NanoVibronix Issues Letter to Stockholders - Seite 3

Relative to the broader market in Europe, we are continuing our evaluation with a significant urologic pharmaceutical company based in Germany. Our previous announcement of the evaluation with Apogepha Pharmaceutical, Inc., provided more detail. This link will take you to the company’s press release. The synergy between the two companies will provide for a mutually beneficial opportunity. We remain hopeful for a longer term agreement.

Research

The University of Michigan will begin facilitating a gold standard Randomized Control Trial (“RCT”) study on the efficacy and patient satisfaction of patients utilizing UroShield. The research, which is being led by the Center for Research and Innovations in Special Populations (CRIISP), an experienced and highly accomplished research team, will be conducted primarily with nursing home residents and is aimed at studying the impact UroShield may have on reducing urinary tract infections, catheter blockages and pain and improving the quality of life of the patients studied. The first phase of the study will include a validation pilot of up to 30 patients in advance of the full study. The full study is expected to include more than 300 patients. We look forward to receiving the researchers’ conclusions and are hopeful of positive outcomes for patients in the study.

UroShield is marketed under the U.S. Food and Drug Administration’s (“FDA”) Enforcement Discretion, the intent of this independent study is to support an application to the FDA for permanent clearance. RCTs are considered the ‘gold standard’ in clinical research, and we are pleased to be working with the team at the University of Michigan.

Product development

We have been working on several exciting improvements to the existing product portfolio as well as exploring new product opportunities. We selected an engineering partner, which was announced on March 28, 2024. We expect the next generation product development to begin in the early part of the second quarter of this year. The goals of the product development are to improve the therapy, reduce cost and “future-proof” the componentry.

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.