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]

Core Viewpoint - Pacira BioSciences, Inc. has received a Paragraph IV Certification Notice Letter from The WhiteOak Group, which has filed an Abbreviated New Drug Application for a generic version of EXPAREL, claiming that the patents are invalid or not infringed [1][2] Patent and Legal Context - WhiteOak alleges that 19 patents related to EXPAREL are invalid, unenforceable, or will not be infringed by their product [2] - The contested patents are from two families, with expiration dates of January 22, 2041, and July 2, 2044 [3] - Pacira has 45 days to file a lawsuit to protect its intellectual property rights, which would trigger a 30-month stay of FDA approval for WhiteOak's ANDA submission [4] Company Overview - Pacira specializes in non-opioid pain therapies, with three commercial-stage products: EXPAREL, ZILRETTA, and iovera° [5] - EXPAREL is a long-acting local analgesic approved for various postsurgical pain management applications, significantly reducing opioid consumption by up to 78% [6]