Financial Performance - For the three months ended June 30, 2023, revenues were approximately $294,000, a decrease of 39% compared to $485,000 for the same period in 2022[81]. - Net loss decreased by approximately $228,000, or 18%, to approximately $1,074,000 for the three months ended June 30, 2023, compared to approximately $1,302,000 in the same period of 2022[94]. - Revenues for the six months ended June 30, 2023, were approximately $648,000, a decrease of approximately 14%, or $109,000, from $757,000 in the same period of 2022[95]. Profitability - Gross profit for the three months ended June 30, 2023, was approximately $216,000, a decrease of 23% from $281,000 in the same period in 2022, with a gross profit margin of 73%[83][84]. - Gross profit increased by approximately 17%, or $64,000, to approximately $451,000 for the six months ended June 30, 2023, compared to $387,000 in the same period of 2022[97]. - Gross profit as a percentage of revenues was approximately 70% for the six months ended June 30, 2023, compared to 51% for the same period in 2022[98]. Expenses - Research and development expenses decreased to approximately $35,000 for the three months ended June 30, 2023, from $61,000 in the same period in 2022, representing 12% of total revenues[86][87]. - Selling and marketing expenses were approximately $227,000 for the three months ended June 30, 2023, down 32% from $333,000 in the same period in 2022, accounting for 77% of total revenues[89][90]. - General and administrative expenses decreased to approximately $963,000 for the three months ended June 30, 2023, from $1,155,000 in the same period in 2022, representing 328% of total revenues[91][92]. - Research and development expenses decreased by approximately 29%, or $37,000, to approximately $90,000 for the six months ended June 30, 2023, from $127,000 in the same period of 2022[99]. - Selling and marketing expenses decreased by approximately 19%, or $102,000, to approximately $441,000 for the six months ended June 30, 2023, compared to $543,000 in the same period of 2022[102]. - General and administrative expenses decreased by approximately 5%, or $113,000, to approximately $1,984,000 for the six months ended June 30, 2023, from $2,097,000 in the same period of 2022[104]. Cash Flow and Liquidity - Cash used in operating activities was approximately $2,429,000 for the six months ended June 30, 2023, compared to $3,740,000 for the same period in 2022[114]. - Cash and cash equivalents decreased to approximately $253,000 as of June 30, 2023, from approximately $2,713,000 as of December 31, 2022[113]. - The company expects to continue incurring losses and negative cash flows from operating activities, raising substantial doubt about its ability to continue as a going concern[109]. 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%[69]. Compliance and Legal Issues - The company reported stockholders' equity of approximately $2.2 million as of March 31, 2023, below the Nasdaq minimum requirement of $2.5 million[76]. - The company submitted a plan to regain compliance with Nasdaq's minimum stockholders' equity standard by July 7, 2023, and was granted an extension through November 20, 2023[77]. - The company faced a legal claim from Protrade Systems, Inc. for damages estimated at $3 million, with an arbitration award of $1,500,250 against the company[70][71]. - The company’s revenues may fluctuate significantly due to varying orders from major customers, indicating potential volatility in financial performance[81].

