{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,28]],"date-time":"2026-07-28T02:58:16Z","timestamp":1785207496035,"version":"3.55.0"},"reference-count":38,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2023,2,13]],"date-time":"2023-02-13T00:00:00Z","timestamp":1676246400000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["JOR Spine"],"published-print":{"date-parts":[[2023,6]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Objective<\/jats:title><jats:p>Whilst microdiscectomy is an excellent reliever of pain for recalcitrant lumbar disc herniation (LDH), it has a high failure rate over time due to the ensuing reduction in mechanical stabilization and support of the spine. One option is to clear the disc and replace it with a nonhygroscopic elastomer. Here, we present the evaluation of biomechanical and biological behavior of a novel elastomeric nucleus device (Kunovus disc device [KDD]), consisting of a silicone jacket and a two\u2010part in situ curing silicone polymer filler.<\/jats:p><\/jats:sec><jats:sec><jats:title>Materials and Methods<\/jats:title><jats:p>ISO 10993 and American Society for Testing and Materials (ASTM) standards were used to evaluate the biocompatibility and mechanics of KDD. Sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, muscle implantation study, direct contact matrix toxicity assay, and cell growth inhibition assay were performed. Fatigue test, static compression creep testing, expulsion testing, swell testing, shock testing, and aged fatigue testing were conducted to characterize the mechanical and wear behavior of the device. Cadaveric studies to develop a surgical manual and evaluate feasibility were conducted. Finally, a first\u2010in\u2010human implantation was conducted to complete the proof of principle.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>The KDD demonstrated exceptional biocompatibility and biodurability. Mechanical tests showed no Barium\u2010containing particles in fatigue test, no fracture of nucleus in static compression creep testing, no extrusion and swelling, and no material failure in shock and aged fatigue testing. Cadaver training sessions showed that KDD was deemed implantable during microdiscectomy procedures in a minimally invasive manner. Following IRB approval, the first implantation in a human showed no intraoperative vascular and neurological complications and demonstrated feasibility. This successfully completed Phase 1 development of the device.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusion<\/jats:title><jats:p>The elastomeric nucleus device may mimic native disc behavior in mechanical tests, offering an effective way for treating LDH by way of Phase 2 and subsequent clinical trials or postmarket surveillance in the future.<\/jats:p><\/jats:sec>","DOI":"10.1002\/jsp2.1250","type":"journal-article","created":{"date-parts":[[2023,2,14]],"date-time":"2023-02-14T03:15:34Z","timestamp":1676344534000},"update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":7,"title":["Phase 1 evaluation of an elastomeric nucleus pulposus device as an option to augment disc at microdiscectomy: Experimental results from biomechanical and biocompatibility testing and first in human"],"prefix":"10.1002","volume":"6","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2083-0549","authenticated-orcid":false,"given":"Xiaolong","family":"Chen","sequence":"first","affiliation":[{"name":"Spine Labs, St. George &amp; Sutherland Clinical School, University of New South Wales  Sydney New South Wales Australia"},{"name":"Kunovus Technologies  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Saeed","family":"Kohan","sequence":"additional","affiliation":[{"name":"St. George Hospital, University of New South Wales  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Divya","family":"Bhargav","sequence":"additional","affiliation":[{"name":"Kunovus Technologies  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Johnathon","family":"Choi","sequence":"additional","affiliation":[{"name":"Kunovus Technologies  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Senori","family":"Perera","sequence":"additional","affiliation":[{"name":"Kunovus Technologies  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Cameron","family":"Dean","sequence":"additional","affiliation":[{"name":"Kunovus Technologies  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Neha","family":"Chopra","sequence":"additional","affiliation":[{"name":"Spine Labs, St. George &amp; Sutherland Clinical School, University of New South Wales  Sydney New South Wales Australia"},{"name":"Spine Service, Department of Orthopaedic Surgery St. George Hospital Campus  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alisha","family":"Sial","sequence":"additional","affiliation":[{"name":"Spine Labs, St. George &amp; Sutherland Clinical School, University of New South Wales  Sydney New South Wales Australia"},{"name":"Spine Service, Department of Orthopaedic Surgery St. George Hospital Campus  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Harvinder S.","family":"Sandhu","sequence":"additional","affiliation":[{"name":"Spinal Surgical Service, Hospital for Special Surgery, Weill Medical College of Cornell University  New York New York USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Esther","family":"Apos","sequence":"additional","affiliation":[{"name":"Kunovus Technologies  Sydney New South Wales Australia"},{"name":"Cmsscidoc Pty Ltd  Melbourne Victoria Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Richard","family":"Appleyard","sequence":"additional","affiliation":[{"name":"Orthopaedic Biomechanics Research Group, Department of Biomedical Sciences, Faculty of Medicine and Health Sciences Macquarie University  Sydney New South Wales Australia"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ashish D.","family":"Diwan","sequence":"additional","affiliation":[{"name":"Spine Labs, St. George &amp; 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