study was to evaluate the safety of the DiscSealTM in the treatment of low back pain for patients with Discogenic Disease (including Degenerative Disc Disease (DDD), Internal Disc Disruption (IDD), and/or nonspecific discogenic disease) of the lumbar spine during the first 90 days following treatment. The secondary objective of this study was to determine device tolerability and to explore preliminary efficacy of DiscSealTM in the treatment of low back pain.
The study results demonstrated a consistent improvement in pain and disability across all six outcomes measures at both the 90 and 180-day time points, including visual analogue scale (VAS) low back pain (LBP) and leg pain, Oswestry disability index (ODI), overall health status (OHS), and patient and clinician global impression of change.
SpineOvations is currently planning to initiate an EU registration study this year. In parallel, the company is exploring strategic partnering or capital funding options to support such study. The goal is to develop and gain regulatory approval of DiscSealTM in an expedited manner.
Our Clinical Study Partners
Patient recruitment management and support are provided by the following partners:
In Europe: 1Med SA
In Australia/New Zealand: Mobius Medical