NewVert, Ltd., Announces Completion of Initial Round of In-Vitro Biomechanical Testing for the Octopus Spinal Annular Repair System (press release)
NewVert Ltd., today announced completion of the initial biomechanical testing phase for its Octopus Spinal Annular Repair System (OSA)(1,2). The Institute of Orthopaedic Research and Biomechanics, (Ulm, Germany), conducted the evaluation.
Hagay Drori, CEO, 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, these successful results attest to the potential utility of this exciting new technology.” Mr. Drori continued, “Our focus now will shift to long-term durability testing for Octopus as we prepare regulatory applications in anticipation of commercial release.”
Stephan Becker, MD(3), Director of Orthopedics & Spine at the Institute for Musculoskeletal Analysis, Research and Therapy (IMSART) in Vienna, Austria commented “The Octopus Spinal Annular Repair System is a unique technology for patients requiring annular repair of the spine. The device has proved itself in the current round of biomechanical studies. Octopus in my opinion has the potential to become an important addition to standard microdiscectomy, avoiding recurrent spinal disc herniation. I am looking forward to offer it to my patients when it becomes commercially available.”
About the Octopus Spinal Annular Repair System
NewVert is developing a novel minimally invasive implant, the Octopus Spinal Annular Repair System (OSA), designed to repair the annulus following discectomy procedures to improve clinical outcomes and reduce the risk of costly re-operations. OSA is a unique deformable implant composed of Nitinol, a super-elastic shape-memory alloy capable of providing mechanical support to the annular spinal tissues during healing post-implantation as well as delivery of therapeutic agents to enhance wound healing and improve patient outcomes.
About the Spinal Annular Repair Market
With an estimated 480,000(4) discectomy procedures for managing lumbar herniation performed each year in the US, lumbar discectomy has been criticized in the medical literature for producing inconsistent results.(5) The most recent data from Spine Patient Outcomes Research Trial (SPORT) reported an overall re-herniation rate of 6% requiring repeat surgery. It has been suggested that following discectomy surgery, approximately 20% to 40% of patients report recurring back pain and 5% to 15% present with recurrent disc herniation. Reoperation rates as 21%(6) have been reported. 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. The recurrent herniation rate of conservative discectomy is 5-18%, while the aggressive discectomy recurrent herniation rate ranges from 2-10%.(7) The total procedure cost for managing a lumbar herniation is estimated to be $43,118(8) per case, with an annual total patient population cost estimated to be over $20 billion.
About The Institute of Orthopaedic Research and Biomechanics, (Ulm, Germany)
The overall goal of research activities at the Institute of Orthopaedic Research and Biomechanics is to better understand the reasons for the degeneration of the musculoskeletal motion apparatus, and to improve and test new therapies to treat these problems. The institute was founded in 1978 as the Research Laboratory for Experimental Trauma Surgery. In 1989 the Research Laboratory became a chair for “Orthopaedic Research and Biomechanics” at the Medical Faculty of the University of Ulm. The University was founded in 1967 and focuses on natural sciences, medicine, engineering sciences, mathematics, economics and computer science.
About NewVert Ltd.
Founded in 2010 by Dr. Hamid Sharim, MD and Mr. Roey Shafrir, B.Sc., NewVert is a privately held, development stage medical device company focused on minimally invasive spinal repair solutions. NewVert is developing a novel, proprietary medical device implant, Octopus Spinal Annular Repair System (OSA), intended to provide a stable platform for tissue healing and superior patient outcomes following lumbar discectomy. For more information regarding NewVert Ltd., and the Octopus Spinal Annular Repair System (OSA), please see www.new-vert.com .
(1) This product is not approved for sale.
(2) Patents pending.
(3) Dr. Becker is a Member of the New-Vert Clinical Advisory Board
(4) Sherman J, Cauthen J, Schoenberg D, et al. Economic impact of improving outcomes of lumbar discectomy. Spine J 2010;10:108-16.
(5) DeBerard MS, LaCaille RA, Spielmans G, et al. Outcomes and presurgery correlates of lumbar discectomy in Utah workers’ compensation patients. Spine J 2009;9:193-203
(6) Carragee EJ, Han MY, Suen PW, Kim D. Clinical outcomes after lumbar discectomy for sciatica: the effects of fragment type and annular competence. J Bone Joint Surg Am 2003;85:102-8.
(7) William C. Watters, Matthew J. McGirt, An evidence-based review of the literature on the consequences of conservative versus aggressive discectomy for the treatment of primary disc herniation with radiculopathy. The Spine Journal 9 (2009) 240-257.
(8) Elisabeth Hansson , Tommy Hansson. The cost-utility of lumbar disc herniation surgery. Eur Spine J (2007) 16:329-337.
SOURCE: NewVert Ltd.