SAN DIEGO, Aug. 24, 2017 /PRNewswire/ -- AVACEN Medical (AVACEN) announced partnering with Morulaa HealthTech of Chennai, India to introduce its FDA-cleared and CE Marked AVACEN 100, Class II medical device, in India for treating the widespread pain associated with fibromyalgia.
Fibromyalgia is characterized by chronic widespread pain. It is estimated that approximately 28 million people in India suffer from fibromyalgia and nearly 400 million with chronic pain. 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, "With over 2 million treatments without a reported adverse effect, the AVACEN 100 is an extremely safe drug-free alternative for fibromyalgia."
Newly published and peer-reviewed fibromyalgia research using the AVACEN Treatment Method describes 100% positive results. 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 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 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 India and Hong Kong.
AVACEN Medical is dedicated to the innovation and design of safe, easy to use, noninvasive drug-free alternatives for wound-healing and 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].
Established by a family with over 100 years of experience in business, Morulaa HealthTech provides turnkey solutions for manufacturers and distributors in the Medical Device sectors. The unique Morulaa model for Product Registration and Distribution, uses in-house regulatory and marketing teams working in-sync with clients to commercialize healthcare products across India and South East Asia. Morulaa HealthTech currently has clients from America, Europe, Asia and Oceania. For more information: www.morulaa.com
IMPORTANT NOTES: The AVACEN 100 is not for sale in the U.S. for any FDA non-cleared or non-approved indication mentioned