Product Development and Market Expansion - The CGuard Carotid Stent System achieved a 30-day DSMI rate of 0.95% in the C-GUARDIANS trial, indicating strong safety and efficacy[74] - The addressable market for the CGuard Carotid Stent System and SwitchGuard NPS is estimated to be approximately $1.3 billion, with a total available market of around $9.3 billion assuming full penetration[77] - The Centers for Medicare and Medicaid Services expanded coverage of carotid artery stenting to include asymptomatic and standard risk patients, significantly increasing the U.S. market potential[78] - The CGuard EPS has been launched in over 30 countries, with a distribution agreement in place for expansion into Asian markets[71] - The C-GUARDIANS trial enrolled 316 patients across 24 sites, completing enrollment in June 2023[72] - The company plans to submit a premarket approval application for the CGuard Prime stent system in Q3 2024, anticipating FDA approval in the first half of 2025[74] - The company is developing a new transcarotid artery revascularization system, SwitchGuard NPS, to enhance its product offerings[76] - The company continues to invest in new indications and manufacturing enhancements for CGuard to improve cost efficiency and performance[76] Financial Performance - For the three months ended September 30, 2024, revenue increased by $254,000, or 16.3%, to $1,810,000 from $1,556,000 during the same period in 2023, driven by growth in existing and new markets[87] - Gross profit for the three months ended September 30, 2024, decreased by $24,000, or 5.6%, to $414,000, resulting in a gross margin of 22.9%, down from 28.1% in the prior year[89] - Research and development expenses for the three months ended September 30, 2024, increased by $1,805,000, or 85.5%, to $3,915,000, primarily due to increased expenses related to the SwitchGuard NPS development and regulatory approval[90] - Selling and marketing expenses for the three months ended September 30, 2024, increased by $596,000, or 68.0%, to $1,472,000, mainly due to compensation expenses as the company builds its U.S. commercial infrastructure[91] - For the nine months ended September 30, 2024, revenue increased by $616,000, or 13.9%, to $5,060,000 from $4,444,000 during the same period in 2023[94] - Gross profit for the nine months ended September 30, 2024, decreased by 20.4%, or $265,000, to $1,037,000, with a gross margin of 20.5%, down from 29.3% in the prior year[96][97] - Research and development expenses for the nine months ended September 30, 2024, increased by 67.2%, or $3,995,000, to $9,941,000, driven by increased compensation and regulatory approval expenses[98] - Net loss for the nine months ended September 30, 2024, increased by $8,320,000, or 57.3%, to $22,831,000, primarily due to increased operating expenses[104] Cash Flow and Financial Position - As of September 30, 2024, the company had an accumulated deficit of $244 million and negative operating cash flows, indicating substantial doubt about its ability to continue as a going concern[105] - Cash provided in investing activities was $4,399,000 for the nine months ended September 30, 2024, compared to cash used of $16,056,000 for the same period in 2023[112] - Cash provided by financing activities was $16,889,000 for the nine months ended September 30, 2024, down from $37,534,000 in the same period of 2023[113] - Current assets exceeded current liabilities by a multiple of 6.4 as of September 30, 2024, with working capital increasing by $990,000 to $39,129,000[114] Regulatory and Compliance - The company received CE mark recertification for CGuard EPS under the EU's Medical Device Regulation in January 2024[71] - There were no off-balance sheet transactions or obligations that materially affect the financial condition[115] - Future operating results may be affected by factors such as distributor ordering patterns, regulatory approvals, and economic conditions[116] - No material changes to contractual obligations and commitments were reported during the nine months ended September 30, 2024[118] - Disclosure controls and procedures were evaluated as effective at the reasonable assurance level as of September 30, 2024[120] - No changes in internal control over financial reporting were noted during the fiscal quarter ended September 30, 2024[121] - There are currently no pending material legal proceedings that may significantly affect the business or financial position[122]

Core Points - InspireMD, Inc. has approved inducement grants of 197,167 shares of restricted stock to five new non-executive employees as part of its compensation strategy [1][2] - The inducement grants are intended to attract individuals who were not previously employees of InspireMD, in compliance with Nasdaq Listing Rule 5635(c)(4) [2] - The restricted stock will vest over a three-year period, with one-third vesting on the first anniversary and the remainder vesting in two equal installments on the second and third anniversaries, contingent on continued employment [3] Company Overview - InspireMD, Inc. focuses on utilizing its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, aiming for excellent acute results and long-term stroke-free outcomes [4] - The company's common stock is traded on Nasdaq under the ticker symbol NSPR [4]

