DiscSeal (hyaluronic acid microspheres) / SpineOvations - LARVOL DELTA

Results of a Pilot Study on the Safety and Early Efficacy of Novel Polymethyl Methacrylate Microspheres and a Hyaluronic Acid Device for the Treatment of Low Back Pain Caused by Degenerative and Diseased Intervertebral Discs of the Lumbar Spine. (PubMed, Cureus) - "DiscSeal was developed to provide patients who are refractory to first-line therapy with a minimally invasive treatment alternative to invasive surgical procedures...Early efficacy shows that DiscSealmay be a promising treatment option for people suffering from discogenic LBP that have not responded to first-line treatment options. A larger, statistically powered study where all diseased discs are treated should be completed to validate the promising results from this early feasibility study."

Clinical • Journal • Back Pain • Immunology • Inflammation • Lumbar Back Pain • Musculoskeletal Diseases • Musculoskeletal Pain • Pain

SpineOvations Announces Final Safety and Efficacy Results for DiscSeal Treatment for Low Back Pain (Yahoo Finance) - P=NA, N=6; "SpineOvations, Inc....announced final results of the DiscSeal pilot human clinical study in patients suffering from low back pain (LBP). At the 180-day end of study endpoint, the primary safety objective was met and final efficacy results showed a clear trend in reduction of low back pain, leg pain and disability....With the successful outcome of this human pilot study, SpineOvations is now focused on planning for either an EU registration or a U.S. pilot/registration study to initiate within 6-months."

Clinical data • New trial • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain

SpineOvations announces interim safety and efficacy results for DiscSeal treatment for low back pain (Yahoo Finance) - P=NA, N=NA; "SpineOvations, Inc....announced today interim results of the DiscSeal pilot human clinical study in patients suffering from low back pain (LBP). At the study mid-point of 90 days, the primary safety objective is being met and interim efficacy results show a clear trend in reduction of low back pain, leg pain and disability....The study is ongoing and will conclude after patients have their final visit at 6 months following treatment. The Company plans to report final study findings to the public in late summer of 2020."

Clinical data • Back Pain • Lumbar Back Pain • Musculoskeletal Pain • Pain