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NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today issued a letter to shareholders from its Chief Executive Officer, Brian Murphy, providing a year in review and vision for 2021.
To Our Shareholders:
NanoVibronix is committed to our strategic vision of commercializing our distinct and effective therapies which we believe enable us to treat patients in need, fill a void in the market, and have the potential to significantly increase value for our shareholders. Through a challenging 2020, we have managed to improve and expand our portfolio, strengthen our regulatory status, and shore up our capital position. We enter 2021 a stronger company in the areas of product portfolio, regulatory status, manufacturing capacity and financial backing, poised to deliver growth in 2021 as the macro environment improves.
2020 Year in Review:
NanoVibronix entered 2020 on a high note, with the initiation of our new contract manufacturer providing greater capacity for finished product, a newly designed portfolio, a private label agreement, two licensing agreements executed, and much more. The global pandemic temporarily dampened the optimistic start to the beginning of 2020, and delayed much of what we had planned. We used that time to further refine all aspects of our business in order to be better prepared for the future … near and far. Here are some of our accomplishments of 2020:
First and foremost, in late September, the FDA decided to exercise its Enforcement Discretion to allow distribution of the UroShield device in the United States during the COVID-19 pandemic. This was the culmination of months of work and cooperation with the FDA reviewers, who saw UroShield as a potential benefit to COVID-19 patients, and the risk associated with Catheter Associated Urinary Tract Infection.
Another major milestone was achieved in December, when NanoVibronix entered into a distribution agreement with Ultra Pain Products, Inc, granting them the exclusive right to sell the updated PainShield® products to and through distributors within the DME sector. The exclusive arrangement is contingent upon meeting a minimum of $7.8 million in product purchases over the next 3 years.
As mentioned above, NanoVibronix shored up our capital position with three separate capital raises. Between August 27 and December 7, we raised approximately $11.2 million in gross proceeds and $9.6 million in net proceeds through three financings in which we sold in aggregate approximately 15 million shares of our common stock at an average price of $0.75 a share. It should also be noted that no warrants were issued to investors in these offerings.
Other accomplishments and advances in 2020 included:
Expanding our patent portfolio.
Executing a license agreement for Canada and Turkey.
Fulfilling our first private label commitment to Medisana.
Receiving the coveted Plus X Award 2020 for PainShield/PT 100 device in the categories of high quality, design, ease of use and functionality.
Coventry University reported statistically significant outcomes for the company’s UroShield device. These results were provided to NICE in the United Kingdom.
Obtaining regulatory approval in New Zealand and fulfilled an initial order to a dominant distributor there.
Identifying and initiating a US contract manufacturer, resulting in a relationship which should increase capacity with a parallel source to finished product.
A look ahead to 2021:
We remain focused on driving profitable growth by expanding and increasing our distribution and licensing channels, nurturing relationships with new and existing accounts and engaging consumers through a variety of creative mediums. Today, we have initial distribution agreements in place, and a solid manufacturing partner and the necessary working capital to meet existing demand. The progress we made during 2020 gives us confidence that 2021 could be a year of notable financial improvement.
We continue to negotiate with sector specific private label agreements. This strategy is intended to develop a long lasting, profitable, forecastable revenue. Covid interrupted our momentum, but we believe that we are on track to aggressively push these discussions forward. From a capital perspective, the capital raises completed during 2020 allowed us to maintain our NASDAQ listing as well as providing us sufficient capital for our operations for the foreseeable future.
We are determined to improve shareholder value through our commercialization efforts and management practices. With relevant technologies which are now more cost efficient, clinically effective, and aesthetically up to date, our future is bright. Thank you for your support through a difficult year, and we look forward to a promising 2021.
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for 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®, all of which are portable devices suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix 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; 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) the geographic, social and economic impact of COVID-19 on the Company’s ability to conduct its business and raise capital in the future when needed, (ii) market acceptance of our existing and new products or lengthy product delays in key markets; (iii) negative or unreliable clinical trial results; (iv) inability to secure regulatory approvals for the sale of our products; (v) intense competition in the medical device industry from much larger, multinational companies; (vi) product liability claims; (vii) product malfunctions; (viii) our limited manufacturing capabilities and reliance on subcontractor assistance; (ix) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (x) our ability to successfully obtain and maintain intellectual property protection covering our products; (xi) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xii) our reliance on single suppliers for certain product components; (xiii) the need to raise additional capital to meet our future business requirements and obligations, given the fact that such capital may not be available, or may be costly, dilutive or difficult to obtain; (xiv) our conducting business in foreign jurisdictions exposing us to additional challenges, such as, e.g., foreign currency exchange rate fluctuations, logistical and communications challenges, the burden and cost of compliance with foreign laws, and political and/or economic instabilities in specific jurisdictions; and (xv) market and other conditions. 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, except as required by law.
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