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].

Financial Performance - Revenues for the three months ended September 30, 2024, were $376 thousand, down from $458 thousand for the same period in 2023, a decrease of about 18%[7] - Gross profit for the nine months ended September 30, 2024, was $1,225 thousand, compared to $889 thousand for the same period in 2023, an increase of approximately 38%[7] - Net loss for the three months ended September 30, 2024, was $998 thousand, compared to a net loss of $727 thousand for the same period in 2023, indicating a worsening of approximately 37%[7] - For the nine months ended September 30, 2024, the net loss was $2,274,000 compared to a net loss of $2,898,000 for the same period in 2023, indicating a decrease in losses[9] - Gross profit for the three months ended September 30, 2024, was approximately $133,000, a decrease of 62% or $216,000 from $349,000 in 2023, with gross profit as a percentage of revenues dropping from 76% to 35%[51] - For the nine months ended September 30, 2024, revenues increased by approximately 91% to $2,114,000 from $1,106,000 in 2023[52] - Gross profit for the nine months ended September 30, 2024, was approximately $1,225,000, an increase of 53% or $425,000 compared to $800,000 in 2023, with gross profit as a percentage of revenues decreasing from 72% to 58%[53] Cash Flow and Liquidity - Cash decreased significantly from $3,283 million on December 31, 2023, to $1,305 million on September 30, 2024, a reduction of about 60%[6] - The company reported a net cash used in operating activities of $1,968,000 for the nine months ended September 30, 2024, compared to $3,111,000 for the same period in 2023, showing an improvement in cash flow management[9] - Cash at the end of the period was $1,305,000, down from $3,787,000 at the end of the previous year, indicating a significant reduction in liquidity[9] - The company has incurred negative cash flows from operating activities and expects to continue this trend through at least fiscal year 2024, raising concerns about its ability to sustain operations[11] - The company has not generated sufficient resources to fund operations for the next twelve months, leading to substantial doubt about its ability to continue as a going concern[11] - The company has substantial doubt about its ability to continue as a going concern due to insufficient resources to fund operations for the next twelve months[60] Expenses - Operating expenses increased to $1,103 thousand for the three months ended September 30, 2024, from $1,019 thousand in the same period of 2023, an increase of about 8%[7] - Research and development expenses for the three months ended September 30, 2024, were $249 thousand, significantly higher than $33 thousand in the same period of 2023, reflecting a substantial increase in investment[7] - Research and development expenses for the nine months ended September 30, 2024, were approximately $557,000, an increase of 353% from $123,000 in 2023, representing 26% of total revenues[53] - General and administrative expenses decreased by approximately 16% to $2,335,000 for the nine months ended September 30, 2024, from $2,780,000 in 2023, with expenses as a percentage of total revenues dropping from 251% to 110%[53] Assets and Liabilities - Total assets decreased from $6,674 million on December 31, 2023, to $4,682 million on September 30, 2024, representing a decline of approximately 30%[6] - Total current liabilities increased from $2,454 million on December 31, 2023, to $2,521 million on September 30, 2024, an increase of approximately 3%[6] - Total liabilities rose from $2,686 million on December 31, 2023, to $2,810 million on September 30, 2024, an increase of about 5%[6] - As of September 30, 2024, total stockholders' equity was $1,872,000, a decrease from $3,988,000 as of December 31, 2023, reflecting ongoing financial challenges[8] Stock and Financing - The number of weighted average common stock outstanding increased from 1,721,026 shares for the three months ended September 30, 2023, to 2,803,181 shares for the same period in 2024, an increase of approximately 63%[7] - The company completed a private placement on August 30, 2023, raising approximately $4,215,000 in net proceeds for general corporate purposes[22] - The company is dependent on additional financing to cover losses and negative cash flows, which may impact its product development and commercial strategy[11] - The company received a Nasdaq compliance letter indicating it did not meet the minimum bid price requirement of $1.00 per share[44] - The company has been notified of potential delisting from Nasdaq due to not meeting the $5,000,000 minimum stockholders' equity requirement[44] Legal and Compliance Issues - Protrade Systems, Inc. claims damages of approximately $3 million against the Company for breach of an Exclusive Distribution Agreement[38] - The arbitrator awarded Protrade $1,500,250, which includes $1,432,000 for "lost profits" and $68,250 for arbitration costs[38] - The Company accrued approximately $2 million for the arbitration award to Protrade as of September 30, 2024, including interest[48] - The Company intends to appeal the arbitration award and has filed an appeal with the Appellate