Distribution agreement leverages U-Deliver’s digital and wholesale channels to expand access to ENvue’s recently launched ENFit Syringes across non-acute care channelsTYLER, Texas, Jan. 28, 2026 (GLOBE NEWSWIRE) -- ENvue Medical, Inc. (NASDAQ: FEED) (NASDAQ: NAOV) (“ENvue,” “ENvue Medical” or the “Company”), a medical technology company specializing in the advancement of intelligent, non-invasive solutions for enteral care across clinical and home care settings, today announced the signing of a distribution ...

Core Insights - ENvue Medical, Inc. has appointed Marc Waldman as Vice President, Commercial to lead its U.S. commercialization strategy and expand its presence in 38 hospitals [1][2] - Waldman brings over 35 years of experience in the medical device industry, having previously increased revenue from approximately $39 million to $70 million during his tenure as North America Sales Director at Avanos Medical [2] - The company specializes in non-invasive solutions for enteral care, with a focus on advancing patient safety and clinical usability [3][4] Company Overview - ENvue Medical, Inc. is headquartered in Tyler, Texas, and focuses on intelligent, non-invasive solutions for enteral care across clinical and home care settings [3] - The company operates two distinct technology platforms, including the ENvue™ Navigation Platform, which assists in placing feeding tubes and is FDA 510(k) cleared for adult use [4] - ENvue Medical also develops acoustic-based therapeutic technologies aimed at treating pain and reducing bacterial colonization [4]

Core Insights - ENvue Medical, Inc. has launched a new line of over-the-counter ENFit Syringes aimed at enhancing enteral care in both clinical and home settings, addressing the need for reliable and high-quality solutions as care shifts beyond hospitals [1][2] Product Launch - The ENFit Syringes are designed for feeding and medication delivery, available in sizes of 2.5 mL, 5 mL, 10 mL, and 60 mL, and will be sold without a prescription through online retailers like Amazon [2] - These syringes comply with ISO 80369-3 global standards and can be reused for up to seven days or 20 uses, promoting safe and consistent enteral delivery [2] Company Overview - ENvue Medical specializes in intelligent, non-invasive solutions for enteral care, with headquarters in Tyler, Texas, and R&D facilities in Tel-Aviv and Nesher, Israel [3] - The company focuses on two technology platforms: the ENvue Navigation Platform for minimally invasive feeding tube placement and acoustic-based therapeutic technologies like PainShield® and UroShield® [4]

Core Insights - ENvue Medical has launched a new development program integrating its NanoVibronix technology to enhance comfort for patients using indwelling nasogastric (NG) tubes [1][2][3] - The program aims to address the discomfort commonly associated with prolonged use of NG tubes, which are essential in hospital care but often lead to nasal and throat discomfort [2][3] Company Overview - ENvue Medical, Inc. specializes in intelligent, non-invasive solutions for enteral care, operating in both clinical and home care settings [5] - The company is headquartered in Tyler, Texas, with research and development facilities in Tel-Aviv and Nesher, Israel [5] - ENvue Medical focuses on two main technology platforms: the ENvue™ Navigation Platform for minimally invasive feeding tube placement and the integration of vibration-based comfort technology [5] Technology and Development - The newly launched program is based on peer-reviewed clinical research showing that surface acoustic wave micro-vibration technology can reduce friction at the tube-tissue interface during NG tube use [2] - The initiative is exploratory and does not represent a commercial product launch or regulatory clearance, but aims to improve patient comfort and support the company's long-term strategy for enteral care [3] - The program will assess technical feasibility, clinical pathways, and regulatory considerations for incorporating vibration-based technology into ENvue's enteral ecosystem [3]

Core Viewpoint - ENvue Medical, Inc. will ring the Nasdaq Opening Bell on January 14, 2026, marking a significant milestone for the company in the medical technology sector [1][3]. Company Overview - ENvue Medical, Inc. specializes in non-invasive therapeutic systems, including enteral access solutions and non-opioid pain management [1][4]. - The company is headquartered in Tyler, Texas, with research and development facilities in Tel-Aviv and Nesher, Israel [4]. Leadership and Ceremony Details - The ceremony will be led by Doron Besser, MD, the CEO of ENvue Medical, along with the leadership team, directors, employees, and key stakeholders [2][3]. - The event will take place at Nasdaq MarketSite in Times Square, New York, from 8:30 A.M. to 9:45 A.M. ET [3]. Technology Platforms - ENvue Medical operates two distinct technology platforms: the ENvue™ Navigation Platform and acoustic-based therapeutic technologies [4][5]. - The ENvue™ Navigation Platform is a minimally invasive electromagnetic navigation system for placing feeding tubes, which has received FDA 510(k) clearance for adult use [5]. - Acoustic-based technologies, such as PainShield® and UroShield®, utilize proprietary low-intensity surface acoustic wave technology for pain treatment and bacterial colonization reduction [5].

