NewVert, Ltd., Announces Results of International Spinal Repair (“ISPR”) Market Survey

NETANYA, Israel--(BUSINESS WIRE)--NewVert Ltd., today announced results of a recently sponsored international survey (ISPR¹) of spine surgeons focused on trend in lumbar discectomy. Recent spine repair literature suggests that out of the 480,000² discectomy procedures performed each year in the US, an overall re-herniation rate of 6% require repeat surgery.

“High reported rates of repeat lumbar discectomy surgery suggest a pressing need for improvements in technique, technology, and outcomes for patients requiring this procedure. The ISPR survey results bear out this observation. Octopus has the potential to provide relief to patients facing either primary or repeat lumbar discectomy surgery.”

Key findings of the ISPR Survey included:

• 77% of respondents believe current lumbar discectomy surgical techniques require improvement in technology
• Over 80% of respondents report repeat lumbar discectomy surgery is required in over 15% of patients seen
• Once a repeat lumbar discectomy surgery is performed, nearly 90% of respondents report a 3^rd procedure in nearly 10% of patients seen

When presented with a description and capabilities of NewVert’s Octopus Spinal Annular Repair System (OSA) ^3,4 respondents reported the following:

• Over 50% believe Octopus will have the potential to reduce re-operation lumbar discectomy surgery rates
• 70% of respondents believe Octopus will reduce total lumbar discectomy surgery procedures by up to 15%

Ory Keynan, MD, Head of the Service for Degenerative Spinal Disorders at the Sourasky Medical Center, Israel, and Chairman of the Clinical Advisory Board for NewVert commented, “High reported rates of repeat lumbar discectomy surgery suggest a pressing need for improvements in technique, technology, and outcomes for patients requiring this procedure. The ISPR survey results bear out this observation. Octopus has the potential to provide relief to patients facing either primary or repeat lumbar discectomy surgery.”

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

About the Spinal Annular Repair Market

With an estimated 480,000⁵ 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.⁶ 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%⁷ 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%.⁸ The total procedure cost for managing a lumbar herniation is estimated to be $43,118⁹ 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.

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¹ Full ISPR Survey results on file at NewVert Ltd.
² Sherman J, Cauthen J, Schoenberg D, et al. Economic impact of improving outcomes of lumbar discectomy. Spine J 2010;10:108–16.
³ This product is not approved for sale.
⁴ Patents pending.
⁵ Sherman J, Cauthen J, Schoenberg D, et al. Economic impact of improving outcomes of lumbar discectomy. Spine J 2010;10:108–16.
⁶ 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
⁷ 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.
⁸ 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.
⁹ Elisabeth Hansson , Tommy Hansson. The cost–utility of lumbar disc herniation surgery. Eur Spine J (2007) 16:329–337.