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

In the news release, Positive Payor Policy Covering coflex® by Select Health of South Carolina for the Surgical Treatment of Lumbar Spinal Stenosis, issued Dec. 11, 2018 by Paradigm Spine, LLC over PR Newswire, we are advised by the company that the fourth and fifth paragraphs have been updated to clarify limitations on the coverage policy. The complete, corrected release follows:

Positive Payor Policy Covering coflex® In Specific Limited Situations For The Surgical Treatment Of Lumbar Spinal Stenosis Issued By Select Health Of South Carolina

- 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 /PRNewswire/ -- Paradigm Spine, LLC, a leader in providing solutions for the treatment of lumbar spinal stenosis, today announced that Select Health of South Carolina has issued a clinical policy, dated September 1, 2018, for the exclusive coverage of the coflex^® interlaminar stabilization device for the treatment of lumbar spinal stenosis under certain specific clinical 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."

The Select Health of South Carolina policy lists several necessary evidence-based criteria and contraindications limiting use of the coflex^® device. All of the following are required for coflex^® to be considered medically necessary: diagnosis of at least moderate lumbar spinal stenosis between L1 and L5 of one or two contiguous vertebrae, requiring surgical decompression; radiography confirming the above diagnosis as well as the absence of gross angular or translatory instability of the spine at index or adjacent levels; the member must experience relief in flexion from their symptoms of leg, buttock, or groin pain, with or without back pain; and completion of at least six months of unsuccessful non-operative treatment consisting of non-steroidal anti-inflammatory drugs and at least one of several conservative approaches.

Select Health of South Carolina considers the device not medically appropriate if any one of several conditions is present, including: more than two vertebral levels that require decompression; any of several conditions resulting in gross instability of the lumbar spine; isthmic spondylolisthesis or spondylolysis; back or leg pain of unknown origin; axial back pain only, without leg, buttock or groin pain; cauda equine syndrome; active or chronic conditions such as obesity, infection, rheumatoid arthritis or other autoimmune disease requiring chronic steroid use, tobacco use, or most malignancies within the past five years; certain allergies; or uncertain commitment to postsurgical rehabilitation.

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.

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SOURCE Paradigm Spine, LLC