CARLSBAD, CA / ACCESSWIRE / February 24, 2020 / SpineOvations, Inc., a California-based medical device company developing novel, minimally invasive therapies for spinal disc diseases, announced today the completion of patient enrollment in the DiscSeal pilot human clinical study in patients suffering from low back pain. As of end of January 2020, all 6 patients have been treated with the investigational product DiscSeal. Australian Medical Research, an affiliate of Waratah Private Hospital in Sydney, and Metro Pain Group, an affiliate of Monash House Private Hospital in Melbourne, Australia are participating in the study.
Thus far in the study, DiscSeal has been well tolerated with no investigational device-related serious adverse events nor safety concerns. The minimally invasive procedure has been easily and quickly performed by the sites as intended.
The purpose of the study is to enroll patients who have low back pain caused by discogenic disease and who have not been adequately treated by first-line medical therapy. The primary objective of the study is to assess product safety over the study duration. The secondary purpose is to assess product performance in reducing levels of pain from the patients' pre-treatment pain levels over a 6-month period. Data from this pilot study will support larger registration studies in the European Union and the US. The study is managed locally by Australian CRO, Mobius Medical.
Diseases of the intervertebral disc continue to be a major cause of pain, disability, and loss of productivity throughout the world. "Achieving completion of enrollment of the DiscSeal study takes us a step closer toward a new option for patients with pain due to discogenic disease. We are grateful to the participating patients and for the support of our research collaborators. We are also pleased that thus far there have been no identified investigational product related safety concerns associated with the study," said Niv Caviar, SpineOvations' CEO.
Dr. Paul Verrills, Clinical Director of Metro Pain Group and study clinical investigator commented, "Our hospital and pain clinic is at the forefront of back pain treatment and research. We continually see a large group of patients who suffer from discogenic disease and have few approved treatment options." Verrills added, "We are pleased to be part of the study and we found the DiscSeal product was easily and rapidly injected under image guidance."
Upon successful completion of the Australian pilot study, SpineOvations' management plans to initiate additional clinical trials to enable European CE Mark and US approvals. The total estimated worldwide market for global orthopedics devices is valued at $34 billion and growing to $44 billion. Currently, patients who fail conservative therapy (NSAIDs, corticosteroids, and epidurals) have no alternative other than invasive surgery such as spinal fusion.
DiscSeal, delivered via a simple percutaneous injection, is 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 minimize progression of internal disc disruption and degenerative disc disease, one of the most 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.