NanoVibronix Inc [NASDAQ: NAOV] is on a roll this morning. The stock started gaining upside momentum pre-market when it gained by over 80%, and it’s not easing up. The stock’s upside momentum started after the company announced that the U.S FDA had given it the authorization to sell UroShield® in the U.S market. The FDA stated that UroShield® can apply the Intended Use Code 081.006: Enforcement Discretion Per Final Guidance. It can also use the FDA Product code QMK.

The FDA authorization has opened the way for the company to start shipping UroShield® to the U.S during the COVID-19 pandemic. This effectively opens up the company’s market at a time when a product like UroShield® is needed in the market.  That’s because, by design, it helps prevent incidents of CAUTI in people suffering from ailments that need the long-term use of indwelling catheters.

UroShield® achieves this because it is ultrasound-based, which means it is uniquely positioned to stop the buildup of bacteria on urinary catheters that are put inside. By its design, it helps cut on the possibility of catheter-related urinary tract infections, while also cutting on the possibility of CAUTI incidence in people that need long-term catheterization.

Commenting on the breakthrough, CEO Brian Murphy stated that the FDA continued to carry out its mandate of protecting the public through various means that include shortening the time needed to review new medical devices that are beneficial to the public during the COVID-19 period.   He added that it is on this basis that the FDA approved UroShield® for its ability to lower urinary tract infections. The CEO also touched on the uniqueness of the product stating that at the moment, the company was not aware of any other devices that have the ability to avoid catheter-linked urinary tract infections with the same level of efficiency as UroShield®.

From an investor perspective, the approval of UroShield® is a big deal for this stock’s value. That’s because it offers the company a foothold in one of the largest markets in the world.  Demand in the U.S is likely to be driven up by COVID-19 has led to an increase in people that need catheterization and the fact that UroShield® has no close competitors in the U.S. This points to higher revenues in the short-term, and a significant increase in the company’s intrinsic value.

About NanoVibronix Inc

NanoVibronix Inc makes and sells non-invasive devices that help prevent biofilm, and in pain therapy. It is headquartered in Elmsford, New York.