NanoVibronix Provides Business Update

Rhea-AI Summary

NanoVibronix, a medical device company, provided a business update highlighting recent developments. CEO Brian Murphy emphasized progress in expanding distribution, raising commercial awareness, and pursuing reimbursements. The company's products, including UroShield®, PainShield®, and WoundShield®, continue to show high patient satisfaction.

The company signed a letter of intent with Kriel Technology Group to explore UroShield distribution in South Africa, with a market evaluation planned for early next year. Independent research presented at major medical conferences demonstrated UroShield's effectiveness in reducing catheter-associated urinary tract infections (CAUTIs).

Reimbursement efforts include a successful application for UroShield actuators on NHS Prescription Services' Drug Tariff and ongoing submissions for full reimbursement in the UK and Germany. The company remains optimistic about expanding its market presence and increasing product awareness globally.

Positive

• Signed a letter of intent with Kriel Technology Group for UroShield distribution in South Africa.
• Independent studies presented at major medical conferences demonstrated UroShield's effectiveness in reducing CAUTIs.
• Reimbursement application for UroShield actuators was approved by NHS Prescription Services.
• Ongoing submissions for full reimbursement in the UK and Germany.

Negative

• Awaiting response for full reimbursement requests in the UK and Germany, with potential delays impacting market penetration.

Insights

Medical Research Analyst

The company's business update highlights several key developments but lacks immediate financial impact. While positive trends are emerging in distribution expansion and clinical validation, there are no concrete financial metrics or revenue projections. The letter of intent with KrielTech for South African distribution and pending reimbursement decisions in Germany and NHS, while promising, are still in exploratory phases with outcomes expected in 2024-2025.

The clinical evidence supporting UroShield's effectiveness in preventing CAUTIs and its presentation at major medical conferences (ICS Madrid and BAUN UK) strengthens the product's credibility. However, the timeline for meaningful revenue generation from these initiatives remains uncertain. The New Zealand study publication scheduled for December 2024 and German reimbursement decision expected in January 2025 are too far out to impact near-term financials.

11/12/2024 - 08:00 AM

TYLER, Texas--(BUSINESS WIRE)-- 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.”

About NanoVibronix, Inc.

NanoVibronix, Inc. (NASDAQ: NAOV) is a medical device company headquartered in Tyler, Texas, with research and development in Nesher, Israel, focused on developing medical devices utilizing its patented low intensity surface acoustic wave (SAW) technology. The proprietary technology allows for the creation of low-frequency ultrasound waves that can be utilized for a variety of medical applications, including for disruption of biofilms and bacterial colonization, as well as for pain relief. The devices can be administered at home without the continuous assistance of medical professionals. The Company’s primary products include PainShield® and UroShield®, which are portable devices suitable for administration at home or in any care setting. Additional information about NanoVibronix is available at: www.nanovibronix.com

Forward-looking Statements

This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with: (i) market acceptance of our existing and new products or lengthy product delays in key markets; (ii) negative or unreliable clinical trial results; (iii) inability to secure regulatory approvals for the sale of our products; (iv) intense competition in the medical device industry from much larger, multinational companies; (v) product liability claims; (vi) product malfunctions; (vii) our limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for our products; (ix) our ability to successfully obtain and maintain intellectual property protection covering our products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xi) our reliance on single suppliers for certain product components, (xii) the need to raise additional capital to meet our future business requirements and obligations, given the fact that such capital may not be available, or may be costly, dilutive or difficult to obtain; (xiii) our conducting business in foreign jurisdictions exposing us to additional challenges, such as foreign currency exchange rate fluctuations, logistical and communications challenges, the burden and cost of compliance with foreign laws, and political and/or economic instabilities in specific jurisdictions; and (xiv) market and other conditions. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (“SEC”), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at: http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events, or otherwise, except as required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241112241838/en/

Investor Contact:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

What recent business developments did NanoVibronix announce?

NanoVibronix announced progress in expanding distribution, raising commercial awareness, and pursuing reimbursements for their products.

Has NanoVibronix signed any new distribution agreements for UroShield?

NanoVibronix signed a letter of intent with Kriel Technology Group to explore distribution opportunities for UroShield in South Africa.

What recent studies support the effectiveness of UroShield?

Independent studies presented at the International Continence Society and the British Association of Urological Nurses demonstrated UroShield's effectiveness in reducing CAUTIs.

What is the status of UroShield reimbursement in the UK?

NanoVibronix's application for UroShield actuators was approved by NHS Prescription Services, and a request for full reimbursement is currently under review.

What is the status of UroShield reimbursement in Germany?

NanoVibronix has submitted a request for full reimbursement in Germany and is awaiting a response from the GKV-SV German health reimbursement authority.