InspireMD, Inc. (NASDAQ:NSPR) is among the  best fundamentally strong penny stocks to buy right now. According to the latest filing with the SEC, Parkman Healthcare Partners LLC has increased its position in InspireMD, Inc. (NASDAQ:NSPR) by 37.1% during the first quarter. Following the purchase of 316,700 shares, the institutional investor now owns 1,171,416 shares of the company’s stock, which translates to an ownership of nearly 3.82%. Powered by a clear procedure-agnostic strategy, InspireMD, Inc. (NAS ...

Company Overview - InspireMD, Inc. is a developer of the CGuard® Prime carotid stent system aimed at preventing strokes [1] - The company is publicly traded on Nasdaq under the ticker symbol NSPR [5] Leadership Appointment - Dan Dearen has been appointed to the Board of Directors, bringing nearly 40 years of experience in the medical device and life sciences sectors [1][2] - His previous roles include President, co-Founder, and Chief Financial Officer of Axonics, Inc., which was acquired by Boston Scientific for $3.7 billion in November 2024 [2][3] Strategic Importance - The appointment of Mr. Dearen is seen as timely as InspireMD continues its U.S. commercial launch of the CGuard Prime stent system [2] - The company aims to lead the carotid intervention market and execute its long-term value-creation strategy [2] Market Potential - Mr. Dearen expressed optimism about InspireMD's potential to change the standard of care in vascular medicine and improve patient outcomes [2] - The company utilizes proprietary MicroNet™ mesh technology to enhance the effectiveness of its carotid stenting products [5]

Summary of InspireMD Conference Call Company Overview - **Company**: InspireMD - **Technology**: Proprietary MicroNet® technology for stroke prevention - **Market Position**: Revolutionizing the carotid intervention market after 20 years of stagnation due to stenting technology and reimbursement issues [2][3] Key Points Market Dynamics - **Reimbursement Changes**: CMS reimbursement approval in October 2023 has significantly impacted the market, allowing InspireMD to address the full 160,000 annual procedures in the U.S. [3][6] - **Market Size**: The U.S. carotid intervention market is approximately $1 billion, with a global market much larger [7] - **Procedure Statistics**: There are about 155,000 procedures in the U.S. annually, with nearly 3 million people globally diagnosed with untreated high-grade carotid stenosis [7] Product and Technology - **Device Approval**: FDA approval for CGuard™ Prime received nine weeks prior to the call, marking a significant milestone for the company [5][18] - **Clinical Outcomes**: Achieved sub-1% complication rates after 30 days, the best ever in carotid intervention [6][11] - **Mechanism of Action**: The device features a 20-micron PET mesh sock to prevent plaque from prolapsing through stent struts, reducing the risk of post-procedural strokes [4][9] Competitive Landscape - **Competitors**: Competing with large strategic companies, particularly following the acquisition of Silk Road Medical by Boston Scientific [26] - **Market Opportunity**: Despite competition, InspireMD believes it has the best product in the market and is well-positioned due to a lack of innovation in carotid stenting over the past 20 years [26][27] Commercial Strategy - **Sales Team**: Focused on hiring experienced sales professionals from the vascular market to drive early commercial traction [15][16] - **Demand Creation**: High demand for the product, with physicians actively seeking the technology [16][17] - **Go-to-Market Strategy**: Targeting specific customers using a claims database to streamline sales efforts [16] Financials and Capital Structure - **Recent Funding**: Raised $113 million in May 2023 and an additional $40 million through PIPE structures, indicating strong investor support [19][20] - **Investment Focus**: Emphasis on capitalizing on market opportunities post-approval, with a focus on growth and establishing a leadership position in the carotid space [18][19] Future Outlook - **Growth Potential**: Anticipated shift from open surgery to stenting, with projections of stenting procedures increasing to 80-85% in the coming years [8] - **Pipeline Development**: Plans for additional products, including a TCAR device called SwitchGuard, expected to be approved by mid-2026 [13][14] Additional Insights - **Patient Impact**: The difference in stroke rates (5% vs. <1%) highlights the significance of the technology for patient outcomes [25] - **Operational Challenges**: The company is focused on maturing its operations to meet high demand while ensuring product quality and physician comfort with the new technology [24] This summary encapsulates the key points discussed during the InspireMD conference call, highlighting the company's strategic position, product innovations, market dynamics, and future growth potential.

