InspireMD(US:NSPR)2024-11-12 14:00Product 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]