Benzinga | Aug 11, 2021 08:34AM EDT

NanoVibronix Reports Receives Registration Approval For Painshield From Australia's Therapeutic Goods Admin.

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 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(r) and PainShield(r) 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(tm) 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.