ALPHARETTA, Ga., March 4, 2019 /PRNewswire/ -- Avanos Medical,
Inc. (NYSE: AVNS) today announced that its study comparing COOLIEF* Cooled Radiofrequency to hyaluronic acid (HA) in the
management of knee pain achieved its primary endpoint with a statistically significant improvement in knee osteoarthritis
patients experiencing at least 50 percent reduction in knee pain at 6 months after treatment (p < 0.0001). COOLIEF*
patients also achieved a statistically greater improvement in their functional outcomes when compared to the HA group at this
6-month time point (p < 0.0001). The full study results will be submitted for presentation and publication in a
peer-reviewed journal later this year.
"These positive results are clinically relevant to the over 30 million people worldwide living with osteoarthritis pain, many
of whom cannot find reliable long-term pain relief from corticosteroid and hyaluronic acid injections or are not appropriate
candidates for surgical options," said orthopaedic surgeon Antonia Chen, M.D./M.B.A. and the Lead
Principal Investigator for the trial. "As a surgeon who focuses on total joint replacement, these new findings are very
important in broadening our knowledge of how to go beyond traditional methods of pain management, so we can better serve our
non-surgical patients and potentially help our surgical patients control their pain and allow them to modify their health for
improved procedural outcomes."
This was a prospective, randomized, multi-center, comparison trial that included 177 patients at 10 sites. Patients with
osteoarthritis of the knee were randomized to receive COOLIEF* Cooled Radiofrequency Thermal Ablation or a single injection of a
commercially available HA. For patients treated with COOLIEF*, 71.1 percent of patients received at least 50 percent
reduction in pain at 6 months compared to 37.8 percent for those treated with HA. COOLIEF* patients showed a mean reduction
of 4.1 points on the 10-point Numeric Rating Scale (NRS pain scale). Based on the WOMAC, the CRFA group reported a
statistically significant mean functional improvement (WOMAC) change from baseline of 49% as compared to a 21% change in the HA
group at the 6-month evaluation.
Lisa Kudlacz, Vice President and General Manager, Global Interventional Pain at Avanos said,
"Non-opioid, minimally invasive approaches to help manage chronic pain in patients with osteoarthritis of the knee and hip are
urgently needed – especially in light of the opioid epidemic. The positive result from this trial combined with the results of
the Davis, et ali steroid comparison study continues to demonstrate that COOLIEF* provides consistent, durable pain
relief associated with this disease and offers patients a solution that provides them long lasting pain relief without the side
effects associated with opioids."
"The results of this study reinforce the findings of previous studies and represent another milestone in our strategy to
increase the adoption of COOLIEF* as a leading non-opioid treatment for patients in chronic pain," said Joe Woody, Chief Executive Officer at Avanos. "Accelerating our investment in clinical trials is an important
component of our investment strategy in COOLIEF*, as we build a strong compendium of clinical evidence that demonstrates the
value of this therapy to both patients and payors. Last year we successfully launched our first direct-to-patient
television commercials and building upon its momentum, recently expanded our campaign in additional U.S. markets to further
increase patient awareness of COOLIEF* as a unique and effective solution to treat chronic pain. Our efforts to directly reach
patients, combined with our focus on clinical evidence and the trial's superior results, position us to successfully target the
$1 billion hyaluronic acid market and bring much-needed non-opioid relief to those in pain."
For more information about COOLIEF* Cooled Radiofrequency for the management of chronic pain, visit avanospainmanagement.com.
About Avanos Medical, Inc.
Avanos Medical, Inc. (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 avanos.com.
i Davis, et al. RAPM 2019.
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SOURCE Avanos Medical, Inc.