NETANYA, Israel--()--NewVert Ltd., today announced appointment of Jeffrey Lotz, PhD, to the Clinical Advisory Board (CAB) for its Octopus Spinal Annular Repair System (OSA)2. The CAB will meet periodically to assess the development strategies for OSA and advise the company on the state of the spinal repair market.
Ory Keynan, MD, Chairman of the CAB commented, “Dr. Lotz is a world leader in the application of bioengineering to orthopedic implants. Dr. Lotz will bring tremendous experience to the CAB as we continue the development of the Octopus Spinal Annular Repair System. The world-class clinical capabilities and real-life experiences represented by this CAB in orthopedic implants and spinal surgical repair make this group uniquely suited to support the ongoing development of NewVert’s Octopus technology.”
Professor Jeffrey Lotz, Ph.D. has been the Director of the Orthopaedic Bioengineering Laboratory at the University of California, San Francisco since 1992. Dr. Lotz earned a doctorate degree in Medical Engineering from the Harvard/MIT Division of Health Sciences and Technology, a Masters Degree in Mechanical Engineering Design from Stanford University, and Bachelors of Science in Mechanical Engineering from UC Berkeley. Dr. Lotz is a Member of the National Institutes of Health Peer Review Committee for Tissue Engineering Grants.
As a principal investigator, Dr. Lotz has procured over $10M in extramural funding for spine-related projects. He has earned several awards for spine research, including the ISSLS Prize (2007), Volvo Award (1998), and the North American Spine Society Award (1993). He serves as a Deputy Editor for the journal Spine, and an Associate Editor for The Spine Journal. He has expertise in spine biomechanics and intervertebral disc biology and has published 150 peer-reviewed journal articles. His laboratory work focuses on identifying mechanisms of intervertebral disc degeneration, exploring tissue engineering approaches for treating low back pain, and the biomechanics of spinal instrumentation.
Dr. Lotz commented, “I am excited to join the Clinical Advisory Board for NewVert. Throughout my career, I have sought new and innovative solutions for patients suffering from degenerative disc disease and injury. The Octopus Spinal Annular Repair System is an interesting and promising approach in minimally invasive repair of the annulus following discectomy procedures. I look forward to working with the NewVert team to advance the development of Octopus.”
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.
On July 10, 2012, NewVert, Ltd., announced formation of a Clinical Advisory Board for the Octopus Spinal Annular Repair System
On July 30, 2012, NewVert, Ltd., announced completion of initial round of in-vitro biomechanical testing for the Octopus Spinal Annular Repair System
On September 10, 2012, NewVert, Ltd., Announces Results of International Spinal Repair (“ISPR”) Market Survey
About the Spinal Annular Repair Market
With an estimated 480,0003 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.4 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%5 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%.6 The total procedure cost for managing a lumbar herniation is estimated to be $43,1187 per case, with an annual total patient population cost estimated to be over $20 billion.
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 Sherman J, Cauthen J, Schoenberg D, et al. Economic impact of improving outcomes of lumbar discectomy. Spine J 2010;10:108–16.
4 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
5 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.
6 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.
7 Elisabeth Hansson , Tommy Hansson. The cost–utility of lumbar disc herniation surgery. Eur Spine J (2007) 16:329–337.