Peak Medical, ENvue’s Exclusive Distributor in UK, Places Significant Order after Reimbursement Decision, Projecting Future Market Demand for UroShield® KitTYLER, Texas, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ENvue Medical, Inc. (NASDAQ: FEED) (NASDAQ: NAOV) (“ENvue,” “ENvue Medical” or the “Company”), a medical technology company specializing in non-invasive therapeutic systems, today announced that the UroShield® Kit has been added to the UK National Health Service (NHS) Drug Tariff Part IX, enabling nationwid ...

Peak Medical, ENvue’s Exclusive Distributor in UK, Places Significant Order after Reimbursement Decision, Projecting Future Market Demand for UroShield® KitTYLER, Texas, Dec. 18, 2025 (GLOBE NEWSWIRE) -- ENvue Medical, Inc. (NASDAQ: FEED) (“ENvue,” “ENvue Medical” or the “Company”), a medical technology company specializing in non-invasive therapeutic systems, today announced that the UroShield® Kit has been added to the UK National Health Service (NHS) Drug Tariff Part IX, enabling nationwide prescription ...

Venus Concept Inc. (NASDAQ:VERO) shows a potential downside of approximately -25.65% in its stock price, indicating a pessimistic outlook from investment analysts.NanoVibronix, Inc. (NAOV) has a negative EPS of -51.81 and a PE ratio of -4.73, highlighting significant market challenges.Bone Biologics Corporation (BBLG) exhibits the highest growth potential among its peers with a price percentage difference of 9.32%, suggesting a more favorable market sentiment.Venus Concept Inc. (NASDAQ:VERO) operates in the ...

TYLER, Texas--(BUSINESS WIRE)--NanoVibronix, Inc. (NASDAQ: NAOV) ("NanoVibronix†or the "Company†), a medical technology company specializing in non-invasive therapeutic systems, today announced that it will change its corporate name from NanoVibronix, Inc. to ENvue Medical, Inc., effective December 12, 2025, to better reflect its new strategic direction and primary focus on its ENvue® feeding-tube placement system ("ENvue†). The Company's ticker for its common stock, listed on the Nasdaq Capital Market, ...

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].

Core Viewpoint - NanoVibronix, Inc. has entered into a definitive agreement for the purchase and sale of 291,204 shares of its common stock at an offering price of $7.01 per share in a registered direct offering [1] Group 1 - The company specializes in non-invasive therapeutic systems [1] - The transaction involves a single institutional investor [1] - The offering price is set at $7.01 per share or common stock equivalent [1]

Core Viewpoint - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - FGI Industries Ltd. (FGI) is up 278% at $15.02 [3] - Senmiao Technology Limited (AIHS) is up 96% at $4.22 [3] - Conifer Holdings, Inc. (CNFR) is up 86% at $2.11 [3] - WEBTOON Entertainment Inc. (WBTN) is up 39% at $20.81 [3] - Nukkleus Inc. (NUKK) is up 18% at $6.08 [3] - Tantech Holdings Ltd (TANH) is up 12% at $2.13 [3] - Check-Cap Ltd. (CHEK) is up 9% at $2.33 [3] - Ivanhoe Electric Inc. (IE) is up 8% at $9.71 [3] - Wolfspeed, Inc. (WOLF) is up 8% at $3.21 [3] - Bolt Projects Holdings, Inc. (BSLK) is up 5% at $3.95 [3] Premarket Losers - Envirotech Vehicles, Inc. (EVTV) is down 17% at $2.27 [4] - Dave & Buster's Entertainment, Inc. (PLAY) is down 15% at $20.40 [4] - NanoVibronix, Inc. (NAOV) is down 12% at $9.37 [4] - ADTRAN Holdings, Inc. (ADTN) is down 10% at $9.37 [4] - Rain Enhancement Technologies Holdco, Inc. (RAIN) is down 10% at $6.00 [4] - CNS Pharmaceuticals, Inc. (CNSP) is down 7% at $8.50 [4] - AVITA Medical, Inc. (RCEL) is down 7% at $6.22 [4] - Vince Holding Corp. (VNCE) is down 7% at $2.60 [4] - Monte Rosa Therapeutics, Inc. (GLUE) is down 6% at $6.50 [4] - Meiwu Technology Company Limited (WNW) is down 6% at $2.06 [4]