Core Viewpoint - InspireMD, Inc. is set to present at the H.C. Wainwright 27th Annual Global Investment Conference on September 10, 2025, highlighting its focus on the CGuard® Prime carotid stent system for stroke prevention [1] Company Overview - InspireMD, Inc. aims to establish its proprietary MicroNet™ mesh technology as the industry standard for carotid stenting, emphasizing superior acute results and long-term stroke-free outcomes [2] - The company's common stock is traded on Nasdaq under the ticker symbol NSPR, and it regularly updates important information for investors on its website [2]

Financial Data and Key Metrics Changes - Total revenue for Q2 2025 increased by 2% to $1.8 million, driven by increased usage in international markets and positive foreign exchange impacts, partially offset by decreased revenue from Russia and European distributors [23][24] - Gross profit decreased by $18,000 or 5.7% to $313,000, with gross margin decreasing to 17.6% from 19% in the same period of 2024 [25] - Total operating expenses increased by $4.7 million or 55% to $13.3 million, primarily due to headcount-related expenses and occupancy costs associated with establishing a U.S. headquarters [26] - Net loss totaled $13.2 million or $0.26 per share, compared to a net loss of $7.9 million or $0.22 per share in Q2 2024 [27] Business Line Data and Key Metrics Changes - The company did not recognize U.S. commercial revenue in Q2 2025 due to FDA approval occurring in the last week of the quarter, but has begun recognizing U.S. sales in Q3 [24] - Over 60,000 implants have been sold globally, reinforcing the company's expertise and commercial infrastructure [24] Market Data and Key Metrics Changes - The carotid intervention market is seeing a shift, with stenting becoming the emerging go-to treatment, supported by a CMS shift in 2023 [9] - Approximately 60,000 annual procedures are performed by 4,000 physicians in the U.S., with a trend towards an endovascular-first mindset [42][46] Company Strategy and Development Direction - The company aims to lead the U.S. carotid interventional market with the CGuard Prime Carotid Stent System, focusing on transforming the carotid intervention market and improving patient outcomes [7][9] - The company is executing a methodical launch strategy, building a strong commercial team and infrastructure to support growth [10][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ability to scale U.S. commercial operations effectively and deliver meaningful growth and value over the coming quarters [21] - The company acknowledges that strong adoption will take time and emphasizes the importance of laying a solid foundation for future expansion [28] Other Important Information - The company raised $40.1 million through a securities purchase agreement and $17.9 million from warrant exercises, significantly strengthening its cash position [20][21] - The company is advancing its clinical pipeline, including pivotal studies in TCAR and exploring new market opportunities in acute stroke care [14][19] Q&A Session Summary Question: Progress with U.S. account openings since FDA approval - Management reported strong early reception with procedures conducted with double-digit physicians and initial stocking orders secured [33][36] Question: Change in expected timelines for TCAR device clearance - Management clarified that the timeline adjustment reflects a broader window for clearance to accommodate uncertainties in product development and regulatory processes [39] Question: Account metrics and targeting strategy - The company is targeting high-volume physicians and accounts, tracking metrics such as revenue and physician engagement in the sales funnel [42][44] Question: Trends in the carotid intervention market - Management noted a shift towards stenting, with expectations of reaching a 50/50 split between surgical and stent-based procedures in the near future [46]

[Recent Business Highlights](index=1&type=section&id=Recent%20Business%20Highlights) InspireMD achieved significant milestones, including FDA approval and U.S. commercial launch of its CGuard Prime carotid stent system, a successful $58 million capital raise, and CE Mark approval for CGuard Prime EPS in Europe, alongside strengthening its leadership team [CEO Commentary](index=1&type=section&id=CEO%20Commentary) CEO Marvin Slosman highlighted the U.S. approval and commercial rollout of the CGuard Prime carotid stent system as significant milestones, validating the company's vision and execution - CEO Marvin Slosman highlighted the U.S. approval and commercial rollout of the CGuard Prime carotid stent system as significant milestones, validating the company's vision and execution[3](index=3&type=chunk) - The company secured **$58 million** in gross proceeds, demonstrating investor confidence, and is focused on scaling with discipline to establish CGuard Prime as the standard of