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NanoVibronix, Inc. (NASDAQ: NAOV) is a forward-thinking medical device company specializing in the development and commercialization of innovative products that leverage its proprietary low-intensity acoustic technology. Located in Elmsford, NY, with a subsidiary, NanoVibronix Ltd., based in Nesher, Israel, the company aims to revolutionize the medical field with cost-effective therapeutic ultrasound applications.
NanoVibronix's groundbreaking technology enables the creation of miniature transducers that transmit low-frequency, low-intensity ultrasound through flexible material surfaces. This unique feature is integral to a range of products designed for various medical applications, particularly those requiring noninvasive methods.
The company's flagship products include:
- PainShield®: A patch-based device carrying FDA clearance, designed for pain management through the delivery of therapeutic ultrasound.
- UroShield®: A device aimed at preventing biofilm formation and reducing urinary tract infections associated with catheter use.
- WoundShield®: A device that promotes wound healing by transmitting low-frequency ultrasound waves to stimulate tissue regeneration.
NanoVibronix's products are designed for home use, enabling patients to receive therapy without the need for medical professionals. This approach not only enhances patient convenience but also reduces healthcare costs.
In addition to its direct-to-patient sales, NanoVibronix partners with distributors to expand its market reach. The company's recent achievements include securing FDA clearance for PainShield® and forming strategic partnerships to enhance product distribution.
Overall, NanoVibronix, Inc. stands out for its innovative approach to medical device technology, focusing on noninvasive solutions for pain management, biofilm prevention, and wound healing, making significant strides in improving patient outcomes.
NanoVibronix (NASDAQ: NAOV), a medical technology company focused on non-invasive therapeutic devices, has completed the acquisition of ENvue Medical Holdings Corp., a private company specializing in enteral feeding solutions. The strategic acquisition aims to strengthen the combined company's market position in enteral feeding technology and therapeutic medical devices.
The merger is expected to leverage ENvue's proprietary technology alongside NanoVibronix's existing portfolio, creating a broader commercial platform with enhanced distribution and operational efficiencies. The combined entity will focus on addressing patient safety challenges in enteral feeding while expanding market reach in the medical device sector.
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.
NanoVibronix (NASDAQ: NAOV) has successfully completed the pilot phase of a Randomized Control Trial study for UroShield® at the University of Michigan. The study, primarily conducted with nursing home residents, focused on evaluating UroShield's impact on reducing urinary tract infections, catheter blockages, and pain associated with long-term urinary catheter use.
The completed pilot phase served as a validation step before advancing to the full study, which is expected to commence in 2025. The research team has achieved their initial goals, including refining recruitment strategies and developing data collection tools. This research complements previous studies and product launches in the UK, Australia, and New Zealand, as well as the recent introduction to the European market. The company is simultaneously preparing for a U.S. launch, pending FDA 510K clearance.
NanoVibronix (NASDAQ: NAOV) has renewed its exclusive distribution agreement with Ultra Pain Products (UPPI) for PainShield distribution for another five years. The agreement includes a minimum purchase commitment of $12 million. The renewal follows UPPI's significant growth over the past four years and its evolution in the non-opioid pain management and injury recovery industry.
The collaboration aims to strengthen both companies' market presence, with UPPI continuing to distribute NanoVibronix's proprietary PainShield as part of its expanding portfolio of technologies. The partnership focuses on providing innovative non-opioid treatment options while prioritizing safety, efficacy, and accessibility in the U.S. market.
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.
NanoVibronix (NASDAQ: NAOV) has signed a non-binding term sheet for a license and supply agreement with APOGEPHA Arzneimittel GmbH, a German pharmaceutical company specializing in urology products. The agreement aims to distribute UroShield throughout Europe. UroShield is an ultrasound-based device designed to prevent bacterial colonization and biofilm on indwelling urinary catheters, potentially reducing catheter-associated urinary tract infections (CAUTI) and associated pain.
Brian Murphy, CEO of NanoVibronix, expressed enthusiasm about partnering with APOGEPHA, citing their leadership in urology and large sales and marketing team as key factors for accelerating UroShield sales in Germany. Dr. Dirk Pamperin, Chairman of APOGEPHA's Management Board, stated their commitment to offering high-quality urological products and their confidence in UroShield's ability to support patients with long-term catheters.
NanoVibronix, Inc. (NASDAQ: NAOV) has signed a letter of intent with Medici Medical , a leading distributor of medical products in Israel, to explore distribution opportunities for its UroShield device in the Israeli healthcare market. This potential partnership aligns with NanoVibronix's strategy to expand distribution and accelerate market adoption of UroShield through established channels.
Brian Murphy, CEO of NanoVibronix, emphasized the importance of partnering with leading distributors to drive market adoption. Medici's CEO, Nufar Cohen, expressed interest in UroShield's reported benefits and plans to evaluate it further through market research. Medici specializes in importing, marketing, and distributing disposable medical devices and has established partnerships with international pharmaceutical companies.
NanoVibronix (NASDAQ: NAOV) reported significant growth in Q2 2024, with revenue reaching $817,000, over 2.5 times higher than Q2 2023. The company reduced its loss from operations by more than 30% to approximately ($674,000). Key highlights include:
1. Increased revenues from Veterans' Health System and Workers' Compensation markets
2. Strong balance sheet with $2.2 million cash and $2.4 million inventory
3. Progress in domestic sales channels, including VA facilities and DME distributors
4. International expansion in Australia, New Zealand, and the UK
5. Ongoing product development and research initiatives
The company remains focused on expanding distribution channels, nurturing relationships with accounts, and engaging consumers to drive profitable growth.
NanoVibronix (Nasdaq: NAOV) announced the start of the pilot phase for the UroShield clinical trial at the University of Michigan. This phase is the initial part of a broader study, following a Research Agreement signed on November 28, 2023. The trial aims to evaluate UroShield's efficacy in reducing urinary tract infections, catheter blockage, and pain, thereby enhancing patient quality of life. The pilot phase involves up to 30 patients, while the full study will involve approximately 300 patients, primarily from nursing homes. The goal is to gather data that will support an application for permanent FDA clearance or approval.
NanoVibronix (NASDAQ: NAOV) issued an update on its business developments and financial performance for Q1 2024. The company reported record first-quarter revenues of $921,000, but also a loss from operations of $568,000. Cash reserves stand at $2.7 million with $2.6 million in inventory. Domestic sales, particularly within the Veterans Affairs (VA) and worker’s compensation markets, are seeing growth, aided by a new General Services Administration (GSA) grant effective May 1, 2024. Internationally, the company has made strides in the UK, Australia, and New Zealand. A significant research study on UroShield by the University of Michigan is underway, potentially bolstering FDA approval efforts. The company is also focused on improving existing products and exploring new opportunities. Key goals include expanding distribution channels and achieving broader market coverage.
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