Core Insights - ENvue Medical's UroShield® Kit has been included in the UK NHS Drug Tariff Part IX, allowing for nationwide prescription reimbursement, which is expected to significantly enhance market access and demand for the product [1][3] - The company has received an initial purchase order from Peak Medical, indicating early commercial interest following the reimbursement decision [2][3] - The UroShield® Kit is designed to reduce catheter-associated urinary tract infections (CAUTIs) and blockages, addressing a significant healthcare challenge in the UK where catheter prevalence is approximately 6-7% in long-term care populations [3][6] Company Overview - ENvue Medical, Inc. specializes in non-invasive therapeutic systems and is headquartered in Tyler, Texas, with R&D facilities in Israel [5] - The company focuses on acoustic-based therapeutic technologies, including the UroShield® Kit, which utilizes proprietary low-intensity surface acoustic wave technology [5] Market Context - The inclusion of the UroShield® Kit in the NHS Drug Tariff Part IX represents a critical reimbursement milestone, removing barriers to access and enabling scalable NHS prescribing [3] - The partnership with Peak Medical is expected to enhance the distribution of the UroShield® Kit across UK hospitals and community settings, reflecting a commitment to improving patient outcomes [2][3]

Core Insights - ENvue Medical's UroShield® Kit has been added to the UK NHS Drug Tariff Part IX, enabling nationwide prescription reimbursement across the UK, which is expected to significantly enhance market access and demand for the product [1][3] - The company has received an initial purchase order from Peak Medical, indicating early commercial demand following the inclusion in the NHS Drug Tariff [2][3] - The UroShield® Kit is designed to reduce catheter-associated urinary tract infections (CAUTIs) and catheter blockages, addressing a significant healthcare challenge in the UK where catheter prevalence is approximately 6-7% in long-term care populations [3][6] Company Developments - The inclusion of UroShield® in the NHS Drug Tariff is seen as a major commercial and reimbursement milestone, removing barriers to access and enabling scalable NHS prescribing [3] - The initial purchase order from Peak Medical provides early revenue visibility for ENvue Medical heading into 2026, marking a first step in establishing a presence in European markets [3] - ENvue Medical is committed to assessing reimbursement frameworks and market access pathways in select European countries as part of its long-term portfolio strategy [3] Market Context - Long-term urinary catheterization is common in the UK, with a significant risk of CAUTIs, which are among the most prevalent device-associated healthcare-acquired infections globally [3][6] - The UroShield® Kit utilizes low-frequency ultrasonic energy to inhibit biofilm formation, thereby reducing the risk of CAUTIs and improving patient outcomes [3][5] - The partnership with Peak Medical is expected to enhance the distribution of innovative, non-invasive solutions within the UK healthcare system [2][3]

Core Viewpoint - Venus Concept Inc. is facing a challenging market outlook with a significant potential downside in its stock price, while Bone Biologics Corporation shows a more optimistic scenario among its peers [1][5][6]. Group 1: Company Performance - Venus Concept Inc. is currently trading at $2.21, with a target price of $1.64, indicating a potential downside of approximately -25.65% [1][6]. - NanoVibronix, Inc. is trading at $4.02 with a market cap of $3.20 million, but has a negative EPS of -51.81 and a PE ratio of -4.73 [2][6]. - Bone Biologics Corporation trades at $2 with a market cap of $3.61 million, showing an EPS of -2.4 and a PE ratio of -2.08 [3][6]. Group 2: Market Sentiment - Bone Biologics Corporation exhibits the highest growth potential among its peers, with a price percentage difference of 9.32%, indicating a more favorable market sentiment [4][6]. - The significant gap between the current and target price of Venus Concept Inc. suggests a pessimistic outlook from investment analysts, leading to its exclusion from coverage [1][5].

