InspireMD(NSPR)

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InspireMD Announces Establishment of Global Headquarters in Miami, Florida to Support Anticipated U.S. Launch and Commercialization of the CGuard Prime Carotid Stent System
GlobeNewswire News Room· 2024-10-15 11:00
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].
InspireMD Announces Approval of Investigational Device Exemption (IDE) Application for CGUARDIANS II Pivotal Study of the CGuard Prime 80cm Carotid Stent System
GlobeNewswire News Room· 2024-10-07 11:00
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]
NSPR Stock Declines Despite PMA Application Submission for CGuard
ZACKS· 2024-09-17 16:41
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 ...
InspireMD Announces Submission of Premarket Approval Application to FDA Seeking U.S. Regulatory Approval of the CGuard™ Prime Carotid Stent System
GlobeNewswire News Room· 2024-09-16 11:00
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(NSPR) - 2024 Q2 - Earnings Call Transcript
2024-08-09 12:58
Financial Data and Key Metrics Changes - Total revenue for Q2 2024 was $1.74 million, a 5.4% increase from $1.65 million in Q2 2023, driven by growth in existing and new markets [14][17] - Gross profit decreased by $160,000 or 32.6% to $331,000, with gross margin dropping to 19% from 29.8% due to increased material and labor costs [17][18] - Net loss for Q2 2024 was $7.91 million or $0.22 per share, compared to a net loss of $5.08 million or $0.24 per share in Q2 2023 [18] Business Line Data and Key Metrics Changes - CGuard revenue for the quarter was $1.74 million, with 2,969 CGuard implants sold, representing nearly 6% growth year-over-year [14][15] - The company has sold over 55,000 CGuard devices to date, establishing a strong market presence [15] Market Data and Key Metrics Changes - The current served market outside the U.S. is approximately 40,000 total procedures, compared to 155,000 in the U.S., indicating significant growth potential in the U.S. market [14][15] - The average sales price (ASP) for CGuard in the U.S. is projected to be significantly higher than the current transfer price of $600 per system in international markets [14][15] Company Strategy and Development Direction - The company is focused on achieving U.S. approval for the CGuard Prime Carotid Stent System in the first half of 2025, with a robust commercial launch planned [4][5] - A strategic agreement has been established with the Jacobs Institute to conduct a feasibility study for CGuard Prime, reflecting the company's commitment to innovation and growth in the neuro community [13] - The company is building a U.S. headquarters in Southeast Florida to support its commercial operations and training [8][24] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the consistency of clinical outcomes from the C-GUARDIANS trial, which is expected to bolster FDA approval efforts [21] - The company anticipates a significant increase in operating expenses, projected to rise by 30% to 40% next year due to U.S. readiness and ongoing clinical trials [26] - Management highlighted overwhelming interest from the vascular surgery community regarding the CGuard product, indicating strong market demand [28] Other Important Information - The company completed enrollment in the CREST-2 clinical trial, which evaluates the effectiveness of carotid stenting versus intensive medical management [11][12] - The company raised $17.9 million from the exercise of Series H warrants, contributing to a cash position of $47.2 million as of June 30, 2024 [18] Q&A Session Summary Question: Feedback on C-GUARDIANS data presented at LINC - Management noted the consistency of the data with real-world outcomes and expressed confidence in FDA approval based on these results [20][21] Question: U.S. commercialization and operating expenses - Management emphasized the focus on U.S. readiness and the hiring of a strong sales force, with a projected increase in operating expenses due to clinical trials and U.S. operations [22][24][26] Question: C-GUARDIANS II trial details - Management reported strong interest from the vascular surgery community and confirmed that trial enrollment is on track, awaiting FDA approval [28][29] Question: CREST-2 data presentation and outcomes - Management indicated that initial analyses will not differentiate by stent type, but future analyses may provide insights into CGuard's performance [30][32] Question: Market impact of CREST-2 outcomes - Management discussed the potential for increased treatment of asymptomatic patients if stenting shows favorable outcomes compared to medical management [36][37] Question: Commercial strategy and value analysis committees - Management is ramping up outreach efforts to ensure quick access to value analysis committees post-approval, leveraging physician enthusiasm for the new technology [39]
InspireMD, Inc. (NSPR) Reports Q2 Loss, Misses Revenue Estimates
ZACKS· 2024-08-06 14:25
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 ...
InspireMD Reports Second Quarter 2024 Financial Results and Provides Business Update
Newsfilter· 2024-08-06 12:09
- 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 ...
InspireMD Reports Second Quarter 2024 Financial Results and Provides Business Update
GlobeNewswire News Room· 2024-08-06 12:09
- 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 ...
InspireMD Congratulates CREST-2 Investigators on Completion of Trial Enrollment
GlobeNewswire News Room· 2024-08-05 11:00
CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials CREST-2 included 23 cases implanted with CGuard TEL AVIV, Israel and MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid Revascularization Endarterectomy or Stenting Trial) clinical trials. The CGuard caro ...
InspireMD Congratulates CREST-2 Investigators on Completion of Trial Enrollment
Newsfilter· 2024-08-05 11:00
CGuard was the only investigational carotid stent approved by FDA for inclusion in the trials CREST-2 included 23 cases implanted with CGuard TEL AVIV, Israel and MIAMI, Aug. 05, 2024 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention Stent System (EPS) for the prevention of stroke, today congratulated the lead investigators on the completion of enrollment in the CREST-2 (Carotid Revascularization Endarterectomy or Stenting Trial) clinical trials. The CGuard caro ...