NANOVIBRONIX RECEIVES REGISTRATION APPROVAL FOR PAINSHIELD FROM TGA AUSTRALIA
NanoVibronix, Inc. (NASDAQ: NAOV) has secured regulatory approval from Australia's TGA for its PainShield device, following the recent approval of UroShield. This allows for distribution in Australia through their new partnership with DukeHill Healthcare Pty Ltd, enhancing access to their ultrasound-based therapeutic devices. PainShield offers treatment for acute and chronic pain, while UroShield aims to reduce urinary catheter infection risks. The strategic partnership positions NanoVibronix to effectively meet market demands in Australia.
- TGA approval for PainShield expands market access in Australia.
- Strategic distribution agreement with DukeHill Healthcare enhances distribution capabilities.
- PainShield offers multiple benefits including ease of use and faster recovery.
- None.
Established Distribution Agreement with DukeHill Enables Quick Speed to Market
ELMSFORD, NY, Aug. 11, 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 the Therapeutic Goods Administration (TGA), The Australian Regulatory body for Therapeutic Devices, has granted approval for the Company’s PainShield for use by patients in Australia.
This approval follows TGA’s recent approval of the Company’s UroShield. As previously announced, the Company signed a distribution agreement with DukeHill Healthcare Pty Ltd (DukeHill HC) to distribute both UroShield® and PainShield® technologies in Australia.
Brian Murphy, Chief Executive Officer of the Company, commented, “This regulatory approval enables us to expand availability of PainShield to Australia and follows closely after TGA’s approval of UroShield just last month. We are positioned to serve beneficiaries in this important market with a strong distribution partner in DukeHill HC, an industry leader with proven distribution capabilities in Australia.”
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.
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.
About DukeHill Healthcare Pty Ltd
DukeHill HC is a leader in advancing clinical education and has a high level of clinical and technical expertise with a strong focus on meeting the changing healthcare requirements in Australia. DukeHill HC’s purpose is to address the needs of healthcare professionals with the supply of quality, cost effective, minimally invasive, and consumable devices which will enable clinicians to obtain best practice outcomes for their patients.
For further information please contact Toni Hill.
DukeHill Healthcare Pty Ltd
Suite 34 Mezzanine Level
Offices First, Aspley Hypermarket
59 Albany Creek Road
Aspley, QLD, Australia 4034
1 300 622 636 / 07 3317 8362
uroshield@dukehillhealthcare.com.au
http://dukehillhealthcare.com.au
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 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 recent approval did NanoVibronix receive for its products?
What is the significance of the distribution agreement with DukeHill Healthcare?
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How does the UroShield device benefit patients?
