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NanoVibronix Receives Registration Approval for UroShield From TGA Australia


ELMSFORD, N.Y.–()–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 its UroShield to be used by patients in Australia.

In addition, the Company also announced that it has signed an agreement with DukeHill Healthcare Pty Ltd (DukeHill HC) to distribute the Company’s UroShield® and PainShield® technologies in Australia.

Brian Murphy, Chief Executive Officer of NanoVibronix Inc., commented, “Approval in Australia is yet another material milestone towards full commercialization of our products, particularly given the rigorous standards by which our UroShield device was measured by TGA. We are enthusiastic about partnering with DukeHill HC, an industry leader with significant sales resources and strong distribution capabilities in Australia. DukeHill HC have already placed their initial order validating their confidence in the technology and market potential, which we are on schedule to fulfil in the coming week, which should lay a firm foundation for immediate revenue recognition.”

Murphy added, “Looking ahead, PainShield, our pain management device, is also now under review by the TGA for registration and distribution in Australia as part of our strategy for global expansion.”

Toni Hill, Managing Director of DukeHill Healthcare Pty Ltd, commented, “We anticipate a strong uptake of UroShield given its Easy to Use, Minimally Invasive, and Clinically Efficacious Platform. The UroShield has met the Australian TGA’s rigorous regulatory requirements and has been added to the official database of healthcare devices in accordance with the Regulations. This registration comes at a pivotal time for long-term catheter patients both in the Community and in Health Care Facilities (Hospital and Aged Care) who are at risk of CAUTI. UroShield enables clinicians to potentially prevent the incidence of infections in the most vulnerable patients that further complicates their care, extends the duration of hospital stays or increases the risk of readmission at a critical time for our Healthcare System. We look forward to PainShield receiving regulatory approval and joining UroShield soon.”

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 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 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

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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.



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