NanoVibronix Advances Development of PainShield and UroShield with Completion of NextGen Prototypes

Rhea-AI Summary

NanoVibronix (NASDAQ: NAOV) has completed the design phase for its next-generation PainShield® and UroShield® devices through a third-party contractor in December 2024. The new prototypes aim to reduce assembly costs and improve user experience.

Key design updates include: an additional therapy mode for enhanced efficacy, future-proofed componentry ensuring availability throughout manufacturing, streamlined software for better performance, and improved user interface with USB-C connectors. For the UroShield® model, a single lead design has been implemented to simplify device setup.

The company is now advancing to the validation and testing phase based on received feedback and protocols. These developments represent a significant milestone in NanoVibronix's strategy to achieve broader healthcare community adoption and increase unit sales of their Surface Acoustic Wave (SAW) Portable Ultrasonic Therapeutic Devices.

Positive

• Successful completion of design phase within budget and timeline
• Cost reduction potential through improved assembly design
• Enhanced product features including additional therapy mode
• Simplified user interface with modern USB-C implementation

Negative

• Products still require further validation and testing before commercialization
• Actual cost savings and market adoption remain uncertain

Insights

Medical Device Analyst

The next-generation prototype development for PainShield® and UroShield® represents an incremental but strategically important advancement. The USB-C integration and streamlined single-lead design for UroShield® address key usability concerns, while component optimization suggests improved supply chain resilience. However, the market impact remains uncertain without specific cost reduction targets or efficacy improvements data.

The focus on "future-proofing" component selection is particularly noteworthy given the ongoing global semiconductor shortages and supply chain disruptions. This could potentially reduce manufacturing delays and stabilize production costs, though the actual impact on margins won't be clear until full production begins.

For a micro-cap company with a market cap of just $2.3M, these developments, while positive, may not significantly alter the company's competitive position in the medical device market without substantial improvements in market penetration and reimbursement coverage. The additional therapy mode could enhance clinical adoption, but success will ultimately depend on clinical validation and pricing strategy.

Manufacturing Operations Expert

The prototype redesign demonstrates strategic focus on operational efficiency through several key manufacturing optimizations. The shift to USB-C connectors and reduced cable complexity for UroShield® should lower assembly costs and reduce potential failure points in production. The streamlined software architecture typically translates to reduced testing requirements and faster production cycles.

However, the announcement lacks specific metrics on expected cost reductions or manufacturing efficiency improvements. For a company of this size, manufacturing optimization is important for achieving economies of scale. The emphasis on component availability suggests a defensive strategy against supply chain disruptions, but success will depend on actual cost savings in production and ability to maintain quality standards during scaling.

Development advancing to verification and testing phase; Aims to future-proof design, lower componentry costs and improve manufacturing

ELMSFORD, N.Y.--(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 announced a third-party contractor engaged by the Company has completed the design phase for the development of the Company’s next generation PainShield® and UroShield® devices.

During the design phase, which was completed in December 2024, the third-party contractor developed prototypes of the Company’s next generation PainShield® and UroShield® devices that aim to reduce both the cost of assembly and the risk profile and minimize user burden.

Brian Murphy, Chief Executive Officer of the Company, commented, “We are pleased with the work the development team completed during the design phase. The prototypes were delivered on-time and within budget, and we are now eager to move forward to the next phase for further validation and testing. We are continuously seeking opportunities to advance our products, drive operational improvements in our business and evolve our products for the benefit of the patients who use them. Completion of this phase represents a major milestone towards our ultimate goal of broader adoption by the healthcare community of PainShield and UroShield and increasing unit sales.”

Design Updates Include:

• Additional mode of therapy to enhance the user experience and improve efficacy.
• Future-Proofing and Optimization of Componentry: The design has been updated to ensure that its current components will remain readily available throughout the manufacturing and commercialization process.
• Streamlining the Software: Efforts have been made to simplify and optimize the software for better performance and ease of use.
• Enhancements to the User Interface: The actuator cable has been redesigned to feature USB-C connectors, and a single lead will now be used for the UroShield® model, enhancing user experience and simplifying device setup.
• Improvements to design to promote cost effective production and regulatory compliance.

The Company is moving to the next phase of development, which will involve further validation and testing based on feedback and protocols the Company has received to date.

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/20250107583432/en/

Investor Contact:

Brett Maas, Managing Principal, Hayden IR, LLC

brett@haydenir.com

(646) 536-7331

Source: NanoVibronix, Inc.

FAQ

What improvements were made to NanoVibronix's (NAOV) next-generation devices?

The improvements include an additional therapy mode, future-proofed componentry, streamlined software, USB-C connectors, and a single lead design for UroShield, all aimed at reducing assembly costs and improving user experience.

When did NanoVibronix (NAOV) complete the design phase for their next-gen devices?

NanoVibronix completed the design phase for their next-generation PainShield and UroShield devices in December 2024.

What is the next phase for NAOV's new PainShield and UroShield devices?

The next phase involves validation and testing based on feedback and protocols received by the company.

How will the new design changes affect NAOV's manufacturing costs?

The new designs aim to reduce assembly costs through optimized componentry and simplified design features, though actual cost savings are yet to be determined.

What user interface improvements were made to NAOV's devices?

The devices now feature USB-C connectors and a single lead for the UroShield model, making the setup process simpler for users.