Intermediate clinical study results presented at SMISS 2021
November 4, 2021
NORWALK, Conn.–(BUSINESS WIRE)–Premia Spine, a medical technology company aiming to change the way debilitating chronic leg and back pain is treated, today announced that intermediate clinical study results supporting the use of its TOPS™ facet arthroplasty system for lumbar spinal stenosis and degenerative spondylolisthesis were presented at the 2021 Society for Minimally Invasive Spine Surgery (SMISS) meeting in Las Vegas by Dr. John Chi, associate professor, Harvard Medical School. The data showed that patients treated with TOPS had consistently good outcomes at the six-week immediate post-operative visit that were maintained and even improved at 12 months.
“These results point to the potential of TOPS becoming a new and exciting option for the treatment of degenerative spondylolisthesis that allows us to stabilize patients while preserving motion,” said Dr. Chi. “While the study remains underway, I am very encouraged by the interim patient-reported data.”
The interim analysis reviewed 153 TOPS patients, 58 of which had reached 12-month follow-up. The patient-reported outcomes demonstrate significant early and sustained improvements in the Oswestry Disability Index (ODI), visual analog scale (VAS)-Back, and VAS-Leg scores:
- Mean baseline ODI, VAS-Back, and VAS-Leg were 57.1, 69.0, and 85.6 respectively
- ODI improved 36.8 points at six weeks and 46.2-points at 12 months
- VAS-Back improved 54.9 points at six weeks and 58.4 points at 12 months
- VAS-Leg improved 73.5 at six weeks and 72.3 points at 12 months
“These interim results add to a large foundation of data we have gathered and are continuing to gather to build clinical evidence for TOPS,” said Premia Spine CEO Ron Sacher. “We are committed to offering a new solution to patients seeking an alternative to fusion for the treatment of spinal stenosis and degenerative spondylolisthesis that allows patients to retain the natural motion of their spine.”
The first and only facet joint replacement system for the lumbar spine, TOPS was developed to provide mobility, stability and durability after decompression for patients with lumbar spinal stenosis and degenerative spondylolisthesis.
Spinal stenosis and degenerative spondylolisthesis are painful, debilitating and highly prevalent conditions impacting over 100 million people globally1. An estimated 350,000 people undergo lumbar spinal fusion each year for these conditions2, representing a $2 billion annual addressable global market.
About Premia Spine
Premia Spine, a medical technology company, aims to improve the lives of chronic leg and back pain patients with its TOPS™ System. TOPS is designed to provide lasting mobility, stability and durability to patients with lumbar spinal stenosis, degenerative spondylolisthesis and related spinal conditions. For more information, visit premiaspine.com.
1 Ravindra, V. M., et al. Degenerative Lumbar Spine Disease: Estimating Global Incidence and Worldwide Volume. Global Spine Journal: 2018, Vol 8, Issue 8. https://journals.sagepub.com/doi/full/10.1177/2192568218770769
2 2019 Spinal Surgery Update. Orthopedic Network News: Volume 30, Number 4, October 2019.
Pazanga Health Communications