Under the Symbol:
NanoVibronix Provides Business Update for the First Quarter of 2019
Friday, May 24, 2019 8:00 AM
ELMSFORD, NY / ACCESSWIRE / May 24, 2019 / NanoVibronix, Inc., (NASDAQ: 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 first quarter ended March 31, 2019.
- Redesigned and improved product performance through the new PainShield® 2.0
- Contracted with an Israeli contract manufacturer with facilities in China
- Initiated contract manufacturer "test run" for UroShield®, with favorable results expected to reduce cost of goods by approximately 50%
- Entered into an agreement with a partner to launch and distribute CBD-infused patches for PainShield
- Received reimbursement approvals for PainShield in the US through commercial and workman's compensation companies
- Entered into an agreement with Protrade to access reimbursement programs for sports programs
- Advanced efforts to obtain acceptance by the UK National Health System and the Institute for Health and Care Excellence
Clinical Study Highlights
- Announced positive interim tennis elbow study results for PainShield; 70% of patients experienced complete resolution or significant improvement in symptoms without the use of opioids
- Completed a "usability" study to facilitate an FDA submission on PainShield to introduce an over-the-counter (OTC) version
- Completed UroShield clinical studies required by the US FDA, including a sheep study, chemical characterization study, and in vitro study
Distribution/Private Label Partner Highlights
- Signed an agreement with a service-disabled veterans organization (SDVO) to access United States Department of Veterans Affairs facilities
- LOI executed for PainShield private label on a worldwide basis
- Entered into an LOI for private label distribution into the Gulf Coast countries
- Added distributors domestically and internationally
- Executed collaboration agreement with Fritz Clinic, which operates 7 locations in North America to offer patients PainShield® as an alternative treatment option for pain, and to aid in decreasing the dependency on opioids for pain relief.
Near Term Goals for 2019
- Complete the redesign and testing of the product offering and fully engage contract manufacturing
- Further reduce cost of goods
- Establish licensing and private label partnerships for expanded market reach
- FDA submission for PainShield OTC
- FDA Submission for UroShield
- Expand distribution network in the United States, Europe and India
- Launch and monetize CBD infused patched for PainShield in Canada
- Mechanical testing required for PainShield and UroShield FDA submissions to begin in Q2 2019
Brian Murphy, CEO of NanoVibronix, commented, "We have been extremely active this year and our focus in 2019 is on expanding our distribution network across Europe and the United States. More importantly, we intend to continue advancing potential licensing and private label opportunities. Our goal is to partner with organizations that have significant sales resources we believe will enable our technologies to penetrate a much broader clinical community. We continue to work toward two separate and unique FDA submissions, which will significantly broaden our sales opportunities. Additionally, we intend to enter into the CBD arena with superior technology and a complementary technology for a CBD-infused PainShield patch that will serve as a further differentiator in the growing yet competitive CBD arena. We are being deliberate and realistic in our approach, but expect rapid adoption of our products."
"The critical and essential upcoming goals in 2019 include our submissions to the FDA for both PainShield and UroShield. The US market is well suited for rapid adoption and provides both favorable economics as well as a sizeable and dynamic healthcare market-representing a significant opportunity for our company."
Mr. Murphy concluded, "We continue to receive positive feedback on the clinical effects of our products. While gratifying, it also serves as a validation of the superiority of our technologies. I believe we have the right technology for the benefit of providers, business partners, patients, and ultimately, our shareholders."
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