- Combination of nanoparticle CBD-infused patch/cream and PainShield® intended as powerful alternative to opioids for treatment of pain
- NanoVibronix partnering with Saralex Group for regulatory approval and global distribution
ELMSFORD, NY / ACCESSWIRE / June 3, 2019 / NanoVibronix, Inc., (NASDAQ: NAOV), a medical device company that produces the PainShield® surface acoustic wave (SAW) device, which utilizes the Company's proprietary and patented low intensity, SAW ultrasound technology, today announced that it is developing a cannabidiol (CBD) patch and cream utilizing a proprietary and nanoparticle-based infusion process. NanoVibronix intends to make the CBD patch as well as similarly formulated CBD cream available in combination with PainShield® as PainShield CBD™.
NanoVibronix intends to demonstrate that coupling the infused patch and cream with PainShield® will increase absorption and may provide sustained pain relief for up to 24 hours. The Company believes that this will be the first known ultrasound-based pain relief product available in combination with CBD, which can be used at home, and outside of a clinical setting, as an opioid-alternative.
NanoVibronix is partnering with Saralex Group Inc., which has successfully launched numerous regulated products in both Canada and the European Union. Saralex plans to manage the regulatory approval process and launch PainShield CBD™ in these markets through highly-regarded e-commerce and retail distribution channels.
''We are excited to announce that we will commence development of an innovative CBD-infused patch and companion cream for PainShield® in partnership with Saralex, who bring more than 25 years of experience successfully launching new products and navigating highly regulated markets,'' said Brian Murphy, CEO of NanoVibronix. ''Combining PainShield® with proprietary, nanoparticle-based CBD could provide a powerful alternative to opioids by actually resolving, rather than masking, pain. PainShield® has been shown in numerous clinical studies to effectively resolve the source of pain by healing nerve and tissue damage. By layering a proprietary CBD formulation to the patch, we believe this product will offer further benefits, including additional pain relief and anti-inflammatory properties designed to accelerate the healing process.''
''PainShield® is a revolutionary product, with a growing body of clinical evidence that supports mass adoption. By applying the latest nanoscience to CBDs and combining the proven benefits of PainShield®, we are in a position to deliver a first-in-class product, expected to heal tissue and relieve pain, providing an effective alternative to opioids,'' commented Joe Santos, President of Saralex. ''The proprietary CBD formulation is designed for maximum bio-availability due to the small molecule size, which is intended to penetrate the central nervous system and bypass the blood-brain barrier in order to maximize efficacy. We are planning an aggressive product launch to drive market awareness and consumer uptake.''
Most CBD infused topicals have a CBD molecule size of 50 nanometers or considerably larger. High bioavailability requires a very small molecule size in order to penetrate the central nervous system and blood-brain barrier. PainShield CBD™ is infused with an advanced nano-CBD formulation with a molecule size of approximately 10 nanometers, which is much smaller than what is regularly available in the market today. NanoVibronix believes this formulation will provide the greatest bioavailability and, therefore, the maximum delivery of potential pain relief.
NanoVibronix expects to launch PainShield CBD™ with Saralex into markets that have legalized or are in the process of legalizing the sale of CBD-infused topicals, including Canada and the European Union. Canada currently allows CBD sales on a prescription-basis with regulatory changes expected in October 2019 that would allow CBD-infused topical sales without prescription. CBD sales are currently permitted in almost all European countries.
About NanoVibronix
NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, New York, with research and development in Nesher, Israel, which is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave (SAW) technology. This technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including the disruption of biofilms and bacteria colonization, as well as providing pain relief. The devices can be administered at home without the assistance of medical professionals. The Company's primary products include PainShield®, UroShield™ and WoundShield™. Additional information about the Company 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 and 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) market acceptance of our existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results (iii) an inability to secure regulatory approvals for the sale of our products, (iv) intense competition in the medical device industry from much larger, multinational companies, (v) product liability claims, (vi) product malfunctions, (vii) our limited manufacturing capabilities and reliance on subcontractors for assistance, (viii) insufficient or inadequate reimbursement by governmental and other third party payers for our products, (ix) our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful, (x) legislative or regulatory reform of the healthcare system in both the U.S. and foreign jurisdictions, (xi) our reliance on single suppliers for certain product components, (xii) the fact that we will need to raise additional capital to meet our business requirements in the future and that such capital may not be available, or may be costly, dilutive or difficult to obtain and (xiii) the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction. 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.
Investor Contacts:
Crescendo Communications
[email protected]
(212) 671-1021
SOURCE: NanoVibronix, Inc.