NanoVibronix Announces Results from UroShield™ Case Series
UroShield Demonstrates Significant Reductions in CAUTIs, Catheter Blockages and Hospital Visits
TYLER, Texas, May 12, 2025--(BUSINESS WIRE)--NanoVibronix, Inc. (NASDAQ: NAOV) (the "Company"), a medical technology company specializing in therapeutic devices, today announced findings from a recent retrospective case series evaluating the clinical impact and patient experience of the UroShield™ system.
The case series, conducted between September 2023 and January 2025 by researchers at University Hospitals Coventry and Warwickshire Partnership NHS, assessed a small group of patients who used the UroShield device for durations ranging from 12 weeks to 17 months. The series reviewed pre- and post-treatment data on catheter-associated urinary tract infections (CAUTIs), catheter blockages, unplanned hospital visits and patient satisfaction.
Key Outcomes of the Case Series Included:
a 94% average reduction in CAUTIs and catheter blockages;
a 92% decrease in unplanned hospital visits;
extended intervals between catheter changes, improving patient comfort and quality of life;
high patient compliance and satisfaction; and
only one patient discontinued due to worsening of pre-existing bladder symptoms.
Importantly, these outcomes reinforce the results from previous studies, including those by Markowitz et al. (2018)1 and Da Silva, Ibbotson, and O'Neil (2021)2, which demonstrated the effectiveness of UroShield in reducing infection risk, improving catheter management, and enhancing overall patient outcomes.
"We believe that this case series reinforces the growing body of clinical evidence supporting UroShield as an effective solution for minimizing catheter-associated risks, improving patient care and the quality of life for patients living with long-term catheterization while reducing healthcare burden," said Brian Murphy, CEO of NanoVibronix, Inc. "The results of this series are another strong affirmation of the device's value for both patient care and healthcare cost reduction."
UroShield utilizes proprietary Surface Acoustic Wave (SAW) technology to prevent bacterial colonization and biofilm formation on indwelling urinary catheters, a critical advancement in reducing complications such as CAUTIs.
The case series will be presented on May 19, 2025, at the Association for Continence Professionals annual conference, ACP 2025. For additional information about the conference, please visit https://fitwise.eventsair.com/acp2025/.
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1 Markowitz. S., Rosenblum. J., Goldstein. M., Gadagkar. H.P., and Litman. L. (2018) The effect of surface acoustic waves on bacterial load and preventing catheter-associated urinary tract infections (CAUTI) in long term indwelling catheters
2 Da Silva. K., Ibbotson. A., and O'Neil. M. (2021) The effectiveness of UroShield in reducing urinary tract infections and patients' pain complaints: Retrospective Data Analysis from Clinical Practice.
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. These forward-looking statements include, but are not limited to: future expectations and plans and prospects for the Company. 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 the Company's 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 the Company's products; (iv) intense competition in the medical device industry from much larger, multinational companies; (v) product liability claims; (vi) product malfunctions; (vii) the Company's limited manufacturing capabilities and reliance on subcontractor assistance; (viii) insufficient or inadequate reimbursements by governmental and/or other third party payers for the Company's products; (ix) the Company's ability to successfully obtain and maintain intellectual property protection covering the Company's products; (x) legislative or regulatory reform impacting the healthcare system in the U.S. or in foreign jurisdictions; (xi) the Company's reliance on single suppliers for certain product components, (xii) the need to raise additional capital to meet the Company's 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) the Company's 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, Quarterly Reports on Form 10-Q, and Current Reports on Form 8-K. 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.
