NanoVibronix Stock

NanoVibronix, Inc. (NanoVibronix) operates as a medical device company. The company focuses on noninvasive biological response-activating devices that target biofilm prevention, pain therapy, and wound healing and can be administered at home, without the assistance of medical professionals.

The company's primary products, which are in various stages of clinical and market development, consists of:

UroShield, an ultrasound-based product that is designed to prevent bacterial colonization and biofilm in urinary catheters, increase antibiotic efficacy and decrease pain and discomfort associated with urinary catheter use, which has been marketed in the U.S. under FDA's policy of enforcement discretion during the COVID-19 pandemic and is undergoing clinical testing that supports 510(k) clearance;

PainShield, a patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures by delivering a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area. The company's PainShield family of products include:

PainShield MD, a single patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures by delivering a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area.

PainShield Plus, a dual patch-based therapeutic ultrasound technology to treat pain, muscle spasm and joint contractures by delivering a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area. Similar to PainShield MD, with a dual ultrasound delivery; and

WoundShield, a patch-based therapeutic ultrasound device intended to facilitate tissue regeneration and wound healing by using ultrasound to increase local capillary perfusion and tissue oxygenation.

Each of the company's UroShield, PainShield, and WoundShield products employs a small, disposable transducer that transmits low frequency, low intensity ultrasound acoustic waves that seek to repair and regenerate tissue, musculoskeletal and vascular structures, and decrease biofilm formation on urinary catheters and associated urinary tract infections.

PainShield, MD is cleared for marketing in the United States by the U.S. Food and Drug Administration. In September 2020, the U.S. Food and Drug Administration exercised its Enforcement Discretion to allow distribution of the UroShield device in the U.S. during the COVID-19 pandemic. While the permitted use is currently temporary, it does permit the import of the UroShield to the U.S. during the ongoing COVID-19 pandemic. All three of the company's products have CE Mark approval in the European Union, and a certificate allowing it to sell PainShield, UroShield and WoundShield in Israel. The company is able to sell PainShield, UroShield and WoundShield in India and Ecuador based on its CE Mark. The company has consummated sale of PainShield and UroShield in the relevant markets. Outside of the United States the company generally applies, through its distributor, for approval in a particular country for a particular product only when it has a distributor in place with respect to such product.

In the United States, PainShield and UroShield requires a prescription from a licensed healthcare practitioner. The company has completed seven separate clinical studies with UroShield that together evaluated approximately 220 patients with urinary catheters. In patients where the UroShield product was used there were no serious adverse events reported, while a variety of clinical beneficial observations were seen, including catheter biofilm reduction, reduction in catheter associated pain, reduction in urinary tract infections, and a significant decrease in bacteriuria rates. The company completes a double blind clinical trial for UroShield in the United States.

In 2017, the company engages Idonea Solutions, Inc., an FDA consultant, to assist in its efforts to obtain clearance under the FDA's Enforcement Discretion, and obtain 510(k) clearance which is still ongoing. The company has entered into recent distribution partnerships for UroShield in the U.K., Australia, and Malta.

The company has one clinical study which is ongoing for its product UroShield. The company announced positive interim results from an independent, real world patient study of its UroShield at Southampton University Health Sciences in December 2021.

In addition, the company continues to expand its clinical development and marketing efforts in North America with respect to PainShield. In February 2018, the company completed a clinical trial to evaluate the effect of PainShield in patients with trigeminal neuralgia. The double blinded, crossover trial was conducted across the United States and included 59 patients with a diagnosis of unilateral trigeminal neuralgia. Among the 59 patients, 30 were in the active treatment group and 29 were in the control group.

In 2019, the company has completed a study which was intended to assess the PainShield's ability to effectively treat Lateral Epicondylitis (Tennis Elbow). This is a double blinded, randomized control trial. The study has been completed and it is contemplating submission to an appropriate journal.

All of the company's products consist of a reusable controller device and a disposable component, which includes a transducer, and in the case of PainShield, a 30 day supply of adhering patches.