care[3](index=3&type=chunk) [Key Achievements](index=1&type=section&id=Key%20Achievements) This section outlines InspireMD's key accomplishments, including regulatory approvals, market launches, capital raising, and leadership appointments - Received premarket application (PMA) approval from the U.S. FDA for the **CGuard Prime carotid stent system**[5](index=5&type=chunk) - Commenced commercial launch of the **CGuard Prime carotid stent system** in the U.S. Market[5](index=5&type=chunk) - Raised **$58 million** in gross proceeds from an equity private placement and warrant exercise to advance growth initiatives[5](index=5&type=chunk) - Received **CE Mark approval** under the European Medical Device Regulation (MDR) for CGuard Prime EPS, with plans to launch in the third quarter[5](index=5&type=chunk) - Strengthened leadership team with the appointment of **Mike Lawless** as Chief Financial Officer and **Raymond W. Cohen** to the Board of Directors[5](index=5&type=chunk) [Financial Results - Second Quarter Ended June 30, 2025](index=1&type=section&id=Financial%20Results%20for%20the%20Second%20Quarter%20Ended%20June%2030%2C%202025) InspireMD reported a modest revenue increase of 2.3% to $1.778 million in Q2 2025, primarily due to CGuard adoption and positive exchange rates, offset by declines in Russia and inventory management. Gross profit decreased by 5.4%, while operating expenses surged by 55.2% due to U.S. sales force expansion and launch preparations, leading to a higher net loss of $13.151 million [Revenue and Gross Profit Q2](index=1&type=section&id=Revenue%20and%20Gross%20Profit%20Q2) This section details the revenue and gross profit performance for the second quarter of 2025 compared to the prior year | Metric | Q2 2025 ($000) | Q2 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------- | :------------- | :------------ | :--------- | | Revenue | 1,778 | 1,739 | 39 | 2.3% | | Gross Profit | 313 | 331 | (18) | (5.4%) | - Revenue increase driven by continued adoption of CGuard technology in existing markets and positive exchange rates, partially offset by decreased revenue from Russia and distributors managing CGuard inventory[4](index=4&type=chunk) [Operating Expenses and Net Loss Q2](index=2&type=section&id=Operating%20Expenses%20and%20Net%20Loss%20Q2) This section presents the operating expenses and net loss for the second quarter of 2025, highlighting significant increases due to strategic investments | Metric | Q2 2025 ($000) | Q2 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------- | :------------- | :------------ | :--------- | | Total Operating Expenses | 13,332 | 8,591 | 4,741 | 55.2% |\n| Financial expense, net | (132) | 351 | (483) | - |\n| Net Loss | (13,151) | (7,909) | (5,242) | 66.3% |\n| Net loss per share (basic & diluted) | (0.26) | (0.22) | (0.04) | 18.2% | - Increase in operating expenses primarily due to higher salaries and share-based compensation tied to U.S. sales force expansion, CGuard Prime launch preparation, U.S. facility rent, and CFO severance fees[7](index=7&type=chunk) - Financial expense, net, decreased due to the impact of foreign exchange and less interest income from investments in marketable securities and money market funds[8](index=8&type=chunk) [Cash and Marketable Securities Q2](index=2&type=section&id=Cash%20and%20Marketable%20Securities%20Q2) This section provides an overview of the company's cash and marketable securities position as of June 30, 2025 | Metric | June 30, 2025 ($000) | December 31, 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------------- | :----------------------- | :------------ | :--------- | | Cash and cash equivalents | 11,509 | 18,916 | (7,407) | (39.2%) |\n| Marketable securities | 7,865 | 15,721 | (7,856) | (50.0%) |\n| Total Cash & Marketable Securities | 19,374 | 34,637 | (15,263) | (44.1%) | [Financial Results - Six Months Ended June 30, 2025](index=2&type=section&id=Financial%20Results%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025) For the first half of 2025, revenue increased slightly by 1.8% to $3.307 million, while gross profit saw a minor decrease of 2.8%. Operating expenses significantly rose by 53.9% due to sales force expansion and product launch activities, leading to a net loss of $24.317 million, a substantial increase from the prior year [Revenue and Gross Profit H1](index=2&type=section&id=Revenue%20and%20Gross%20Profit%20H1) This section details the revenue and gross profit performance for the six months ended June 30, 2025, compared to the prior year | Metric | H1 2025 ($000) | H1 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------- | :------------- | :------------ | :--------- | | Revenue | 3,307 | 3,250 | 57 | 1.8% |\n| Gross Profit | 605 | 623 | (18) | (2.8%) | - Revenue increase driven by continued adoption of CGuard technology, offset by decreased revenue from Russia, the impact of exchange rates, and distributors managing CGuard