Wednesday, December 22, 2021
NanoVibronix Inc., a medical device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that it has commenced sales in Europe with the signing of a distribution agreement with Medina Healthcare Ltd (“Medina”) in Malta.
Brian Murphy, Chief Executive Officer of NanoVibronix Inc., commented, "NanoVibronix have has already obtained regulatory approval to sell our range of devices into all European countries. We are eager to leverage Medina’s strong distribution capabilities in Malta and establish a foothold that will help us achieve broader distribution to other parts of Europe. This agreement is consistent with our strategy to partner with leading organizations that have significant sales resources and can rapidly penetrate global markets. Medina placed its initial order validating their confidence in our technology and the market potential for our devices. UroShield enables clinicians to potentially prevent the incidence of infections in the most vulnerable, and PainShield will empower patients to manage their chronic pain at a critical time for our healthcare system.”
Medina Healthcare Ltd. provides a comprehensive range of medical solutions that address the changing needs of European healthcare.
John Soler, CEO of Medina Healthcare Ltd commented, “Following discussions with clinicians, we anticipate strong uptake of UroShield and PainShield devices as medical professionals seek minimally invasive, consumable devices that enable the delivery of the best therapies for their patients. The partnership with NanoVibronix allows us to provide solutions that both prevent the incidence of infections in the most vulnerable patients and help many people gain relief from chronic pain.”
UroShield is an ultrasound-based product that is designed to prevent bacterial colonization and biofilm on indwelling urinary catheters and increase antibiotic efficacy, ultimately reducing the incidence of catheter-associated urinary tract infections (CAUTI). UroShield is also intended to decrease pain and discomfort associated with urinary catheter use.
PainShield is an ultrasound device, consisting of a reusable driver unit and a disposable patch, which contains a proprietary therapeutic transducer. PainShield 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 been acknowledged by several sports icons and 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 Medina Healthcare Ltd
Medina Healthcare is an industry leader in advancing clinical education and has a high level of clinical and technical expertise along with an established, wide-ranging distribution network. This provides the company with a strong focus on meeting the changing healthcare needs both in Malta and the wider European health market.
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.
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 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.
Brett Maas, Managing Principal, Hayden IR, LLC