NanoVibronix Reports Successful Interim Trial Results for Use of PainShield(TM) in Patients with Trigeminal Neuralgia; Represents Potential Alternative to Opioid and Surgical Interventions
ELMSFORD, NY–(Marketwired – November 29, 2017) – 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 interim trial 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 and CE Mark approval in Europe, and is available online at www.nanovibronix.com.
Trigeminal Neuralgia is considered one of, if not the most, painful chronic condition, and is often called the “suicide disease.” 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 is being conducted across the US with the intent to recruit 60 patients with a diagnosis of unilateral trigeminal neuralgia. To date, 45 patients have completed the study, with 23 in the active treatment group and 22 in the control group. There was a significant difference in the outcomes of the two groups relative to pain, quality of life, and breakthrough medications taken. In addition to measurable differences in all aforementioned measurement categories, there was a general improvement in uninterrupted sleep. The results have been further validated in the crossover group from placebo device to the PainShield group. The Company expects to complete the trial in the first quarter of 2018, at which time the comprehensive data will be submitted for publication.
Brian Murphy, Chief Executive Officer of NanoVibronix Inc., commented, “We are excited to report the interim results of our PainShield™ study for patients with Trigeminal Neuralgia. We believe our instrument has the potential to help millions of patients worldwide suffering from this painful and debilitating condition. Current interventions have a high rate of recurrence, and chronic systemic use of opioids has been shown to destroy lives. We are encouraged by the interim results of our study as we believe this illustrates the ability of PainShield™ to help treat a very challenging patient population and potentially eliminate or reduce the need for opioids.”
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 groundbreaking 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.