NanoVibronix CEO Brian Murphy Provides Business Update in Letter to Shareholders - Seite 3

New Product Development

We introducted two new products in the second half of this year, PainShield Plus and PainShield Relief. PainShield Plus has already been shipped to customers and is performing well. We expect PainShield Relief, our over-the-counter product, to be submitted for 510K clearance by the end of November.  We are awaiting final testing of the product’s energy production technical performance, which is on schedule to be completed by mid-November. Once submitted to the Federal Drug Administration (FDA), we expect a response within 90 days with a target release for clearance in Q1 2022. 

Catalysts

There are several expected near-term catalysts for our business including:

• Completion of NHS evaluation of UroShield. After a lengthy clinical and economic NHS evaluation of UroShield, we expect NICE Guidance to be completed in the next few months. Accordingly, we are actively preparing for NHS adoption of UroShield in early 2022.
• Launch of PainShield Relief, our first non-prescription device for the consumer market
• Launch of sales in Canada and the Middle East
• Granting of three additional patents by the end of 2021
• Continued growth and product adoption from our distributor network

Balance Sheet

Our balance sheet remains strong with approximately $8.6 million in cash and no debt, outside of the ordinary course of business payables, as of September 30,2021 providing us with the financial flexibility and capital to fund our growth initiatives, support manufacuturing to deliver on an increasing level of orders and invest in product development.

In Conclusion

Much has changed over the past year and many more changes and improvements are planned. I believe the most significant change is how rapidly we are advancing our product sales, despite the headwinds caused by Covid-19. We have several significant“shots on goal” and are always looking for the opportunity to add more. Any one of these could singularly transform the company relative to our profile today. While there is still much work to be done, be assured that I am dedicated to a successful NanoVibronix. 

I wish all of our shareholders Happy Holidays.”

About NanoVibronix 

NanoVibronix Inc. (NASDAQ: NAOV) is a medical device company headquartered in Elmsford, NY with research and development in Nesher, Israel, that is focused on developing medical devices utilizing its proprietary and patented low intensity surface acoustic wave technology. The company's technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including the disruption of biofilms and bacteria colonization, as well as providing pain relief. The devices can be administered at home, without the assistance of medical professionals. The company's primary products include PainShield, UroShield and WoundShield. Additional information about the company is available at: www.nanovibronix.com.