- 70% of patients using PainShield experienced complete resolution or significant improvement in symptoms without the use of opioids
- PainShield had no adverse events or complications and was deemed both safe and effective
ELMSFORD, NY / ACCESSWIRE / March 7, 2019 / NanoVibronix, Inc, (NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today announced results of a study entitled, "The Effects of the NanoVibronix's PainShield® Surface Acoustic Waves on the Symptoms of Lateral Epicondylitis." The clinical study was conducted by Dr. David Lemak, a leading orthopedic surgeon with Birmingham Orthopedic and Sports Specialists.
The trial was a randomized, double blinded study for 30 days that evaluated the effectiveness and safety of PainShield™ Surface Acoustic Wave (SAW) technology on patients suffering from pain and discomfort, as well as limited mobility caused by the effects of chronic or acute lateral epicondylitis (LE) ("tennis elbow"). A total of 24 patients were enrolled, half of whom were treated with the PainShield™ device plus physical therapy and the other half were treated with a placebo device plus physical therapy. Two of the patients did not complete the trial. Patients were not allowed to use opioids during the trial, nor were they allowed to have any type of injections (cortisone or any other) at any time during the study or within the last 30 days. Patients were allowed to take standard over-the-counter anti-inflammatory medication such as ibuprofen.
While the study is ongoing with additional patients enrolling, based on the initial results, seven out of ten patients (70.0%) who completed the study using PainShield plus physical therapy had complete resolution or significant improvement in pain. Among the placebo group plus physical therapy, five out of twelve patients (41.7%) experienced complete resolution or significant improvement in pain. Upon completion of the trial, the Company will have full results, which it expects to publish later this year.
Tennis elbow is a painful condition due to inflammation of the tendons that join the forearm muscles to the outside of the elbow, which become damaged from overuse. PainShield is a wearable, battery powered electronic unit that delivers localized therapeutic ultrasound to relieve pain and induce soft tissue healing. PainShield can be easily utilized by patients from the convenience of home or in healthcare facilities.
Brian Murphy, Chief Executive Officer of NanoVibronix, commented, "We are pleased to report the initial results of this study, which saw a significant improvement in reported pain among patients using PainShield™ versus the placebo device. PainShield had no adverse events or complications and was deemed safe and effective in treating patients with tennis elbow. This is important, because we are not aware of any other clinically proven treatment for tennis elbow. To date, the PainShield™ device and our SAW technology has been used both commercially and in clinical trials and there have been no reported adverse events. We believe this study further validates that PainShield represents an effective alternative to opioids."
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 PainShieldÔ, UroShieldÔ and WoundShieldÔ. 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.
SOURCE: NanoVibronix, Inc
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