AVACEN Medical announced today that it has launched a $2 million campaign on Crowdfunder.com to support further company clinical trials and FDA applications. This is in response to the encouraging outcomes of an AVACEN sponsored pilot and a follow-up fibromyalgia study involving 22 subjects and separate anecdotal results relating to other common medical conditions. These results were derived from an AVACEN therapeutic medical device and treatment method that noninvasively transfers heat into the circulatory system.
Fibromyalgia affects approximately 200 to 400 million people worldwide according to The National Fibromyalgia Association. It is characterized by chronic widespread pain. Tender Point Count is one of the techniques used to clinically diagnose fibromyalgia; the assessment requires that there is pain when applying finger pressure to 11 or more of the 18 American College of Rheumatology defined pressure sensitive tender points scattered over the neck, back, chest, elbows, hips, buttocks, and knees.
According to information published in the Society for Neuroscience (SfN) annual meeting and poster program, the 28 day AVACEN follow-up study showed a statistically significant reduction of over 40% in the widespread pain index and a reduction in tender point counts to a level that is below that used for clinical assessment.
The research studies evaluated an investigational device that is not cleared by the FDA for the treatment of fibromyalgia. The design and the associated protocols were approved by the Institutional Review Boards of the University of California San Diego and the U.S. Department of Veteran Affairs. Pre- and post-treatment evaluations were conducted at the UCSD Pain Medicine Clinic in San Diego, CA. Tobias Moeller-Bertram was the Principle Investigator.
Current first line therapies for the multi-billion dollar fibromyalgia market are Cymbalta (duloxetine), Lyrica (pregabalin), Savella (Milnacipran), and Elavil (Amitriptyline) but only a few patients obtain any sustainable relief of pain and the potential adverse effects of these agents often outweigh the benefit for most patients. There are currently no known FDA approved or cleared medical devices that treat the widespread pain associated with fibromyalgia.
In August of 2014 the FDA approved the Company's application for AVACEN 100 clearance as a Class II medical device for over the counter sales 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.
US Patent No. 8,679,170 issued to AVACEN covers key aspects of the AVACEN therapeutic device and methods. The patent describes systems expected to allow multiple therapeutic uses to alleviate symptoms associated with a circulatory, neurological, lymphatic, or endocrinal dysfunction, or any combination thereof.