Division, Second Department[48] - The company received a letter from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance period until October 7, 2024[60] Operational Challenges - The ongoing conflict in Israel may adversely affect the company's operations, including potential disruptions in supply chains and labor availability[59] - The company may face challenges in raising additional capital, which is necessary to finance losses and negative cash flows from operations[60] Internal Controls and Governance - As of March 31, 2024, the company's disclosure controls and procedures were deemed ineffective due to material weaknesses in internal control over financial reporting[56] - The company has remediated the material weakness related to the issuance of shares in excess of authorized shares, implementing new approval procedures for equity issuances[57] - The company has expanded consultations with third-party specialists to enhance documentation and monitoring of financial reporting processes[57] - Management is reviewing and refining the overall design of the company's internal control environment to improve effectiveness[57] - The company has implemented a risk assessment process with the assistance of a third-party service provider to strengthen internal controls over financial reporting[57] Miscellaneous - The report was signed by Brian Murphy, CEO, and Stephen Brown, CFO, on November 14, 2024[64]

Financial Performance - Revenue for the three months ended June 30, 2024, was $817 thousand, an increase of 177.6% compared to $294 thousand for the same period in 2023[7]. - Gross profit for the six months ended June 30, 2024, was $1,092 thousand, up 68.7% from $646 thousand in the same period of 2023[7]. - Net loss for the three months ended June 30, 2024, was $688 thousand, compared to a net loss of $1,074 thousand for the same period in 2023, indicating an improvement of 36.0%[7]. - The net loss for the six months ended June 30, 2024, was $1,276,000, compared to a net loss of $2,171,000 for the same period in 2023[11]. - For the three months ended June 30, 2024, revenues increased by approximately 178% to $817,000 compared to $294,000 in the same period of 2023[41]. - Gross profit for the three months ended June 30, 2024 was approximately $428,000, representing a 98% increase from $216,000 in 2023, with a gross margin percentage decrease from 73% to 52%[41]. - For the six months ended June 30, 2024, revenues increased by approximately 168% to $1,738,000 compared to $648,000 in the same period of 2023[43]. - Gross profit for the six months ended June 30, 2024 was approximately $1,092,000, an increase of 142% from $451,000 in 2023, with a gross margin percentage decrease from 70% to 63%[43]. Cash and Assets - Total assets decreased from $6,674 million on December 31, 2023, to $5,696 million on June 30, 2024, representing a decline of approximately 14.6%[6]. - Cash decreased from $3,283 million on December 31, 2023, to $2,170 million on June 30, 2024, a reduction of 33.9%[6]. - As of June 30, 2024, the company had cash totaling $2,170,000, down from $3,283,000 at the beginning of the period[11]. - As of June 30, 2024, the company had a cash balance of approximately $2,170,000, down from $3,283,000 as of December 31, 2023[44]. - Cash used in operating activities was approximately $1,132,000 for the six months ended June 30, 2024, compared to $2,429,000 for the same period in 2023[44]. Liabilities and Equity - Total stockholders' equity decreased from $3,988 million on December 31, 2023, to $2,841 million on June 30, 2024, a decline of approximately 28.8%[6]. - Total liabilities increased from $2,686 million on December 31, 2023, to $2,855 million on June 30, 2024, an increase of 6.3%[6]. - The company has accrued approximately $2.0 million for the arbitration award to Protrade as of June 30, 2024, including interest[48]. Operating Expenses - Operating expenses for the three months ended June 30, 2024, totaled $1,102 thousand, a decrease of 10.0% from $1,225 thousand in the previous quarter[7]. - Research and development expenses surged by approximately 434% to $187,000 for the three months ended June 30, 2024, primarily due to product redevelopment costs[42]. - Selling and marketing expenses decreased by approximately 12% to $199,000 for the three months ended June 30, 2024, compared to $227,000 in 2023[42]. - General and administrative expenses decreased by approximately 88% to $716,000 for the three months ended June 30, 2024, down from $963,000 in 2023[42]. - Research and development expenses for the six months ended June 30, 2024 increased by approximately 242% to $308,000, driven by product redevelopment and clinical trial costs[43]. Going Concern and Financial Challenges - The company expects to incur losses and negative cash flows from operating activities through at least fiscal year 2024, indicating ongoing financial challenges[12]. - The company has incurred significant losses and negative cash flows, raising substantial doubt about its ability to continue as a going concern[12]. - Management has substantial doubt about the Company's ability to continue as a going concern due to insufficient resources to fund operations for the next twelve months[51]. - The financial