Pacira BioSciences PCRX announced that the FDA has cleared its application to market a new Smart Tip for the iovera system designed to access the medial branch nerves to manage chronic low back pain. Please note that this hand-held medical device was added to Pacira’s portfolio following the acquisition of MyoScience.

The iovera system is a groundbreaking, FDA-approved, drug-free treatment that alleviates pain through cryoneurolysis. This technique uses targeted cold therapy to temporarily disrupt a nerve's ability to transmit pain signals. Patients usually experience immediate pain relief after treatment, with effects lasting for several months as the nerve naturally regenerates.

Per Pacira, chronic low back pain is a widespread issue in the United States, leading to disability, extended work absences and frequent opioid prescriptions, often resulting in dependency. While millions of Americans seek treatment annually, only a small fraction undergo interventional procedures.  Pacira’s new iovera Smart Tip aims to bridge these gaps and enhance care standards.

In the past three months, PCRX’s shares have gained 19.9% against the industry’s 10% decline.

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More on the FDA Approval of New Smart Tip for PCRX’s Iovera

Pacira’s iovera portfolio previously included a three-pronged Smart Tip with 8.5-mm 27-gauge needles for superficial nerves and a 90-mm 20-gauge Smart Tip for deeper nerves. It has been widely used to manage knee pain and is also effective for treating pain in the hip, shoulder, chest, foot, ankle and other areas.

Following the latest approval, the new 25-gauge, 180-mm Smart Tip expands treatment capabilities by targeting deeper nerves like the medial branch nerve, specifically addressing chronic low back pain linked to facet-mediated pain. Designed for use with a cannula or introducer, this innovative Smart Tip enables precise ice ball formation around deeper peripheral nerves, enhancing pain management options.

The FDA-cleared new iovera Smart Tip provides a promising alternative to traditional treatments like radiofrequency ablation (RFA), which comes with notable drawbacks. Unlike RFA, where pain relief may take 1-2 weeks to manifest, the iovera treatment offers immediate effects. Additionally, RFA's intense heat can damage surrounding tissues and blood vessels, potentially causing painful neuritis (nerve inflammation).

Pacira’s iovera cryoneurolysis also demonstrated significant benefits over RFA treatment for facet-mediated chronic back pain in a randomized pilot study.

Per the data readout, patients treated with iovera experienced significantly greater pain reduction, with scores more than 2 points lower on the 0-10 NRS Pain scale at 180 and 360 days compared to RFA. After 360 days of treatment, iovera patients experienced statistically and clinically significant improvements in functional outcomes, measured average Oswestry Disability Index (ODI) scores improving from moderate disability to minimal disability. Additionally, more iovera patients reported satisfaction with their pain management compared to those receiving RFA. No serious adverse events were observed throughout the study.

PCRX’s Other Marketed Products

Apart from the iovera system, Pacira’s marketed portfolio of products comprises two drugs – Exparel and Zilretta.

Exparel is PCRX’s flagship pain-management product, which was initially launched in 2012. The drug is indicated for postsurgical local analgesia in patients aged six years and older. It is also indicated for regional analgesia in adults via an interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa and femoral nerve block in the adductor canal.

Zilretta, on the other hand, is approved as an extended-release intra-articular therapy providing relief to osteoarthritis (OA) patients with knee pain.

Pacira is also currently looking to expand Zilretta’s indication to include treatment for OA pain in the shoulder. It initiated a phase III study in the first quarter of 2024 to evaluate the efficacy of Zilretta in shoulder OA. Based on the success of the study, the company plans to seek label expansion of the drug for this indication.

Pacira BioSciences, Inc. Price and Consensus

Pacira BioSciences, Inc. price-consensus-chart | Pacira BioSciences, Inc. Quote

PCRX’s Zacks Rank & Stocks to Consider

Pacira currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks from the sector are Castle Biosciences CSTL, CytomX Therapeutics CTMX and Halozyme Therapeutics HALO, each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 30 days, 2024 estimates for Castle Biosciences’ earnings per share have remained constant at 34 cents. During the same timeframe, loss per share estimates for 2025 have remained constant at $1.84. In three months, shares of Castle Biosciences have gained 11.9%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 172.72%.

In the past 30 days, estimates for Halozyme Therapeutics’ 2024 earnings per share have Improved from $4.05 to $4.07. Estimates for 2025 earnings per share have increased from $4.80 to $4.81 during the same timeframe. In three months, Halozyme Therapeutics’ shares have gained 1%.

HALO’s earnings beat estimates in three of the trailing four quarters and matched once, delivering an average surprise of 14.86%.

In the past 30 days, estimates for CytomX Therapeutics’ 2024 loss per share have remained constant at 5 cents. Estimates for 2025 loss per share have remained constant at 35 cents during the same timeframe. In three months, CytomX Therapeutics’ stock has lost 11.3%.

CTMX’s earnings beat estimates in two of the trailing four quarters and missed the mark in the other two, delivering an average surprise of 115.70%.

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