subslover
11月前
NanoVibronix Announces ENvue Drive – First Intelligent Robotic Platform in Development for Bedside Feeding Tube and Vascular Line Navigation
ENvue Targeting $10 Billion+ Market Opportunity with Scalable AI-Enhanced Clinical Robotics
TYLER, Texas--(BUSINESS WIRE)-- NanoVibronix, Inc. (NASDAQ: NAOV) (“NanoVibronix” or the “Company”), a medical technology company specializing in non-invasive therapeutic systems, today announced the official launch of a next-generation robotic development initiative within its ENvue Medical (“ENvue” or “ENvue Medical”) division. The new platform, ENvue Drive™, is being developed to automate electromagnetic navigation for enteral and vascular access procedures at the bedside.
This significant step reinforces ENvue’s leadership in clinical navigation and addresses the critical unmet need to increase procedural volume with fewer hands at the bedside. The system, now in engineering development, is being designed to integrate with the Company’s FDA-cleared electromagnetic guidance technology for enteral access, offering automated alignment and positional stability, while allowing clinicians to remain in full control.
“ENvue’s Drive platform marks a transformative move for bedside clinical care,” said Dr. Doron Besser, CEO of NanoVibronix and ENvue Medical. “By embedding intelligent robotics into high frequency clinical workflows, starting with feeding tubes and expanding into vascular areas, we believe that we are addressing a major clinical challenge of doing more with fewer hands without compromising precision or safety while giving clinicians a new level of confidence and consistency in care.
“Importantly, the Drive platform is a scalable foundation for intelligent bedside navigation. Through this initiative, we believe we are building a future-ready solution portfolio that can evolve with clinical demands across multiple care settings and drive growth.”
Addressing a Growing Global Demand
Each year, tens of millions of nasoenteric tube and vascular access procedures are performed globally. ENvue’s new robotic platform is positioned to address a growing clinical need to automate high-volume, bedside procedures in the face of workforce shortages and increasing patient complexity.
Key Market Drivers :
The global enteral feeding devices market is projected to reach $3.99 billion by 2030, driven by aging populations, higher procedural complexity and the rise in chronic illness (Source: Grand View Research, 2024).
The vascular access device market, including PICC lines, is currently valued at $6.2 billion, forecasted to exceed $10.5 billion by 2030 (Source: Markets and Markets, 2024).
In the United States alone, over 10 million nasoenteric feeding tubes are placed annually (Source: internal market data purchased by ENvue Medical, 2025).
The robotic catheter navigation segment is expected to grow at over 14% CAGR, reaching $500 million by 2030 (Source: BIS Research, 2023).
Dr. Besser continued, “Despite these massive procedural volumes, to our knowledge, no intelligent robotic system currently exists to assist with electromagnetic navigation during enteral or vascular access at the bedside. ENvue Drive aims to fill this gap.”
Designed to Assist, Not Replace
ENvue Drive is being developed to augment clinician performance, not replace it, particularly in critical care settings such as ICUs, step-down units and telemetry wards.
Development goals include:
Automated bedside alignment of ENvue’s electromagnetic probe
Real-time, stabilized positioning during nasoenteric and PICC procedures
Reduced need for multiple clinicians to perform a procedure, ideal during nurse shortages
Hands-free functionality for increased safety, consistency and reproducibility
Seamless integration with existing ENvue consoles and software
Development and Regulatory Status
The robotic platform is currently in preclinical development phase, with engineering prototypes in process and clinical advisor input underway. The system has not yet been submitted to the U.S. Food and Drug Administration (FDA) and is not yet cleared for clinical use.
The Company expects to initiate formal regulatory planning and submission milestones later this year and anticipates having a functional prototype by year-end. All future development remains subject to applicable regulatory approvals.
Building on Recent Strategic Momentum
This announcement follows a strong second quarter for NanoVibronix and ENvue Medical including:
Execution of a dual-system acquisition agreement with a major Northeastern U.S. hospital, reinforcing ENvue’s momentum in adult enteral feeding tube navigation.
Issuance of a new U.S. patent protecting ENvue’s electromagnetic guidance system for pediatric feeding applications.
Continued geographic expansion across the Southeast, Midwest, and Northeastern U.S., with growing market penetration.
Dr. Besser, concluded, “In the quarters ahead, we expect to share meaningful updates on our hardware and software development progress, new clinical collaborations and advisory board appointments, as well as our regulatory roadmap. We are also actively pursuing technical partnerships, AI-powered capabilities and clinical research initiatives to further strengthen the impact and scalability of our platform.”
About NanoVibronix, Inc.
NanoVibronix, Inc. (NASDAQ: NAOV) is a medical technology company advancing both non-invasive and minimally invasive solutions across clinical and home care settings. Headquartered in Tyler, Texas, with research and development in Nesher, Israel, the Company focuses on two distinct technology platforms:
Acoustic-based therapeutic technologies, including PainShield® and UroShield®, which utilize proprietary low-intensity surface acoustic wave (SAW) technology. These devices are intended for use in home or care settings and are designed to treat pain, reduce bacterial colonization, and disrupt biofilms.
