AVACEN Medical Device for Autistic Spectrum Disorder Behavior Management Launched in Hong Kong

SAN DIEGO, Jan. 22, 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 Hong Kong to address the challenge of autistic spectrum disorder (ASD) behavior management.

Hong Kong is home to 25,000 registered autistic children, according to the Autism Children Foundation.

According to a 2017 article published in the South China Morning Post, "Sandra Tsang Kit-man, an associate professor at the University of Hong Kong's department of social work and social administration, expects more than 10,000 schoolchildren to be diagnosed with autism in 2017-2018, up from 7,200 in 2015-2016."

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 discounting the AVACEN 100's normal price from $2995 to $1495 for devices, ordered by families with autistic children, that are shipped to Hong Kong. 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. They will also be asked to submit a 10-min video clip for analysis before and after the 60-day trial." He added, "The feedback from these surveys and videos will accompany our U.S. clinical trial results we plan to submit to the FDA to gain approval to treat ASD behavior using the AVACEN 100 in the U.S."

ASD behavior management success related to 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 rapidly by infusing into the circulatory system using the palm of the hand.

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 ASD children for days or even weeks [1] [2]. The Company believes this explains why using the AVACEN 100 daily has been observed to produce in continuous normalization of certain aspects of ASD 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 headquartered in San Diego and 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. 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: Where medical device regulatory restrictions exist; the AVACEN 100 is not for sale in any country for any non-cleared or non-approved indication mentioned in this document.

[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