inventory levels[10](index=10&type=chunk) [Operating Expenses and Net Loss H1](index=2&type=section&id=Operating%20Expenses%20and%20Net%20Loss%20H1) This section presents the operating expenses and net loss for the six months ended June 30, 2025, highlighting significant increases due to strategic investments and launch preparations | Metric | H1 2025 ($000) | H1 2024 ($000) | Change ($000) | Change (%) | | :----- | :------------- | :------------- | :------------ | :--------- | | Total Operating Expenses | 25,084 | 16,297 | 8,787 | 53.9% |\n| Financial income, net | 162 | 733 | (571) | (77.9%) |\n| Net Loss | (24,317) | (14,941) | (9,376) | 62.8% |\n| Net loss per share (basic & diluted) | (0.48) | (0.43) | (0.05) | 11.6% | - Operating expenses increased due to higher salaries and share-based compensation for U.S. sales force expansion, development and regulatory activities for SwitchGuard NPS, CGuard Prime launch preparation, U.S. facility rent, promotional activities, and CFO severance fees[12](index=12&type=chunk) - Financial income, net, decreased primarily due to a reduction in income from investments in marketable securities and money market funds, as well as an increase in financial expenses from exchange rate fluctuations[14](index=14&type=chunk) [Conference Call and Webcast Details](index=3&type=section&id=Conference%20Call%20and%20Webcast%20Details) Management will host a conference call on August 5, 2025, at 8:30 a.m. ET to discuss financial results and corporate developments, followed by a question-and-answer session - Conference call scheduled for Tuesday, August 5, 2025, at **8:30 a.m. ET**[16](index=16&type=chunk) | Detail | Information | | :----- | :---------- | | Domestic Call | 1-800-579-2543 | | International Call | 1-785-424-1789 | | Conference ID | IMD2Q25 | | Webcast Link | https://viavid.webcasts.com/starthere.jsp?ei=1723041&tp_key=b02c396fff | [About InspireMD, Inc.](index=3&type=section&id=About%20InspireMD%2C%20Inc.) InspireMD is a developer of carotid stenting products utilizing its proprietary MicroNet™ mesh technology, aiming to set the industry standard for stroke prevention with superior acute results and durable, stroke-free long-term outcomes. The company's stock trades on Nasdaq under NSPR - InspireMD seeks to utilize its proprietary MicroNet™ mesh technology to make its products the **industry standard** for carotid stenting[18](index=18&type=chunk) - The company aims to provide outstanding acute results and durable, stroke-free long-term outcomes for stroke prevention[18](index=18&type=chunk) - InspireMD's common stock is quoted on Nasdaq under the ticker symbol **NSPR**[18](index=18&type=chunk) [Forward-looking Statements](index=4&type=section&id=Forward-looking%20Statements) This section contains cautionary statements regarding future events, financial performance, strategies, and regulatory environment, emphasizing that actual results may differ materially due to various known and unknown risks and uncertainties. Investors are advised to review SEC filings for detailed risk factors - This press release contains forward-looking statements regarding InspireMD's expectations, hopes, beliefs, intentions, or strategies concerning future events and financial performance[20](index=20&type=chunk) - Forward-looking statements are not guarantees of future performance and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company's control, and cannot be predicted or quantified[20](index=20&type=chunk) - Risks include recurring losses, going concern doubts, need for additional capital, market acceptance, regulatory approvals, clinical trial results, competition, intellectual property protection, manufacturing dependence, and economic conditions[20](index=20&type=chunk) - Investors and security holders are urged to read the Company's filings with the SEC, including the Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, for more detailed information about risk factors[20](index=20&type=chunk) [Investor Contacts](index=4&type=section&id=Investor%20Contacts) Contact information for investor relations is provided through Webb Campbell of Gilmartin Group LLC and a general investor relations email - Investor inquiries can be directed to **Webb Campbell** at Gilmartin Group LLC or via **investor-relations@inspiremd.com**[21](index=21&type=chunk) [Condensed Consolidated Financial Statements](index=5&type=section&id=Condensed%20Consolidated%20Financial%20Statements) This section presents the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024, and the condensed consolidated balance sheets as of June 30, 2025, and December 31, 2024 [Condensed Consolidated Statements of Operations](index=5&type=section&id=CONDENSED%20CONSOLIDATED%20STATEMENTS%20OF%20OPERATIONS) This section provides the unaudited condensed consolidated statements of operations for the three and six months ended June 30, 2025 and 2024 | Metric (U.S. dollars in thousands) | Q2 