Pacira Data Shows iovera° Outperforms RFA in Chronic Back Pain Study

Event summary

  • A randomized pilot study published in *Pain Physician* compared Pacira BioSciences’ iovera° cryoneurolysis to radiofrequency ablation (RFA) for chronic low back pain (CLBP).
  • Patients treated with iovera° demonstrated significantly lower pain scores (3.1 vs. 5.4 at 180 days, 3.0 vs. 6.1 at 360 days) and improved functional disability (ODI scores of 10.1 vs. 20.6 at 360 days) compared to RFA.
  • The study reported that 45.5% of iovera° patients versus 75% of RFA patients required additional spine injections after 180 days.
  • No treatment-related adverse events were reported in either group.
  • Pacira recently received FDA clearance for a new ‘SmartTip’ designed to allow deeper nerve access for lumbar applications.

The big picture

Chronic low back pain represents a substantial economic burden in the U.S., driving opioid use and disability claims. Pacira’s iovera° offers a non-opioid alternative to RFA, a standard treatment with potential tissue damage. The pilot study’s positive results, while preliminary, suggest iovera° could capture a portion of this large market, but broader adoption hinges on larger, more definitive clinical trials and favorable reimbursement.

What we're watching

Clinical Adoption
The pace of adoption of iovera° by clinicians will depend on broader acceptance of cryoneurolysis as a viable alternative to RFA, particularly given the pilot study’s small sample size.
Regulatory Pathway
Further clinical evidence and FDA approvals for expanded indications will be critical for Pacira to meaningfully penetrate the chronic low back pain market, which represents a significant unmet need.
Competitive Landscape
The emergence of competing cryoneurolysis technologies or alternative pain management solutions could erode iovera°’s market share and limit Pacira’s revenue growth.

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Biotechnology Medical Devices