PhonlamaiPhoto/iStock via Getty Images

NanoVibronix, Inc. (NASDAQ:NAOV ) is a commercial-stage medical device company based out of New York, with research and development center in Israel. The company develops therapeutic devices using its proprietary, patented low intensity surface acoustic wave (SAW) technology patent protected through August 2033. The SAW technology creates low-frequency ultrasound waves that can be utilized for a variety of therapeutic applications, such as disruption of biofilms and bacterial colonization, as well as pain relief. The company recently entered the over-the-counter (OTC) market with the planned launch of PainShield RELIEF, a derivative of its prescription-based PainShield.

The company’s products use small, disposable transducers that transmit low frequency, low intensity ultrasound acoustic waves. These devices are used to eliminate pain, repair and regenerate tissue in musculoskeletal/vascular structures, and decrease bio-film formation on urinary catheters thereby reducing risk of Catheter Associated Urinary Tract Infections (CAUTI). Their effectiveness, size and ease of use make these portable ultrasound devices suitable for administration at home without the assistance of medical professionals, enabling patient independence and cost-effective home-based care.

The company’s primary products are PainShield, UroShield, and WoundShield.

PainShield is a scientifically proven ultrasound therapy that delivers fast pain relief for nerve and soft tissue damage without drugs, or surgery, or side effects. The device is a wearable, battery-powered electronic unit that uses an actuator applied on the skin at or near the location of pain, and through which localized energy is delivered creating therapeutic effects to relieve pain and induce soft tissue healing. PainShield can be used to treat both acute and chronic pain, and may be used immediately post-injury or post-op.

PainShield’s ultrasound waves penetrate and propagate along the tissue while generating mechanical effects such as acoustic streaming and deep tissue micro-vibrations, which produce “bio-physical effects including altered cell membrane potential, change in cell membrane transport mechanism, increased protein synthesis, enhanced vascular permeability and increased local blood circulation,” which result in therapeutic effects such as decreased trigger point sensitivity, protein and collagen synthesis, bone and soft tissue repair, tissue rebuilding, reduced inflammation, decreased spasms, and reduced pain.

PainShield is approved for use in the U.S. by clinical prescription. It has also been approved by the Centers for Medicare and Medicaid (CMS) since January 2020 for reimbursement for Medicare beneficiaries on a national basis. The company also recently launched the OTC derivative of PainShield named PainShield RELIEF that can be used without clinical prescription. The company has submitted a trademark application to the U.S. Patent and Trademark Office (USPTO), and plans to apply in the very near term for clearance of the OTC derivative to the U.S. Food and Drug Administration (FDA) after submission of the final results of the lateral epicondylitis (tennis elbow) study.

UroShield is a urology therapy device composed of two components: a single-use disposable clip to be discarded with catheter replacement, and the portable driver unit (AC or battery-powered) providing power to the disposable clip. The ultrasonic waves generated by the clip create an acoustic shield on the surfaces of the catheter, interfering with bacterial attachment, preventing formation of bacterial biofilm, and preventing the development of infections (bacteriuria/UTI), while also reducing catheter pain and discomfort. The use of UroShield also increases antibiotic efficiency and may even eliminate or reduce the need for antibiotics.

The clip-on UroShield can be attached to any external urinary tract catheter, potentially providing relief from spasm and catheter pain. The FDA exercising its Enforcement Discretion in September 2020, allowed distribution of the UroShield device in the U.S. using “Intended Use Code (IUC) 081.006: Enforcement discretion per final guidance, and FDA product code QMK (extracorporeal acoustic wave generating accessory to urological indwelling catheter for use during the COVID-19 pandemic).” The device aids in the prevention of CAUTI incidence in patients needing long-term indwelling catheterization. The company also recently completed the application process with the CMS to receive a reimbursement code for its UroShield devices and has been granted approval and reimbursement at favorable rates from the Federal Supply Schedule.

WoundShield is a portable, hands-free ultrasound device that accelerates healing of acute and chronic wounds, while improving local blood circulation, and enhancing oxygenation and topical drug delivery. WoundShield can be incorporated into negative pressure wound therapy providing a synergetic healing effect.

WoundShield is not for sale yet in the U.S. The company signed a license agreement in March 2020 with SANUWAVE Health, Inc. (OTCPK:SNWV) for the manufacture and delivery of the WoundShield technology. SANUWAVE received the worldwide, exclusive rights to the WoundShield product and technology, while the company received warrants to purchase 127,000 shares of SANUWAVE stock, and is eligible to receive milestone payment of $250,000 upon FDA approval, and 10% royalty on SANUWAVE’s gross revenues from sales or rentals of WoundShield. SANUWAVE will bear the costs and clinical validation responsibilities associated with obtaining approval for WoundShield from the FDA and other regulatory agencies around the world.

NanoVibronix has a market capitalization of $77.28 million at a stock price of $2.79, about midpoint in the 52-week range of $0.54 and $4.19. Shares outstanding are 24.93 million with the public holding 86.2%, while institutions, public corporations, private corporations and insiders hold 9.4%, 3.25%, 0.64% and 0.52% shares, respectively.

With $5.7 million in cash at the end of the 2Q-2021 and zero debt, the company has a cash run through the next twelve months, i.e. until 2Q-2022. The company plans to meet short-term liquidity requirements as well as to advance long-term plans with proceeds generated from equity financings, or strategic alliances with third parties, either alone or in combination with equity financing. As of 6/30/2021, the company had no issuable shares. At its annual general meeting on 8/17/2021, the board approved an amendment to the company’s Amended and Restated Certificate of Incorporation to increase the number of shares of the company’s common stock authorized for issuance from 24,109,635 shares to 40,000,000 shares.

The company had an accumulated deficit of $44.788 million as of 6/30/2021, and will have to raise funds for ongoing operations as it may take a couple more years until the company reaches positive cash flow from sales revenues.

The company has been in litigation since February 26, 2021 with Protrade Systems, Inc. who filed a Request for Arbitration with the International Court of Arbitration of the International Chamber of Commerce alleging the company is in breach of an Exclusive Distribution Agreement dated March 7, 2019 between Protrade and the company, claiming damages estimated at $3 million. Final resolution of the arbitration is expected by February 2022 (if not dismissed or settled earlier). The company disputes the claims asserted by Protrade and intends to respond to the Request and defend against the claims vigorously.

NanoVibronix has a unique, scientifically proven, proprietary technology with tremendous potential especially with the launch of the OTC derivative product. The company also has CMS approval for medicare reimbursement for its primary products. The next catalysts for the company are the approval of the OTC product PainShield RELIEF, public offering of stock and result of Protrade litigation, all probable in 1Q-2022. We will keep a close watch on this company.

Thanks for reading. At the Total Pharma Tracker, we offer the following:-

Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. 

For investors requiring hands-on support, our in-house experts go through our tools and find the best investible stocks, complete with buy/sell strategies and alerts.

Sign up now for our free trial, request access to our tools, and find out, at no cost to you, what we can do for you. 

This article was written by

Disclosure: I/we have no stock, option or similar derivative position in any of the companies mentioned, and no plans to initiate any such positions within the next 72 hours. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.