VitaDisc® for intervertebral disc degeneration
VitaDisc® is a class III medical device that targets Chronic Lower Back Pain (CLBP) due to Intervertebral Disc Degeneration (IVDD). IVDD is the most common cause of CLBP, associated with ~40% of cases. It is a slowly progressive condition that evolves over decades in a self-amplifying disease cycle. This means it lends itself very well to early, disease-modifying intervention.
VitaDisc® tackles the disease before irreversible damage (such as annular tears or disc herniation) occurs and resets the state of the disc to its healthy baseline. When administered to discs with Pfirrmann grades II-IV degeneration, VitaDisc®’s effects are expected to last years. VitaDisc® can be easily repeated with no cumulative morbidity.
We are planning small and large animal biocompatibility testing in compliance with ISO10993 for next year, and will start human studies in 2024.
Osteoarthritis products for synovial joints
We are currently at the R&D stage, exploring the technology’s potential as a stand-alone bioactive material and as an inducer to pluripotent stem cells.
We have thus far have seen evidence in bovine and human cell cultures that the solubilized notochordal matrix powder is capable of stimulating native or pluripotent stem cells to proliferate and produce a substantial increase in glycosaminoglycans and type-II collagen matrix.