FDA clears Halyard’s Coolief RF device for treating OA pain

Halyard Health (NYSE:HYH) said today it won FDA clearance for its Coolief cooled radiofrequency thermal system designed for treating moderate to severe chronic osteoarthritis knee pain

The Alpharetta, Ga.-based company claims that the Coolief is the 1st and only RF treatment to be cleared by the FDA for relieving OA pain.

“I see many patients who suffer with chronic osteoarthritis knee pain in my practice who are not immediate candidates for knee replacement surgery due to co-morbidities, such as obesity or other chronic health issues. Coolief Cooled RF treatment provides significant pain relief for patients with OA of the knee until they are able to undergo surgery. Until now there have been few options available for my patients,” study investigator Dr. Timothy Davis of Orthopedic Pain Specialists said in a prepared statement.

Clearance came based on results from a 151-patient prospective, randomized trial comparing the Coolief system to intra-articular steroid injections in patients suffering from OA knee pain.

Results indicated that 74.1% of participants treated with the Coolief system reported pain reduced by at least 50% at 6 months. Of those patients, 65.4% reported continued pain reduction at 12 months post procedure.

Initially, 67.1% and 62.7% of the Coolief and control participants reported severe arthritis symptoms, respectively. At 12 months, only 5.2% of Coolief patients reported similar levels of symptoms, versus 37.3% of control group patients. Coolief-treated patients also reported low Oxford Knee Scores at 12 months, with 11.5% reporting severe pains.

“Many OA patients try unsuccessfully for years to treat their chronic knee pain with conservative pain therapies before turning to surgery. This treatment is clinically proven to be significantly more effective in relieving OA knee pain, increasing functionality, and decreasing the need for pain medication for up to a year. The U.S. consumes an astounding 80 percent of the global opioid supply with only five percent of the population. At Halyard we are committed to helping curb the opioid epidemic by providing solutions that help patients manage pain without the risk of addiction,” global interventional pain GM Lisa Kudlacz said in a press release.

In February, Halyard Health saw shares rise after the company reported 4th-quarter results that topped the consensus forecast on Wall Street.

Halyard, the Kimberly-Clark (NYSE:KMB) spinout that debuted back in October 2014, posted profits of $10.0 million, or 21¢ per share, on sales of $410.0 million for the 3 months ended Dec. 31. That amounts to a -31.0% profit slide on sales growth of 2.1% compared with Q4 2015.

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