The company also has a direct sales component, where it sells directly to consumers, in order to satisfy customer demand generated through on-line advertising and social media. The company has seen an increase in demand as a direct result of an expanded social media and on-line advertising presence.

The company's proprietary technology consists of a small, thin (1 millimeter) transducer that is capable of transmitting ultrasonic acoustic waves onto treatment surfaces with a radius of up to 10 centimeters beyond the transducer.

The company is also aware of one product, the SAM Sport family of products, which received FDA approval and has CE Mark approval, marketed by ZetrOZ, Inc.

The company's UroShield product provides vibrations along the surface of the urinary catheter that is in contact with urethral tissue.

On March 21, 2023, the company announced that it filed a new provisional patent application with the United States Patent and Trademark Office (USPTO) entitled 'Multiple Frequency Surface Acoustic Waves for Internal Medical Device' (the Patent Application) related to its UroShield.

On March 15, 2023, the company announced the positive evaluation results for its UroShield device, presented at a recent medical conference by clinicians from the Royal National Orthopaedic Hospital (RNOH).

In April 2022, the company announced that UroShield was approved for sale by NHS Supply Chain through a new contract. This new contract with NHS Supply Chain provides a dedicated end-to-end supply chain service of the company's UroShield for every NHS healthcare organization.

Products

Product Design, Packaging, Identity

All products were redesigned in the fourth quarter 2019, with an updated look and improved performance. These new designs were coupled with new branding, packaging, instructional manuals, and marketing materials. Beginning in the fourth quarter of 2019, the company's manufacturers in China have commenced producing the redesigned products for distribution and delivered their first completed units in April 2020.

UroShield

UroShield is intended to prevent bacterial colonization and biofilm formation, increase antibiotic efficacy in the catheter lumen and decrease pain and discomfort associated with urinary catheter use. It is designed to be used with any type of indwelling urinary catheter regardless of the material or coating. UroShield is similar in design to WoundShield and PainShield, in that it uses a driver unit that produces low frequency, low intensity ultrasound. The driver unit connects to a disposable transducer that is clipped onto the external portion of the catheter to deliver ultrasound therapy to all catheter surfaces, as well as the tissue surrounding the catheter.

UroShield has undergone a number of clinical trials. The Heidelberg 1 trial, conducted in 2005-2006, which the company sponsored, was a 22 patient randomized, double blind, sham-controlled, independent trial that tested UroShield's safety and ability to prevent biofilm in patients with an indwelling Foley catheter. The trial demonstrated that UroShield prevented biofilm in all patients with the active device as compared to biofilm being found in seven of eleven of the control patients.

As recently announced, the company submitted to The National Institute for Health and Care Excellence, for review, the findings from an independent evaluation of its UroShield device on patients who had used the device for up to two years. Clinical data from the study conducted by Coventry University's Assistant Professor, Ksenija Maravic da Silva, during 2020 reported statistically significant outcomes for the device, including a reduced number of urinary tract infections (UTIs), reduced instances of prescribed antibiotics, reduced catheter blockages, reduced the need for unplanned catheter changes and reduced pain reported as a result of catheter associated complications.

In September 2022, UroShield was approved for sale by the U.K.'s National Health System's (NHS) internal supply organization, NHS Supply Chain, through a new contract.

On March 1, 2023, the company launches its month-to-month rental program for UroShield.

Regulatory Strategy

UroShield received CE Mark approval in September 2007 and was also approved for sale by the Israeli Ministry of Health in 2008. The company is able to sell UroShield in India and Ecuador based on its CE Mark. The company is working toward reinstatement of its Canadian license.

In the European Union, UroShield has been marketed for the prevention of CAUTI and biofilm, decreased pain and discomfort associated with urinary catheters and increased antibiotic efficacy.

In September 2020, the FDA exercised its Enforcement Discretion to allow distribution of the UroShield device in the United States. According to the FDA, UroShield device can use 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).