2025 | Q2 2024 | H1 2025 | H1 2024 | | :--------------------------------- | :------ | :------ | :------ | :------ | | Revenues | 1,778 | 1,739 | 3,307 | 3,250 | | Cost of revenues | 1,465 | 1,408 | 2,702 | 2,627 | | Gross Profit | 313 | 331 | 605 | 623 | | Research and development | 3,834 | 3,401 | 7,893 | 6,026 | | Selling and marketing | 4,172 | 1,445 | 6,922 | 2,682 | | General and administrative | 5,326 | 3,745 | 10,269 | 7,589 | | Total operating expenses | 13,332 | 8,591 | 25,084 | 16,297 | | Loss from operations | (13,019)| (8,260) | (24,479)| (15,674)| | Financial income (expense), net | (132) | 351 | 162 | 733 | | Net Loss | (13,151)| (7,909) | (24,317)| (14,941)| | Net loss per share – basic and diluted | (0.26) | (0.22) | (0.48) | (0.43) | | Weighted average shares | 51,003,900 | 35,877,926 | 50,508,660 | 35,060,450 | [Condensed Consolidated Balance Sheets](index=6&type=section&id=CONDENSED%20CONSOLIDATED%20BALANCE%20SHEETS) This section presents the unaudited condensed consolidated balance sheets as of June 30, 2025, and the audited balance sheets as of December 31, 2024 | Metric (U.S. dollars in thousands) | June 30, 2025 | December 31, 2024 | | :--------------------------------- | :------------ | :---------------- | | **ASSETS** | | | | Cash and cash equivalents | 11,509 | 18,916 | | Marketable securities | 7,865 | 15,721 | | Total current assets | 25,463 | 40,521 | | Total non-current assets | 7,879 | 6,286 | | Total assets | 33,342 | 46,807 | | **LIABILITIES AND EQUITY** | | |\n| Total current liabilities | 9,068 | 7,678 | | Total long-term liabilities | 4,031 | 3,043 | | Total liabilities | 13,099 | 10,721 | | Total equity | 20,243 | 36,086 | | Total liabilities and equity | 33,342 | 46,807 | - All June 30, 2025, financial information is derived from the Company's 2025 unaudited financial statements (Form 10-Q), and December 31, 2024, information from the 2024 audited financial statements (Form 10-K)[27](index=27&type=chunk)

Core Insights - InspireMD, Inc. has achieved significant milestones, including FDA approval for its CGuard Prime carotid stent system and the commencement of its commercial rollout in the U.S. [3][10] - The company raised $58 million in gross proceeds, indicating strong investor confidence in its growth potential [3][10] Financial Results for Q2 2025 - Total revenue for Q2 2025 increased by $39,000, or 2.3%, to $1,778,000 compared to $1,739,000 in Q2 2024, driven by the adoption of CGuard technology [4] - Gross profit decreased by $18,000, or 5.4%, to $313,000 from $331,000 in Q2 2024 [5] - Total operating expenses rose by $4,741,000, or 55.2%, to $13,332,000 compared to $8,591,000 in Q2 2024, primarily due to increased salaries and costs associated with the U.S. sales force expansion [6] - Net loss for Q2 2025 was $13,151,000, or $0.26 per share, compared to a net loss of $7,909,000, or $0.22 per share, in Q2 2024 [8] Financial Results for the First Half of 2025 - Revenue for the first half of 2025 increased by $57,000, or 1.8%, to $3,307,000 from $3,250,000 in the same period of 2024 [11] - Gross profit for the first half decreased by $18,000, or 2.8%, to $605,000 compared to $623,000 in the first half of 2024 [12] - Total operating expenses for the first half increased by $8,787,000, or 53.9%, to $25,084,000 compared to $16,297,000 in the same period of 2024 [13] - Net loss for the first half totaled $24,317,000, or $0.48 per share, compared to a net loss of $14,941,000, or $0.43 per share, for the same period in 2024 [15] Business Developments - The company received PMA approval from the FDA for the CGuard Prime carotid stent system and commenced its commercial launch in the U.S. [10] - InspireMD also received CE Mark approval for CGuard Prime EPS under the European Medical Device Regulation, with plans for a launch in Q3 [10] - The leadership team was strengthened with the appointment of Mike Lawless as CFO and the addition of Raymond W. Cohen to the Board of Directors [10]

[FORM 10-Q](index=1&type=section&id=FORM%2010-Q) [PART I - FINANCIAL INFORMATION](index=3&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) 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](index=3&type=section&id=Item%201.