Paradigm spine highlights data presented at isass 2018 further validating decompression with coflex power per kwh

"coflex ® is the only posterior lumbar motion preservation solution with proven long-term outcomes for patients with moderate to severe spinal stenosis," said Marc Viscogliosi, Chairman and CEO of Paradigm Spine. "Five years after the FDA IDE study, these analyses demonstrate that coflex leads to decreased operative time, less blood loss, shorter hospital stays and overall is significantly less invasive than fusion. As a result, coflex is more cost-effective for the healthcare system while preserving positive clinical outcomes. These findings are substantial and important because they reflect real-world considerations surgeons take into account when treating patients."

The first podium presentation "5-year Follow-up of Interlaminar Stabilization Surgery in the ≤ 65 Year Old Patient: More Value, Less Cost," provided a sub-analysis of a cohort from the original multi-center, prospective, randomized, controlled Investigational Device Exemption (IDE) clinical trial that showed:

The lightning podium presentation "Medical Cost Savings for Lumbar Spinal Stenosis Treated with Decompression and Interlaminar Stabilization as an Alternative to Fusion" examined the potential economic impact of utilizing decompression with coflex versus decompression with fusion. The analysis showed:

A second lightning podium presentation "Comparison of Decompression with Interlaminar Stabilization vs. Decompression with Fusion in Patients Requiring Surgical Treatment for Spinal Stenosis Grade I Spondylolisthesis at 5 Year Follow-Up" provided a sub-analysis of a cohort from the FDA IDE trial comparing the efficacy of decompression with coflex versus decompression with fusion and concluded:

Lumbar spinal stenosis (LSS), affecting 1.6 million patients annually in the United States, is a debilitating and degenerative disease often associated with significant leg and back pain, leg numbness and weakness, and significant reduction in an active lifestyle. Historically, the two traditional surgical treatment options for LSS included decompression alone or decompression with lumbar fusion. Decompression alone has proven effective at relieving pain symptoms caused by lumbar spinal stenosis, however, patients may not experience long term symptomatic relief, resulting in subsequent epidural injections for pain management, or additional surgeries for conversion to a fusion. Decompression with fusion has proven to provide pain relief and stabilize the diseased segment, but may lead to adjacent level disease requiring subsequent surgeries.

Paradigm Spine, LLC, founded in 2004, is a privately held company and remains 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. For additional information visit www.paradigmspine.com or www.coflexsolution.com.