Accordingly, the FDA's Enforcement Discretion clears the way for import of UroShield to the U.S. during the Covid-19 pandemic, immensely expanding the company's addressable market for the device during this time period. The device is designed to aid in the prevention of CAUTI incidence in patients requiring long-term indwelling catheterization, defined as 14 days or greater.

The company intends to seek 510(k) clearance from the U.S. Food and Drug Administration (FDA) through the de novo classification process for UroShield. The company is seeking advice from the FDA prior to submission. The company also intends to seek advice and validation of supporting studies. It intends to undertake in advance of a De Novo application.

Sales and Marketing

Since the FDA exercised its Enforcement Discretion to allow the distribution of the UroShield device in the United States, the company has been actively seeking partnerships for marketing its product in the United States. The business opportunity for UroShield is in the hundreds of millions in U.S. dollars to the extent that UroShield obtains permanent marketing authorization from the FDA, is recognized as effective and becomes widely adopted for use on catheters. To that end, the company is seeking a strategic partnership with various companies which have an existing footprint in the Urology market. The company has appointed distributors for UroShield in the United Kingdom. Malta, and Australia.

The company announced in December 2022 that it has appointed a new distributor in the United Kingdom. The newly appointed distributor is Peak Medical.

From time to time, the company had interest from strategic companies in the catheter market to partner, license or acquire the UroShield technology. These strategic partners are active in the urology market and may be interested in integrating UroShield as an accessory, into its range of products.

PainShield

PainShield is an ultrasound device, consisting of a reusable driver unit and a disposable patch, which contains the company's proprietary therapeutic transducer.

On March 1, 2023, the company launches its month-to-month rental program for Painshield.

Regulatory Strategy

PainShield received 510(k) clearance from the FDA in August 2008 as an ultrasonic diathermy device intended to apply ultrasonic energy to generate deep heat within body tissues for the treatment of selected medical conditions, such as relief of pain, muscle spasms, and joint contractures. PainShield received CE Mark approval in July 2008 and was also approved for sale by the Israeli Ministry of Health in 2010. The company is able to sell PainShield in India and Ecuador based on its CE Mark.

The PainShield Plus, is a dual applicator device, which will also be submitted for specific clearance from the FDA. Submission for PainShield Plus was made in late February 2022. The company receives FDA clearance in November 2023.

Sales and Marketing

PainShield was introduced in 2009 as a treatment for pain, such as tendonitis, sports injuries, pelvic pain, and neurologic pain, depending on the scope of the approval or clearance from each applicable jurisdiction, and the company has sold over 5,000 units since its introduction. The company enters into distribution agreements in United States, Europe, Australia, and India for the distribution of PainShield. The company intends to seek additional distribution opportunities in Europe, East Asia and Ecuador. In addition, the company sells PainShield directly to patients through its website in jurisdictions where direct-to-consumer sale is permitted. The company is ramping up its marketing efforts in the U.S. market and throughout the world to establish licensing and private label partnerships as well.

The company has identified a unique application for PainShield in applicable foreign jurisdictions where such application is authorized, which is the treatment of a severe facial nerve pain called Trigeminal Neuralgia, otherwise known as tic douloureux. The FDA lists facial application as a contraindication and has not cleared or approved PainShield for such use in the United States. The company is in the process of pursuing FDA approval of the PainShield for Trigeminal Neuralgia, which will likely require additional data and clinical investigation to support an application for premarket approval (PMA) for this indication, if such PMA is required by FDA.

GlobalData's epidemiological analysis forecasts that the total prevalent cases of trigeminal neuralgia in the seven major markets (United States, France, Germany, Italy, Spain, the U.K and Japan).

The company has also identified a market for PainShield in the professional sports industry, where in some cases, reimbursement may be available from sports alumni organizations or, more likely, self-pay. In order to pursue this market, it is exhibiting at sports trainers' meetings, pursuing alumni associations, advertising in their media, and has recently engaged a national distributor in the United States.