Financial Performance - Revenues for the three months ended March 31, 2023, were approximately $354,000, an increase of 30% or $82,000 compared to $272,000 in the same period of 2022[85]. - Gross profit increased by approximately 122% to $235,000 for the three months ended March 31, 2023, compared to $106,000 in the same period of 2022[88]. - Gross profit as a percentage of revenues improved to approximately 66% for the three months ended March 31, 2023, from 39% in the same period of 2022[89]. - Research and development expenses decreased to approximately $55,000 for the three months ended March 31, 2023, from $66,000 in the same period of 2022, representing a decrease of 17%[89]. - Selling and marketing expenses were approximately $214,000 for the three months ended March 31, 2023, a slight increase of 2% from $210,000 in the same period of 2022[92]. - General and administrative expenses increased by approximately 8% to $1,021,000 for the three months ended March 31, 2023, compared to $942,000 in the same period of 2022[95]. - Net loss decreased by approximately $35,000, or 3%, to approximately $1,097,000 for the three months ended March 31, 2023, from $1,132,000 in the same period of 2022[99]. - Cash used in operating activities was approximately $1,200,000 for the three months ended March 31, 2023, compared to $1,741,000 for the same period in 2022[105]. - As of March 31, 2023, the company had cash and cash equivalents of approximately $1,512,000, down from approximately $2,713,000 as of December 31, 2022[104]. - The company expects to continue incurring losses and negative cash flows from operating activities, indicating a need for additional capital to sustain operations[100]. Legal and Regulatory Matters - As of March 31, 2023, the company accrued approximately $1.9 million related to the arbitration award to Protrade, including $0.4 million in interest[76]. - The company is involved in ongoing legal proceedings with Protrade, which claims damages estimated at $3 million[69]. - The company faced delays in production and regulatory approvals due to COVID-19, which may continue to affect operations and financial condition[68]. - The company is subject to risks related to global economic instability, inflation, and market acceptance of its products[65]. - The company has reduced disclosure obligations as a "smaller reporting company," which may affect investor attractiveness[65]. Business Operations - The company focuses on noninvasive biological response-activating devices for wound healing and pain therapy, with products like WoundShield, PainShield, and UroShield[67]. - The company relies on third-party manufacturers and professionals, which may be impacted by external economic factors[68]. - The company experienced a reverse stock split at a ratio of 1-for-20 on February 8, 2023, and regained compliance with Nasdaq listing requirements on February 28, 2023[82]. - The company reported a history of losses and anticipates continued losses, which may impact future financial performance[65]. - The company has a critical accounting policy that requires subjective judgments and estimates, with no material changes since December 31, 2022[83].

Production and Operational Challenges - The company reported a significant delay in production due to COVID-19, with a temporary shutdown of its third-party manufacturer in China for 60 days, impacting sales orders initially scheduled for Q1 2020[326]. - The company experienced operational disruptions due to COVID-19, affecting staffing and the ability to obtain financial records[326]. Financial Performance - Revenues for the year ended December 31, 2022, were approximately $752,000, a decrease of 56% or $943,000 compared to $1,695,000 in 2021, primarily due to the suspension of PainShield Plus by the FDA[364]. - Gross profit for 2022 was approximately $167,000, representing a gross profit margin of 22%, down from $770,000 and 45% in 2021, attributed to decreased revenues and increased costs[366][367]. - The net loss for the year ended December 31, 2022, decreased by approximately $8,834,000 or 62% to approximately $5,448,000 from $14,282,000 in 2021[380]. - Cash used in operating activities was approximately $7,035,000 in 2022, an increase of $2,668,000 compared to $4,367,000 in 2021[387]. - As of December 31, 2022, the company had cash of approximately $2,713,000, down from $7,737,000 as of December 31, 2021[386]. - The company expects to continue incurring losses and negative cash flows from operating activities, raising substantial doubt about its ability to continue as a going concern[381]. Expenses and Cost Management - Research and development expenses were approximately $283,000 in 2022, a decrease of 3% from $293,000 in 2021, with R&D expenses as a percentage of total revenues rising to 38% from 17%[368][369]. - Selling and marketing expenses decreased by 12% to approximately $965,000 in 2022, with expenses as a percentage of total revenues increasing to 128% from 65% in 2021 due to lower revenues[370][371]. - General and administrative expenses were approximately $3,931,000 in 2022, a decrease of 22% from $5,059,000 in 2021, mainly due to a prior year arbitration settlement expense[373]. Regulatory and Compliance Updates - The U.S. CMS approved the company's PainShield™ for Medicare reimbursement on a national basis, with the product now available under HCPCS code K1004[335]. - The company received FDA 510(k) clearance for PainShield MD PLUS on November 28, 2023, allowing it to apply ultrasonic energy for treatment of selected medical conditions[344]. - The company is working with a third-party laboratory to conduct testing for PainShield Relief to support its resubmission for reimbursement after an initial rejection[346]. - The company faced a Nasdaq deficiency notice due to its stock price falling below the minimum bid price of $1.00 per share, with a compliance period granted until August 29, 2022[339]. - A reverse stock split was executed on February 8, 2023, at a ratio of 1-for-20, allowing the company to regain compliance with Nasdaq listing requirements[343]. Legal and Licensing Agreements - The company accrued approximately $1.9 million for the arbitration award to Protrade as of December 31, 2022, which includes $0.4 million of interest accrued in 2022[334]. - The company signed a license agreement with Sanuwave Health, Inc. for the manufacture and delivery of WoundShield technology, which includes a $250,000 milestone payment and 10% royalty on gross revenues from sales or rentals[336]. Future Outlook - Future operating results may be affected by various factors, including distributor ordering patterns and regulatory approvals, with potential impacts from economic conditions and currency fluctuations[390].