ENvue™ Navigation Platform, developed and operated by ENvue Medical, with offices in Arlington Heights, Illinois, and Tel Aviv, Israel, is a minimally invasive electromagnetic navigation system intended to assist clinicians in placing feeding tubes into the gastrointestinal tract. FDA 510(k) cleared for adult use, ENv
INV4
12月前
Don't know... But I think it's worth more than market cap of the stock right now IMHO.
In the United States alone, approximately 400,000 preterm infants and a large population of additional pediatric patients, including those in intensive care, surgical recovery and chronic care undergo feeding tube placement annually. Combined, these high-risk groups account for over 1.5 million procedures per year, representing a single U.S. market opportunity of more than $150 million annually in capital systems and disposables. ENvue’s newly granted patent strengthens its ability to serve this critical segment with real-time, precision-guided navigation.
“We believe the addressable market for our pediatric navigation platform is substantial,” said Dr. Doron Besser, CEO of the Company. “Accordingly, this patent reflects our commitment to addressing this market opportunity by developing more precise, real-time enteral access solutions tailored to the needs of vulnerable patient populations. We continue to innovate with the goal of expanding clinical capabilities and meeting unmet needs in the field of enteral access.”
https://ih.advfn.com/stock-market/NASDAQ/nanovibronix-NAOV/stock-news/96221829/envue-medical-granted-u-s-patent-for-pediatric-fe
$NAOV
subslover
1年前
Successful Independent Study of the NanoVibronix UroShield® Device Published in the Australian and New Zealand Continence Journal
UroShield Cited as Effective in Preventing CAUTIs and Blockages, Having a Major Impact on Quality of Life and Reducing Healthcare Resource Costs
ELMSFORD, N.Y.--(BUSINESS WIRE)-- NanoVibronix, Inc. (NASDAQ: NAOV) (the “Company”), a medical technology company specializing in non-invasive therapeutic devices, today announced that an independent health service study of its UroShield® is published in The Australian and New Zealand Continence Journal.
The study highlights UroShield’s effectiveness in preventing catheter-associated urinary tract infections (CAUTIs) and recommends its adoption for appropriate patients with indwelling urinary catheters (IUCs). Researchers found that patients using UroShield experienced an 86% reduction in UTI incidence; 70% reduction in catheter blockages; 82.8% less bladder irrigations performed and 52.3% less catheter changes. The clinicians reported improved overall catheter comfort and a reduction in the need for catheter-related interventions.
Brian Murphy, CEO of NanoVibronix, Inc., commented, “This study underscores the benefits of UroShield in enhancing patient care by reducing CAUTI incidence and catheter blockages, minimizing catheter complications and improving overall comfort. Notably, researchers found that UroShield required less nursing time, which eased workload demands and resulted in measurable cost savings for the healthcare provider."
From the article:
“The introduction of the UroShield® device within a New Zealand District Nursing Service significantly improved the lives of patients with indwelling urinary catheters. This Quality Improvement project demonstrated a reduction in catheter-associated urinary tract infections and blockages, leading to fewer interventions and enhanced patient comfort. The project highlighted how UroShield® can reduce healthcare costs and improve the quality of life for patients, suggesting its potential for use in similar healthcare settings.”
“The final cost analysis has shown a significant reduction in resource expenditure due to a combination of less interventions, and less urgent call outs. The UroShield® proved to have a 63.5% reduction in resource cost over the 5 months of the project.”
The complete article is available at https://www.publish.csiro.au/CJ/pdf/CJ24043.
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 surf
subslover
1年前
NanoVibronix Secures $12 Million Minimum Purchase Commitment for PainShield with Extension of Distribution Agreement
Extends Relationship with Ultra Pain Products, Inc for Distribution of PainShield for Five Years
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 it has renewed its exclusive distribution agreement with Ultra Pain Products, Inc. (“UPPI”) for the distribution of the Company’s PainShield for another five years.
Brian Murphy, CEO of NanoVibronix, commented, "We are thrilled to extend our partnership with Ultra Pain Products for another five years and secure a minimum purchase commitment of our products valued at $12 million. UPPI’s impressive growth, transition into manufacturing and dedication to innovation align perfectly with our values and goals. Their ability to deliver affordable and effective solutions to patients makes them an ideal partner to help us continue to make a difference."
The Company’s decision to renew the distribution agreement comes in recognition of UPPI’s remarkable growth over the past four years and its evolution into a leading force in the non-opioid pain management and injury recovery industry. The renewed agreement underscores the continued collaboration between the two companies and ensures that NanoVibronix’s proprietary PainShield product is a part of Ultra Pain Products’ expanding portfolio of proven and groundbreaking technologies.
Ari Alayev, President of Ultra Pain Products, commented, “We are honored to continue our exclusive distribution agreement with NanoVibronix. We view our partnership as a collaboration that strengthens each organization’s impact in the market. This renewal is a testament to our shared vision and the mutual trust we have built over the past four years. We are excited to continue to offer PainShield as part of our growing roster of innovative technologies as we continue to expand our offerings and lead the charge in non-opioid treatment options.”
The agreement reflects the companies’ mutual dedication to supporting injury recovery and empowering patients with advanced solutions that prioritize safety, efficacy, and accessibility. Together, they remain committed to driving forward the non-opioid treatment landscape in the U.S.