NanoVibronix Receives Australian Approval for UroShield

NanoVibronix Inc., a healthcare device company that produces the UroShield and PainShield Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, has received approval for the UroShield from the Therapeutic Goods Administration (TGA)—the Australian Regulatory body for Therapeutic Devices.
 
In addition, the company also has signed an agreement with DukeHill Healthcare Pty Ltd. (DukeHill HC) to distribute the UroShield and PainShield technologies in Australia.
 
CEO Brian Murphy 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 should lay a firm foundation for immediate revenue recognition. 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.”

UltraShield 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 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. 
 
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 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 healthcare 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.”
 
DukeHill HC advances 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.
 
NanoVibronix Inc. is a medical device company headquartered in Elmsford, N.Y., 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.