Medical Device for Relief of Autistic Behavior to be Launched in India

SAN DIEGO, Jan. 17, 2018 /PRNewswire/ -- AVACEN Medical, Inc. (AVACEN) announced that it is launching sales of its AVACEN 100, an FDA-cleared and CE marked class II dry-heat therapy medical device, in India to provide relief of autistic behavior.

According to the Hindustan Times - Delhi India (2017), "1 in 89 children between the ages of two and nine years in India suffer from Autism Spectrum Disorder (ASD). Based on the 2011 census data, this will mean 2.2 million children in that age group in India are autistic. If extrapolated, this means at least 13 million people in India live with the condition". This has a devastating impact on those who suffer from autism and their personal support systems. In addition, autism imposes a large economic burden on public and private healthcare providers.

Thomas G Muehlbauer, CEO of AVACEN Medical stated, "During our launch we will be deeply discounting AVACEN 100's ordered by families with autistic children and shipped to India. In return for the lower price families must agree to complete a daily diary describing their child's progress at home and in school during the 60-day money-back trial period." He added, "The feedback from these surveys will accompany clinical trial results we plan to submit to the FDA to gain approval to treat autism behavior with the AVACEN 100 in the U.S."

Autistic behavior relief from using the AVACEN 100 has been reported for years by parents who initially purchased the device for themselves and then had their ASD children try it. Improvements range from speech impediments quickly disappearing, to increased classroom participation and enthusiastic homework completion. These encouraging developments have also been accompanied by school grades skyrocketing from D's to A's and B's in just a few months.

According to Gavin Wiswell, a Healthcare Executive from San Marcos, California, "Within the first two weeks of using the AVACEN 100 device for 30 minutes, twice a day, my 6-year-old son shocked us by reading a children's book that he had never read before; from cover to cover, out loud, using his finger to point and perfectly pronounce each word. He typically would recite them back to us from memory, so this was a major breakthrough for our son!"

With approximately 3 million treatments and zero reported adverse effects, the AVACEN 100 is the only known medical device able to safely and noninvasively warm the body by rapidly infusing heat into the circulatory system.

The AVACEN 100 mechanism of action has been thought to mimic the effects of a moderate fever. For over 30 years moderate fever has been recognized as a catalyst for normalizing autistic children for days or even weeks [1] [2]. This explains why using the AVACEN 100 daily has been observed to produce in continuous normalization of certain aspects of autistic behavior.

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, peripheral neuropathy 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].

E.U. and Health Canada 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.

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 including autism.

[1] Cotterill RMJ. Fever in autistics. Nature 1985;313:426.

[2] Brown G. The sometimes son. Humanist 1999;59:46e7. Accessed 2012 at:
https://www.thefreelibrary.com/The+Sometimes+Son.-a053536208

SOURCE AVACEN Medical

Related Links

https://avacen.com