Pacira BioSciences Secures FDA Approval For New iovera SmartTip to Manage Chronic Low Back Pain

On Tuesday, Pacira BioSciences, Inc.  PCRX received FDA clearance to market a new Smart Tip designed to access the medial branch nerves to manage chronic low back pain.

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, lasting for months as the nerve regenerates.

Also Read: Pain Management-Focused Pacira BioSciences Loses Patent Fight For Key Drug, JP Morgan Analyst Downgrades On Unclear Path

To date, the ioveraº portfolio has consisted of either a three-pronged Smart Tip featuring 8.5-mm long 27-gauge needles to treat superficial nerves or a single, 90-mm long, 20-guage Smart Tip ideally suited to treat deeper nerves.

It is most commonly used to treat knee pain but frequently used to manage pain in the hip, shoulder, chest, foot & ankle, and more.

This new, 25-gauge 180-mm Smart Tip will allow for the treatment of deeper nerves, such as the medial branch nerve. It is specifically designed to relieve chronic low back pain associated with facet-mediated pain.

This longer-needle Smart Tip is designed for use through a cannula or introducer, allowing ice ball formation at deeper peripheral nerves.

Annually, 28 to 30 million Americans seek treatment for chronic back pain, yet only 2 to 3 million undergo interventional procedures.

With the introduction of this new iovera° Smart Tip, Pacira aims to address these gaps and elevate the standard of care.

The company adds that the product offers an alternative to conventional treatments, such as radiofrequency ablation, with substantial limitations.

A single-center randomized pilot study of the iovera° system showed:

• Patients treated with iovera° reported pain scores more than 2 points lower at 180 and 360 days than those treated with RFA on the 0-10 NRS Pain scale.
• At 360 days, patients in the iovera° group showed statistically and clinically significant improvements in functional outcomes, as evidenced by average Oswestry Disability Index (ODI) scores improving from moderate to minimal disability.
• More iovera° patients expressed satisfaction with their pain management compared to those receiving RFA.
• No serious adverse events were observed over the course of the study.

Price Action: PCRX stock is up 1.50% at $18.91 at the last check Tuesday.

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