The Kunovus Disc Device aims to preserve the structural and biomechanical integrity of the lumbar intervertebral disc in patients undergoing a discectomy procedure

Chronic low back pain is frequently due to the defects or failures of the lumbar intervertebral disc, leading to herniation of the inner disc material. This can cause irritation and/or mechanical compression of the spinal cord or the exiting nerves, which results in pain and/or reduced mobility. The conventional surgical approach for treating lumbar disc herniation is discectomy, wherein the loose nuclear fragments in the spinal canal are removed and clearance of the nuclear cavity is performed. Although discectomy generally results in immediate pain relief, the operated disc may gradually collapse and become a source of recurrent pain. Recent data shows that one in five discs will re-herniate within the first decade of surgery, necessitating another surgical procedure. The Kunovus System and the Kunovus Disc Device have been developed to address this procedural lacuna and aims to preserve the structural and biomechanical integrity of the lumbar intervertebral disc after a discectomy procedure.

Achievements
Achievements
  • Multiple US patents issued protecting the core technology
  • Rigorous biomechanical testing on the device (in vitro testing, fatigue, aged-fatigue, static creep, shock, and expulsion testing)
  • BioCompatibility and Toxicology studies completed per ISO 10993
  • BioCompatibility Lapine study completed
  • "Worst case scenario" Ovine studies completed
  • Human cadaver study - validation of surgical techniques for device implantation
  • Collaborations with leading spine surgeons and hospitals worldwide
The Kunovus Disc Device consists of an inflatable balloon which is first inserted into the nucleus cavity following discectomy, and then receives a two-part in situ curing biomaterial. Elastomeric flexible containment balloon provides bespoke size and avoids extrusion. The in situ curing biomaterial cures within 3 minutes after mixing and forms a uniform elastomeric implant that restores the structure and biomechanical integrity of the intervertebral disc.
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6/22 Belgrave Street
Kogarah
Sydney, NSW 2217

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Disclaimer: The Kunovus System and the Kunovus Disc Device are not approved in any jurisdiction for clinical use. The System and the Device are investigational only at this stage and not available for commercial sale.

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