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
-- New data published in Pain Physician shows significant improvement in functional outcomes with iovera° --
-- Fewer iovera° patients required additional spine injections after 180 days --
-- No treatment-related adverse events were reported --
BRISBANE, Calif., Dec. 02, 2025 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced results from a randomized 30-patient pilot study evaluating iovera° cryoneurolysis versus radiofrequency ablation (RFA) for chronic low back pain (CLBP). The study, published in Pain Physician, the official journal of the American Society of Interventional Pain Physicians, demonstrated favorable safety, pain reduction, and functional disability outcomes for patients treated with iovera° over a 12-month period.
The ioveraº system is a drug-free treatment that relieves pain via cryoneurolysis, a process whereby focused cold therapy is applied to a targeted nerve, temporarily interrupting its ability to transmit pain signals. Pain relief is typically experienced immediately after treatment, with the effects lasting up to 90 days as the nerve gradually regenerates.
CLBP is the leading cause of disability in the U.S. and a major driver of opioid use, with facet-mediated pain representing up to 45% of cases. RFA, a standard interventional treatment, uses heat to destroy targeted nerves but can damage nearby tissue underscoring the need for alternative, tissue-sparing approaches like cryoneurolysis.
The unblinded, single-center pilot study evaluated patients with facet-mediated CLBP who were randomized to receive either iovera° cryoneurolysis or RFA. Baseline characteristics, including pain scores, BMI, pain duration, and disability were similar between groups.
Key Published Findings:
- Patients treated with iovera° experienced significantly lower pain scores at both 180 and 360 days compared with those treated with RFA
- Day 180: 3.1 vs. 5.4 (p=0.01)
- Day 360: 3.0 vs 6.1 (p=0.01)
- Functional disability improved more substantially with iovera°, with Oswestry Disability Index (ODI) scores significantly lower at 360 days
- Day 360: 10.1 vs 20.6 (p=0.002)
- Fewer iovera° patients required additional spine injections after 180 days
- 45.5% of iovera° patients vs. 75% of RFA patients needed additional treatments
- No treatment-related adverse events were reported in either group across the 12-month follow-up period.
- The study was not blinded, and the short tip of the cryoneurolysis device restricted its use to patients with low body mass indexes.
"These published findings highlight the potential of iovera° to offer immediate, sustained and meaningful pain relief without the disadvantages of radiofrequency ablation," said Jonathan Slonin, M.D., MBA, Chief Medical Officer at Pacira BioSciences. "With chronic low back pain contributing to disability, opioid prescriptions, and significant economic burden, we are encouraged by these data and how they support our ongoing spine tip development program."
The results further support ongoing collaborative initiatives to expand the clinical evidence for iovera° across spine-related pain pathways. A new SmartTip to allow deeper nerve access for lumbar applications was recently cleared by the FDA.
To learn more about these findings and their implications for future spine care innovation, read the full study in Pain Physician.
About iovera®°
The iovera° system uses the body's natural response to cold to treat peripheral nerves and immediately reduce pain without the use of drugs. Treated nerves are temporarily stopped from sending pain signals for a period of time, followed by a restoration of function. Treatment with iovera° works by applying targeted cold to a peripheral nerve. A precise cold zone is formed under the skin that is cold enough to immediately prevent the nerve from sending pain signals without causing damage to surrounding structures. The effect on the nerve is temporary, providing pain relief until the nerve regenerates and function is restored. Treatment with iovera° does not include injection of any substance, opioid, or any other drug. The effect is immediate and can last up to 90 days. The iovera° system is not indicated for treatment of central nervous system tissue. Additional information is available at www.iovera.com.
Indication and Select Important Safety Information for iovera°
Indication: iovera° applies freezing cold to peripheral nerve tissue to block and/or relieve pain for up to 90 days. It should not be used to treat central nervous system tissue.
Important Safety Information
- Do not receive treatment with iovera° if you experience hypersensitivity to cold or have open and/or infected wounds near the treatment site.
- You may experience bruising, swelling, inflammation and/or redness, local pain and/or tenderness, and altered feeling at the site of application.
- In treatment area(s), you may experience damage to the skin, skin darkening or lightening, and dimples in the skin.
- You may experience a temporary loss of your ability to use your muscles normally outside of the treatment area.
- Talk to your doctor before receiving treatment with iovera°.
About Pacira
Pacira delivers innovative, non-opioid pain therapies to transform the lives of patients. Pacira has three commercial-stage non-opioid treatments: EXPAREL® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block, an adductor canal nerve block, and a sciatic nerve block in the popliteal fossa for postsurgical pain management; ZILRETTA® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and iovera®º, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. The company is also advancing the development of PCRX-201 (enekinragene inzadenovec), a novel locally administered gene therapy with the potential to treat large prevalent diseases like osteoarthritis. To learn more about Pacira, visit www.pacira.com.
Forward-Looking Statements
Any statements in this press release about Pacira's future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words "anticipate," "believe," "can," "could," "estimate," "expect," "intend," "may," "plan," "project," "should," "will," "would," and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to: '5x30', our growth and business strategy, our future outlook, the strength and efficacy of our intellectual property protection and patent terms, our future growth potential and future financial and operating results and trends, our plans, objectives, expectations (financial or otherwise) and intentions, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio and product development programs, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation ("NOPAIN") Act, the expected cost savings and benefits of a July 2025 reduction in force and any other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from these indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the failure to realize the anticipated benefits and synergies from the acquisition of GQ Bio Therapeutics GmbH; risks associated with acquisitions, such as the risk that the businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and United States economic conditions (including tariffs, inflation and rising interest rates), and our business, including our revenues, financial condition, cash flows and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA, iovera° and any of our other product candidates, including PCRX-201; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome ("pMVL") drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; assumptions used for estimated future cash flows associated with determining the fair value of the Company and the anticipated funding or benefits of our share repurchase program. and factors discussed in the "Risk Factors" of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.
Investor Contact: Susan Mesco, (973) 451-4030 [email protected] Media Contact: Kim Hamilton, (908) 721-7067 [email protected]
