InspireMD(NSPR) - 2025 Q2 - Quarterly Report

FORM 10-Q PART I - FINANCIAL INFORMATION This section presents the company's unaudited condensed consolidated financial statements and management's discussion and analysis for the interim period Item 1. Financial Statements This section presents the unaudited condensed consolidated financial statements for InspireMD, Inc., including balance sheets, statements of operations, changes in equity, cash flows, and detailed notes Condensed Consolidated Balance Sheets This statement provides a snapshot of the company's assets, liabilities, and equity at specific points in time | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | % Change | | :-------------------- | :------------ | :---------------- | :----- | :------- | | Cash and cash equivalents | $11,509 | $18,916 | $(7,407) | -39.16% | | Marketable securities | $7,865 | $15,721 | $(7,856) | -49.97% | | Total Current Assets | $25,463 | $40,521 | $(15,058)| -37.16% | | Total Assets | $33,342 | $46,807 | $(13,465)| -28.77% | | Total Current Liabilities | $9,068 | $7,678 | $1,390 | 18.10% | | Total Liabilities | $13,099 | $10,721 | $2,378 | 22.18% | | Total Equity | $20,243 | $36,086 | $(15,843)| -43.91% | Condensed Consolidated Statements of Operations This statement details the company's revenues, expenses, and net loss over specific reporting periods | Metric (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Change | % Change | | :-------------------- | :------------------------------- | :------------------------------- | :----- | :------- | | Revenues | $1,778 | $1,739 | $39 | 2.24% | | Gross Profit | $313 | $331 | $(18) | -5.44% | | Total Operating Expenses | $13,332 | $8,591 | $4,741 | 55.19% | | Net Loss | $(13,151) | $(7,909) | $(5,242)| 66.28% | | Net Loss Per Share (basic and diluted) | $(0.26) | $(0.22) | $(0.04)| 18.18% | | Metric (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Change | % Change | | :-------------------- | :----------------------------- | :----------------------------- | :----- | :------- | | Revenues | $3,307 | $3,250 | $57 | 1.75% | | Gross Profit | $605 | $623 | $(18) | -2.89% | | Total Operating Expenses | $25,084 | $16,297 | $8,787 | 53.92% | | Net Loss | $(24,317) | $(14,941) | $(9,376)| 62.75% | | Net Loss Per Share (basic and diluted) | $(0.48) | $(0.43) | $(0.05)| 11.63% | Condensed Consolidated Statements of Changes in Equity This statement outlines the changes in the company's equity components over the reporting period | Equity Component (in thousands) | Balance at Jan 1, 2025 | Net Loss | Exercise of pre-funded warrants | Issuance of common stock | Exercise of Warrants Series I | Share-based compensation | Balance at Jun 30, 2025 | | :------------------------------ | :--------------------- | :------- | :------------------------------ | :----------------------- | :---------------------------- | :----------------------- | :---------------------- | | Common stock (shares) | 26,611,033 | - | 1,411,553 | 273,621 | 1,408,752 | 2,847,929 | 32,552,888 | | Additional paid-in capital | $289,589 | - | - | $696 | $1,838 | $5,940 | $298,063 | | Accumulated deficit | $(253,506) | $(24,317)| - | - | - | - | $(277,823) | | Total equity | $36,086 | $(24,317)| * | $696 | $1,838 | $5,940 | $20,243 | - The company's total equity decreased significantly from $36,086 thousand at January 1, 2025, to $20,243 thousand at June 30, 2025, primarily due to a net loss of $24,317 thousand, partially offset by capital raised through share issuance and warrant exercises[26] Condensed Consolidated Statements of Cash Flows This statement reports the cash generated and used by operating, investing, and financing activities | Cash Flow Activity (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | Change | % Change | | :-------------------------------- | :----------------------------- | :----------------------------- | :----- | :------- | | Net cash used in operating activities | $(17,125) | $(9,418) | $(7,707)| 81.84% | | Net cash provided by investing activities | $7,024 | $10,323 | $(3,299)| -31.96% | | Net cash provided by financing activities | $2,643 | $17,854 | $(15,211)| -85.19% | | Increase (decrease) in cash and cash equivalents | $(7,407) | $18,745 | $(26,152)| -139.52% | | Balance of cash and cash equivalents at end of the period | $11,509 | $28,385 | $(16,876)| -59.46% | Notes to the Condensed Consolidated Financial Statements These notes provide detailed explanations and additional information supporting the condensed consolidated financial statements NOTE 1 - DESCRIPTION OF BUSINESS InspireMD is a medical device company focused on its MicroNet™ stent platform, facing going concern doubts despite recent CGuard Prime approvals and U.S. launch - InspireMD, Inc. is a medical device