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NanoVibronix Announces UroShield and PainShield Meet New Zealand Medicines and Medical Devices Safety Authority Regulatory Requirements

2020年12月08日 PM10:00
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ELMSFORD, N.Y.

NanoVibronix, Inc. (NASDAQ: NAOV), a medical device company that produces the UroShield® and PainShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today announced that its UroShield and PainShield meet the New Zealand Medical Devices Safety Authority regulatory requirements and have been added to the official WAND database in accordance with the Regulations. Coupled with this approval, the company signed an agreement, and fulfilled its first shipment, with Obex Medical Ltd to distribute both of the Company’s technologies throughout New Zealand.

Brian Murphy, Chief Executive Officer of NanoVibronix Inc., commented, “This agreement with Obex Medical Ltd provides us with strong distribution capabilities in New Zealand and further advances our strategy to penetrate new markets globally by partnering with leading organizations with significant sales resources. Obex Medical has already placed its initial order, validating their confidence in our technology and the market potential of our products. UroShield enables clinicians to potentially prevent the incidence of catheter-related infections that further complicate patient care, extend the duration of hospital stays or increase the risk of readmission, which is more important than ever before given this critical time for healthcare systems around the world.”

Pieter Wijnhoud, CEO of Obex Medical Ltd, commented, “UroShield and PainShield meet the New Zealand Medical Devices Safety Authority regulatory requirements and have been added to the official WAND database in accordance with the regulations. This registration comes at a time when utilising UroShield with vulnerable long-term catheter patients who are at risk of CAUTI may reduce unplanned clinician visits and hospitalizations, thereby potentially preventing exposure to SARS-CoV-2 in patients at higher risk of developing severe disease from COVID-19. We anticipate strong uptake as we meet the needs of medical professionals with the supply of minimally invasive, consumable devices that enable the delivery of the best therapy for the patient.”

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. The FDA recently exercised its “enforcement discretion,” which provides access to the product for patients in the United States for the duration of the Covid-19 pandemic. PainShield has been cleared by the FDA.

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 Obex Medical

Obex is an industry leader in advancing clinical education and has a high level of clinical and technical expertise with a strong focus on meeting the changing needs of healthcare in Australasia. Obex’s purpose is to meet the needs of healthcare professionals with the supply of minimally invasive consumable and implantable devices which will enable the delivery of the best diagnosis and therapy to ensure best outcomes for patients.

For further information about Obex Medical, please contact:

Pieter Wijnhoud.

NZ +64 9 630 3456
info@obex.co.nz

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®, UroShield® and WoundShield®, all of 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201208005377/en/

CONTACT

Investor Contacts:

NanoVibronix, Inc.

bmurphy@nanovibronix.com

(630) 338-5022

Or:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

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