NanoVibronix, a medical device company specialising in therapeutic ultrasound technology, has successfully concluded the pilot phase of its UroShield clinical trial in the US. The company announced that the trial met its primary objectives, setting the stage for expanded clinical evaluations and regulatory engagement.
The UroShield device employs advanced ultrasonic technology to address catheter-associated complications, including infections, blockages, and patient discomfort. By emitting low-frequency ultrasound waves, the device prevents bacterial colonisation and biofilm formation, offering a novel solution to persistent challenges in urinary catheter management.
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The global urology therapy device market is projected to grow at a compound annual growth rate of 2.31%, increasing from $9.23bn in 2015 to $11.08 billion by 2033. This growth is driven by technological advancements in minimally invasive treatments and diagnostic tools, coupled with an ageing population more susceptible to urological conditions. Supportive healthcare policies and regulations further enhance market adoption of innovative technologies such as UroShield.
Graysen Vigneux, a medical analyst at leading data and analytics company GlobalData, remarked: “The completion of the pilot phase in the US represents a significant achievement for NanoVibronix. The UroShield device addresses a critical unmet need in infection control and catheter management, with the potential to significantly improve quality of life for patients requiring long-term catheterisation.”
The results of the US trial align with earlier studies conducted in Europe, where UroShield demonstrated marked reductions in catheter-related infections and improved patient outcomes. These findings underscore the device’s potential to revolutionise urinary care with a noninvasive, patient-friendly solution.
Vigneux added: “Reducing catheter-associated infections not only benefits patients but also mitigates the financial strain on healthcare systems. Innovative devices like UroShield could become a cornerstone of care, reducing antibiotic reliance and combating antimicrobial resistance.”
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By GlobalDataLooking ahead, NanoVibronix plans to secure US Food and Drug Administration clearance and scale production to meet anticipated demand in the US. As awareness of the impact of catheter-related complications grows, UroShield is poised to redefine the standard of care in urinary management.
