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NanoVibronix Reports Successful Trial Results for Use of PainShield™ in Patients with Trigeminal Neuralgia; Reinforces Potential as Alternative to Opioids and Surgical Interventions
ELMSFORD, N.Y., July 24, 2018 (GLOBE NEWSWIRE) -- NanoVibronix, Inc, (NASDAQ:NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today announced successful results for its PainShield™ device in treating patients with Trigeminal Neuralgia. PainShield™ is an ultrasound-based product that is designed to treat pain in nerves, muscles, joints and soft tissue through delivery of a localized ultrasound, and induces soft tissue healing in targeted areas. PainShield™ has received 510(k) clearance from the U.S. Food and Drug Administration, CE Mark approval in Europe, and Health Canada approval. PainShield™ is available online at www.nanovibronix.com and through select distributors.
Trigeminal Neuralgia, also known as prosopalgia, suicide disease, or Fothergill’s disease is a neuropathic disorder characterized by episodes of intense pain in the face, originating from the trigeminal nerve. Trigeminal Neuralgia is considered one of, if not the most, chronically painful conditions, and is associated with a high suicide rate directly attributable to the condition. Trigeminal neuralgia is pain that spreads over the face and down the neck. As many as 280,000 individuals in the U.S. and 7 million worldwide are estimated to suffer from the condition. Current treatments are limited to medications such as opioids and surgical interventions, which have a high rate of recurrence.
The double blinded, crossover trial was conducted across the US and included 59 patients with a diagnosis of unilateral trigeminal neuralgia. Among the 59 patients, 30 were in the active treatment group and 29 were in the control group. The values which were assessed include Visual Analog Scale (VAS) pain score, both baseline prior to trial and VAS pain score at the end of the study. The study also assessed breakthrough medications per week at the start of the trial and breakthrough medications per week at the end of the trial, with a particular focus on the use of opioids. Breakthrough medications are used for chronic pain directly related to the pre-existing Trigeminal Neuralgia condition.
There was a significant difference in the outcomes of the two groups relative to pain, quality of life, and breakthrough medications taken, which was directly correlated to pain experienced during treatment. Specifically, the control group saw an improvement in baseline scores of 2.3% versus the treatment group, which saw a 55.2% improvement in baseline scores. Additionally, the control group saw a reduction in breakthrough pain medication of 1.5% versus the treatment group, which saw a 46.4% reduction in breakthrough pain medication. In addition to measurable differences in all aforementioned measurement categories, there was a general improvement in uninterrupted sleep. The Company plans to have the final comprehensive data submitted for publication in a leading industry journal.
Brian Murphy, Chief Executive Officer of NanoVibronix Inc., commented, “We are very pleased to report the final results of our PainShield™ study for patients with Trigeminal Neuralgia. We saw a dramatic improvement in both pain scores and the use of pain medications such as opioids. We look forward to having these results published in a leading medical journal and aggressively marketing the device to physicians in order to help the millions of patients worldwide suffering from this painful and debilitating condition. Given the current opioid crisis, the fact we can help reduce dependence on medications, will also help save lives. This was a very challenging patient population and we look forward to conducting similar studies, where we believe we can replicate our success for other painful conditions.”
NanoVibronix Inc. (NASDAQ:NAOV) is a medical device company headquartered in Elmsford, NY with research and development in Nesher, Israel, that is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave technology. The company's technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including the disruption of biofilms and bacteria colonization, as well as providing pain relief. The devices can be administered at home, without the assistance of medical professionals. The company's primary products include PainShield®, UroShield™ and WoundShield™. Additional information about the company is available at: www.nanovibronix.com.
SAFE HARBOR STATEMENT: This release contains certain statements that are, or may be deemed to be, forward-looking statements within the meaning of section 27A of the Securities Act of 1933 and section 21E of the Securities Exchange Act of 1934, and are made in reliance upon the protections provided by such Acts for forward-looking statements. We have identified forward-looking statements by using words such as "expect," "believe," and "should." Although we believe our expectations are reasonable, our operations involve a number of risks and uncertainties that are beyond our control, and these statements may turn out not to be true. Risk factors associated with our business, including some of the facts set forth herein, are detailed in the Company's Form SEC filings.