statements do not include adjustments that might be necessary if the Company is unable to continue as a going concern[51]. - The Company may need to reduce activities or cease operations if it is unsuccessful in commercializing its products and raising capital[51]. Capital Raising and Compliance - The Company must satisfy Nasdaq's continued listing requirements, including a minimum stockholders' equity of $2.5 million and a minimum closing bid price of $1.00 per share[52]. - The Company received a letter from Nasdaq indicating non-compliance with the minimum bid price requirement, with a compliance period of 180 days until October 7, 2024[52]. - The Company may need to raise additional capital to finance its losses and negative cash flows from operations, with no assurances of favorable terms[51]. - The ongoing conflict in the region may disrupt business operations and affect the ability to raise additional funds[51]. - The Company plans to use proceeds from equity financings or strategic alliances to meet short-term liquidity requirements and advance long-term plans[44]. Legal and Arbitration Matters - The company accrued approximately $2 million for the arbitration award to Protrade as of June 30, 2024, including interest, classified in "Other accounts payable and accrued expenses"[32]. - The arbitrator awarded Protrade $1,500,250 for "lost profits" and arbitration costs due to the company's failure to supply a year's supply of patches[32]. - The company intends to vigorously pursue its opposition to the arbitration award in all appropriate forums[32]. - Legal fees paid to FisherBroyles LLP for the Protrade litigation amounted to $76,034 for the six months ended June 30, 2024[33]. Market and Product Development - The global wound care device market was approximately $20.8 billion in 2022 and is projected to grow to $27.2 billion by 2027, representing a CAGR of 5.4% from 2022 to 2027[37]. - The company’s product candidates may not be developed or commercialized successfully, posing risks to future financial performance[35]. - The company has identified material weaknesses in its internal control over financial reporting and is taking steps to remediate these issues[46][47]. - The company is facing risks related to operations in Israel due to recent conflicts, which may affect its ability to raise capital and conduct business[49].

Financial Performance - For the three months ended March 31, 2024, revenues increased by approximately 160% to $921,000 compared to $354,000 for the same period in 2023, primarily due to increased sales from the UPPI distributor and new customers from Veteran Administration facilities [91]. - Gross profit for the three months ended March 31, 2024, was approximately $664,000, representing an increase of about 183% from $235,000 in the same period of 2023, with a gross profit margin of 72% compared to 66% in 2023 [93][94]. - Net loss decreased by approximately 46%, from approximately $1,097,000 in Q1 2023 to approximately $588,000 in Q1 2024 [103]. - Cash used in operating activities was approximately $579,000 in Q1 2024, compared to $1,200,000 in Q1 2023 [111]. Research and Development - Research and development expenses rose to approximately $121,000 for the three months ended March 31, 2024, a 120% increase from $55,000 in the same period of 2023, mainly due to the initiation of a clinical trial at the University of Michigan [95]. - Research and development expenses as a percentage of total revenues decreased from 16% in Q1 2023 to approximately 13% in Q1 2024 [96]. Expenses - Selling and marketing expenses decreased by approximately 23%, from $214,000 in Q1 2023 to approximately $165,000 in Q1 2024 [98]. - General and administrative expenses decreased by approximately 7%, from $1,021,000 in Q1 2023 to approximately $947,000 in Q1 2024 [100]. - Interest expense remained constant at $34,000 for both Q1 2024 and Q1 2023 [102]. Cash Position - As of March 31, 2024, the company had a cash balance of $2,700,000 after using $583,000 in operations during the three months ended March 31, 2024, raising concerns about its ability to continue as a going concern [76]. - Cash balance as of March 31, 2024, was approximately $2,700,000, down from approximately $3,283,000 as of December 31, 2023 [110]. - Cash provided by financing activities was approximately $0 in Q1 2024, compared to $7,000 in Q1 2023 [113]. Market Outlook - The global wound care device market is projected to grow from approximately $20.8 billion in 2022 to $27.2 billion by 2027, at a CAGR of 5.4% [75]. Compliance and Legal Matters - The company accrued approximately $2.0 million for the arbitration award to Protrade, which includes interest, as of March 31, 2024 [83]. - The company received a letter from Nasdaq indicating non-compliance with the minimum bid price requirement of $1.00 per share, with a compliance period of 180 days until October 7, 2024 [84][85]. - The company had no material commitments to capital expenditures as of March 31, 2024, other than $2 million owed under a court decision [108]. Future Concerns - The company expects to continue incurring losses and negative cash flows from operations, raising substantial doubt about its ability to continue as a going concern [105].

