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Elmsford, NY, Oct. 28, 2021 (GLOBE NEWSWIRE) -- NanoVibronix, Inc, (NASDAQ: NAOV), a medical device company utilizing the Company's proprietary and patented low intensity surface acoustic wave (SAW) technology, today provided the following business update and letter to shareholders from its Chief Executive Officer, Brian Murphy:
"It is my sincere pleasure to address you through this letter and inform you of the progress, opportunities and potential of NanoVibronix. I hope to use this letter as a means to highlight the work we have done, but more importantly, the work we intend to do to build upon our success.
As you may already be aware, I have worked in the medical device and medical biologics industry for over 30 years. My background is mostly commercialization of new technologies at various levels in each organization, from sales to the executive level. Our Chairman, Christopher Fashek, whom I have worked with for many years, also has an extraordinarily successful history in commercializing new and existing technologies. It is the collective honor of our team to have been given the opportunity to serve in these roles, for a company with such an effective and versatile Surface Acoustic Wave (SAW) technology platform. We believe that both our existing products and future innovations will serve the medical community well and benefit patients suffering from chronic conditions.
As 2021 comes to a close, I want to share an overview of recent accomplishments, provide an update on current projects and convey our expectations relative to several impactful issues.
Sales and Marketing Activities
Our sales and marketing initiatives, which are gaining traction, are focused on three distinct initiatives related to product adoption and commercialization
Support of our existing sales network
Developing a critical mass as validation of product acceptance
We continue to seek category specific license partners where there is a mutual benefit. The foundationally necessary components viewed as essential, include retaining quality personnel, product integrity, and product cost.
Our activities related to reimbursement continue to show progress. The PainShield™ product earned a dedicated Medicare reimbursement code (K1004) several months ago, and we continue to work toward a reimbursement value. We have retained the law firm Latham & Watkins to assist the company in this area.
Additionally, we recently announced our first contractual agreement in the Workers’ Compensation arena. Our product is a great adjunct to the services provided in this market, and we intend to pursue additional agreements of this nature.
Covid-19 has limited our ability to present our technologies in person as many professional exhibitions have been cancelled or became virtual. We continue to look for opportunities to present and look forward to onsite participation at expos and trade conferences as soon as those opportunities are available.
Demand for our products continues to strengthen, which we believe will soon be reflected in our financial results.
Like most business, supply chain constraints are currently a challenge for our business, but we are identifying alternative and parllel sources for componentry, with the additional benefit of improved economics sourcing. In addition to component alternatives, we are also exploring contract manufacturing opportunities. While we ended the third quarter with a backlog of orders, we expect to be current with fulfillments by the end of Q4.
We have committed to a Q1 2022 delivery of a more significant quantity than ever before.
Product Validation Research
The success of medical devices is reliant upon strong clinical evidence, and we have been active in this area. Following the succesful independent study published earlier this year, we are completing an additional clinical study in the United Kingdom on UroShield™ which we expect to be published next year. Additionally, we recently released the final results of a randomized control trial using PainShield™ to treat the pain and physical limitations of Tennis Elbow (Lateral Epicondylitis). The tennis elbow study achieved exceptional results using PainShield™,reporting an incredible 92% effectiveness in resolving the pain associated with Lateral Epicondylitis, solid proof of an effective clinical application.
The UroShield™ is currently approved for sale in the United States, Europe, Australasia and India and has been shown to prevent Catheter Associated Urinary Tract Infection (CAUTI). The PainShield™ is currently approved for sale in the United States, Europe, Australasia and India, and is intended to treat and resolve pain through the application of our proprietary, patented, Surface Acoustic Wave (SAW) technology. We continue to actively seek oppertunities to conduct further research and hope to be able to update shortly.
New Product Development
We introducted two new products in the second half of this year, PainShield Plus™ and PainShield Relief™. PainShield Plus has already been shipped to customers and is performing well. We expect PainShield Relief, our over-the-counter product, to be submitted for 510K clearance by the end of November. We are awaiting final testing of the product’s energy production technical performance, which is on schedule to be completed by mid-November. Once submitted to the Federal Drug Administration (FDA), we expect a response within 90 days with a target release for clearance in Q1 2022.
There are several expected near-term catalysts for our business including:
Completion of NHS evaluation of UroShield. After a lengthy clinical and economic NHS evaluation of UroShield, we expect NICE Guidance to be completed in the next few months. Accordingly, we are actively preparing for NHS adoption of UroShield in early 2022.
Launch of PainShield Relief, our first non-prescription device for the consumer market
Launch of sales in Canada and the Middle East
Granting of three additional patents by the end of 2021
Continued growth and product adoption from our distributor network
Our balance sheet remains strong with approximately $8.6 million in cash and no debt, outside of the ordinary course of business payables, as of September 30,2021 providing us with the financial flexibility and capital to fund our growth initiatives, support manufacuturing to deliver on an increasing level of orders and invest in product development.
Much has changed over the past year and many more changes and improvements are planned. I believe the most significant change is how rapidly we are advancing our product sales, despite the headwinds caused by Covid-19. We have several significant“shots on goal” and are always looking for the opportunity to add more. Any one of these could singularly transform the company relative to our profile today. While there is still much work to be done, be assured that I am dedicated to a successful NanoVibronix.
I wish all of our shareholders Happy Holidays.”
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, (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.
CONTACT: Brett Maas Managing Principal, Hayden IR, LLC 646-536-7331 firstname.lastname@example.org