Core Viewpoint - NanoVibronix, Inc. experienced a significant stock surge of 71.80 percent to $11.15 following the announcement of a new patent for its subsidiary ENvue Medical Holdings LLC, enhancing its position in non-invasive therapeutic systems [1] Stock Performance - The stock opened at $9.43 and fluctuated between $8.86 and $17.40, compared to a previous close of $6.49 on the Nasdaq [1] - Trading volume increased dramatically to 51.6 million shares, significantly higher than the average of 171,842 shares [2] - NanoVibronix's stock is currently within a 52-week range of $4.71 to $162.50 [2] Patent Announcement - The U.S. Patent No. 12,409,105 B2 was issued for the "Insertion Device Positioning Guidance System and Method," which strengthens NanoVibronix's patent portfolio [1]

Merger and Acquisitions - The merger with ENvue Medical Holdings was completed on February 14, 2025, with NanoVibronix acquiring 100% of Predecessor ENvue[171]. - The company issued 3,318 shares of common stock representing 4.9% of outstanding shares prior to the merger, along with Pre-Funded Warrants for 12,526 shares and 5,772 shares of Series X Non-Voting Convertible Preferred Stock[171]. - A reverse stock split of 1-for-10 was executed on August 11, 2025, affecting all common stock share amounts in the quarterly report[173]. - The Series H Preferred Stock private placement on July 22, 2025, raised $8 million in gross proceeds, with an initial conversion price of $10.10 per share[178]. - The 2025 Underwritten Offering of 40,000 shares of Series G Convertible Preferred Stock raised approximately $8.2 million in net proceeds after expenses[182]. - The Series X Preferred Stock conversion price was reduced to $20.40 following the 2025 Underwritten Offering[183]. - ENvue issued a promissory note for $360,000 with an 8% annual interest rate, which was fully repaid in Q2 2025[185][189]. Financial Performance - For the three months ended June 30, 2025, revenues were approximately $494 thousand, a decrease of 40% or $323 thousand compared to $817 thousand in the same period of 2024[219]. - Gross profit for the three months ended June 30, 2025, was approximately negative $35 thousand, a decrease of 108% or $463 thousand from positive $428 thousand in 2024[221]. - For the six months ended June 30, 2025, revenues decreased by approximately 13%, totaling $1,519 thousand compared to $1,738 thousand in 2024[232]. - Gross profit for the same period decreased by approximately 69%, amounting to $334 thousand compared to $1,092 thousand in 2024[233]. - The net loss for the six months ended June 30, 2025, was approximately $5,843 thousand, a decrease of 358% compared to a net loss of $1,276 thousand in 2024[244]. - Financial income, net for the six months ended June 30, 2025, was approximately $259 thousand compared to an expense of $45 thousand in 2024[242]. - Interest expense for the same period was $197 thousand, up from $68 thousand in 2024, primarily due to the amortization of debt discount on the Alpha loans[243]. Expenses - Research and development expenses increased by approximately 420% to $972 thousand for the three months ended June 30, 2025, compared to $187 thousand in 2024, primarily due to clinical trial costs[223]. - Selling and marketing expenses rose by approximately 260% to $717 thousand for the three months ended June 30, 2025, compared to $199 thousand in 2024, mainly due to the inclusion of ENvue's operations[225]. - General and administrative expenses increased by approximately 215% to $2,252 thousand for the three months ended June 30, 2025, compared to $716 thousand in 2024, largely due to professional fees related to the Merger[227]. - Research and development expenses increased by approximately 388%, reaching $1,502 thousand compared to $308 thousand in 2024[235]. - Selling and marketing expenses rose by approximately 193%, totaling $1,066 thousand compared to $364 thousand in 2024[238]. - General and administrative expenses increased by approximately 116%, amounting to $3,594 thousand compared to $1,662 thousand in 2024[240]. Revenue Composition - The gross profit margin percentage was approximately negative 7% for the three months ended June 30, 2025, compared to positive 52% in 2024[222]. - Research and development expenses as a percentage of total revenues were approximately 197% for the three months ended June 30, 2025, compared to 23% in 2024[224]. - Selling and marketing expenses as a percentage of total revenues were approximately 145% for the three months ended June 30, 2025, compared to 24% in 2024[226]. - General and administrative expenses as a percentage of total revenues were approximately 456% for the three months ended June 30, 2025, compared to 88% in 2024[228]. - The portion of revenues derived from the largest direct medical equipment distributor decreased from 38% in 2024 to 4% in 2025[220]. Cash Flow and Financial Position - As of June 30, 2025, the company reported a cash balance of approximately $4,060, an increase from approximately $752 as of December 31, 2024[250]. - The company incurred recurring losses and negative cash flows from operations, with an accumulated deficit of $75,988 as of June 30, 2025[245]. - The company faced delisting from Nasdaq due to non-compliance with the minimum bid price and stockholders' equity requirements[191][192].

