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NanoVibronix Provides Business Update for the Third Quarter of 2019
ELMSFORD, N.Y., Nov. 19, 2019 /PRNewswire/ -- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the PainShield® Surface Acoustic Wave (SAW) Portable Ultra Sonic therapeutic device, today provided a business update for the third quarter ended September 30, 2019.
"This has been a productive and important quarter for NanoVibronix, positioning us for accelerating growth in 2020 and beyond," commented Brian Murphy, CEO of NanoVibronix. "In the past few quarters, we have significantly expanded our manufacturing capabilities, growing capacity from approximately 100 per month to, initially, over 1,000 per month with the ability to grow. Simultaneously, we have broadened our distribution channels, adding key partners to directly target key potential customers, including the Federal Supply Schedule and CMS/Medicare, and we are making progress in our efforts to target the Veterans Administration and European customers through private label arrangements. We believe that we have the optimal team in place to deliver. We enter the fourth quarter in the best strategic position in our company's history, and I am excited about the opportunities in front of us."
Mr. Murphy continued, "Our new Chinese manufacturer has finished first products on November 15th, and should have 3,000 units completed by early January. Our current pipeline, including back orders, and fulfilling our first private label order, will consume the majority of our initial production. Our new licensing arrangement with Medisana is progressing as planned, and this manufacturing capability enables us to support Medisana's growth. Other potential partners are in various stages of discover, clinical testing, and market testing, which we feel very comfortable about."
- PainShield® surface acoustic wave device receives Centers for Medicare & Medicaid Services (CMS) reimbursement code for home use beginning in 2020, which could substantially increase its marketability and usage through many different channels
- All products have been redesigned with an updated look and functionality
- The Company and a major potential partner are conducting ongoing research on PainShield
- Next generation product designs have been initiated
- PainShield, and PainShield Supplies were added to the Federal Supply Schedule through NanoVibronix' relationship with Marathon Medical, a Service Disabled Veteran Owned Small Business (SDVOSB). Accordingly, Marathon Medical can now sell PainShield and related supplies to the Veterans Health Administration, the largest integrated health care system in the United States, providing care at 1,255 health care facilities, including 170 VA Medical Centers and 1,074 outpatient sites of care of varying complexity, and the U.S. Department of Justice to combat pain and provide an opioid alternative pain management system.
- NanoVibronix expanded its relationship with Medisana, resulting in an initial Original Equipment Manufacturing (OEM) purchase order. The Company will commence the manufacture of a specialized product for Medisana based on its PainShield® device called the PT-100. The product will be sold directly and exclusively via Medisana.
- The Company signed a distribution agreement with ProTrade Systems, a medical equipment distributor in the U.S. for thousands of patients, elite athletes, athletic trainers, professional teams, special military forces, orthopedic surgeons, sports medicine doctors, and physical therapists.
- NanoVibronix entered into a non-exclusive license agreement with Ideal Medical International Limited, wherein Ideal Medical will serve as a non-exclusive international distributor for UroShield® and PainShield® in various regions around the world.
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, which is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave (SAW) technology. This 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.