%20Financial%20Statements) 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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=7&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Changes%20in%20Equity) 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](index=26&type=chunk) [Condensed Consolidated Statements of Cash Flows](index=12&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=13&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes provide detailed explanations and additional information supporting the condensed consolidated financial statements [NOTE 1 - DESCRIPTION OF BUSINESS](index=13&type=section&id=NOTE%201%20-%20DESCRIPTION%20OF%20BUSINESS) 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](index=31&type=chunk)[32](index=32&type=chunk) - 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](index=33&type=chunk) - 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](index=35&type=chunk) - 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](index=38&type=chunk)[39](index=39&type=chunk) [NOTE 2 - BASIS OF PRESENTATION](index=14&type=section&id=NOTE%202%20-%20BASIS%20OF%20PRESENTATION) 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](index=41&type=chunk) - Interim results for the six and three months ended June 30, 2025, are not necessarily indicative of results for the entire fiscal year[41](index=41&type=chunk) [NOTE 3 - RECENTLY ISSUED ACCOUNTING PRONOUNCEMENTS](index=15&type=section&id=NOTE%203%20-%20RECENTLY%20ISSUED%20ACCOUNTING%20PRONOUNCEMENTS) 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](index=45&type=chunk) - 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](index=45&type=chunk) - The Company is currently evaluating the potential impact of these ASUs on its consolidated financial statements and disclosures[45](index=45&type=chunk) [NOTE 4 – FAIR VALUE MEASUREMENTS](index=15&type=section&id=NOTE%204%20%E2%80%93%20FAIR%20VALUE%20MEASUREMENTS) 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](index=46&type=chunk) [NOTE 5 - MARKETABLE SECURITIES](index=17&type=section&id=NOTE%205%20-%20MARKETABLE%20SECURITIES) 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](index=47&type=chunk) | 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](index=17&type=section&id=NOTE%206%20-%20EQUITY) 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](index=14&type=chunk)[50](index=50&type=chunk) | 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](index=52&type=chunk) - 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](index=53&type=chunk)[55](index=55&type=chunk)[58](index=58&type=chunk) [NOTE 7 – RELATED PARTIES TRANSACTIONS](index=18&type=section&id=NOTE%207%20%E2%80%93%20RELATED%20PARTIES%20TRANSACTIONS) 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](index=59&type=chunk) [NOTE 8 - NET LOSS PER SHARE](index=19&type=section&id=NOTE%208%20-%20NET%20LOSS%20PER%20SHARE) 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](index=60&type=chunk) - Potential dilution from options, warrants, and unvested restricted stock/units is excluded from diluted EPS calculation because their effect is anti-dilutive[60](index=60&type=chunk) | 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](index=19&type=section&id=NOTE%209%20%E2%80%93%20LEASE%20AGREEMENTS) 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](index=65&type=chunk) - 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](index=65&type=chunk) [NOTE 10 - FINANCIAL INSTRUMENTS](index=20&type=section&id=NOTE%2010%20-%20FINANCIAL%20INSTRUMENTS) 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](index=66&type=chunk) - Allowance for expected credit loss was immaterial as of June 30, 2025, and December 31, 2024[66](index=66&type=chunk) [NOTE 11- INVENTORY](index=20&type=section&id=NOTE%2011-%20INVENTORY) 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](index=67&type=chunk) [NOTE 12 - ACCOUNTS PAYABLE AND ACCRUALS - OTHER](index=20&type=section&id=NOTE%2012%20-%20ACCOUNTS%20PAYABLE%20AND%20ACCURALS%20-%20OTHER) 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](index=68&type=chunk) [NOTE 13 - DISAGGREGATED REVENUE](index=20&type=section&id=NOTE%2013%20-%20DISAGGREGATED%20REVENUE) 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](index=21&type=section&id=NOTE%2014%3A%20SEGMENT%20INFORMATION) 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](index=71&type=chunk) - The Chief Operating Decision Maker (CEO) uses consolidated net income to measure segment profit or loss and allocates resources[71](index=71&type=chunk) | 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](index=21&type=section&id=NOTE%2015%3A%20SUBSEQUENT%20EVENTS) 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](index=74&type=chunk) - 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](index=75&type=chunk) - On August 1, 2025, **445,292 shares** were sold under the ATM program, generating approximately **$1.1 million** in gross proceeds[76](index=76&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=23&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=23&type=section&id=Forward-Looking%20Statements) 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](index=80&type=chunk) - 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](index=80&type=chunk)[83](index=83&type=chunk) [Overview](index=24&type=section&id=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](index=82&type=chunk) - CGuard Prime, the next-generation carotid artery stenting (CAS) stent platform, received PMA approval from the U.S. FDA on June 23, 2025[82](index=82&type=chunk) - 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](index=87&type=chunk)[88](index=88&type=chunk) - 