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.

The AVACEN Treatment Method (ATM) is an entirely new concept in chronic pain treatment that provides whole-body muscular relaxation by rapidly and non-invasively infusing heat into the circulatory system to increase microvascular circulation, reduce blood viscosity and enhance deep tissue nutrition.

The AVACEN 100 is a patented and FDA-Cleared Class II medical device that incorporates heat therapy and negative pressure to increase local circulation and infuse heat into a unique vascular network, located in the palm of the hand. Unlike other medical devices providing local pain relief, the AVACEN 100’s unique mechanism of action offers widespread pain relief.

AVACEN recently received CE (Conformité Européenne) Mark approval to treat widespread pain associated with fibromyalgia. The CE Mark 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.

AVACEN has been awarded 4 U.S. and multiple International patents for its apparatus and methods that support its innovative and unique medical process called The AVACEN Treatment Method (ATM). 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.

Intended Use & Indications

U.S. FDA-Clearance: The AVACEN 100 is a non-invasive class II medical device that is cleared by the FDA as 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.

Outside the U.S. (E.U. CE Mark 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.

IMPORTANT: The AVACEN 100 is not for sale in the U.S. or outside the U.S. for any non-cleared or non-approved indications. For more details on Contraindications, Warnings and Precautions, please view the AVACEN 100 User Guide.

Company’s Keywords:

arthritis pain, wholebody muscular relaxation, muscle & joint pain, muscle spasms, minor strains & sprains, noninvasive & drugfree, microvascular circulation, fdacleared class ii medical device, no prescription needed overthecounter, wellness