company specializing in the MicroNet™ stent platform for vascular and coronary disease, with CGuard™ EPS as its carotid product[31][32] - The company received CE Mark approval for CGuard Prime carotid stent system on June 13, 2025, and FDA PMA approval on June 23, 2025, followed by a commercial launch in the U.S. in July 2025[33] - There is substantial doubt about the company's ability to continue as a going concern due to an accumulated deficit, history of net losses, and negative operating cash flows, requiring additional capital within the next 12 months[35] - The company's operations in Israel, including its production facility, have been largely unaffected by regional conflicts as of June 30, 2025, but the situation remains volatile with potential for future material impact[38][39] NOTE 2 - BASIS OF PRESENTATION Unaudited consolidated financial statements are prepared consistently with annual statements, and interim results are not indicative of full fiscal year performance - The unaudited consolidated financial statements are prepared on the same basis as annual statements, with all necessary recurring adjustments included[41] - Interim results for the six and three months ended June 30, 2025, are not necessarily indicative of results for the entire fiscal year[41] NOTE 3 - RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS The company is evaluating the impact of ASU 2023-09 (Income Taxes) and ASU 2024-03 (Expense Disaggregation Disclosures) on future financial statements - ASU 2023-09, 'Income Taxes (Topic 740): Improvements to Income Tax Disclosures,' effective for fiscal years beginning after December 15, 2024, aims to enhance income tax transparency[45] - ASU No. 2024-03, 'Income Statement—Reporting Comprehensive Income—Expense Disaggregation Disclosures (Subtopic 220-40),' effective for fiscal years beginning after December 15, 2026, will require more detailed expense disclosures[45] - The Company is currently evaluating the potential impact of these ASUs on its consolidated financial statements and disclosures[45] NOTE 4 – FAIR VALUE MEASUREMENTS The company measures financial assets at fair value using a three-level hierarchy, classifying money market funds as Level 1 and U.S. government bonds as Level 2 | Asset (in thousands) | Total (June 30, 2025) | Level 1 | Level 2 | Level 3 | | :------------------- | :-------------------- | :------ | :------ | :------ | | Money market funds | $2,499 | $2,499 | $- | $- | | U.S government bonds | $7,865 | $- | $7,865 | $- | | Asset (in thousands) | Total (December 31, 2024) | Level 1 | Level 2 | Level 3 | | :------------------- | :------------------------ | :------ | :------ | :------ | | Money market funds | $6,281 | $6,281 | $- | $- | | U.S government bonds | $15,721 | $- | $15,721 | $- | - Cash equivalents and marketable securities are classified within Level 1 and Level 2, utilizing quoted market prices or market observable inputs for fair value determination[46] NOTE 5 - MARKETABLE SECURITIES All marketable securities have maturities under one year, with their fair value decreasing due to maturities exceeding additions - All marketable securities had contractual maturities of less than one year as of June 30, 2025, and December 31, 2024[47] | Metric (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------- | :----------------------------- | :----------------------------- | | Balance at beginning of period | $15,721 | $29,383 | | Additions | $11,749 | $1,960 | | Maturity | $(19,760) | $(13,000) | | Balance at end of period | $7,865 | $18,778 | NOTE 6 - EQUITY As of June 30, 2025, InspireMD had 32.5 million common shares outstanding, 1,718 Series C Preferred shares, and 24.7 million pre-funded warrants, with significant warrant exercises and share grants - As of June 30, 2025, the company had 32,552,888 common shares issued and outstanding, 1,718 Series C Preferred shares, and 24,735,716 outstanding pre-funded warrants[14][50] | Warrant Series | Number of underlying Common stock | Exercise price | | :------------- | :-------------------------------- | :------------- | | Series F | 14,815 | $7.4250 | | Series G | 1,092,344 | $10.230 | | Series I | 11,505,326 | $1.3827 | | Series J | 12,914,086 | $1.3827 | | Series K | 12,914,078 | $1.3827 | | Total Warrants | 38,440,649 | | - Following FDA approval of CGuard Prime, 1,408,752 Series I Warrants were exercised for approximately $1,948 thousand in proceeds by June 30, 2025[52] - During the six months ended June 30, 2025, the company granted 3,053,064 restricted shares (fair value ~$8.07 million), 558,417 restricted share units (fair value ~$1.54 million), and options to purchase 1,022,274 shares (fair value ~$2.08 million) to employees and directors[53][55][58] NOTE 7 – RELATED PARTIES TRANSACTIONS