NanoVibronix Issues Letter to Shareholders - Seite 2

Product development

We have been working on several exciting improvements to the existing product portfolio as well as exploring new product opportunities. Within the next 30 days, we plan to conduct onsite visits with two qualified product development organizations with the intent of partnering with the most qualified partner.

Reimbursement

Our ongoing efforts to obtain full approval from the Centers for Medicare & Medicaid Services (“CMS”) with acceptable terms is now in its fourth year. In the last cycle, our application for full approval was not approved due to a lack of “life-cycle” testing. At that time, we engaged an independent testing laboratory, Carmel Labs, to conduct the required testing. The testing was intended to satisfy the requirement for a three-year life expectancy with consideration to our patient use criteria. We submitted the final report with our application to CMS in March 2023. The report provided the required information what we believe the regulatory agency was seeking. CMS invited NanoVibronix to a public meeting to present our findings and to answer CMS’s questions, which was held June 1, 2023. We were notified in August 2023, that we did not satisfy their request. Subsequently, we requested and facilitated a meeting with CMS leadership to clarify the deficiencies and asked them to reconsider. At this time, we are awaiting a response.

Reimbursement is currently approved in the Veterans Health system and several Worker’s Compensation plans, Third Party Administrators and insurance companies. Our revenues for this market in Q3 were approximately $227,000, and our goal is to more than double that number in Q4. Sales continue to grow in both segments, and we are in the process of adding sales resources where we believe are appropriate.

Research

The University of Southampton recently completed its UroShield study and has submitted it for publication. The study, as announced on August 30, 2023, reported positive outcomes from a study of UroShield that was conducted at the University in the United Kingdom. There are several market opportunities for UroShield, and as such, we are prioritizing our marketing efforts and initiating our "Gold Standard” study with a major U.S. university.

A look ahead

We remain focused on driving profitable growth by expanding and increasing our distribution and licensing channels, nurturing relationships with new and existing accounts and engaging consumers through a variety of creative mediums. Today, we have initial distribution agreements in place, a solid manufacturing partner and the necessary working capital to meet existing and anticipated demand.