May 26, 2020 / Carlsbad, CA — 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.
Change from Baseline (90-Day Interim results)
|Pain & Disability Measures|
|End Point||Average % improvement – All Patients (n = 6)||Average % improvement
– Excluding patient with pain from recurrent unrelated pain event (n = 5)
|Leg Pain VAS||47%||56%|
|Other Outcome Measures|
|Overall Health Status||55%||78%|
|Clinician Global Impression of Change*||83%||100%|
|Patient Global Impression of Change*||83%||100%|
* Percent of patients slightly to very much improved
Five of the six patients had multi-level disc disease at baseline, contributing to their pain sequalae. However, as a safety precaution, treatment for this initial safety study was limited to only one diseased disc per patient, regardless of the number of pain generating discs evaluated. In the study, only one patient presented with single-level disc disease, enabling treatment of the entire pain generating source for only that patient. For that patient, the pain reduction was 100% at 90 days for VAS LBP, VAS Leg Pain, ODI.
Additional patient-specific analyses include:
- Responder Group Analysis: Three patients met the definition of responder (patients demonstrating pain reductions of 25% or more at 90 days in pain and disability measures). In these patients, pain and disability improved an average of 60% across both VAS pain measures and ODI.
- Severe Disc Disease Findings: Two patients met the definition of severe disc disease, defined as Pfirrmann Grade 4 diseased discs. In these patients, on average pain improved by greater than 62% in both VAS measures and ODI.
“These results show great promise and at this point indicate a clear trend in pain improvement and also support the safety of the product,” said William Taylor, MD, Neurosurgeon, and Chairman of the SpineOvations Scientific Advisory Board. He continued, “What is of most interest is the higher than average results based on specific sub-groups. Although these results are not statistically powered, they demonstrate clear trends that, if maintained through the course of the study, will guide the clinical design in a larger registration study.”
“We are very pleased with these results and they give hope to developing a minimally invasive product that could be the first U.S. approved and indicated therapy for Degenerative Disc Disease and other discogenic disease disorders,” said Niv Caviar, SpineOvations’ CEO. “The entire industry is seeking non-opioid, non-drug treatment approaches that can be administered quickly and simply in an outpatient setting and provide long lasting pain relief. This is the intended DiscSeal product profile. Additionally, since all of the study patients have already tried and failed first line conservative therapy, their choice effectively is either back surgery or alternative therapies not approved by the FDA. What the study has demonstrated thus far, is that DiscSeal may potentially offer a safe and effective solution to reduce pain for patients refractory and non-responsive to standard therapy,” added Caviar.
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.
DiscSeal, delivered via a simple percutaneous injection, is an investigational medical device comprised of a patented and proprietary formulation of biocompatible synthetic microspheres and a hyaluronic acid carrier specifically designed for disc augmentation. DiscSeal is intended to treat the progression and symptoms of internal disc disruption and degenerative disc disease, common causes of low back pain. DiscSeal is a viscous material that can be injected with a small gauge needle in a rapid manner via a minimally invasive procedure under local anesthesia.
In preclinical studies, DiscSeal injection was well tolerated and remains in the injected disc without extrusion, and the intervertebral disc maintains its anatomically ideal thickness. DiscSeal utilizes technology from commercially approved materials and products. DiscSeal was developed with the intent to provide structural support and sealing in diseased intervertebral discs that cause low back pain.
SpineOvations is a clinical-stage medical device company focused on developing innovative minimally invasive therapies to treat low back pain. SpineOvations’ DiscSeal technology is patented. SpineOvations was founded by well-known spinal and neurosurgeons. For further information, visit: www.spineovations.com.
Niv Edward Caviar
Chief Executive Officer
VP, Corporate Development, Marketing
Source: SpineOvations, Inc.