SAN DIEGO, Oct. 13, 2016 /PRNewswire/ -- Today AVACEN Medical (AVACEN), a medical device company, whose fibromyalgia clinical trial results can be found on ClinicalTrials.gov, announced it strongly supports the new rule and steps taken by the National Institutes of Health (NIH) to expand and enforce the requirement of clinical trial results publication on ClinicalTrials.gov. The objective of this new initiative to make this valuable data more widely available to the public.
Recently the U.S. Department of Health & Human Services posted a news release on their website containing the following quotes: "Access to more information about clinical trials is good for patients, the public and science," said NIH Director Francis S. Collins, M.D., Ph.D. "The final rule and NIH policy we have issued today will help maximize the value of clinical trials, whether publicly or privately supported, and help us honor our commitments to trial participants, who do so much to help society advance knowledge and improve health."
According to AVACEN Medical CEO, Thomas Muehlbauer; "For a long time I have been disappointed that the majority of prestigious medical research institutions have blatantly violated a federal law requiring public reporting of clinical study results." Muehlbauer added, "Not reporting study results can deny patients and doctors access to important data to help evaluate the safety and potential benefits of new treatments. After completing our fibromyalgia study, I found that posting the trial results on ClinicalTrials.gov to be a time consuming and arduous process. And, if our results were not so encouraging, I most likely would have considered avoiding the reporting process. Hopefully this process can be simplified to increase reporting compliance."
How extensive is the non-reporting problem?
An investigation conducted by Statnews.com, a well-recognized health and medical reporting website, found that the worst offenders included four of the top 10 recipients of federal medical research funding from the National Institutes of Health. The result being that these violations have left gaping holes in a federal database used by millions of patients, their relatives, and medical professionals, often to compare the effectiveness and side effects of treatments for deadly diseases such as advanced breast cancer.
About AVACEN Medical (AVACEN.com)
AVACEN Medical is dedicated to the innovation and design of safe, easy to use, noninvasive drug-free alternatives for the palliative management of pain associated with numerous chronic and acute conditions including the temporary relief of minor muscle and joint pain and stiffness associated with arthritis and potentially other symptoms that can cause joint pain, for conditions such as CRPS, Fibromyalgia, and Lyme Disease. Founded in 2009, AVACEN Medical is headquartered in San Diego. Contact: Ryan Jeffcoat at (888) 428-2236 x 711 or info@AVACEN.com.
About AVACEN 100 Patents
The US Patent Office has issued 3 Patents to AVACEN which include apparatus claims directed to features of the Heat Therapy apparatus manufactured by AVACEN and method claims directed to specific methods of use, referred to by the company as the AVACEN Treatment Method. The patents also cover innovations embodied in its AVACEN 100 system, which is expected to allow multiple therapeutic uses to alleviate symptoms associated with a circulatory, neurological, lymphatic, or endocrinal dysfunction, or any combination thereof.
Patents have also been issued for China, Australia, Japan, UK, France, Germany, Spain, Canada and Sweden. Patents are pending in India and Hong Kong.
IMPORTANT NOTE: The AVACEN 100 is FDA-cleared as a heat therapy system indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; muscle spasms; minor strains and sprains; and muscular relaxation; and the temporary increase of local circulation where applied.
It is not available for sale in the U.S. or globally for any non-cleared indication mentioned in this document.
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SOURCE AVACEN Medical