NanoVibronix Provides Business Update in Letter to Shareholders

Rhea-AI Summary

NanoVibronix, Inc. (NASDAQ: NAOV) has announced a 53% year-over-year growth in Q2 and is making strides in commercializing its PainShield and UroShield medical devices. Sales to VA facilities are increasing despite some administrative challenges. The company submitted a 510(k) application for PainShield MD Plus and is optimistic about FDA approval, which could boost revenue. Efforts for CMS reimbursement codes are ongoing. With a shift in manufacturing to Singapore for efficiency, NanoVibronix aims to enhance its product distribution and market presence.

Positive

• 53% year-over-year growth in Q2.
• Increasing sales of PainShield MD at VA facilities.
• Submission of 510(k) application for PainShield MD Plus, expecting FDA approval to boost revenue.
• Efforts for CMS reimbursement codes showing cooperation with regulators.
• Shift of manufacturing to Singapore for increased efficiency.

Negative

• Administrative challenges have slowed order increases for PainShield MD.

ELMSFORD, N.Y.--(BUSINESS WIRE)-- 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 in a letter to shareholders from its Chief Executive Officer, Brian Murphy:

To Our Shareholders:

We are making progress toward further commercialization and efficiencies of our supply chain. We continue to grow our business as exemplified by our 53% year-over-year growth in Q2. I can assure you that our vision for a fully commercialized portfolio of distinct and effective therapies and the investment thesis for our business remain unchanged.

PainShield

Our PainShield family of products, which includes the original PainShield MD, and pending clearance of PainShield MD Plus, continues to comprise the majority of our business. There are a number of work streams that are happening simultaneously to increase distribution and get these products to those that can benefit from them.

First, sales of PainShield MD to Veterans Administration (VA) facilities are starting to increase, and we are encouraged by increasing adoption. We have encountered a few administrative challenges that have tamped down a more material increase in orders. However, we are working diligently to overcome these ‘speed bumps’ and are encouraged by the opportunities to further strengthen this important revenue stream. Together with our VA partner, Delta Medical, we are now ‘vendorized’ in over 100 Veterans facilities. In each of these facilities, many of the clinicians support utilizing PainShield to address chronic pain and prevention of opioids.

In May, we informed you that we submitted a 510(k) application to the U.S. Food and Drug Administration (FDA) for our PainShield® MD PLUS, a dual-actuator ultrasound pain therapy device. PainShield Plus leverages the technology of its predicate device, PainShield MD, to provide pain relief and treat soft tissue injuries. Since that time, the FDA has requested clarifications, and we are working to provide a timely response. We look forward to providing further updates as we progress through the process with the FDA. Upon approval, we believe that this product can help increase our revenue, and we expect to have available inventory to meet the expected demand.

PainShield Relief, our over-the-counter product, is ready for submission to the FDA pending a small-scale technical study. Given that this product will be made available without a prescription, the opportunities are vast. Not only will we be able to leverage our sports injury research, but also allow consumer access to a distinct and highly effective source of pain relief.

We are continuing our efforts to gain approval from the Centers for Medicare and Medicaid (CMS) to receive a reimbursement code for our PainShield products. We presented to the HCPCS Work Group earlier this summer and have provided the requested documentation. There has been a high degree of communication and cooperation between CMS and NanoVibronix, including a recent on-on-one committee call. We are hopeful of receiving a positive Benefit Category Determination and valuation.

In the Workers’ Compensation space, we are in advanced discussions with another large workers’ compensation intermediary to include PainShield. We expect this relationship can further accelerate our penetration into the workers’ comp space as we exit 2022. Furthermore, we will be attending the Workers’ Compensation Institute (WCI) national conference to meet with prospective customers and network with professional to generate additional sales leads. The WCI conference brings together insurance companies, clinicians, key decision makers and influencers.

We believe that each of these workstreams is a key lever for increasing units sold and accelerating our growth. Collectively, we expect they will drive meaningful improvement to our top-line.

UroShield

The opportunities for UroShield remain plentiful, and we expect contribution from this product will increase over time as we continue with our marketing initiatives and launch our ‘Gold Standard’ study.

The Randomized Control Trial (RCT) , which is currently in the design stage, will soon initiate a contract with a Principal Investigator. The study is intended to fill the gap in our clinical evidence which will be required by the FDA for permanent 510K clearance.

Earlier this year, we signed an international marketing, sales and clinical management agreement with Medtech Solutions Group (MTSG), a leader in the commercialization of healthcare technologies, to help us commercialize UroShield and PainShield in certain parts of Europe, Asia, Africa, South America and the Middle East. Since that time, we are evaluating with several opportunities that have been presented to our management team.

Our Australian distributor, DukeHill, launched an educational webinar series for UroShield a few weeks ago to increase awareness of the product and drive increased sales. It is our intent to conduct additional webinars like this, to assist them in the adoption of UroShield in Australia.

Operations

Earlier this summer, we announced our plans to shift the majority of our third-party manufacturing operations to Singapore. This transition is nearly completed, and we will benefit from increased efficiencies while reducing our risk of supply disruptions and geopolitical instability going forward. This move also puts us in a stronger position to be able to scale our manufacturing and increase throughput to meet increases in demand. The first finished product is expected to be delivered in September.

Thank you for your continued support.

Kind regards,

Brian Murphy
Chief Executive Officer

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® and UroShield®, which are portable devices suitable for administration at home without assistance of medical professionals. Additional information about NanoVibronix is available at: www.nanovibronix.com.

Forward-looking Statements

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 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20220818005573/en/

Investor Contact:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

What is the recent growth figure for NanoVibronix, Inc. (NAOV)?

NanoVibronix reported a 53% year-over-year growth in Q2.

What products does NanoVibronix focus on for commercialization?

NanoVibronix focuses on PainShield and UroShield in its commercialization efforts.

How is NanoVibronix addressing distribution challenges?

The company is increasing sales to VA facilities and working to overcome administrative challenges.

What is the status of the PainShield MD Plus application with the FDA?

NanoVibronix submitted a 510(k) application for PainShield MD Plus and is responding to FDA requests for clarification.

Where is NanoVibronix moving its manufacturing operations?

The company is shifting most of its manufacturing operations to Singapore for better efficiency.