Sales and Market Performance - The company reported a significant increase in sales of PainShield and UroShield in 2023, following a slight decline in 2022, with specific figures not disclosed[21]. - PainShield has sold over 8,000 units since its introduction in 2009, targeting pain management for conditions such as tendonitis and sports injuries[117]. - The market for PainShield is significant, with approximately 76.5 million adult Americans suffering from chronic pain, representing about 26% of the adult population[104]. - The global catheter market was valued at USD 37.3 billion in 2018, with a projected CAGR of 9.7% through 2026, indicating strong market potential for UroShield[74]. - The business opportunity for UroShield in the U.S. is estimated to be in the hundreds of millions of dollars, contingent on obtaining permanent marketing authorization from the FDA[88]. Product Development and Clinical Trials - The company completed seven clinical studies with UroShield, evaluating approximately 220 patients, showing no serious adverse events and beneficial outcomes such as reduced catheter-associated urinary tract infections (CAUTI)[25]. - In August 2023, the company announced positive results from a recent clinical study of UroShield, indicating its effectiveness in reducing infection and improving patient experiences[27]. - PainShield demonstrated a 55.2% improvement in baseline pain scores in a clinical trial for trigeminal neuralgia, compared to a 2.3% improvement in the control group[27]. - Clinical trials have shown that UroShield significantly reduces pain and discomfort related to catheter use, with a notable reduction in antibiotic use[91]. - A community-based Patient Reported Outcomes (PRO) study is planned to measure UroShield's impact on CAUTI prevention, blockage prevention, and pain reduction[84]. Regulatory and Reimbursement Challenges - The company faced challenges with reimbursement for PainShield, having been denied by CMS in September 2022 due to a lack of "life-cycle" testing, and is currently evaluating resubmission options[23]. - The company emphasizes the importance of insurance coverage and reimbursement from third-party payers for the sales volumes and prices of its products[23]. - PainShield is currently under evaluation for reimbursement by Medicare, with the company exploring options to secure reimbursement values[108]. - The company has engaged regulatory counsel and FDA consultants to facilitate applications for reimbursement and clearance under FDA policies[24]. Distribution and Market Expansion - UroShield was approved for sale by NHS Supply Chain, providing full clinical support to all patients needing the device[34]. - The contract with NHS Supply Chain for UroShield has been extended for up to four years, ensuring continued supply[35]. - UroShield actuators will be fully reimbursed by the NHS starting November 1, 2023, allowing clinicians to prescribe the product through NHS contracts[36]. - A non-binding letter of intent was signed with Apogepha Arzneimittel GmbH to explore distribution of UroShield in Germany and other European markets[37]. - The company is expanding clinical development and marketing efforts in North America for PainShield, with ongoing research to support reimbursement code applications[24]. Technology and Innovation - UroShield is designed to prevent bacterial colonization and biofilm formation, increasing antibiotic efficacy and decreasing pain associated with urinary catheter use[59]. - Clinical trials demonstrated that UroShield prevented biofilm in all patients with the active device compared to 63.6% in the control group, with a significant decrease in pain and discomfort[61]. - The company is developing Renooskin for the facial rejuvenation market, with previous studies indicating comparable efficacy to Retinol A[156]. - The WoundShield instillation patch allows for the administration of therapeutic agents into the wound area through a sonophoresis effect, enhancing treatment efficacy[128]. Financial and Economic Factors - The company has a history of losses and expects continued losses due to various economic factors[13]. - Global economic instability, including conflicts such as the Russia-Ukraine situation, may adversely affect the company's financial condition[13]. - Increasing inflation could negatively impact the company's operations and cash flows[13]. - The ability to raise funding for clinical studies and obtain FDA approval is critical for the company's future[13]. Intellectual Property and Compliance - The company is focused on securing intellectual property rights to protect its innovations and enhance commercial opportunities[157]. - The company holds a patent portfolio that includes at least four issued U.S. patents related to its proprietary surface acoustic wave (SAW) technology, with expiration dates ranging from December 19, 2023, to August 20, 2033[161]. - The company operates under strict compliance with U.S. fraud and abuse laws, which can lead to civil and criminal penalties for violations[191]. - The company is classified as a "smaller reporting company," which may affect its attractiveness to investors[13].

