NanoVibronix Provides Business Update Highlights Business Momentum with Recent Achievements; Importance of Shareholder Support for Proxy Proposal ELMSFORD, N.Y.

Provides Business Update

Business Momentum with Recent Achievements; Importance of Shareholder Support for Proxy Proposal

ELMSFORD, N.Y., June 3, 2021 (Business Wire)

-- NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the UroShield and PainShield Surface Acoustic

Wave ("SAW") Portable Ultrasonic Therapeutic Devices, today provided an update on its business.

are executing against a business plan that we believe will lead to a significant increase in revenue beginning in the second quarter

of this year and pave the way for progressively improving financial results throughout 2021 and beyond," added Murphy. "We

are optimistic about the projected growth of our business, and we believe that we are sufficiently capitalized to support our near-term

operating plans. We are selling our products at higher gross margins while reducing our operational risk by pursuing parallel manufacturing

operations and targeting alternative channels for sourcing our components. The demand for our devices remains encouraging, as we work

to penetrate a market that we believe to be largely underserved."

the Portfolio, Increasing Product Availability and Improving Manufacturing

the end of 2020, the company launched the next generation of its PainShield device, PainShield Plus, which extends the functionality

of its core product and broadens the opportunities for application. The PainShield Plus sells at a higher price point and expands the

company's target market to increase opportunities for revenue growth. Delivery of the first devices is expected to be in Q2 2021.

the company expanded and replaced its original distribution agreement with Ultra Pain Products, Inc. ("UPPI") to extend the

term and increase minimum purchase requirements. UPPI is the exclusive distributor of PainShield and PainShield Plus

devices to the Durable Medical Equipment ("DME") distribution sector of the healthcare market in the United States. In doing

so, the company increased the revenue opportunity significantly with UPPI. The company fulfilled the first order in the second quarter

of 2021 and is working diligently to accelerate manufacturing and fulfill subsequent orders.

the company is working to establish manufacturing capabilities both in the United States and Israel that will run parallel to its existing

manufacturing operations located in Asia. In addition to providing expanded capacity for output, this will reduce operational risk from

reliance on a sole manufacturer and positions the company to negotiate private-label agreements by complying with requirements of the

Trade Agreements Act ("TAA").

business momentum is expected to increase as we bolster our sales channels and improve and expand our manufacturing operations,"

added Murphy. "Based on what we have delivered to UPPI thus far, we expect our 2021 second quarter results will reflect increased

sales from our revised distribution agreement. Importantly, the configuration of our manufacturing operations should provide us with

additional resources to meet demand and target new markets. Adding additional manufacturing operations aligns our business with conditions

identified in the Trade Agreements Act and should clear the path for us to negotiate private-label arrangements with governmental agencies,

like the Veterans Administration."

Regulatory Requirements to Reach More Patients in Need and Increase Sales

Centers for Medicare and Medicaid Services ("CMS") recently expanded its reimbursement approval for the company's PainShield

product by adding the device to its DME schedule. PainShield is now reimbursable as an approved medical device under a unique reimbursement

code assigned by CMS, K1004. The approval expands the original CMS approval to include reimbursement as a device for the many millions

of beneficiaries enrolled in Medicare and paves the way for expanded distribution.

the company's urology therapy device, was added to the Federal Supply Schedule during the first quarter of 2021, making it easier

for veterans being treated by the VA to secure and utilize the UroShield device and further expanding the company's addressable

commented, "Clearing the regulatory reimbursement requirements is a process that takes time, and we are tackling the approval steps

one by one. We are currently awaiting clearance of the final hurdle from CMS for the PainShield which relates to establishing reimbursement

value and conditions for product application. We believe that clearing this last remaining regulatory requirement will pave the way for

an accelerating flow of orders from patients and their providers."

