The initial biomechanical testing phase for NewVert’s Octopus Spinal Annular Repair System (OSA) has been successfully completed, according to a company press release. OSA is a deformable implant composed of nitinol, a super-elastic shape-memory alloy capable of providing mechanical support to the annular spinal tissues during post-implantation healing. The product is designed to repair the annulus following discectomy procedures and, hopefully, reduce the risk of costly re-operations. Developers say it is intended to provide a stable platform for tissue healing following a lumbar discectomy.
NewVert, Ltd is located in Netanya, Israel and The Institute of Orthopaedic Research and Biomechanics, of Ulm, Germany, performed the testing. Hagay Drori, CEO, of NewVert Ltd., commented on the results of the evaluations. “We are thrilled to have reached this important development milestone. Octopus successfully completed the initial biomechanical testing phase, simulating spinal annular repair during ‘worst case’ biomechanical loading scenarios, ” according to the July 30 press release.
Company officials report that, for managing lumbar herniation, there are an estimated 480, 000 discectomy procedures performed each year in the U.S. According to Drori, lumbar discectomy has been criticized in the medical literature for producing inconsistent results. The most recent data from Spine Patient Outcomes Research Trial reported an overall re-herniation rate of 6% requiring repeat surgery. Surgeons have estimated that, following discectomy surgery, approximately 20% to 40% of patients report recurring back pain and 5% to 15% present with recurrent disc herniation.
Surgeons have noted re-operation rates of 21%. Drori says that the rate of recurrent herniation is dependent on whether the discectomy was “conservative” or “aggressive.” Aggressive discectomy can accelerate degenerative processes, be a source of back pain and cause a relapse in symptoms. Conservative discectomy can potentially cause less operative pain, but it is associated with a higher recurrent herniation rate.
Drori says that the recurrent herniation rate of conservative discectomy is 5-18%, while the aggressive discectomy recurrent herniation rate ranges from 2-10%. The total procedure cost for managing a lumbar herniation he estimates to be $43, 118 per case, with an annual total patient population cost of over $20 billion. Hamid Sharim, M.D. and Roey Shafrir founded NewVert in 2010. It is a privately held development stage medical device company focused on minimally invasive spinal repair solutions.
