Health Canada Grants the First Class II Medical Device License for Systemically Treating the Widespread Pain Associated With Fibromyalgia

SAN DIEGO, Sept. 26, 2017 /PRNewswire/ -- AVACEN Medical, Inc. (AVACEN) announced that its AVACEN 100 Class ll medical device previously licensed for treating joint pain associated with arthritis and offering drug-free muscular relaxation in Canada is now licensed for treating the widespread pain associated with fibromyalgia.

Prior to the AVACEN 100, the only way to systemically treat the widespread pain associated with fibromyalgia was to use drugs such as Lyrica, Cymbalta or Savella.

The AVACEN 100 has been successfully helping those with widespread pain associated with fibromyalgia in the European Union. Fibromyalgia diagnosed Amanda in Essex, England commented, "I had difficulty driving, getting dressed and washing my hair, experiencing no sleep at all, tremendous pain, with every movement sending my body in painful spasm... I cannot recommend [the AVACEN 100] enough, how this has and is helping me... the physio will be amazed with my progress."

Fibromyalgia has recently been thrust into the spotlight by Lady Gaga revealing she has been living with the disorder, which is characterized by chronic widespread pain. Per the National Fibromyalgia Association, fibromyalgia affects an estimated 10 million people in the U.S. and an estimated 3-6% of the world population. The incidence rises with age, so that by age 80, approximately 8% of adults meet the American College of Rheumatology classification of fibromyalgia. It has a devastating impact on those who suffer from the disease and their personal support systems. In addition, it imposes a large economic burden on public and private healthcare providers.

The AVACEN 100 is a Class II medical device that uses the AVACEN Treatment Method. It recently received CE (Conformité Européenne) Mark approval to treat widespread pain associated with fibromyalgia.  The CE Mark allows AVACEN to market the AVACEN 100 to the European Union's 28 member countries where many prescription drugs available in the U.S. have been rejected by regulatory officials for treating fibromyalgia pain.

The AVACEN Treatment Method is an entirely new concept in chronic pain treatment that noninvasively and safely infuses heat into the circulatory system to create muscular relaxation while increasing microcirculation throughout the body. Unlike other medical devices providing local pain relief, the AVACEN 100's unique mechanism of action offers widespread pain relief.

AVACEN Medical CEO Thomas Muehlbauer described the AVACEN 100 as "the only medical device on the market today able to provide non-invasive, rapid whole-body treatment, using a single point of contact. It is the ideal drug-free and safe alternative for relief of muscle and joint pain." Muehlbauer added, "Our newly published and peer-reviewed research shows 100% positive results were recorded for the full therapeutic treatment group."

The AVACEN 22-person fibromyalgia study was conducted under a Cooperative Research Development Agreement with the U.S. Department of Veterans Affairs at the University of California San Diego Center for Pain Medicine, Perlman Medical Center and the VA Medical Center, San Diego.

The 28-day AVACEN follow-up study produced a statistically significant reduction of over 40% in the widespread pain index and a reduction in average tender point counts from approximately 15 to 9 (11 is used for clinical assessment). Study details can be found at https://www.avacen.com/fms and are also published on the National Institutes of Health ? ClinicalTrials.gov website.

About AVACEN 100 Patents

The US Patent Office has issued 4 Patents to AVACEN.  The patents cover innovations embodied in the 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, Sweden and Canada. Patents are pending in other countries.

About AVACEN Medical

AVACEN Medical is dedicated to the innovation and design of safe, easy to use, noninvasive drug-free alternatives for the 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 conditions that can cause joint pain, such as CRPS, Reynaud's, and Lyme Disease. Founded in 2009, AVACEN Medical is headquartered in San Diego. Contact: Ryan Jeffcoat at (888) 428-2236 x 711 or [email protected].

SOURCE AVACEN Medical