Pacira BioSciences' Iovera System Delivers Stronger Pain Relief Than RFA in Latest Clinical Trial Data

Recent pilot study results from Pacira BioSciences PCRX are turning heads in the chronic pain management space. The company’s iovera system—a drug-free device that uses cold therapy to temporarily block pain signals—significantly outperformed radiofrequency ablation (RFA) across multiple clinical endpoints in treating chronic low back pain (CLBP).

The Data That Matters: Iovera vs RFA Head-to-Head

When it comes to numbers, the results speak clearly. The pilot study tracked 30 patients with facet-mediated CLBP, randomly assigned to receive either iovera cryoneurolysis or conventional RFA treatment. Here’s what happened:

Pain Relief Comparison: Patients treated with iovera reported significantly lower pain scores at both 180 days (3.1 vs 5.4) and 360 days (3.0 vs 6.1) compared to the RFA group. This sustained improvement suggests that iovera’s cryoneurolysis approach—which uses targeted cold to disrupt nerve signaling without heat damage—may provide more durable benefits than heat-based alternatives.

Functional Recovery: The Oswestry Disability Index, a key measure of functional improvement, showed iovera patients experienced substantially better outcomes. At 360 days, the iovera group scored 10.1 versus 20.6 for RFA, indicating significantly greater restoration of mobility and daily function.

Revision Treatment Rates: Perhaps most telling was the need for additional interventions. Only 45.5% of iovera patients required follow-up spine injections within 180 days, compared to 75% in the RFA group—a meaningful difference suggesting iovera’s effects held up better over time.

Why This Matters for the Market

CLBP ranks as the leading cause of disability in the United States and drives substantial opioid consumption, with facet-mediated pain accounting for up to 45% of cases. The traditional RFA approach has limitations: heat-based therapy can damage surrounding tissue, creating a genuine need for gentler alternatives. Iovera’s cryoneurolysis mechanism sidesteps this issue, using cold rather than heat to achieve temporary nerve numbing—a tissue-sparing advantage that addresses a clear clinical gap.

The iovera system, acquired by Pacira BioSciences through its MyoScience purchase, works by delivering immediate pain relief, with effects typically lasting several months as the treated nerve naturally regenerates. Most notably, the pilot study recorded no treatment-related adverse events in either group over 12 months, suggesting a favorable safety profile.

Expanding the Opportunity: New Spine Procedure Access

Adding momentum to these clinical wins, Pacira BioSciences received FDA clearance in early 2025 for a new SmartTip designed to enable deeper nerve access for lumbar procedures, including sciatic nerve block techniques in the popliteal fossa region. This innovation could unlock additional applications for iovera beyond the current facet joint focus, potentially opening new revenue streams.

The Broader Portfolio Supporting Growth

Beyond iovera, Pacira BioSciences markets two established pain-management products. Exparel, the company’s flagship drug launched in 2012, handles postsurgical local analgesia and regional nerve blocks across multiple anatomical sites. Zilretta, an extended-release intra-articular therapy, delivers osteoarthritis pain relief to knee patients, with the company currently pursuing shoulder OA indication expansion through a Phase III trial initiated in 2024.

This diversified portfolio positions Pacira to capture value across multiple pain-management segments, with iovera’s strong clinical data potentially driving adoption across the broader spine pain market.

Stock Performance and Investment Perspective

PCRX shares have gained 26.1% over the past year, outpacing the broader biotech sector’s 9.1% growth. While Pacira BioSciences currently holds a Zacks Rank #3 (Hold), the iovera pilot study results and expanded SmartTip clearance could support continued investor interest in the stock’s pain-management narrative.