SAN DIEGO, July 21, 2017 /PRNewswire/ -- AVACEN Medical (AVACEN) announced partnering with Morulaa HealthTech of Chennai, India to introduce its AVACEN 100, Class II medical device, in India. Initial focus will be to reduce the number of limb amputations resulting from foot ulcers, a common complication associated with diabetes.
According to the Diabetic Foot Society in India, every year 200,000 diabetic patients in India undergo amputations of a leg for inadequately treated diabetic foot ulcers. This has a devastating impact on those who suffer from the amputation and their personal support systems. In addition, it imposes a large economic burden on public and private healthcare providers.
AVACEN recently received CE (Conformité Européenne) Mark approval to market the AVACEN 100 to the European Union’s 28 member countries to increase microcirculation during treatment. AVACEN believes this is the first time a medical device has been approved for improving whole-body microcirculation - the vascular link whereby tissue and single cells are supplied with oxygen and nutrients, and toxins are carried away. Adequate microcirculation is critical to supporting the wound-healing process.
The AVACEN 100 uses an entirely new concept to increase microcirculation. It noninvasively and safely infuses heat into the circulatory system forcing the body to dilate peripheral capillaries to radiate off this excess heat.
AVACEN Medical CEO Thomas Muehlbauer described the AVACEN 100 as “the only medical device on the market today able to provide non-invasive, whole-body treatment, using a single point of contact. It is the ideal drug-free and safe alternative for rapid healing of foot ulcers from the inside.” Muehlbauer added, “With over 1 million safe treatments, we frequently hear reports of rapid wound healing, especially after surgery. Recently our device was credited with saving the limb of a patient at a major university hospital who was given a 1 to 2% chance of retaining the limb by the attending physician. Closer to home, my diabetic mother would only have one leg if it wasn’t for our device. That makes this product launch in India very personal.”
India has 70 million diabetics. Health experts warn that India is on track to reach 120 million cases, or nearly 10 percent of the population, in the next eight years. That would put it on par with the United States, which counts 9.3 percent of the population as diabetic, or China, where 11 percent of the populationor 109 millionhave been diagnosed, according to the International Diabetes Federation.
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.
About AVACEN Medical
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 169150@email4pr.com.
About Morulaa HealthTech
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. or E.U. for any non-cleared or non-approved indication mentioned in this document.
E.U. CE-Approval: 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; the temporary relief of widespread pain associated with fibromyalgia; muscular relaxation; and the temporary increase of microcirculation.
U.S. 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.
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SOURCE AVACEN Medical
