AVACEN 100 is the only non-invasive medical device with proven systemic efficacy and safety currently available in the OTC market to warm the body from the inside out.
SANTA CLARA, California, Oct. 23, 2017 /PRNewswire/ -- Based on its recent analysis of the OTC fibromyalgia pain management devices industry, Frost & Sullivan recognizes AVACEN Medical with the 2017 European New Product Innovation Award for its AVACEN 100. It is a Class II medical device that utilizes the AVACEN Treatment Method, a drug-free alternative form of non-invasive, augmentative dry heat device-based therapy that aims to provide effective treatment for the widespread pain associated with fibromyalgia.
"The treatment of fibromyalgia remains challenging, and the underlying pathology is poorly understood. There is a need for alternative non-invasive treatments or adjunct therapy that can help alleviate pain in fibromyalgia patients. Device-based therapies are important since a placebo-controlled study showed that fibromyalgia patients reported modest improvements in pain, tender points, fatigue, and sleep after electro-stimulation," said Brahadeesh Chandrasekaran.
The AVACEN 100 is FDA-cleared for marketing in the United States for the temporary relief of joint pain associated with arthritis; and muscular relaxation. In 2017 the AVACEN 100 received the CE Mark and Health Canada approval adding widespread fibromyalgia pain management for the EU and Canada. A recent peer-reviewed clinical efficacy study published in 2017 reported that out of 22 patients evaluated, those who received the AVACEN 100 device treatment for 15 minutes twice a day demonstrated an overall reduction of more than 40% in their widespread pain index scores after 28 days. Out of these subjects, 93% reported a reduction of 29.4% or more in widespread pain index scores. Also, 62% reported a lower tender point count of two or more points while 57% reported a reduction of 20% or more in overall symptom severity score rating. With more than 2 million uses there has been no report of an adverse effect, which shows that the device is extremely safe and reliable.
The key benefits of AVACEN 100 for patients are:
- Cost-effectiveness: The product is drug-free, which significantly reduces the economic burden on the patient.
- Ease of use: The AVACEN 100 device contains two components, a vacuum chamber and a heat-transfer element. The digital panel on the device provides instructions for use in English, French, and Spanish, and the simple one-touch button makes it easy to operate by anyone, especially seniors.
- Systemic treatment: The device treats the whole body from the inside out. Other existing non-invasive pain treatment devices, such as pulsed electromagnetic fields, do not have the capacity to penetrate deeply enough throughout the human body.
AVACEN 100 is the only approved OTC medical device that non-invasively increases microcirculation systemically by marginally heating the blood temperature without adverse effects. Improved microcirculation solves a myriad of problems, especially for people over 40 years old because over 80% of this population has a deficient or compromised microcirculatory system that leads to various pain-related complications.
"The AVACEN 100 is unique in that it is the only non-invasive OTC medical device available to alleviate the widespread pain in fibromyalgia patients on the market. As a result, of its ability to increase microcirculation it has gathered significant interest from not only pain management professionals but also other clinical specialists, such as those working in orthopedic, diabetes, and wound healing specialties," said Brahadeesh Chandrasekaran.
AVACEN Medical, through its first-to-market OTC and drug-free pain relief product, aligns itself with the changing industry dynamics and offers a safe and effective solution with a unique approach to helping fibromyalgia sufferers. It not only aims to treat the widespread pain associated with fibromyalgia, but also to aid in wound healing, migraine pain control, stress management, muscle relaxation, and physical rehabilitation. For these reasons, AVACEN Medical has earned Frost & Sullivan's 2017 European New Product Innovation Award.
Each year, Frost & Sullivan presents this award to the company that has developed an innovative element in a product by leveraging leading-edge technologies. The award recognizes the value-added features/benefits of the product and the increased ROI it gives customers, which in turn raises customer acquisition and overall market penetration potential.
Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry.
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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SOURCE Frost & Sullivan