Financial Performance - For the three months ended September 30, 2023, revenues increased by approximately 372% to $458,000 compared to $97,000 for the same period in 2022[85]. - Gross profit for the three months ended September 30, 2023 was approximately $349,000, an increase of approximately 336% from $80,000 in the same period in 2022[87]. - Revenues for the nine months ended September 30, 2023, were approximately $1,106,000, an increase of approximately 30%, or $252,000, compared to $854,000 in the same period of 2022[99]. - Gross profit for the nine months ended September 30, 2023, was approximately $800,000, an increase of approximately 71%, or $333,000, from $467,000 in the same period of 2022[102]. - Net loss decreased by approximately $228,000, or 24%, to approximately $727,000 for the three months ended September 30, 2023, from approximately $955,000 in the same period of 2022[98]. Expenses - Research and development expenses decreased by approximately 7% to $33,000 for the three months ended September 30, 2023, down from $49,000 in 2022[90]. - Selling and marketing expenses decreased by approximately 12% to $190,000 for the three months ended September 30, 2023, compared to $217,000 in 2022[93]. - General and administrative expenses increased by approximately 8% to $796,000 for the three months ended September 30, 2023, up from $738,000 in 2022[95]. - Research and development expenses decreased by approximately 30%, or $53,000, to approximately $123,000 for the nine months ended September 30, 2023, from $176,000 in the same period of 2022[104]. - Selling and marketing expenses decreased by approximately 17%, or $129,000, to approximately $631,000 for the nine months ended September 30, 2023, from $760,000 in the same period of 2022[107]. - General and administrative expenses for the nine months ended September 30, 2023, were approximately $2,780,000, a decrease of approximately 2%, or $55,000, from $2,835,000 in the same period of 2022[109]. Market and Revenue Sources - The percentage of revenues attributable to PainShield Plus was 53% for the three months ended September 30, 2023, compared to 0% in 2022[86]. - The percentage of revenues derived from distributors increased to 96% for the three months ended September 30, 2023, up from 83% in 2022[86]. - The global wound care device market is projected to grow from approximately $20.8 billion in 2022 to $27.2 billion by 2027, at a CAGR of 5.4%[73]. Compliance and Financial Position - The company reported stockholders' equity of approximately $2.2 million, below the Nasdaq minimum requirement of $2.5 million[80]. - The company has until November 20, 2023, to demonstrate compliance with Nasdaq's minimum stockholders' equity requirement[81]. - General and administrative expenses as a percentage of total revenues were approximately 174% for the three months ended September 30, 2023, compared to 761% for the same period in 2022[96]. - Interest expense for the three months ended September 30, 2023, was $35,000, up from $0 in the same period of 2022[97]. - Cash used in operating activities was approximately $3,111,000 for the nine months ended September 30, 2023, compared to $5,704,000 for the same period in 2022[122]. - As of September 30, 2023, the company had a cash balance of approximately $3,787,000, compared to approximately $2,713,000 as of December 31, 2022[121].