SpineOvations reports final results of DiscSeal trial, eyes US pilot study

Alan Condon -   Print  |

Minimally invasive spine therapy company SpineOvations on Sept. 14 reported final results of its DiscSeal clinical trial.

Five things to know:

1. DiscSeal is a viscous material injected percutaneously into the intervertebral diseased disc of patients under local anesthesia.

2. The study enrolled six patients at two Australian sites in February to explore the safety and efficacy of DiscSeal in patients suffering from lumbar pain.

3. The product demonstrated an improvement in lumbar pain, leg pain and disability at the 90-day midpoint and 180-day endpoint.

4. Six outcomes measures were used to evaluate DiscSeal, including the visual analogue scale, Oswestry disability index, low back pain and leg pain.

5. SpineOvations aims to secure a European Union registration or U.S. pilot study within the next six months and expedite the product's approval.

Click here for more information on the clinical trial.

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