NANOVIBRONIX ANNOUNCES PLAN TO EXPAND PRODUCT PORTFOLIO WITH INTRODUCTION OF PAINSHIELD RELIEF FOR OVER-THE-COUNTER (OTC) USE AND PLANS FOR FUTURE PRODUCT LAUNCH
NanoVibronix, Inc. (NASDAQ: NAOV) announces its entry into the Over-the-Counter (OTC) pain relief market with the launch of PainShield RELIEF™, a non-prescription ultrasound device aimed at providing rapid pain relief for soft tissue and nerve damage. CEO Brian Murphy notes this significant market expansion opens new revenue opportunities for the company. Plans are in place for a U.S. launch and trade show reveals in early to mid-2022. The company is also preparing to submit a regulatory application to the FDA and protect its trademark.
- Entering the OTC pain relief market with PainShield RELIEF significantly expands the total addressable market.
- The device offers a non-prescription solution, increasing accessibility for pain sufferers.
- Plans for a U.S. launch and participation in trade shows may enhance brand visibility and sales.
- PainShield RELIEF is expected to address specific pain relief needs more effectively than existing products.
- Potential regulatory hurdles with the FDA approval process could delay product launch.
- Intense competition from larger medical device companies poses a risk to market penetration.
- Market acceptance is uncertain, which could impact sales performance.
Significantly Expands Addressable Market
Elmsford, NY, Aug. 16, 2021 (GLOBE NEWSWIRE) -- NanoVibronix, Inc., (NASDAQ: NAOV), a Healthcare device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that it intends to enter the Over-the-Counter (OTC) pain relief market with the introduction of PainShield RELIEF™, a non-prescription ultrasound therapy device that delivers fast pain relief for nerve and soft tissue damage.
Brian Murphy, Chief Executive Officer of NanoVibronix Inc., commented, "Entering the OTC pain relief market with our newest product in the PainShield family significantly expands our total addressable market and opens up new opportunities for growth through several additional revenue streams. Those suffering from pain will have ready access to the device with no need for clinician prescription. Plans are under way for an official launch in the U.S. and select parts of the world and product reveal in the coming months at a number of trade shows targeting a variety of athletic interests including tennis and golf. We are targeting the specific pain relief indications and the retail channels to address them as an OTC alternative to less effective interventions. The company expects widespread availability by early to mid-2022.”
The company has submitted its trademark application to the U.S. Patent and Trademark Office (USPTO) for protection of the PainShield RELIEF and expects to submit for clearance to the U.S. Food and Drug Administration (FDA) in the very near term.
Murphy continued, “The pain relief market is flooded with products that simply mask the pain versus providing proven pain resolution. We believe the opportunities are endless with this product. Our initial entry, as well as our next generation, which is currently in development, are expected to be unique to the market, as is Surface Acoustic Wave (Low Level, Low Frequency Ultrasound) technology. Our entry into the OTC market will be preceded by submission of the final results of our Lateral Epicondylitis (Tennis Elbow) study.”
PainShield is an ultrasound device that delivers a localized ultrasound effect to treat pain and induce soft tissue healing in a targeted area, while keeping the level of ultrasound energy at a safe and consistent level. Its range of applications includes acute and chronic pain resolution through its many mechanisms of action. The product has broad applications for sports injuries. PainShield can be used by patients at home or work or in a clinical setting and can be used even while the patient is sleeping. Patient benefits include ease of application and use, faster recovery time, high compliance, and increased safety and efficacy over existing devices that rely on higher-frequency ultrasound.
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, e.g., 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.
FAQ
What is the new product launched by NanoVibronix (NAOV)?
When will PainShield RELIEF be available in the market?
What does PainShield RELIEF aim to address?
What market is NanoVibronix entering with PainShield RELIEF?
Is PainShield RELIEF a prescription or non-prescription product?
