Benzinga | Jul 29, 2021 09:00AM EDT

NanoVibronix Receives Registration Approval For UroShield From TGA Australia

Signs Agreement with DukeHill Healthcare for Distribution of UroShield(r) and PainShield(r) in Australia

NanoVibronix, Inc., (NASDAQ:NAOV), a Healthcare device company that produces the UroShield(r) and PainShield(r) 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(r) and PainShield(r) 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(r) 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.