CARLSBAD, CA / ACCESSWIRE / September 14, 2020 / SpineOvations, Inc., a California-based medical device company developing novel, minimally invasive therapies for spinal disc diseases, 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. The study enrolled six patients with low back pain caused by discogenic disease not responding to first-line medical therapy. Enrollment was 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 Lead Principal Investigator is Dr. James Yu, MD, FANZCA, FFPMANZCA, FIPP.
The study demonstrated that the safety, tolerability and adverse event profile of DiscSeal was as expected for this patient population with no safety concerns. The minimally invasive procedure has been easily and quickly performed by the investigators, with all patients discharged on the day of procedure, as intended.
The primary objective of the study was to assess product safety over the study duration. The safety review of the study was managed by an independent medical monitor. Based on the overall safety results, interim MRI reviews, and study adverse events, there have been no product-related safety concerns. Two serious adverse events (SAEs) were reported, one was gastrointestinal in nature and the other progression of existing discogenic disease and low back pain co-morbidities. Both SAEs were reviewed by the independent medical monitor and deemed not to be investigational product or procedure related. All other adverse events were mild-to-moderate, expected as part of the injection procedure or not related to the device. 'We are very pleased with the safety results of this study. We developed DiscSeal containing well characterized, biocompatible materials and injected only in diseased discs that were determined to be able to contiguously contain the material. This was verified by the post-study MRI results, lack of safety-related issues, and final patient safety assessments,' said Dr. Neville Alleyne, Orthopedic Spine Surgeon, Chief of Orthopedics at TriCity Medical Center and Co-Founder of SpineOvations.
The secondary study objective was to assess product performance in reducing levels of pain and disability from pre-treatment pain levels over a 6-month period. The final results show a consistent improvement in pain and disability across all six outcomes measures at both the 90- and 180-day time points (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.
Change from Baseline - Pain and Disability Measures
Change from Baseline - Overall Health Status
DiscSeal treatment was associated with noticeable clinical improvement in back pain, leg pain, functionality and overall health status.
Additional patient-specific analyses:
- Effects with Full Treatment
Five of the six patients had multi-level disc disease at baseline, contributing to their pain sequelae. 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 180 days for VAS LBP, VAS leg pain, ODI.
- Responder Group Analysis
Four patients (66%) met the sponsor definition of ‘responder' (patients demonstrating pain reductions of 25% or more at 180 days in pain measures). In this ‘responder group', VAS LBP reduction was 58%, and VAS leg was 58% reduction.
- Average Improvement with Adjustment for Patient with Other Factors Unrelated to Discogenic Pain
One of the study patients had numerous additional factors and non-related medical events throughout the study that had a marked effect on the efficacy results. The overall average efficacy improvement for all remaining patients at 180 days with this patient removed was -45% LBP VAS, -38% Leg Pain VAS, -27% for ODI, and +86% for OHS.
'These results show great promise and at this point indicate a clear trend in pain improvement. It is also good to see there were no unexpected safety issues,' said Dr. James Yu, Lead Principal Investigator at Australian Medical Research. He continued, 'Back pain management is a complicated clinical discipline. Patients respond differently to various pain treatments. It is reassuring to see that a majority of the patients at our clinical site had noticeable improvement in VAS low back pain, VAS leg pain, ODI, or overall health status. Some of our patients had an improvement across all these measurements. As these patients have already failed first line, conservative therapy, it is an encouraging sign for DiscSeal's development as a future viable therapy.'
'The safety and efficacy results from our initial human pilot study met all of our expectations of success. This pilot study gives hope that DiscSeal could be the first minimally invasive product for degenerative disc disease and other discogenic disease disorders in the U.S. and Europe, following successful regulatory approval by FDA, and CE Mark,' said Niv Caviar, SpineOvations' CEO. 'The entire medical community 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 product profile of DiscSeal. Additionally, since all of the study patients had already tried and failed first line conservative therapy, DiscSeal may offer a future viable choice to either back surgery or alternative therapies not approved by the FDA,' added Caviar.
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. 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 DiscSeal in an expedited manner.
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.
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