WoundShield

The company's WoundShield product was granted the European Wound Closure Customer Value Leadership Award, Ultrasound Therapy - Wound Closure. WoundShield is intended to treat acute and chronic wounds with a disposable treatment patch that delivers localized therapeutic low frequency ultrasound. The WoundShield patch has two configurations: one that is placed adjacent to the wound and another, called the instillation patch, that is placed on the wound to enable instillation through sonophoresis, a process that increases the absorption of semisolid topical compounds, including medications, into the skin. In March 2020, the company signed a license agreement with Sanuwave Health, Inc. (Sanuwave) for the manufacture and delivery of its WoundShield technology. In return, Sanuwave has received the worldwide, exclusive rights to the company's WoundShield product and technology.

WoundShield delivers surface acoustic waves to the location of the wound. Surface acoustic waves move laterally across the surface of the wound, which enables the transfer of the acoustic energy of the waves along the entire wound surface in a continuous and consistent mode, providing access to the waves' benefits for a longer treatment period than conventional ultrasound without the need for supervision or a treatment session by a clinician.

Regulatory Strategy

The company's general regulatory strategy for WoundShield has been focused on seeking U.S. Food and Drug Administration approval for a variety of indications. WoundShield obtained CE Mark approval in November 2012. Sanuwave has received the worldwide, exclusive rights to the company's WoundShield product and technology.

Sales and Marketing

In March 2020, the company signed a license agreement with Sanuwave Health, Inc. for the manufacture and delivery of its WoundShield technology.

Regulatory Strategy

The company's general regulatory strategy for WoundShield has been to allow its licensee to pursue FDA clearance.

Sales and Marketing

In March 2020, the company signed a license agreement with Sanuwave Health, Inc. for the manufacture and delivery of its WoundShield technology.

Over-the-counter products, such as the anticipated PainShield Relief product that the company is developing, if ultimately cleared for marketing by the FDA.

New Product Under Development

Renooskin

In 2016, the company started developing a device for the facial rejuvenation market called Renooskin. Previous in vitro studies on human skin were done showing that the SAW technology provided skin rejuvenation comparable to Retinol A which is a well-accepted anti-aging cream. The company has developed a head band like applicator for the PainShield SAW treatment and are in the process of arranging for a pilot trial with a cosmetic dermatologist and/or plastic surgeon. The company is considering several paths towards commercialization.

Intellectual Property

Patents

The company's patent portfolio includes at least the following issued patents, as well as a number of corresponding foreign patents in relevant jurisdictions: U.S. Patent No. 7,393,501 to Method, Apparatus and System for Treating Biofilms Associated With Catheters (expiring on December 19, 2023); U.S. Patent No. 7,829,029 to Acoustic Add-On Device for Biofilm Prevention in Urinary Catheter (expiring on October 27, 2025); U.S. Patent No. 9,028,748 to System and Method for Surface Acoustic Wave Treatment of Medical Devices" (expiring on July 11, 2030); and U.S. Patent No. 9,585,977 directed to System and Method for Surface Acoustic Waves Treatment of Skin (expiring on August 20, 2033). These patents cover a wide range of embodiments and applications of the company's proprietary surface acoustic wave (SAW) technology, including its commercialized PAINSHIELD, PAINSHIELD PLUS, WOUNDSHIELD and UROSHIELD devices. Specifically, the patents provide for methods of generating SAW on surfaces of indwelling medical devices and to topical and urological applications therefor for alleviating pain, wound healing, and preventing formation of bacterial biofilms on catheters.

In addition to the above patents, the company's pending patent applications and new filings are representative of its ongoing efforts to broaden its portfolio as it continues to develop new applications for the company's ultrasound technology. Pending patent applications related to UROSHIELD devices are directed to Multiple Frequency Surface Acoustic Waves for Internal Medical Device and System, Device, and Method for Mitigating Bacterial Biofilms Associated with Indwelling Medical Devices. The new patent applications cover the next generation of UROSHIELD devices operating at multiple frequencies and devices which are compatible in portable and wireless systems.

