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Devices Regulatory

 News Release - May 23, 2017

New Concept for Treating Pain Approved by Health Canada

SAN DIEGO, May 23, 2017 -- (Healthcare Sales & Marketing Network) -- AVACEN Medical (AVACEN) announced its CE marked AVACEN 100, Class-II, medical device has received Health Canada Medical Device License approval.

The AVACEN 100 uses The AVACEN Treatment Method, an entirely new concept in pain treatment. By noninvasively and safely infusing heat into the circulatory system, the device provides 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 systemic widespread pain relief.

AVACEN Medical, CEO Thomas Muehlbauer, described the AVACEN 100 as "the only OTC 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, "The most exciting aspect of this approval is that the Canadian market has shown high demand and acceptance for innovative new alternatives to pharmaceuticals for treating pain."

AVACEN intends to apply to Health Canada to add the treatment of fibromyalgia widespread pain to match its European Union approvals.

Fibromyalgia is characterized by chronic widespread pain. It affects approximately 200 to 400 million people worldwide per The National Fibromyalgia Association. 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.

New data from Canada shows the average direct costs of fibromyalgia syndrome (FMS) add up to C$3804 per patient each year. Overall, this data demonstrates the substantial societal burden of the disease. The study, published online May 5 in BMC Musculoskeletal Disorders, calculated productivity loss as well. In addition to prescribed medications, 66.67% of the study participants bought over-the-counter pain medication, and 52.63% purchased natural health products, which are included in out-of-pocket costs. Those who had a paid job lost an average of 5.6 days to pain during the past 3 months, and patients who were not employed lost an average of 25.1 days in household productivity.

A Clinical Evaluation Report highlighted AVACEN's very promising 22-person fibromyalgia study. One hundred percent (100%) positive results were recorded for the full therapeutic treatment group with 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). The AVACEN 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.

With an estimated 1.5 million adverse-event free sessions, the AVACEN 100 may also relieve joint pain from other conditions, such as CRPS, Reynaud's, and Lyme Disease. As for muscular relaxation, it has been found to be effective in the relief of: pain related to pinched nerves; stress; panic disorder; and generalized anxiety among other negative health symptoms.

IMPORTANT NOTES: The AVACEN 100 is not for sale in the in the U.S., Canada, E.U. and India for any non-cleared or non-approved indication mentioned in this document.

U.S. FDA, Health Canada and India FDA-Clearance: 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; muscular relaxation; and the temporary increase of local circulation where applied.

E.U. Approval: In addition to the above U.S. FDA-clearance description - the temporary relief of widespread pain associated with fibromyalgia; and the temporary increase of microcirculation.

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 fibromyalgia, CRPS, Reynaud's, and Lyme Disease. Founded in 2009, AVACEN Medical is headquartered in San Diego, California. Contact: Ryan Jeffcoat at (888) 428-2236 x 711 or 161206@email4pr.com.


Source: AVACEN Medical

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