Mergers and Acquisitions - The company completed a merger on February 14, 2025, with Predecessor ENvue, resulting in ENvue Medical Holdings LLC becoming a wholly-owned subsidiary[121]. - Following the merger, holders of Predecessor ENvue's equity own 85.0% of the outstanding equity of the company, assuming conversion of Series X Preferred Stock[136]. Financial Performance - For the three months ended March 31, 2025, revenues were approximately $1,025,000, an increase of approximately 11% compared to $921,000 for the same period in 2024, primarily due to the merger with ENvue[165]. - Gross profit for the three months ended March 31, 2025, was approximately $369,000, a decrease of approximately 44% from $664,000 in 2024, with gross profit as a percentage of revenues dropping to 36% from 72%[167][168]. - Research and development expenses increased by approximately 338% to $530,000 for the three months ended March 31, 2025, compared to $121,000 in 2024, representing 52% of total revenues[169][170]. - Selling and marketing expenses rose by approximately 112% to $349,000 for the three months ended March 31, 2025, compared to $165,000 in 2024, accounting for 34% of total revenues[171]. - General and administrative expenses increased by approximately 42% to $1,342,000 for the three months ended March 31, 2025, compared to $946,000 in the same period of 2024[173]. - General and administrative expenses as a percentage of total revenues were approximately 131% for the three months ended March 31, 2025, up from 103% in 2024[175]. - Net loss decreased by approximately $1,907,000 or 324% to approximately $2,495,000 for the three months ended March 31, 2025, from approximately $588,000 in the same period of 2024[177]. - Cash used in operating activities was approximately $1,343,000 for the three months ended March 31, 2025, compared to approximately $579,000 for the same period in 2024[184]. - Cash provided by financing activities was approximately $1,050,000 during the three months ended March 31, 2025, primarily from the issuance of a short-term loan payable[185]. - The company incurred net losses of approximately $2,523,000 during the three months ended March 31, 2025, with negative cash flow from operating activities of $1,343,000[178]. - As of March 31, 2025, the company had cash of approximately $601,000, down from approximately $752,000 as of December 31, 2024[183]. Stock and Securities - The company raised approximately $10 million from the underwritten public offering of 400,000 shares of Series G Convertible Preferred Stock on May 16, 2025[124]. - Holders of Series G Preferred Stock are entitled to receive cumulative dividends at a rate of 9% per annum until the fifth anniversary of issuance[123]. - The company issued a promissory note for $360,000 on April 11, 2025, with an interest rate of 8.0% and a maturity date of June 11, 2025[127]. - A reverse stock split of 1-for-11 was executed on March 12, 2025, affecting all common stock share amounts[132]. - The company entered into a private placement agreement on February 13, 2025, selling a senior convertible debenture with an aggregate principal amount of $1.3 million[138]. - The A&R Debenture has a conversion price of $4.8906, subject to customary anti-dilution adjustments[139]. - The January 2025 Warrant has an exercise price of $6.8296 per share and is exercisable for a term of five and a half years from stockholder approval received on February 24, 2025[142]. Market and Operational Insights - The company has initiated commercialization efforts for its medical devices through its subsidiary ENvue[121]. - The percentage of revenues attributable to PainShield MD was 56% for the three months ended March 31, 2025, compared to 59% in 2024, while PainShield Plus accounted for 19% in 2025, up from 10% in 2024[166]. - The largest direct medical equipment distributor, Ultra Pain Products LLC, contributed 49% of revenues in Q1 2025, up from 38% in Q1 2024[166]. - The company’s revenues may fluctuate due to varying consumer purchases, indicating that growth may not be linear or consistent[165]. - Major changes in assets were primarily attributable to the merger, significantly impacting the overall asset base of the company[182]. - Future operating results may be affected by various factors, including regulatory approvals, clinical trial phases, and geopolitical conditions[186]. Compliance and Regulatory Matters - The company did not regain compliance with Nasdaq's minimum bid price requirement by October 7, 2024, leading to a hearing request to avoid delisting[145][146]. - On April 9, 2025, the company received confirmation of compliance with Nasdaq's Bid Price Rule and Equity Rule, following a reverse stock split[148][149]. Financial Outlook - The company expects to continue incurring losses and negative cash flows from operations, indicating a need for additional capital to finance ongoing operations[179].