Saturday, September 23, 2023
Saturday, September 23, 2023

OrthogenRx Announces Response in The Journal of Bone and Joint Surgery

OrthogenRx, Inc., today announced that “The Journal of Bone and Joint Surgery (JBJS)” has published a response in the journal’s Orthopaedic Forum, titled Consequences on Private Insurance Coverage: The AAOS Clinical Practice Guidelines and Hyaluronic Acid Injection”, authored by C. Thomas Vangsness Jr., MD, Thomas C. Adamson III, MD, FACP and OrthogenRx Co-CEO, Michael Daley, PhD.

The purpose of the response is to point to a more judicious approach for the treatment of OA knee pain highlighting: 1) The need for a more comprehensive treatise to include considerations from recent publications, 2) Additional considerations of the risks and benefits for the target patient population of all treatment options for treating chronic OA knee pain, and 3) Reported benefits that might be afforded by intra-articular (IA) hyaluronic acid (HA) therapy. The full article can be found here.

“We continue to focus on optimizing patient care & access, and believe that IA HA plays a central role in the armamentarium for clinicians in the optimal management of OA knee pain,” said Michael Daley, Ph.D., co-CEO at OrthogenRx. “Clinical Practice Guidelines (CPGs) can be useful but can also lead to denying coverage which effectively denies patient access to safe and effective treatment options. We believe this is an unintended consequence of CPGs and is clearly not in the best interest of patients.”

A previously published study, Impact of Clinical Practice Guidelines on Use of Intra-Articular Hyaluronic Acid and Corticosteroid Injections for Knee Osteoarthritis, Bedard et al. (2018) examines the impact of the 2013 American Academy of Orthopedic Surgeons (AAOS) Clinical Practice Guidelines (CPGs) on intra-articular treatment for osteoarthritis knee pain over the past 5 years. The study investigators concluded “Subtle but significant changes in hyaluronic acid injections occurred following the publication of the clinical practice guidelines.” The authors cited that decreased utilization of HA injections may have been warranted due to the cost of treatment and questionable efficacy.

The recently published response counters this position and addresses some recently reported economic and medical benefits not acknowledged within the AAOS CPGs. The response also documents the negative impact of the recommendations on private insurance coverage decisions for almost 30% of the insured U.S. patients.

The authors of the published response state: “We believe that eliminating the use of IA HA as one of the nonsurgical treatment options available to clinicians would not be prudent. While there may be some debate on the efficacy of HA injections, several meta-analyses and systematic reviews support their use with minimal safety concerns.”

OrthogenRx continues to advocate for the use of HA injections as a safe, effective, and cost-considerate treatment for reducing the effects of OA knee pain.

Medical Device News Magazine
Our publication is dedicated to bringing our readers the latest medical device news. We are proud to boast that our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall purpose and objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

More News!

FDA Grants Fast Track Designation to 9MW3011

9MW3011 has been approved to clinical study by NMPA and FDA, respectively. The first person has been dosed in the clinical study in China in March, 2023.

MicuRx receives FDA Qualified Infectious Disease Product (QIDP) and Fast Track Designation for Contezolid and Contezolid acefosamil

"We are pleased to gain the QIDP and Fast Track designations for DFI as recognition that contezolid and contezolid acefosamil are novel new agents to meet an important unmet need in this common and challenging infection", stated Dr Zhengyu Yuan, Chief Executive Officer at MicuRx. 

Via Nova Therapeutics Announces FDA clearance of Investigational New Drug (IND) Application for VNT-101

"We look forward to evaluating VNT-101 in the clinic," said Don Ganem MD, Co-Founder and CEO of Via Nova Therapeutics. "This is an important step to developing a flu antiviral with a novel mechanism of action, and a milestone for Via Nova Therapeutics as we advance our first compound into the clinic."

FDA OK’s ensoETM for Use in Cardiac Ablations to Reduce Risk of Esophageal Injury

Published studies that have examined the use of ensoETM for this purpose include the pilot eCOOL-AF study, the IMPACT study and a large multi-center analysis of over 25,000 patients (in press at the Journal of the American College of Cardiology: Clinical Electrophysiology). These studies have found up to an 83 percent reduction in esophageal injuries, and a significant reduction in risk of atrioesophageal fistula (AEF), one of the most dreaded complications of ablation procedures. Receives FDA Clearance and Breakthrough Device Designation has also received FDA Breakthrough Device Designation for its obstructive hydrocephalus software tool. This is the first radiology triage device to be granted Breakthrough status since the inception of the FDA Breakthrough Devices Program.

By using this website you agree to accept Medical Device News Magazine Privacy Policy