Financial Performance - For the three months ended September 30, 2022, revenues were approximately $97,000, a decrease of 81% or $402,000 compared to $499,000 in the same period of 2021[85]. - Gross profit for the three months ended September 30, 2022, was approximately $80,000, down 65% or $148,000 from $228,000 in the same period of 2021[87]. - Gross profit as a percentage of revenues increased to approximately 82% for the three months ended September 30, 2022, compared to 46% in the same period of 2021[88]. - Revenues for the nine months ended September 30, 2022, were approximately $854,000, a decrease of approximately 7%, or $66,000, from $920,000 in 2021[103]. - Gross profit for the nine months ended September 30, 2022, was approximately $467,000, a decrease of approximately 9%, or $46,000, from $513,000 in 2021[105]. - Net loss decreased by approximately $5,720,000, or 86%, to approximately $955,000 for the three months ended September 30, 2022, from approximately $6,675,000 in the same period of 2021[101]. - Net loss for the nine months ended September 30, 2022, decreased by approximately $8,419,000, or 71%, to approximately $3,389,000 from approximately $11,808,000 in the same period of 2021[117]. Expenses - Research and development expenses for the three months ended September 30, 2022, were approximately $49,000, slightly down from $50,000 in the same period of 2021[89]. - Research and development expenses as a percentage of total revenues were approximately 51% for the three months ended September 30, 2022, compared to 10% in the same period of 2021[89]. - Selling and marketing expenses for the three months ended September 30, 2022, were approximately $217,000, a decrease of 11% or $28,000 from $245,000 in the same period of 2021[91]. - Selling and marketing expenses as a percentage of total revenues were approximately 224% for the three months ended September 30, 2022, compared to 49% for the same period in 2021[93]. - General and administrative expenses decreased by approximately 8%, or $63,000, to approximately $738,000 for the three months ended September 30, 2022, from $801,000 in 2021[95]. - General and administrative expenses as a percentage of total revenues were approximately 332% for the nine months ended September 30, 2022, compared to 289% in 2021[112]. Cash Flow - Cash used in operating activities was approximately $5,704,000 for the nine months ended September 30, 2022, compared to $3,504,000 for the same period in 2021[124]. - The company had a cash balance of just over $1,972,000 as of September 30, 2022, down from approximately $7,737,000 as of December 31, 2021[123]. Regulatory and Legal Issues - 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[70]. - The company is facing regulatory challenges, including a notification from the FDA to discontinue new marketing of PainShield Plus products until formal approval is obtained[82]. - The company is involved in ongoing legal proceedings with Protrade Systems, Inc., which claims damages estimated at $3 million[73]. Revenue Sources - The portion of revenues derived from distributors was 83% for the three months ended September 30, 2022, down from 95% in the same period of 2021[86].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-36445 NanoVibronix, Inc | Title of each class | Trading Symbol | Name of each exchange on which registered | | --- | --- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-36445 NanoVibronix, Inc (Exact name of registrant as specified in its charter) (Former name, former address and former f ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-36445 NanoVibronix, Inc. (Exact name of registrant as specified in its charter) | Delaware | 01-0801232 | | --- | --- | | (State or other juris ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-36445 NanoVibronix, Inc (Exact name of registrant as specified in its charter) | Delaware | 01-0801232 | | --- | --- ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-36445 NanoVibronix, Inc (Exact name of registrant as specified in its charter) | Delaware | 01-0801232 | | --- | --- | | ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2021 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number: 001-36445 NanoVibronix, Inc (Exact name of registrant as specified in its charter) | Delaware | 01-0801232 | | --- | --- ...