NanoVibronix Inc (NASDAQ: NAOV) is climbing in the market this morning, trading on premarket gains of nearly 100%. The movement comes after the comapny announced that it will be entering the United States market. Here’s what’s going on:
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NAOV Stock Climbs On US Market Entry
In a press release issued early this morning, NanoVibronix announced that the FDA has decied to exercise its Enforcement Discretion to allow the distribution of the UroShield device in the United States.
As a result, the UroShield device can now be sold to customers in the United States. In particular, the approval to market the product in the United States is related to the COVID-19 pandemic, with the FDA pointing to the device as a extracorporeal acoustic wave generating accessory to urological indwelling catheter for use during the COVID-19 pandemic.
In the release, NAOV explained that UroShield is an ultrasonic-based product designed to prevent bacterial colonization and biofilm on indwelling urinary catheters and increase antibiotic efficiency. The device can also decrease pain and discomfort experienced by patients who use urinary catheters.
In a statement, Brian Murphy, CEO at NAOV, had the following to offer:
The FDA continues its critical work to protect public health, including expediting the review of medical devices that may be of beneficial use during the COVID-19 pandemic. After reviewing the body of scientific evidence that we presented, the agency took decisive action to clear the way for patient access to UroShield for the duration of the Covid-19 pandemic. The evidence presented to the FDA on UroShield demonstrated decreases in the risk of catheter-associated urinary tract infections and related complications in patients using UroShield who required long-term indwelling catheterization. Importantly, we are unaware of any other commercially available device that can prevent catheter-associated urinary tract infection incidence and achieve results comparable to UroShield.
Catheter-associated urinary tract infections are a greater risk for critically ill patients and according to the Centers for Disease Control and Prevention, urinary tract infections (UTI) are the most common type of healthcare-associated infection reported. Among UTIs acquired in the hospital, approximately 75% are associated with a urinary catheter, and between 15-25% of hospitalized patients receive urinary catheters during their hospital stay. Approximately 40% of all hospital acquired infections are attributable to CAUTI.
Moreover, high rates of catheter-associated urinary tract infections are observed in high-risk nursing home and long-term care facility populations that have been greatly impacted by COVID-19 and frequently with patients who have one or more underlying conditions predisposing them to more severe illnesses. Reducing the risk of these infections may reduce catheter changes and prevent exposure to infectious diseases such as COVID-19 by minimizing healthcare personnel or caregiver interactions with patients.
Hospitals are continually seeking opportunities to improve patient care and quality performance metrics such as the number of catheter-associated urinary tract infections.
We believe that the FDA’s enforcement discretion for UroShield enables hospitals to be better equipped to improve CAUTI metrics and provide patients with access to a device that can potentially prevent the incidence of infections that further complicate care, extend the duration of hospital stays or increase the risk of readmission at a critical time for our healthcare system. UroShield has been proven to be safe and cost-effective and has regulatory approval in a number of countries around the globe. Introduction to the U.S. market during the Covid-19 pandemic is a significant next step in reaching a critical mass of healthcare facilities and providers.
This Is Big News
The news released by NanoVibronix proved to be overwhelmingly positive. While the company’s products have been used in Europe and other regions, the United States has been a market the company has been working to tap into.
With the news released, today, NAOV will have the ability to tap into the world’s largest economy, greatly expanding its potential to drive significant revenues. As a result, the stock is one that’s worth watching closely.
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