NETANYA, Israel, March 2, 2017 /PRNewswire/ --
Theranica Bio-Electronics, a newly established medical device company offering a 'smart' patch that delivers neuromodulation therapy, announced that that American Academy of Neurology's (AAN) has decided to include in its press release program the article describing the results of its pilot study using the Nerivio Migra device. The study, which included 86 patients, took place at the Rambam Medical Center in Israel and was led by Professor David Yarnitsky.
Encouraged by the extremely promising results in terms of clinical efficacy and safety, Prof. Yarnitsky and his research team submitted the detailed article of the study and its results to NEUROLOGY (http://www.neurology.org/# ), one of the world's most popular, highly-cited and peer-reviewed journals in the field of neurology. The article, titled "Non-painful remote electrical stimulation alleviates episodic migraine pain", is now made public in the Journal's site, and will appear in print on the March 28th issue of NEUROLOGY. It is included in the Highlights and Patient Papers sections, as well as in Neurology Today publication.
The article has also been selected to be included in the American Academy of Neurology's (AAN) press release program, and was published yesterday, titled "Wireless Stimulation May Ease Migraine Pain as Well as Drugs" (https://www.aan.com/PressRoom/Home/Archives ).
Theranica's Nerivio Migra addresses the widespread problem of migraine headaches by providing neuromodulation therapy through a non-invasive, drug-free, wearable, and disposable 'smart' patch. The product is applied at the onset of a migraine headache to provide rapid and significant relief, often eliminating all pain completely.
"My team and I were delighted to see the encouraging outcome, as its impact will resonate in several areas", says Prof. Yarnitsky. "First and foremost, we have seen that patients who used the device early enough in their migraine episode found it to be as effective as using Triptans, the most commonly used rescue medication today, but without any reported side-effects. We found that 64 percent of the patients using active stimulation reported a 50 percent reduction in pain, while only 26 percent of patients using the sham stimuli reported this reduction. The individuals who started with severe or moderate pain experienced reduction to mild or no pain 58 percent of the time, compared with only 24 percent for the sham, and similar to the 59 percent result of the triptans".
"The results of this study can potentially make a dramatic improvement in the quality of life of dozens of millions of migraineurs around the world," said Professor Stephen Silberstein, Director of Jefferson Headache Center, at the Thomas Jefferson University in Philadelphia, and former President of the American Headache Society (AHS). "In addition to the high clinical efficacy and no significant risk, this device is the only migraine solution not to be applied on the head or neck, which tend to become hypersensitive during a migraine attack. Being applied on the arm, possibly under the sleeve, may allow migraine patients normal functionality even on migraine days."
"We are witnessing the outbreak of the e-health era, where patients are increasingly seeking drug-free, non-invasive solutions, also known as 'electroceuticals'", adds Alon Ironi, CEO and co-founder of the company. "The Nerivio Migra, fully operated by a smartphone application and deploying a unique clinical mechanism of action, is Theranica's first product. We plan to address additional widespread, debilitating medical conditions with similar electroceuticals."
Following the outcome of the pilot study, the company is now moving forward with seeking FDA clearance and CE mark.
Regulatory Disclaimer: The Nerivio Migra is an Investigational Device, limited by US Federal Law to Investigational Use Only in the United States, exclusively for Clinical Investigation.
Disclosures: Prof. Yarnitsky and Prof. Silberstein serve on the Medical Advisory Board of Theranica Ltd.
About Theranica: Theranica is a medical device company combining advanced neuromodulation therapy with modern wireless technology to develop proprietary wearable solutions that address various medical conditions and diseases. The noninvasive and therapeutic 'smart' patches are controlled by a smartphone app to allow for personalized, portable, and affordable care. The patch consists of a proprietary 'smart' chip that delivers electrical pulses to neuro-modulate the sensory nerves under the skin. The first application of the technology is for treatment of migraine headaches.
Theranica will be presenting at the upcoming AAN 2017 annual meeting taking place in Boston, MA during April 22-28.
SOURCE Theranica Bio-Electronics