NanoVibronix (NAOV) Provides Business Update

NanoVibronix, Inc. (NASDAQ: NAOV) (the “Company”), a medical device company that produces the UroShield®, PainShield® and WoundShield® Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices, today provided an update on recent business developments.

Brian Murphy, Chief Executive Officer of NanoVibronix, Inc., commented, “We have made substantial progress over the last several months with regards to expanding distribution, raising commercial awareness and pursuing reimbursements from regulatory authorities. Our products continue to deliver impressive results with high patient satisfaction and importantly, we believe are positioned to fill a void in the market. We are highly optimistic about the prospects for our business given the success we are having towards increasing market penetration.”

Expanding Distribution

Expanding distribution of the Company’s products with leading distributors is a key driver to accelerating market adoption of UroShield. Following substantial interest from clinicians in South Africa, the Company has signed a letter of intent with Kriel Technology Group (Pty) Ltd (“KrielTech”), to explore opportunities for distribution of the Company’s UroShield device in South Africa. KrielTech will conduct a market evaluation early next year to better understand the market opportunity. Given the broadening acceptance of UroShield, the Company is optimistic about reaching a distribution agreement with KrielTech and the opportunities to enter this new market with it as a partner.

Leveraging Independent Research to Increase Product Awareness

Catheter-associated urinary tract infections (CAUTIs) continue to be a major concern in healthcare settings, particularly for patients who require long-term catheterization. Research has explored the use and effectiveness of the Company’s UroShield in a number of settings and circumstances. Time and again, UroShield has been proven effective in reducing the incidence of CAUTI.

Independent studies of UroShield were recently presented at major medical conferences including the International Continence Society (“ICS”) in Madrid and the British Association of Urological Nurses (“BAUN”) in the United Kingdom. At ICS, a study on spinal injury patients was presented that concluded, “This device provides a solution to the problem of recurrent infection and catheter blockages, improving the quality of life for spinal injury patients.” At BAUN, clinicians presented real world patient studies that demonstrated both the clinical effectiveness of the device and the economic benefits to the health system.

In New Zealand, where UroShield now has insurance coverage, an independent study of UroShield regarding the effectiveness of UroShield is scheduled to be published in the Australian and New Zealand Continence Journal in December 2024.

Pursuing Additional Reimbursements

The Company’s application for UroShield actuators to be available on NHS Prescription Services’ Drug Tariff was approved for reimbursement in 2023. Following this success, in July of this year, the Company submitted a request for full reimbursement of UroShield for all NHS patients and is currently awaiting a response from NHS.

In Germany, the Company’s submission for full reimbursement for UroShield was recently completed and the product indications are:

• Reduction of urinary tract infections due to biofilm formation
• Avoiding blockage of the catheter
• Avoidance or relief of pain, discomfort and spasms

The Company is awaiting response from GKV-SV German health reimbursement authority, which could be as soon as January 2025.

Murphy concluded, “We are committed to our strategic vision of developing, improving and commercializing our distinct and effective therapies. The areas we are focusing on are showing positive results. We are making measurable progress towards expanding distribution globally and increasing awareness among healthcare and insurance providers and government regulators.”

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