Spine Ovations is a LaunchPad Alumni Company
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CARLSBAD, CA / ACCESSWIRE / May 26, 2020 / SpineOvations, Inc., a California-based medical device company developing novel, minimally invasive therapies for spinal disc diseases, 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 enrolled six patients with low back pain caused by discogenic disease not responding to first-line medical therapy at two sites, Australian Medical Research, an affiliate of Sydney Spine & Pain Clinic in Sydney, and Metro Pain Group, an affiliate of Monash House Private Hospital in Melbourne, Australia. The study's principal investigator is Dr. James Yu, MD, FANZCA, FFPMANZCA, FIPP.
Thus far in the study, the safety, tolerability and adverse event profile of DiscSeal was as expected for this patient population with no investigational device-related serious adverse events or safety concerns. The minimally invasive procedure has been easily and quickly performed by the sites as intended.
The primary objective of the study is to assess product safety over the study duration. The safety review of the study is being managed by an Independent Medical Monitor. "Based on results of the overall safety to date, interim MRI reviews, and study adverse events, there have been no product-related safety events or concerns. One patient experienced an unrelated serious adverse gastrointestinal event that required treatment and then resolved. All other adverse events were mild-to-moderate adverse events, expected as part of the injection procedure or not related to the device," said Dr. Robert Wright, Independent Medical Monitor.
The secondary study purpose is to assess product performance in reducing levels of pain and disability from pre-treatment pain levels over a 6-month period. The interim results show an improvement in pain and disability across all six outcomes measures (Visual Analogue Scale (VAS) Low Back Pain (LBP) and Leg Pain, Oswestry Disability Index (ODI), Overall Health Status, and Patient and Clinician Global Impression of Change). One patient experienced an acute pain exacerbation deemed not related to the product or discogenic disease during the study period and was successfully treated. The data are summarized below both with the full patient cohort and excluding the patient with the recurrent unrelated pain event.
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