AVACEN Medical is launching a campaign on Crowdfunder.com to help raise $2 million and support the development of an investigational therapy for fibromyalgia, as well as its application to the U.S. Food and Drug Administration (FDA). The company has decided to launch the campaign as a result of the encouraging results from previous studies conducted to evaluate the treatment, as announced in a press release.
The company has been dedicated to the development of a non-invasive therapeutic medical device and treatment method designed to carry heat to the circulatory system. Therefore, AVACEN conducted a 28 day follow-up study with 22 fibromyalgia patients, from which the company’s scientists observed the treatment ability in decreasing about 40% the pain, according to the widespread pain index, as well as the tender point counts to a level that is below what used for clinical assessment.
Even though the medial device is not yet approved by the FDA for the treatment of fibromyalgia, the positive results of the study encouraged the company to conduct further trials. The data was presented at the Society for Neuroscience (SfN) annual meeting and poster program, and the company will now use the funds to continue the device’s development.
The treatment already received approval from the Institutional Review Boards of the University of California San Diego and the U.S. Department of Veteran Affairs, while the trials conducted to assess pre- and post-treatment reactions took place at the UCSD Pain Medicine Clinic in San Diego, CA, under the guidance of Tobias Moeller-Bertram, who is the principle investigator in the study.
Patients who suffer from fibromyalgia currently have access to very few therapeutic options, which are essentially comprised of Cymbalta (duloxetine), Lyrica (pregabalin), Savella (Milnacipran), and Elavil (Amitriptyline). However, even with these options, the relief of the pain, one of the most severe symptoms of fibromyalgia, is only achieved in only a small group of patients.
In addition, there are currently no medical devices approved or cleared by the FDA directly thinking on relieving the pain of fibromyalgia patients. This is why the research being conducted by AVACEN is so anticipated among not only the community of fibromyalgia patients, but also the medical community.