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](index=91&type=chunk) [Recent Developments](index=26&type=section&id=Recent%20Developments) 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](index=93&type=chunk)[94](index=94&type=chunk) - The company received CE Mark approval under the EU's MDR for the CGuard Prime Embolic Prevention System on June 12, 2025[95](index=95&type=chunk) - Series I warrants were fully exercised in June and July 2025, generating **$16.9 million** in net proceeds[96](index=96&type=chunk) - 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](index=97&type=chunk)[98](index=98&type=chunk) [Critical Accounting Policies](index=27&type=section&id=Critical%20Accounting%20Policies) 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](index=100&type=chunk) - The U.S. dollar is the currency of the primary economic environment for the company's operations[101](index=101&type=chunk) [Results of Operations](index=27&type=section&id=Results%20of%20Operations) 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](index=27&type=section&id=Three%20months%20ended%20June%2030%2C%202025%2C%20compared%20to%20the%20three%20months%20ended%20June%2030%2C%202024) 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](index=106&type=chunk) - General and administrative expenses rose by **42.2%** due to new hires for U.S. headquarters, salary increases, and expected severance payments[107](index=107&type=chunk) [Six months ended June 30, 2025, compared to the six months ended June 30, 2024](index=28&type=section&id=Six%20months%20ended%20June%2030%2C%202025%2C%20compared%20to%20the%20six%20months%20ended%20June%2030%2C%202024) 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](index=113&type=chunk) - Selling and marketing expenses surged by **158.1%** due to increased compensation and travel for building U.S. commercial infrastructure[114](index=114&type=chunk) [Liquidity and Capital Resources](index=29&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=118&type=chunk) - Management plans to fund operations through continued commercialization, additional equity sales, debt, strategic partnerships, and warrant exercises[119](index=119&type=chunk) | 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](index=30&type=section&id=Off%20Balance%20Sheet%20Arrangements) 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](index=129&type=chunk) [Factors That May Affect Future Operations](index=30&type=section&id=Factors%20That%20May%20Affect%20Future%20Operations) 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](index=130&type=chunk) - Other economic conditions, such as individual country reimbursement policies, may also impact customer demand[130](index=130&type=chunk) [Contractual Obligations and Commitments](index=31&type=section&id=Contractual%20Obligations%20and%20Commitments) 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](index=131&type=chunk) [Recently Adopted and Issued Accounting Pronouncements](index=31&type=section&id=Recently%20Adopted%20and%20Issued%20Accounting%20Pronouncements) 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](index=132&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=133&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=31&type=section&id=Management's%20Conclusions%20Regarding%20Effectiveness%20of%20Disclosure%20Controls%20and%20Procedures) 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](index=135&type=chunk) [Changes in Internal Control over Financial Reporting](index=31&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) 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](index=136&type=chunk) [PART II - OTHER INFORMATION](index=31&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section includes legal proceedings, risk factors, equity sales, and other required disclosures [Item 1. Legal Proceedings](index=31&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=138&type=chunk) [Item 1A. Risk Factors](index=31&type=section&id=Item%201A.%20Risk%20Factors) 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](index=32&type=section&id=Going%20Concern%20Uncertainty) 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](index=140&type=chunk) - This uncertainty could adversely affect the company's ability to obtain new financing on reasonable terms or at all[140](index=140&type=chunk) [Risks Related to Operations in Israel](index=32&type=section&id=Risks%20Related%20to%20Operations%20in%20Israel) 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](index=141&type=chunk) - 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](index=143&type=chunk) - 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](index=145&type=chunk) [Changes to Trade Policy](index=33&type=section&id=Changes%20to%20Trade%20Policy) 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](index=150&type=chunk) - 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](index=151&type=chunk) - 