The company incurred $48 thousand in expenses for administrative services from a CEO immediate family member for U.S. expansion during the six months ended June 30, 2025 | Period | 2025 (in thousands) | 2024 (in thousands) | | :-------------------- | :------------------ | :------------------ | | Three months ended June 30 | $24 | $15 | | Six months ended June 30 | $48 | $30 | - A member of the CEO's immediate family provided administrative services for the Company's U.S. expansion[59] NOTE 8 - NET LOSS PER SHARE Basic and diluted net loss per share calculations include common stock, pre-funded warrants, and restricted stock units, excluding anti-dilutive potential shares - Basic and diluted net loss per share are computed by dividing net loss by the weighted average number of common stock, pre-funded warrants, and restricted stock units outstanding[60] - Potential dilution from options, warrants, and unvested restricted stock/units is excluded from diluted EPS calculation because their effect is anti-dilutive[60] | Metric | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Weighted average number of ordinary shares used in computing net loss per share - basic and diluted | 51,003,900 | 35,877,926 | 50,508,660 | 35,060,450 | NOTE 9 – LEASE AGREEMENTS InspireMD recognized increased operating lease right-of-use assets and liabilities from a new U.S. headquarters lease and an amended Israeli lease - On May 18, 2025, the Company recognized a $302 thousand increase in operating lease right-of-use assets and liabilities upon commencement of the lease for Suite 280 at its U.S. headquarters[65] - On May 28, 2025, an amendment to the Israeli Lease extended the term through December 31, 2028, and added space, increasing operating lease right-of-use assets and liabilities by $692 thousand[65] NOTE 10 - FINANCIAL INSTRUMENTS The carrying amounts of financial instruments approximate fair value due to short-term maturities or market rate measurements, with immaterial expected credit loss allowance - The carrying amounts of financial instruments approximate their fair value due to short-term maturities or measurement using prevailing market rates[66] - Allowance for expected credit loss was immaterial as of June 30, 2025, and December 31, 2024[66] NOTE 11- INVENTORY Total inventory increased to $3,054 thousand by June 30, 2025, primarily due to higher raw materials and work in process | Inventory Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Finished goods | $14 | $18 | | Work in process | $865 | $638 | | Raw materials and supplies | $2,175 | $1,914 | | Total Inventory | $3,054 | $2,570 | - Total inventory increased by $484 thousand, or 18.8%, from December 31, 2024, to June 30, 2025, mainly due to increases in work in process and raw materials[67] NOTE 12 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER Total other accounts payable and accruals increased to $7,550 thousand, driven by higher employee-related, clinical trial, and operating lease accruals | Category (in thousands) | June 30, 2025 | December 31, 2024 | | :-------------------------------- | :------------ | :---------------- | | Employees and employee institutions | $3,638 | $3,414 | | Accrued vacation and recreation pay | $680 | $369 | | Accrued expenses | $1,016 | $1,325 | | Clinical trial accrual | $1,058 | $519 | | Current Operating lease liabilities | $917 | $542 | | Other | $241 | $255 | | Total | $7,550 | $6,424 | - The increase in other payables was primarily due to higher accruals for employees, vacation, clinical trials, and current operating lease liabilities[68] NOTE 13 - DISAGGREGATED REVENUE Total revenue increased slightly for both three and six-month periods, with regional growth in Germany, Italy, Poland, Latin America, and Asia, offset by declines elsewhere | Geographic Area (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Germany | $360 | $307 | $602 | $549 | | Italy | $324 | $264 | $586 | $558 | | Poland | $249 | $207 | $474 | $359 | | Other* | $845 | $961 | $1,645 | $1,784 | | Total Revenues | $1,778 | $1,739 | $3,307 | $3,250 | | Principal Customer | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :----------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Customer A | 20% | 18% | 18% | 17% | | Customer B | 14% | 12% | 14% | 11% | NOTE 14: SEGMENT INFORMATION InspireMD operates as a single segment focused on carotid artery and vascular disease products, reporting a significant net loss with increased R&D, S&M, and G&A expenses - The Company operates as a single operating and reporting segment, developing, manufacturing, and marketing products for carotid artery and other vascular diseases, including the CGuard™ stent platform[71] - The Chief Operating Decision Maker (CEO) uses consolidated net income to measure