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AVACEN Medical Recipient of Frost & Sullivan's 2017 New Product Innovation Award for Its Fibromyalgia Pain Management Device
Date:10/12/2017

SAN DIEGO, Oct. 12, 2017 /PRNewswire/ -- AVACEN Medical, Inc. (AVACEN) announced that Frost & Sullivan has recognized the company with their 2017 New Product Innovation Award for Its fibromyalgia pain management device. The award is based on extensive primary and secondary medical device market research by Frost & Sullivan's industry experts.

AVACEN Medical, through its first-to-market OTC, drug-free pain relief product, the AVACEN 100, offers a safe and effective solution with a unique approach to treating fibromyalgia widespread pain.

AVACEN 100
AVACEN 100

Brahadeesh Chandrasekaran, healthcare industry analyst with Frost & Sullivan and contributor to Forbes, the BBC, and most recently keynote speaker at the 2017 Boston BIOMEDEVICE conference on the "Future of the Medical Device Industry" recently stated:"The key AVACEN 100 benefits for patients are cost effectiveness, ease of use, and systemic treatment." He continued, "Some of the major drawbacks with existing devices in the market are either they are not easy to use or are invasive in nature, especially for patients above 65 years of age. Some require constant supervision and are generally expensive. Further, existing non-invasive devices such as pulsed electromagnetic fields do not have the capacity to penetrate deeply enough throughout the entire human body and are not systemic."

"We are grateful to be recognized by Frost & Sullivan, whose analysts closely track our industry," stated AVACEN Medical CEO, Thomas Muehlbauer. He added, "To be grouped with other 2017 award recipients such as Amazon, GE Healthcare, and Phillips Healthcare is even more of an honor."

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. As per the National Fibromyalgia Association, fibromyalgia affects an estimated 10 million people in the United States and an estimated 3-6% of the global 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 and Health Canada approval to treat widespread pain associated with fibromyalgia.  CE marking 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.

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 Frost & Sullivan

Frost & Sullivan works in collaboration with clients to leverage visionary innovation that addresses the global challenges and related growth opportunities that will make or break today's market participants. For more than 50 years, they have been developing growth strategies for the global 1000, emerging businesses, the public sector, and the investment community.

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 info@AVACEN.com.

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