55.2% improvement in baseline pain scores versus 2.3% for the control group
46.4% reduction in breakthrough pain medication, including opioids, versus 1.5% versus for the treatment group
PainShield™ had no adverse events or complications and was deemed both safe and effective
ELMSFORD, N.Y., Feb. 25, 2019 (GLOBE NEWSWIRE) -- NanoVibronix, Inc., (NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today announced the publication of an independent study entitled, “The Effect of a Surface Acoustic Wave (SAW) Device on the Symptomatology of Trigeminal Neuralgia,” which was published in the January 2019 issue of Journal of Anesthesiology and Pain Research, a leading peer-reviewed journal in the field of anesthesiology. The study publication is available at: https://www.omicsonline.org/open-access/the-effect-of-surface-acoustic-wave-saw-device-on-the-of-trigeminal-neuralgia.pdf.
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 U.S. 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 that 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 treatment group experienced a 55.2% improvement in baseline pain scores versus 2.3% for the control group. The treatment group experienced a 46.4% reduction in breakthrough pain medication versus 1.5% for the control group. In addition to measurable differences in all aforementioned measurement categories, there was a general improvement in uninterrupted sleep.
Brian Murphy, Chief Executive Officer of NanoVibronix, commented, “This publication is a major independent validation of the PainShield™ device. This was a very challenging patient population and we were pleased to see a dramatic improvement in both pain scores and the reduced use of pain medications such as opioids. Given the current opioid crisis, the fact we can help reduce dependence on medications, may also help save lives. Now that this study is published in a prestigious peer reviewed scientific journal, we will be aggressively marketing the device to physicians in order to help the millions of patients worldwide suffering from this painful and debilitating condition. We also believe we can replicate our success for other painful conditions.”
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York with research and development in Nesher, Israel, that is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave (SAW) 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.
This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) market acceptance of our existing and new products, (ii) negative clinical trial results or lengthy product delays in key markets, (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital raising may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. More detailed information about the Company and the risk factors that may affect the realization of forward looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.