Pending patent applications related to PAINSHIELD, PAINSHIELD PLUSTM, WOUNDSHIELD devices are directed to Transdermal Patch of a Portable Ultrasound-Generating System for Improved Delivery of Therapeutic Agents and Associated Methods of Treatment; Portable Ultrasound System and Methods of Treating Facial Skin by Application of Surface Acoustic Waves and Improved Injection Needle Assembly.

Trademarks

In addition to patent protection, the company owns numerous registered trademarks for its commercialized WOUNDSHIELD (in the U.S. and Canada), NanoVibronix (in the U.S. and Canada), WOUNDSHIELD (in the U.S. and Canada), PAINSHIELD (in the U.S. and Canada), and UROSHIELD (in the U.S.). Generally, the protection afforded by trademarks is perpetual, subject to paying timely renewals and continuing proper use in commerce.

Research and Development

For the year ended December 31, 2022, the company's research and development expenses included approximately $283,000.

Manufacturing and Suppliers

In December 2018, the company announced it appointed Quasar Engineering Ltd, as contract manufacturer for the PainShield, UroShield and WoundShield, as well as other devices. Following its agreement with Sanuwave, Quasar is no longer the manufacturer of the WoundShield. Quasar is a medical device manufacturer, located in China, with over 30 years of experience, serving major brands worldwide, with complex catheters, disposables, and FDA regulated assemblies. Starting in the fourth quarter of 2019, the company started using Quasar to manufacture all of its newly redesigned products.

The company's most significant suppliers for these components are B Star, Inc and Plastic One.

Customers

The company sells its products both directly, through its website, and indirectly via distribution agreements, with approximately 99% of its sales coming through distributors in 2022. The company has exclusive and non-exclusive distribution agreements for its products with medical product distributors based in the United States, in the United Kingdom and various countries throughout Europe, India, Canada and Asia. For the year ended December 31, 2022, the company's two largest customers were Applied Medical Solutions LLC who comprised approximately 44% of total sales and Ultra Pain Products Inc, who comprised approximately 36% of total sales.

The company is in discussions with several distribution companies with access to various markets in the United States, Europe, and Asia, as well as Veterans Administration facilities. The company's agreements stipulate that distributors will be responsible for carrying out local marketing activities and sales. The company is responsible for training, providing marketing guidance, marketing materials, and technical guidance. The company's agreements with distributors are generally for a term of approximately two to three years and automatically renew for an additional annual terms unless modified by either party.

Competition

The company faces competition from established medical device companies, such as Neurometrix Inc., Zetrox, Kinetic Concepts, Inc., (a subsidiary of the 3M Company) and Smith & Nephew plc, manufacturers of certain portable ultrasound devices capable of self-administered use, as well as from academic institutions, government agencies, and private and public research institutions in the United States and abroad.

Government Regulation

Each of the company's products must be approved, cleared by, or registered with the U.S. Food and Drug Administration (FDA) before it is marketed in the United States. Before and after approval or clearance in the United States, its products, approved or cleared products and product candidates, are subject to extensive regulation by FDA under the Federal Food, Drug, and Cosmetic Act and/or the Public Health Service Act, as well as by other regulatory bodies. PainShield has already obtained 510(k) marketing approval by the U.S. Food and Drug Administration. The company is in the process of conducting clinical and non-clinical testing to support a submission for FDA clearance for PainShield Relief as an over-the-counter drug.

Accordingly, the FDA's Enforcement Discretion clears the way for import of UroShield to the U.S. for limited use during the Covid-19 pandemic. WoundShield and PainShield are classified as Class II medical devices and require the U.S. Food and Drug Administration authorization prior to marketing, by means of 510(k) clearance. The company has the Health for PainShield, WoundShield and UroShield, a certificate by the Israel Ministry of Health allowing it to sell PainShield, WoundShield and UroShield in Israel, a certificate allowing the company to sell PainShield in Australia. The company is able to sell PainShield, WoundShield and UroShield in India and Ecuador based on its CE Mark.

History

NanoVibronix, Inc., a Delaware corporation, was founded in 2003. The company was incorporated in 2003.