CARLSBAD, CA / ACCESSWIRE / November 21, 2019 / SpineOvations, Inc., a California-based medical device company developing novel minimally invasive therapies for spinal disc diseases, announced today that it has commenced clinical study of DiscSeal. The company received Australian regulatory approval to initiate a pilot human clinical study in patients suffering from low back pain and the first patient has been treated with the investigational product DiscSeal at Australian Medical Research, a research facility in Sydney's Waratah Private Hospital. The study will enroll 6 to 10 patients who have low back pain caused by discogenic disease and whom have not been adequately treated by first-line medical therapy, across two clinical sites in Australia. The primary purpose 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. In the minimally invasive procedure, DiscSeal is administered into the intervertebral diseased disc (IVD) of patients suffering from low back pain under local anesthesia. Data from this pilot study are intended to support larger registration studies in the European Union and the US.
Although, back pain is one of top three reasons for patients to visit a doctor and low back pain is experienced by 80% of people at some point, to date there have been no FDA-approved drugs or non-invasive devices indicated for low back pain caused by discogenic disease. "The successful injection of our first human patient is a watershed moment in the development of the DiscSeal. All of our pre-clinical, scale up, stability and biocompatibility studies supported advancing DiscSeal to human testing for safety and efficacy. We are very pleased to have commenced our human study to develop further scientific and clinical evidence for our product development process," said Niv Caviar, SpineOvations CEO.
James Yu, M.D. at Sydney Spine and Pain, and Clinical Director of Australian Medical Research is the lead investigator in this discogenic low back pain study. "Discogenic back pain is a very common medical condition and, while many clinical approaches exist, very few are supported by clinical evidence for use in low back pain. It is desirable to be able to utilize a regulatory-approved product that can be injected into the IVD via a minimally invasive manner and provide long term relief for patients. We hope that DiscSeal can be a new treatment option for pain specialists such as myself," said Dr. Yu.
Upon successful completion of the Australian pilot study, SpineOvations' management plans to initiate clinical pivotal trials for Europe's CE Mark approval. A CE Mark approval will enable commercialization in Europe. Further, SpineOvations' management plans to eventually conduct a US clinical trial after the EU study independently or with a large life science partner. 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, epidural injections) have no alternative other than invasive surgery such as spinal fusion.
DiscSeal, delivered via a simple percutaneous injection, comprises a patented and proprietary formulation of biocompatible synthetic microspheres and a hyaluronic carrier specifically designed for disc augmentation, thereby minimizing progression of internal disc disruption and disc degeneration 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 remained in the injected disc without extrusion, and the intervertebral disc maintained its anatomically ideal thickness. DiscSeal utilizes technology derived from commercially approved dermal fillers and improves clinical performance of traditional bulking, sealing, and hydration of dermal fillers for the intervertebral disc treatment. To date over 30 million Americans and Europeans have been injected with over one dozen commercially approved dermal filler brands.
SpineOvations (SO) is a clinical stage medical device company focused on developing innovative minimally invasive therapies treating low back pain. SpineOvations' DiscSeal technology is patented. SpineOvations was founded by well-known spinal and neurosurgeons and led by experienced executives in the life sciences. For further information, visit: www.spineovations.com.
Niv Edward Caviar
Chief Executive Officer
VP, Corporate Development, Marketing
SOURCE: SpineOvations, Inc.