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](index=152&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=34&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=153&type=chunk) [Item 3. Defaults Upon Senior Securities](index=34&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) This section states that there were no defaults upon senior securities during the reporting period - There were no defaults upon senior securities[154](index=154&type=chunk) [Item 4. Mine Safety Disclosures](index=34&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This section indicates that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable[155](index=155&type=chunk) [Item 5. Other Information](index=34&type=section&id=Item%205.%20Other%20Information) 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](index=156&type=chunk) [Item 6. Exhibits](index=34&type=section&id=Item%206.%20Exhibits) 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](index=158&type=chunk)[159](index=159&type=chunk) - 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](index=159&type=chunk) - Inline XBRL documents for the instance, schema, calculation, definition, labels, and presentation linkbases are also included[159](index=159&type=chunk) [SIGNATURES](index=36&type=section&id=SIGNATURES) This section contains the required signatures for the Form 10-Q filing

Core Viewpoint - InspireMD is accelerating its commercialization strategy in the competitive carotid intervention market following the FDA pre-market approval of its core product, CGuard® Prime carotid stent system, and a successful financing round of approximately $58 million [2][12]. Financing and Strategic Moves - InspireMD completed a financing transaction totaling approximately $58 million, which includes $40.1 million from PIPE financing led by OrbiMed and Marshall Wace, and an additional $17.9 million from warrant exercises at a price of $2.42 per share [3][12]. - The financing will be utilized for sales and marketing, R&D investments, working capital, and other operational needs to establish a comprehensive launch platform in the U.S. market [3][12]. - The appointment of Raymond W. Cohen to the board is a strategic move to enhance the company's governance and leverage his extensive experience in the medical technology sector [5][12]. Product Overview - CGuard Prime is a next-generation carotid stent system that integrates structural innovation and clinical safety, featuring proprietary MicroNet® technology designed to prevent embolic events during procedures [6][11]. - The stent's design includes an outer MicroNet® layer for continuous embolic protection and an inner SmartFit™ nickel-titanium stent that simplifies surgical operations [7][11]. Clinical Data and Market Entry - CGuard Prime demonstrated excellent safety and efficacy in the C-GUARDIANS trial, with a 30-day major adverse event rate of only 0.95% and a one-year rate of 1.93%, the lowest reported in public carotid stent studies [11][12]. - The FDA granted PMA approval for CGuard Prime in June 2025, and the company is preparing for a commercial launch in the U.S. market, supported by a national coverage decision (NCD) from CMS [12][13]. Strategic Expansion - InspireMD is exploring the adaptability of CGuard Prime for TCAR (transcarotid artery revascularization) procedures and plans to expand its product portfolio to include next-generation stent systems and integrated brain protection solutions [13][14]. - The company aims to transition from a stent manufacturer to a creator of a new paradigm in stroke intervention, leveraging clinical data and capital to drive market access and accelerate commercialization [14].

Core Viewpoint - InspireMD, Inc. has appointed Raymond W. Cohen to its Board of Directors, bringing over 40 years of experience in medical technology to enhance the company's strategic vision and operational execution [1][2]. Company Overview - InspireMD is focused on developing the CGuard® Prime carotid stent system aimed at preventing strokes, utilizing proprietary MicroNet™ mesh technology to achieve superior acute results and long-term outcomes [6]. Leadership Experience - Raymond W. Cohen has a notable track record, having co-founded Axonics, Inc., which went public in 2018 and was acquired by Boston Scientific for $3.7 billion in November 2024 [2]. - Cohen previously served as Chairman of SoniVie Ltd., which was acquired by Boston Scientific for $600 million, and has held leadership roles in various medical technology companies [3][4]. Strategic Goals - The company is shifting its focus towards the commercial launch of the CGuard Prime stent system following its recent PMA approval, with expectations of capturing market share and delivering long-term value [2][5]. - Cohen expressed confidence in InspireMD's potential to lead the U.S. carotid stent market due to its innovative approach and commitment to clinical excellence [5].