Pacira announces FDA clearance for new back pain treatment ti

Published 01/07/2025, 08:13 AM
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Dr. Jonathan Slonin, Chief Medical (TASE:PMCN) Officer of Pacira, stated that the FDA clearance marks a crucial advancement in providing a drug-free solution for long-lasting pain relief. The company's commitment to improving the lives of those with chronic back pain is reflected in this development. InvestingPro data reveals that 5 analysts have recently revised their earnings upwards for the upcoming period, suggesting growing confidence in the company's prospects. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers. InvestingPro data reveals that 5 analysts have recently revised their earnings upwards for the upcoming period, suggesting growing confidence in the company's prospects. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

The iovera° system, which operates through cryoneurolysis, has been used for various types of pain, including knee, hip, shoulder, and ankle pain. Cryoneurolysis involves applying cold therapy to a nerve, temporarily halting its ability to transmit pain signals. Immediate pain relief after treatment is reported to last for months. With revenue growth of 4.4% in the last twelve months and a strong current ratio of 2.25, the company maintains a solid financial foundation for its innovative medical solutions.

This latest FDA approval introduces a longer-needle Smart Tip that can be used through a cannula or introducer, allowing for ice ball formation at deeper peripheral nerves. Chronic low back pain is a significant health issue in the United States, often leading to disability, work absences, and opioid dependency.

A pilot study comparing iovera° cryoneurolysis to radiofrequency ablation (RFA) for chronic back pain highlighted the benefits of the iovera° system. Patients treated with iovera° reported lower pain scores and improved functional outcomes over a year, with no serious adverse events noted.

Dr. Jonathan Slonin, Chief Medical Officer of Pacira, stated that the FDA clearance marks a crucial advancement in providing a drug-free solution for long-lasting pain relief. The company's commitment to improving the lives of those with chronic back pain is reflected in this development.

Pacira is known for its non-opioid pain therapies, including EXPAREL® for postsurgical pain and ZILRETTA® for osteoarthritis knee pain. The iovera° system is part of their portfolio, offering drug-free pain control through targeted cold temperature application.

This news article is based on a press release statement from Pacira BioSciences.

In other recent news, Pacira BioSciences reported significant advancements in its non-opioid pain therapies. The company presented new clinical data showing its gene therapy candidate, PCRX-201, provided sustained improvements in knee pain, stiffness, and function for up to 104 weeks in patients with moderate to severe osteoarthritis of the knee. These results stem from a phase 1 trial involving 72 patients. Pacira's CEO, Frank D. Lee, expressed optimism about advancing PCRX-201's clinical investigation, with a phase 2 study planned for 2025.

In financial developments, Pacira reported its third quarter 2024 results, with EXPAREL sales rising from $128.7 million the previous year to $132 million. The company's non-GAAP gross margin stood at 78%, and the adjusted EBITDA was reported at $54.7 million. Pacira reiterated its 2024 revenue guidance of $680 million to $705 million, with adjusted gross margins between 74% and 76%.

These recent developments underscore Pacira's ongoing commitment to non-opioid pain therapies and patient care. The company is focusing on strategic initiatives for accelerated growth in 2025, despite challenges with ZILRETTA. The upcoming implementation of the NOPAIN reimbursement policy is anticipated to enhance EXPAREL access and support long-term growth in non-opioid pain management.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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