Core Insights - NanoVibronix, Inc. will change its corporate name to ENvue Medical, Inc. effective December 12, 2025, to align with its strategic focus on the ENvue® feeding-tube placement system [1] - The company's stock ticker will change to "FEED" on the same date, with no action required from current stockholders [2] Company Strategy - The company aims to scale hospital utilization, enhance its commercial presence, and develop a comprehensive enteral-feeding ecosystem around ENvue through both internal and external opportunities [2] - The rebranding signifies a new phase characterized by precision enteral access, technology-driven growth, and clinical excellence [2] Company Overview - NanoVibronix, Inc. specializes in non-invasive and minimally invasive medical technology solutions, with headquarters in Tyler, Texas, and R&D in Nesher, Israel [3] - The company focuses on advancing standards in non-invasive therapy and minimally invasive navigation, emphasizing patient safety, clinical usability, and technological innovation [3] Product Information - The ENvue Navigation Platform is a minimally invasive electromagnetic navigation system designed to assist clinicians in placing feeding tubes, providing real-time visualization during the procedure [5] - The platform is FDA 510(k) cleared for adult use and may expand to include pediatric and vascular access applications in the future [5]

Mergers and Acquisitions - As of September 30, 2025, NanoVibronix, Inc. completed a merger with ENvue Medical Holdings, resulting in the formation of two wholly-owned subsidiaries: NanoVibronix Ltd. and ENvue Medical Holdings LLC[179]. Financial Performance - For the three months ended September 30, 2025, revenues were approximately $722 thousand, an increase of 92% compared to $376 thousand in the same period of 2024[212]. - Gross profit for the three months ended September 30, 2025, was approximately $189 thousand, a 42% increase from $133 thousand in 2024[214]. - For the nine months ended September 30, 2025, revenues were approximately $2,241 thousand, a 6% increase from $2,114 thousand in 2024[225]. Expenses - Research and development expenses decreased by approximately 11% to $221 thousand for the three months ended September 30, 2025, compared to $249 thousand in 2024[216]. - Selling and marketing expenses surged by approximately 349% to $812 thousand for the three months ended September 30, 2025, from $181 thousand in 2024[218]. - General and administrative expenses increased by approximately 108% to $1,403 thousand for the three months ended September 30, 2025, compared to $673 thousand in 2024[220]. - Research and development expenses for the nine months ended September 30, 2025, increased by approximately 209% to $1,723 thousand from $557 thousand in 2024[229]. - Selling and marketing expenses for the nine months ended September 30, 2025, rose by approximately 245% to $1,878 thousand compared to $545 thousand in 2024[232]. - General and administrative expenses for the nine months ended September 30, 2025, were approximately $4,997 thousand, an increase of 114% from $2,335 thousand in 2024[234]. Cash Flow and Financing - As of September 30, 2025, the company reported a cash balance of approximately $6,980 thousand after incurring approximately $6,696 thousand in cash used in operating activities[240]. - As of September 30, 2025, the company had cash and cash equivalents of approximately $6,980 thousand, a significant increase from approximately $752 thousand as of December 31, 2024[246]. - Cash used in operating activities for the nine months ended September 30, 2025, was approximately $6,696 thousand, compared to approximately $1,968 thousand for the same period in 2024[247]. - Cash provided by financing activities during the nine months ended September 30, 2025, was approximately $12.8 million, primarily from net proceeds of $17.1 million from the issuance of common stock, preferred stock, and warrants[248]. Compliance and Regulatory Matters - The company received a compliance extension from Nasdaq to demonstrate adherence to the minimum bid price and equity requirements by March 31, 2025[189]. - On April 9, 2025, the company demonstrated compliance with Nasdaq's bid price and equity requirements, avoiding delisting[190]. - The company is subject to a one-year mandatory panel monitor following compliance with Nasdaq requirements[191]. - The company has identified inaccuracies in its 510(k) application for the PainShield MD Plus product and intends to halt future sales of the product[251]. - The company is subject to risks common in the biopharmaceutical industry, including regulatory approvals and competition from new products[252]. Capital Requirements and Future Outlook - The company's future capital requirements will depend on the successful commercialization of its products and the development of future product offerings[249]. - The company anticipates that future operating results will be subject to quarterly variations based on various factors, including distributor ordering patterns and regulatory approvals[250]. Asset Changes - Major changes in assets are primarily attributable to a merger, reflecting the revaluation and consolidation of assets[244]. - Cash provided in investing activities was approximately $111 thousand for the nine months ended September 30, 2025, mainly from cash acquired in the merger[247]. - The company has no off-balance sheet transactions or obligations that may materially affect its financial condition as of September 30, 2025[243]. Stock and Offerings - In September 2025, the company conducted a registered direct offering, issuing 74,114 shares of common stock and prefunded warrants for a total net proceeds of approximately $1.88 million[181]. - The Series H Initial Closing on July 22, 2025, generated gross proceeds of $8 million from the sale of 8,889 shares of Series H Convertible Preferred Stock[185]. - The Series H Purchase Agreement allows for the potential issuance of up to $44 million in additional Series H Preferred Stock over a 36-month period[184]. - The company executed a 1-for-10 reverse stock split effective August 11, 2025, to comply with Nasdaq listing requirements[182].