Stockholder Approval to Increase Share Authorization

company will be asking stockholders to approve a proposal to increase the number of common shares authorized for issuance from 24.1 million

shares to 40 million shares at an Annual Meeting of Stockholders to be held on August 17, 2021. The increase is being requested to provide

the company with a sufficient number of authorized shares to meet its existing preferred stock conversion obligations and warrant and

option obligations and leave the company with an additional capacity to pursue a modest level of strategic transactions at the Board's

discretion if such opportunities arise.

of March 31, 2021, the company had approximately 24.1 million shares of common stock authorized as well as issued and outstanding leaving

no capacity to meet future potential needs for shares upon conversion of certain shares of Series C, Series D and Series E Preferred

Stock or the exercise of outstanding warrants and stock options.

is presently no capacity for issuing new shares of common stock to meet our obligations under existing derivative instruments that may

convert to equity," commented Mr. Murphy. "These instruments were previously issued to fund our growth and incentivize employees.

We believe that the inability for our preferred shareholders and warrant holders to convert to equity has created a significant overhang

on the valuation of the company's stock because it creates a liability on our balance sheet as well as a derivative liability for

our warrants and leaves the company unnecessarily exposed to potential claims if we cannot fulfill the conversions of these securities

in the future. We believe it is in the best interest of all stockholders that our share authorization be increased to clear the way for

us to meet existing conversion obligations as they may arise, reduce the volatility in our earnings resulting from the quarterly mark-to-market

exercise [for our related derivative liabilities] required by GAAP and create value for all stockholders going forward. We have sized

the request for increased shares to also provide us with the flexibility to finance any strategic transaction that represent a compelling

opportunity to enhance stockholder value. Importantly, with approximately $8.0 million in cash as of the end of the first quarter, we

are well-positioned to fund existing operations and near-term, organic growth opportunities. We have no plans to issue additional equity

our capital structure with the realities of our current obligations comes at a pivotal time in our company's evolution,"

added Murphy. "We believe an approval of an increase in the number of authorized shares is crucial to protect the interests of

current stockholders and make NanoVibronix a more attractive investment opportunity for new investors. Failure to approve the proposal

could create the need to issue debt and recapitalize the company by repurchasing shares under unfavorable market conditions in order

to meet our obligations. We believe that approving the proposal eliminates that financing risk."

company did not receive sufficient votes to pass a proposal for an amendment to increase the authorized number of stocks of common stock

to 45 million shares at the company's Special Meeting of Stockholders held on May 6, 2021. Accordingly, the company has responded

with a more modest proposal that the Board believes will still meet the needs of the company.

proposal would amend the company's amended and restated certificate of incorporation to increase the number of authorized shares

of common stock from approximately 24.1 million to 40 million.

concluded, "We have accomplished a great deal to move our business forward and lay a foundation for long-term, sustainable growth.

Our achievements reflect the quality of our products and our commitment to bringing innovative, home devices to market for the benefit

of millions of patients in need of alternative, at home therapies. As we continue to execute our business plan over the coming quarters,

we believe the results of our efforts will become more apparent in our financial results and there will be tangible returns on the investments

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 , 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.

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) our history of losses and expectation

of continued losses; (ii) the geographic, social and economic impact of COVID-19 on the Company's business operations; (iii) our

ability to raise funding for, and the timing of, clinical studies and eventual U.S. Food and Drug Administration approval of our product

candidates; (iv) the risk that we may not obtain the requisite votes at our annual meeting to increase the number of authorized shares

of common stock; (v) regulatory actions that could adversely affect the price of or demand for our approved products; (vi) market acceptance

of existing and new products; (vii) favorable or unfavorable decisions about our products from government regulators, insurance companies

or other third-party payers; (viii) risks of product liability claims and the availability of insurance; (vix) our ability to successfully

develop and commercialize our products and to generate internal growth; (x) risks related to computer system failures and cyber-attacks;

(xi) our ability to obtain regulatory approval in foreign jurisdictions; (xii) uncertainty regarding the success of our clinical trials

for our products in development; (xiii) risks related to our operations in Israel, including political, economic and military instability;

(xiv) the price of our securities is volatile with limited trading volume; (xv) our ability to comply with the continued listing requirements