Core Viewpoint - InspireMD, Inc. has established its global headquarters in Miami, Florida, in preparation for the anticipated U.S. launch of the CGuard Prime carotid stent system in the first half of 2025, pending FDA approval [1][2]. Company Developments - The new headquarters is a strategic move to support the potential FDA approval of CGuard Prime and to build a world-class commercial and operational team [2]. - The South Florida location is chosen for its rich history in medical device innovation, providing access to talent and resources necessary for the company's growth [2]. Product and Market Strategy - InspireMD is focused on building its marketing, training, and sales operations teams in South Florida to create a robust U.S. commercial organization [3]. - The company has submitted the final module of its Premarket Authorization (PMA) application to the FDA for the CGuard Prime carotid stent system [3]. Technology and Vision - InspireMD aims to utilize its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, emphasizing outstanding acute results and durable, stroke-free long-term outcomes [4].

Core Points - InspireMD, Inc. has received FDA approval for its Investigational Device Exemption (IDE) Application to start the CGUARDIANS II pivotal study for the CGuard Prime 80cm Carotid Stent System during transcarotid revascularization (TCAR) procedures [1] - The company aims to enhance stroke prevention and carotid disease management through its CGuard platforms, with a focus on expanding its market presence in the U.S. and globally [3] - The CGUARDIANS II study is expected to facilitate the approval of the CGuard Prime for optimized TCAR procedures [3] Company Overview - InspireMD utilizes its proprietary MicroNet® technology to establish its products as the industry standard for carotid stenting, aiming for superior acute results and long-term stroke-free outcomes [4] - The common stock of InspireMD is traded on Nasdaq under the ticker symbol NSPR [4] Key Personnel - Dr. Patrick Geraghty and Dr. Patrick Muck have been appointed as lead investigators for the CGUARDIANS II trial, bringing significant expertise to the study [2][3]

InspireMD (NSPR) recently announced that it has submitted a Premarket Approval (PMA) application to the FDA seeking marketing approval for the CGuard Prime carotid stent system in the United States. NSPR's quest for U.S. approval of its next-generation CGuard Prime stent, which offers best-in-class clinical outcomes to treat carotid artery disease and stroke prevention, has advanced significantly with the submission of the PMA application to the FDA. Upon successful marketing approval of the CGuard Prime ca ...

PMA based on overwhelmingly positive results from the pivotal C-GUARDIANS clinical study that were first presented at LINC 2024 in May U.S. commercial launch anticipated in H1 2025, if approved TEL AVIV, Israel and MIAMI, Sept. 16, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today announced that it has submitted a Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) seekin ...

InspireMD, Inc. (NASDAQ:NSPR) Q2 2024 Earnings Conference Call August 6, 2024 8:30 AM ET Company Participants Chuck Padala - IR, Life Advisors Marvin Slosman - CEO Craig Shore - CFO Shane Gleason - CCO Conference Call Participants Adam Maeder - Piper Sandler Frank Takkinen - Lake Street Capital Markets Operator Good morning, and welcome to the InspireMD Second Quarter 2024 Earnings Call. Currently, all participants' are in a listen-only mode. Later, you will have the opportunity to ask questions during the ...

InspireMD, Inc. (NSPR) came out with a quarterly loss of $0.22 per share versus the Zacks Consensus Estimate of a loss of $0.19. This compares to loss of $0.24 per share a year ago. These figures are adjusted for nonrecurring items. This quarterly report represents an earnings surprise of -15.79%. A quarter ago, it was expected that this company would post a loss of $0.15 per share when it actually produced a loss of $0.21, delivering a surprise of -40%. Over the last four quarters, the company has surpasse ...

Exhibit 99.1 — — InspireMD Reports Second Quarter 2024 Financial Results and Provides Business Update - Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-year primary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial – - On track to submit a Premarket Approval (PMA) application to the FDA this quarter - - Raised gross proceeds of $17.9 million from full exercise of Series H ...

- Announced positive outcomes from the C-GUARDIANS IDE clinical trial of the CGuard™ Prime carotid stent system demonstrating a one-year primary endpoint event rate of 1.95%, the lowest for any carotid stent or embolic protection device pivotal trial – - On track to submit a Premarket Approval (PMA) application to the FDA this quarter - - Raised gross proceeds of $17.9 million from full exercise of Series H warrants triggered by announcement of C-GUARDIANS data - -- Management to host investor conference ca ...