Pacira BioSciences Announces Results From 12-Month Pilot Study Demonstrating Favorable Safety and Significant Improvements in Pain With iovera° Compared to Radiofrequency Ablation in Chronic Low Back Pain

Core Insights - The study published in Pain Physician shows that iovera° cryoneurolysis significantly improves functional outcomes for chronic low back pain patients compared to radiofrequency ablation (RFA) [1][6] - Patients treated with iovera° experienced lower pain scores and improved functional disability over a 12-month period [8] Study Findings - The pilot study involved 30 patients with facet-mediated chronic low back pain, comparing iovera° to RFA [4] - At 180 days, pain scores for iovera° patients were 3.1 compared to 5.4 for RFA patients (p=0.01) [8] - At 360 days, pain scores for iovera° patients were 3.0 compared to 6.1 for RFA patients (p=0.01) [8] - Functional disability, measured by the Oswestry Disability Index (ODI), showed iovera° patients scoring 10.1 at 360 days versus 20.6 for RFA patients (p=0.002) [8] - Fewer iovera° patients required additional spine injections after 180 days, with 45.5% needing further treatment compared to 75% of RFA patients [8] - No treatment-related adverse events were reported in either group during the 12-month follow-up [8] Treatment Mechanism - The iovera° system utilizes cryoneurolysis, applying focused cold therapy to targeted nerves to interrupt pain signal transmission [2][8] - Pain relief is typically immediate and can last up to 90 days as the nerve regenerates [2][9] Industry Context - Chronic low back pain is a leading cause of disability in the U.S. and contributes significantly to opioid use [3] - The need for alternative, tissue-sparing approaches like cryoneurolysis is underscored by the potential tissue damage associated with RFA [3] - The FDA recently cleared a new SmartTip for iovera° to allow deeper nerve access for lumbar applications, supporting ongoing clinical evidence expansion [6]