Devices Orthopaedic Neurosurgery Reimbursement

 News Release - December 11, 2018

Positive Payor Policy Covering coflex(R) by Select Health of South Carolina for the Surgical Treatment of Lumbar Spinal Stenosis

Coverage policy issued by Select Health of South Carolina

Select Health of South Carolina serves more than 364,000 lives

Policy exclusively covers coflex® Interlaminar Stabilization®

coflex® is a non-fusion, motion-preserving implant for treatment of lumbar spinal stenosis

Lumbar spinal stenosis affects 1.6 million U.S. patients annually

NEW YORK, Dec. 11, 2018 -- (Healthcare Sales & Marketing Network) -- Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis, today announced issuance of a Select Health of South Carolina Clinical Policy, dated September 1, 2018, for the exclusive coverage of the coflex® interlaminar stabilization device for the treatment of lumbar spinal stenosis in patients meeting certain eligibility criteria.

Lumbar spinal stenosis ("LSS"), affecting 1.6 million patients annually, is a debilitating and degenerative disease in older patients (>50 years) often associated with significant leg and back pain, leg numbness and weakness, causing a significant reduction in an active lifestyle. Traditional surgical treatment options for LSS include a decompression that removes bone and soft tissue and may also require a fusion to stabilize the spine. The coflex® device is a non-fusion, motion-preserving stabilization implant that is FDA PMA approved for the treatment of lumbar spinal stenosis and is used in conjunction with a decompression, or used in lieu of a spinal fusion.

Marc Viscogliosi, Paradigm Spine Chairman & CEO, commented, "This payor coverage adds to our growing momentum, enabling expanded access to our unique coflex® solution, which is backed by more than 90 peer-reviewed published articles, including landmark long-term follow-up clinical studies, and coverage policy recommendations from spine medical societies."

On November 1, 2018, Paradigm Spine entered into a definitive agreement with RTI Surgical, Inc. whereby RTI will acquire all outstanding equity interest in Paradigm Spine. RTI has expressed its commitment to continue building coflex® into a therapy of choice for orthopedic surgeons given its demonstrated value and effectiveness for patients.

To learn more about coflex® Interlaminar Stabilization®, please visit www.coflexsolution.com.

About Paradigm Spine, LLC

Paradigm Spine, LLC, founded in 2004, is focused on the design and development of solutions for the disease management of spinal stenosis. The Company's signature product is the coflex® Interlaminar Stabilization® device, which is currently used in over 60 countries worldwide. coflex® is the only lumbar spinal device that has produced Level I evidence in two separate prospective, randomized, controlled studies against two different control groups, changing the standard of care for lumbar spinal stenosis treatment. On November 1, 2018, Paradigm Spine entered into a definitive agreement with RTI Surgical, Inc. whereby RTI will acquire all outstanding equity interest in Paradigm Spine. For additional information visit www.paradigmspine.com or www.coflexsolution.com.

Source: Paradigm Spine

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