Avanos Medical, Inc. Announces Publication of Clinical Trial Demonstrating Superiority of COOLIEF* over Hyaluronic Acid Injections for the Management of Chronic Knee Pain

Rhea-AI Summary

Avanos Medical announced the publication of a clinical trial comparing COOLIEF* Cooled Radiofrequency ablation to hyaluronic acid (HA) for chronic knee pain management. Conducted with 177 subjects, the trial indicated that 71.1% receiving CRFA experienced ≥ 50% pain relief after 6 months, compared to 37.8% for HA. The COOLIEF procedure shows enhanced durability and effectiveness, with future data anticipated at 12, 18, and 24 months. This breakthrough could significantly improve treatment options for over 9 million people in the U.S. suffering from knee osteoarthritis.

Positive

• 71.1% of subjects reported ≥ 50% pain relief with CRFA at 6 months, compared to 37.8% for HA.
• COOLIEF procedure shows clinically superior results and extended pain relief durability.
• Future publications expected to provide further insights at 12, 18, and 24 months.

Negative

• None.

ALPHARETTA, Ga., Sept. 3, 2020 /PRNewswire/ -- Avanos Medical, Inc. (NYSE: AVNS) today announced the publication of a large, randomized, multicentered clinical trial comparing the safety and efficacy of COOLIEF* Cooled Radiofrequency ablation to hyaluronic acid (HA) injection for the management of chronic knee pain caused by osteoarthritis. The results from the clinical trial were published in the Journal of Bone & Joint Surgery, the official journal of the American Orthopedic Association.

Knee osteoarthritis is a painful and sometimes debilitating condition affecting more than 9 million people in the United States alone. Existing treatments consist of short-lasting and often repetitive nonsurgical options, followed by surgical intervention for those who are appropriate candidates. COOLIEF* Cooled RF is an FDA cleared minimally invasive procedure that has shown extended clinical durability in the management of knee OA pain.

This clinical trial enrolled 177 subjects that met inclusion criteria who were subsequently randomized to receive either cooled radiofrequency ablation (CRFA) or a single hyaluronic acid (HA) injection. Subjects were evaluated for pain (Numerical Rating Scale = NRS), function (Western Ontario & McMaster University Osteoarthritis Index = WOMAC), quality of life (Global Perceived Effect = GPE) and safety at 1, 3 and 6 months.

At the 6-month timepoint, 71.1% of subjects receiving CRFA reported ≥ 50% pain relief compared to 37.8% of subjects receiving HA. Those receiving CRFA had a 48.2% improvement in WOMAC score at 6 months, compared to 22.6% of subjects treated with HA. Additionally, 72.4% of subjects in the CRFA group reported improvements in GPE compared to 40.2% in the HA group.

"I am very encouraged by the results from this clinical trial," said Dr. Lynn Kohan, associate professor at the University of Virginia Medical School, an investigator in the clinical trial. "The non-operative knee OA patient used to be one of my hardest patients to treat because there simply weren't safe and effective treatments with good clinical durability. Now, when I see these patients, I am excited to share this treatment option with them."

While the manuscript published today in The Journal of Bone & Joint Surgery represents the 6-month timepoint, the clinical trial was designed to capture longer follow-up with subjects receiving CRFA. The 12-month, 18-month and 24-month timepoints will be reported in future publications.

"We are excited to announce the publication of this trial," said Tom Kupec, vice president and general manager, interventional pain at Avanos, "and I am most pleased about the fact that these results show tremendous consistency in response when compared to previously published trial data on COOLIEF* Cooled RF. We continue to invest in high-quality clinical research and are pleased that these results were accepted for publication in such a prestigious journal."

About COOLIEF* Cooled RF: COOLIEF* Cooled RF uses water-cooled technology that enables more RF energy to safely deactivate pain-transmitting sensory nerves. This creates a larger, spherical lesion that distally projects 45% or greater beyond the probe's tip, allowing physicians to approach the target nerve from any angle. These features increase the likelihood of successful ablation and improve patient outcomes. COOLIEF* Cooled RF has been shown to provide up to 24 months of pain relief, improved physical functionality, and reduced drug utilization.

About Avanos Medical:
Avanos Medical (NYSE: AVNS) is a medical technology company focused on delivering clinically superior breakthrough medical device solutions to improve patients' quality of life. Headquartered in Alpharetta, Georgia, Avanos is committed to addressing some of today's most important healthcare needs, such as reducing the use of opioids while helping patients move from surgery to recovery. Avanos develops, manufactures and markets its recognized brands in more than 90 countries. For more information, visit www.avanos.com and follow Avanos Medical on Twitter (@AvanosMedical), LinkedIn and Facebook.

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SOURCE Avanos Medical, Inc.

FAQ

What were the results of the Avanos Medical clinical trial comparing COOLIEF and hyaluronic acid?

The trial found that 71.1% of subjects receiving COOLIEF reported ≥ 50% pain relief after 6 months, compared to 37.8% for those receiving hyaluronic acid.

How many subjects participated in the COOLIEF clinical trial?

A total of 177 subjects participated in the clinical trial.

What condition does COOLIEF aim to treat?

COOLIEF is designed for managing chronic knee pain caused by osteoarthritis.

When will further results from the clinical trial be published?

Further results are expected to be published at 12, 18, and 24 months.

What are the implications of the clinical trial results for patients?

The results suggest COOLIEF may offer a more effective and durable treatment option for patients suffering from knee osteoarthritis.