The AVACEN 100 is not for sale in the U.S. for any FDA non-cleared indication mentioned in this document including FIBROMYALGIA.
The AVACEN 100, Class-IIa, OTC medical device has received the European Union CE (Conformité Européenne) Mark approval for the temporary relief of widespread pain associated with fibromyalgia.
The Company’s AVACEN 100 uses The AVACEN Treatment Method, an entirely new concept in chronic pain treatment by noninvasively and safely infusing heat into the circulatory system to create muscular relaxation while increasing microcirculation throughout the body. Unlike other medical devices providing local pain relief, the AVACEN 100’s unique mechanism of action offers widespread pain relief.
CE approval for fibromyalgia treatment was based on a Clinical Evaluation Report which highlighted AVACEN’s very promising 22-person fibromyalgia study. One hundred percent (100%) positive results were recorded for the full therapeutic treatment group. The AVACEN study was conducted under a Cooperative Research Development Agreement with the U.S. Department of Veterans Affairs at the University of California San Diego Center for Pain Medicine, Perlman Medical Center and the VA Medical Center, San Diego.
The Society for Neuroscience 2013 Annual Meeting abstract program disclosed the 28-day AVACEN follow-up study produced a statistically significant reduction of over 40% in the widespread pain index and a reduction in average tender point counts from approximately 15 to 9 (11 is used for clinical assessment). Study details are published on the National Institutes of Health – ClinicalTrials.gov website.
AVACEN TREATMENT METHOD CLINICAL STUDY SUMMARY
Patients: Twenty female and two male participants, whose ages ranged from 21 to 76 years (M = 48 years), that were diagnosed with fibromyalgia according to the 2010 ACR diagnostic criteria. Three withdrew due to personal reasons.
Methods: Group A (n=5) underwent one therapeutic warming session for 10 minutes daily and Group B (n=17 started, n=14 completed) underwent two 15-minute therapeutic warming sessions daily. The following commonly recognized fibromyalgia endpoints were evaluated (a total of 10): widespread pain index, patient global impression of change, tender point count, fibromyalgia impact questionnaire, Beck depression inventory, fatigue severity ratings, cognitive symptom severity, symptom severity score (including somatic) and weekly pain intensity ratings. Additional unconventional exploratory analysis of HRV and Cytokines was performed to observe perception correlations of the study subjects. A study of the cutaneous innervation of the skin was proposed but not studied due to budgetary constraints.
Results: The warming sessions of 10 minutes daily resulted in a decrease in widespread pain and weekly pain intensity symptoms for the majority of the patients in Group A. Moreover, increasing the warming sessions to two 15 minute sessions daily demonstrated a pronounced reduction of pain symptoms in the second group of participants in Group B. Data were analyzed with either a paired t-test, or the Wilcox signed rank test depending on parametric or non-parametric distribution. All data are presented as Mean ± SEM. Comparing the data from before and after treatment for Group B indicated a statistically significant reduction (p = 0.05) in Tender Point Counts (TPC), Widespread Pain Index (WPI) score and Symptom Severity (SS) score.
Inspections of HRV and Cytokines found no statistically significant data. Although there appears to be a difference in these scores from pre to post, these differences did not reach statistical significance (based on t-test analyses).
No adverse events related to use of the ATM device or the ATM warming therapy were reported by any of the participants during the study.
Conclusion: These results provide the first indications that the AVACEN Treatment Method (ATM) has a statistically significant effect on the key scientifically recognized FM diagnosis metrics of WPI, TPC and SS.