Reports on Commercial Progress for both PainShield® and UroShield®
ELMSFORD, NY / ACCESSWIRE / April 2, 2019 / NanoVibronix, Inc., (NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today provided a business update for the year-ended December 31, 2018.
"2018 was a transformational year for the Company, as we laid the foundation for anticipated growth in latter part of 2019 and beyond," said Brian Murphy, CEO of NanoVibronix. "Specifically, we completed a number of important trials, which we believe will be important for expanded regulatory approvals and validation for distributors, as well as potential partners. We have also built out our commercial infrastructure and are implementing global sales and marketing initiatives. Our products are in the final stage of being updated, to improve appearance and performance. Lastly, we have outsourced our manufacturing, which we believe should result in meaningful cost savings, and in turn, expect may allow us to lower our selling price, increase production to meet revenue expectations, open additional markets, and improve profitability. Heading into 2019, we are off to a strong start for both our PainShield® and UroShield®." Some of the key anticipated upcoming milestones include:
- finalizing the updated product design and launching contract manufacturing;
- FDA Submission for PainShield OTC and UroShield;
- licensing and distribution agreements.
"In terms of PainShield, we announced in January we began collaborating with the Fritz Clinic, which has been at the forefront of tackling the opioid epidemic, by providing patients with alternative treatments to address the underlying cause of pain, rather than simply masking it with pain killers. We believe this partnership is a significant validation of our technology and the first of what we expect will be many more such partnerships."
"We also announced a number of important publications around PainShield. In February 2019, we announced the publication of an independent study, entitled, "The Effect of a Surface Acoustic Wave (SAW) Device on the Symptomatology of Trigeminal Neuralgia," in the Journal of Anesthesiology and Pain Research, a leading peer-reviewed journal in the field of anesthesiology. The double blinded, crossover trial demonstrated 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. In March, we announced interim results of a study entitled, "The Effects of the NanoVibronix' PainShield® Surface Acoustic Waves on the Symptoms of Lateral Epicondylitis" (tennis elbow). 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. We look forward to having the full results of this study published later this year."
"We continue to gather data in support of UroShield as well. As an example, we recently announced the publication of an independent study, entitled "The Effect of Surface Acoustic Waves on Bacterial Load and Preventing Catheter-Associated Urinary Tract Infections (CAUTI) in Long Term Indwelling Catheters," which was published in the December 2018 issue of Medical & Surgical Urology, a leading peer-reviewed journal in the field of urology. This study was a double blinded randomized control trial of the UroShield™ device. 55 patients in a skilled nursing facility chain treated with long term indwelling catheters were evaluated. The study demonstrated the ability of UroShield to dramatically reduce CFUs and there were no reported infections in the treatment group. Importantly, CAUTI is a leading cause of morbidity and mortality within hospitals and skilled nursing facilities, as well as major financial burden to the healthcare system. We believe UroShield™ has the potential to both save lives and dramatically reduce healthcare costs."
"We are getting very positive responses from potential distributors of UroShield on the heels of our recent trials and publications. In the fourth quarter alone, we signed new distributors for UroShield in Israel, India, and Switzerland. More recently, we announced an exclusive agreement with a leading distributor in Italy. We believe we are now poised for growth heading into 2019, through the combination of strong clinical data, increased manufacturing capacity, a redesigned product, and a growing distribution network."
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.
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 or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results (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 may not be available, or 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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