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For more information, visit Protagonist Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of rusfertide and the timing of rusfertide regulatory submissions. In some cases, you can identify these statements by forward–looking words such as 'anticipate,' 'believe,' 'may,' 'will,' 'expect,' or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Janssen and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading 'Risk Factors' contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release. 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These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements: the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States and with respect to international trade relations; competitive pressures and developments; changes to applicable laws and regulations, including tax, tariff and other trade-related rules; challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof; uncertainty of commercial success for new and existing products; manufacturing difficulties or delays; fluctuations in interest and currency exchange rates; claims or concerns regarding the safety or efficacy of marketed products or product candidates; the impact of health crises, like the novel coronavirus pandemic; the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals; the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or other initiatives to restructure our operations will lead to the expected benefits; and other factors identified in Takeda's most recent Annual Report on Form 20-F and Takeda's other reports filed with the U.S. Securities and Exchange Commission, available on Takeda's website at: or at Takeda does not undertake to update any of the forward-looking statements contained in this press release or any other forward-looking statements it may make, except as required by law or stock exchange rule. Past performance is not an indicator of future results and the results or statements of Takeda in this press release may not be indicative of, and are not an estimate, forecast, guarantee or projection of Takeda's future results. Takeda Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. _____________________________________________________ Kuykendall A et al. Results From VERIFY, a Phase 3, Double-Blind, Placebo (PBO)-Controlled Study of Rusfertide for Treatment of Polycythemia Vera (PV). Oral presentation at: American Society of Clinical Oncology (ASCO) Annual Meeting, June 1, 2025. Chicago, IL. LBA3. PROMIS Fatigue Short Form 8a Total T-Score. MFSAF v4.0 Total Symptom Score 7. View source version on Disclaimer: The above press release comes to you under an arrangement with Business Wire. Business Upturn takes no editorial responsibility for the same.
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Forward-looking statements can generally be identified by words such as 'potential,' 'can,' 'will,' 'may,' 'could,' 'trend,' 'potentially,' 'upcoming,' 'progression,' 'progress,' 'investigating,' 'investing,' 'look beyond,' or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for Pluvicto, or regarding potential future revenues from Pluvicto. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that Pluvicto will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that Pluvicto will be commercially successful in the future. In particular, our expectations regarding Pluvicto could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people's lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. References Data on file. Pluvicto [prescribing information]. Millburn, NJ: Advanced Accelerator Applications USA, Inc.; 2025. An International Prospective Open-label, Randomized, Phase III Study Comparing 177Lu-PSMA-617 in Combination With SoC, Versus SoC Alone, in Adult Male Patients With mHSPC (PSMAddition). identifier: NCT04720157. Updated March 5, 2025. Accessed June 2, 2025. Oing C, Bristow RG. Systemic treatment of metastatic hormone-sensitive prostate cancer—upfront triplet versus doublet combination therapy. ESMO Open 2023l doi: 10.1016/ Sartor O, J. de Bono KN, Chi K, et al. Lutetium-177–PSMA-617 for Metastatic Castration-Resistant Prostate Cancer. NEJM 2021; doi: 10.1056/NEJMoa2107322. Morris M, Castellano D, Herrmann K, et al. 177Lu-PSMA-617 versus a change of androgen receptor pathway inhibitor therapy for taxane-naive patients with progressive metastatic castration-resistant prostate cancer (PSMAfore): a phase 3, randomised, controlled trial. The Lancet 2024; doi: 10.1016/S0140-6736(24)01653-2. University of Chicago Medicine. Lutetium-177 PSMA Therapy for Prostate Cancer (Pluvicto). Accessed June 18, 2024. Jadvar H. Targeted Radionuclide Therapy: An Evolution Toward Precision Cancer Treatment [published correction appears in AJR Am J Roentgenol. 2017 Oct;209(4):949. doi: 10.2214/AJR.17.18875]. AJR Am J Roentgenol. 2017;209(2):277-288. doi:10.2214/AJR.17.18264 Jurcic JG, Wong JYC, Knoc SJ, et al. Targeted radionuclide therapy. In: Tepper JE, Foote RE, Michalski JM, eds. Gunderson & Tepper's Clinical Radiation Oncology. 5th ed. Elsevier, Inc. 2021;71(3):209-249 # # # Novartis Media Relations E-mail: [email protected] Novartis Investor RelationsCentral investor relations line: +41 61 324 7944 E-mail: [email protected] Disclaimer: The above press release comes to you under an arrangement with GlobeNewswire. Business Upturn takes no editorial responsibility for the same. GlobeNewswire provides press release distribution services globally, with substantial operations in North America and Europe.
