NanoVibronix Issues Letter to Stockholders - Seite 2

Reimbursement

After four years, our efforts to obtain full approval for PainShield from the Centers for Medicare & Medicaid Services (“CMS”) have been met with persistent challenges. 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 information that we believed the regulatory agency required. CMS invited NanoVibronix to a public meeting to present its 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 facilitated a meeting with CMS leadership to clarify the deficiencies and asked them to reconsider. Our efforts to obtain CMS approval continue.

Reimbursement is currently approved in the Veterans’ Health System and several worker’s compensation plans, third party administrators and insurance companies. Our revenues in these markets have, and continue, to grow substantially. Through our strategic, exclusive distributor partners for select markets, and through our direct sales efforts, we are seeing growth every month. The sales growth follows the payer and patient testimonials of superior product efficacy.

International update

We continue to make progress and generate additional sales in the Australian and New Zealand markets. Full reimbursement for UroShield is being considered in both markets although the timing is unknown at this point in time. If reimbursement was to be granted, we believe there would be a significant increase in demand for our urology products.

In the United Kingdom, we continue to leverage our contract with the National Health Services (“NHS”) supply chain and our supplies reimbursement through the NHS Prescription Services’ Drug Tariff, which became effective on November 1, 2023. We continue to make progress with our Uroshield product and have experienced more interest since then. Our U.K. distributor, Peak Medical Limited, continues to add to their inventory and is actively pursuing market opportunities throughout the country. Fourth quarter 2023 sales in the U.K. surpassed the cumulative total sales since first introducing the product into the country.