segment profit or loss and allocates resources[71] | Expense Category (in thousands) | Three months ended June 30, 2025 | Three months ended June 30, 2024 | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :------------------------------ | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Total Cost of Revenues | $1,465 | $1,408 | $2,702 | $2,627 | | Total Research and development | $3,834 | $3,401 | $7,893 | $6,026 | | Total Selling and marketing | $4,172 | $1,445 | $6,922 | $2,682 | | Total General and administrative| $5,326 | $3,745 | $10,269 | $7,589 | | Segment net Loss | $(13,151) | $(7,909) | $(24,317) | $(14,941) | NOTE 15: SUBSEQUENT EVENTS Subsequent to June 30, 2025, Series I warrants were fully exercised, and the company completed a private placement and ATM program, raising substantial capital - Subsequent to June 30, 2025, 11,505,326 Series I warrants were exercised, resulting in 943,641 common shares and 10,561,685 pre-funded warrants, generating approximately $15,907 thousand in proceeds[74] - On July 30, 2025, the Company completed a private placement offering, issuing 6,791,380 common shares and pre-funded warrants for up to 9,764,804 common shares, raising approximately $40.1 million in gross proceeds[75] - On August 1, 2025, 445,292 shares were sold under the ATM program, generating approximately $1.1 million in gross proceeds[76] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's perspective on the company's financial condition and operational results, highlighting business overview, product approvals, critical accounting policies, and liquidity challenges Forward-Looking Statements This section cautions readers about inherent risks and uncertainties associated with forward-looking statements in the report - The report contains forward-looking statements regarding future events, financial performance, strategies, and competitive environment, which are subject to risks and uncertainties[80] - Key risks include recurring losses, negative operating cash flows, need for additional capital, clinical development and market acceptance of products, regulatory approvals, manufacturing dependence, and geopolitical instability[80][83] Overview This section provides a general business description, product focus, and market opportunity for the company - InspireMD is a medical device company focused on developing and commercializing products for carotid artery disease and other vascular diseases, utilizing its proprietary CGuard™ stent platform[82] - CGuard Prime, the next-generation carotid artery stenting (CAS) stent platform, received PMA approval from the U.S. FDA on June 23, 2025[82] - The C-GUARDIANS pivotal study demonstrated positive 30-day (0.95% DSMI rate) and one-year (1.95% DSMI and ipsilateral stroke rate) follow-up results, supporting the PMA submission[87][88] - The company estimates the addressable market for CGuard Carotid Stent System and SwitchGuard NPS to be approximately $1.3 billion, with a total available market of approximately $9.3 billion[91] Recent Developments This section highlights key corporate and product milestones, including regulatory approvals and financing activities - FDA granted PMA approval for the CGuard Prime Carotid Stent System on June 23, 2025, followed by its official commercial launch in the United States in July 2025[93][94] - The company received CE Mark approval under the EU's MDR for the CGuard Prime Embolic Prevention System on June 12, 2025[95] - Series I warrants were fully exercised in June and July 2025, generating $16.9 million in net proceeds[96] - A private placement offering closed on August 1, 2025, raising approximately $40.1 million in gross proceeds through the sale of common stock and pre-funded warrants[97][98] Critical Accounting Policies This section discusses the significant accounting policies that require management's most difficult, subjective, or complex judgments - There have been no material changes to the company's critical accounting policies since December 31, 2024, as described in the Annual Report on Form 10-K[100] - The U.S. dollar is the currency of the primary economic environment for the company's operations[101] Results of Operations This section analyzes the company's financial performance, including revenue, gross profit, and operating expenses, for the reporting periods Three months ended June 30, 2025, compared to the three months ended June 30, 2024 Revenues increased by 2.3% to $1,778 thousand, but gross profit decreased by 5.4%, while operating expenses surged by 55.2% to $13,332 thousand, leading to a 66.3% increase in net loss | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | % Change | | :-------------------- | :------------ | :------------ | :----- | :------- | | Revenues | $1,778 | $1,739 | $39 | 2.3% | | Gross Profit | $313 | $331 | $(18) | -5.4% | | R&D Expenses | $3,834 | $3,401 | $433 | 12.7% | | S&M Expenses | $4,172 | $1,445 | $2,727 | 188.7% | | G&A Expenses | $5,326 | $3,745 | $1,581 | 42.2% | | Financial Income (Expense), net | $(132) | $351 | $(483) | -137.6% | | Net Loss | $(13,151) | $(7,909) | $(5,242)| 66.3% | - Selling and marketing expenses increased significantly by 188.7% due to building U.S. commercial infrastructure for CGuard Prime launch[106] - General and administrative expenses rose by 42.2% due to new hires for U.S. headquarters, salary increases, and expected severance payments[107] Six months ended June 30, 2025, compared to the six months ended June 30, 2024 Revenues increased by 1.8% to $3,307 thousand, but gross profit decreased by 2.8%, while operating expenses rose by 53.9% to $25,084 thousand, resulting in a 62.8% increase in net loss | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | % Change | | :-------------------- | :------------ | :------------ | :----- | :------- | | Revenues | $3,307 | $3,250 | $57 | 1.8% | | Gross Profit | $605 | $623 | $(18) | -2.8% | | R&D Expenses | $7,893 | $6,026 | $1,867 | 31.0% | | S&M Expenses | $6,922 | $2,682 | $4,240 | 158.1% | | G&A Expenses | $10,269 | $7,589 | $2,680 | 35.3% | | Financial Income (Expense), net | $162 | $733 | $(571) | -77.9% | | Net Loss | $(24,317) | $(14,941) | $(9,376)| 62.8% | - Research and development expenses increased by 31.0% due to SwitchGuard NPS development and the CGUARDIANS II pivotal study[113] - Selling and marketing expenses surged by 158.1% due to increased compensation and travel for building U.S. commercial infrastructure[114] Liquidity and Capital Resources This section discusses the company's ability to meet its short-term and long-term financial obligations and its plans for funding operations - As of June 30, 2025, the company had an accumulated deficit of $278 million and a net loss of $24.3 million, leading to substantial doubt about its ability to continue as a going concern for the next 12 months[118] - Management plans to fund operations through continued commercialization, additional equity sales, debt, strategic partnerships, and warrant exercises[119] | Cash Flow Activity (in thousands) | Six months ended June 30, 2025 | Six months ended June 30, 2024 | | :-------------------------------- | :----------------------------- | :----------------------------- | | Net cash used in operating activities | $(17,125) | $(9,418) | | Net cash provided by investing activities | $7,024 | $10,323 | | Net cash provided by financing activities | $2,643 | $17,854 | Off Balance Sheet Arrangements This section discloses any off-balance sheet transactions or arrangements that could materially affect the company's financial position - The company has no off-balance sheet transactions, arrangements, obligations, or relationships with unconsolidated entities that would materially affect its financial condition or results of operations[129] Factors That May Affect Future Operations This section outlines various internal and external factors that could influence the company's future financial performance - Future operating results are subject to quarterly variations due to distributor ordering patterns, regulatory approvals, clinical trial phases, manufacturing efficiencies, and foreign exchange rate fluctuations (Euro weakening, NIS strengthening against USD)[130] - Other economic conditions, such as individual country reimbursement policies, may also impact customer demand[130] Contractual Obligations and Commitments This section details the company's significant contractual obligations and commitments - There were no material changes to the company's contractual obligations and commitments during the six months ended June 30, 2025, compared to the year ended December 31, 2024[131] Recently Adopted and Issued Accounting Pronouncements This section refers to disclosures regarding new accounting standards and their potential impact on the financial statements - Refer to Note 3 of the condensed financial statements for information on new accounting pronouncements adopted[132] Item 3. Quantitative and Qualitative Disclosures About Market Risk This section states that there are no applicable quantitative and qualitative disclosures about market risk for the company - This item is not applicable to the company[133] Item 4. Controls and Procedures Management, including the CEO and CFO, concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025, with no material changes in internal control Management's Conclusions Regarding Effectiveness of Disclosure Controls and Procedures This section presents management's assessment of the effectiveness of the company's disclosure controls and procedures - Management, including the CEO and CFO, concluded that disclosure controls and procedures were effective at the reasonable assurance level as of June 30, 2025[135] Changes in Internal Control over Financial Reporting This section reports any material changes in the company's internal control over financial reporting during the period - There were no changes in internal control over financial reporting during the fiscal quarter ended June 30, 2025, that materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[136] PART II - OTHER INFORMATION This section includes legal proceedings, risk factors, equity sales, and other required disclosures Item 1. Legal Proceedings The company is not currently involved in any material legal proceedings and is unaware of any claims that would significantly affect its business, financial position, or operating results - There are no pending material legal proceedings, and the company is not aware of any legal proceedings or claims that would significantly affect its business, financial position, or operating results[138] Item 1A. Risk Factors This section updates the company's risk factors, emphasizing going concern doubts, Israeli operations risks, and potential impacts from trade policy changes Going Concern Uncertainty This section highlights the significant doubt about the company's ability to continue operations due to financial challenges - Management has concluded that substantial doubt exists about the company's ability to continue as a going concern due to recurring losses and negative operating cash flows[140] - This uncertainty could adversely affect the company's ability to obtain new financing on reasonable terms or at all[140] Risks Related to Operations in Israel This section details the potential adverse impacts of geopolitical instability in Israel on the company's business and operations - The company's manufacturing facility, key personnel, and offices are located in Israel, making its business directly affected by the political, economic, and military conditions in the region[141] - Recent conflicts, including a preemptive strike by Israel on Iran and subsequent retaliatory attacks, have created a volatile situation with a significant risk of broader regional escalation[143] - Disruptions to the manufacturing facility, raw material procurement, or product shipment from Israel could materially and adversely affect the business, as the company currently relies entirely on its Tel Aviv facility for CGuard production[145] Changes to Trade Policy This section discusses the potential negative effects of evolving trade policies, including tariffs, on the company's costs and operations - Changes in U.S. or international trade policies, including tariffs and customs regulations, could adversely affect the company's business, reputation, financial condition, and results of operations[150] - The company currently manufactures all products in Israel and is transitioning manufacturing of CGuard Prime finished goods to a contract manufacturer in North Carolina[151] - New tariffs on medical devices from Israel could materially increase cost of goods sold for the U.S. market, negatively impacting gross margins and pricing flexibility[152] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds This section indicates that there were no unregistered sales of equity securities or use of proceeds to report during the quarter - There were no unregistered sales of equity securities and use of proceeds to report[153] Item 3. Defaults Upon Senior Securities This section states that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[154] Item 4. Mine Safety Disclosures This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[155] Item 5. Other Information During the quarter ended June 30, 2025, no director or officer of the company adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement - No director or officer adopted or terminated a Rule 10b5-1 or non-Rule 10b5-1 trading arrangement during the quarter ended June 30, 2025[156] Item 6. Exhibits This section lists all exhibits filed as part of the Form 10-Q, including various amendments to the Certificate of Incorporation, Bylaws, Certificates of Designation, and certifications required by the Sarbanes-Oxley Act - The exhibits include amendments to the Certificate of Incorporation, Bylaws, and Certificates of Designation of Preferred Stock[158][159] - Certifications from the Chief Executive Officer and Chief Financial Officer pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 are filed herewith[159] - Inline XBRL documents for the instance, schema, calculation, definition, labels, and presentation linkbases are also included[159] SIGNATURES This section contains the required signatures for the Form 10-Q filing