Business
InspireMD Announces Second Quarter 2020 Financial Results
In the second quarter the Company was granted approval to market its CGuard™ MicroNet stent in Brazil and completed an $11.5 million capital raise; reported
About this update from Inspiremd Inc.
[{"type":"text","content":" In the second quarter the Company was granted approval to market its CGuard™ MicroNet stent in Brazil and completed an $11.5 million capital raise; reported outstanding results in studies treating patients with the CGuard™ MicroNET stent\n Management to host investor conference call today, August 5, 2020 at 8:30am ET TEL AVIV, Israel, Aug. 05, 2020 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for the prevention of stroke caused by the treatment of Carotid Artery Disease (CAD), today announced financial and operating results for the second quarter ended June 30, 2020. Second Quarter 2020 and recent highlights: Received approval from the Brazilian registration authority (ANVISA), to market the CGuard™ MicroNet®- covered stent, effectively clearing it for sale and distribution in Brazil. SUPRI Artigos Médicos Hospitalares Ltda. will serve as distribution partner. Completed an $11.5 million follow-on underwritten public offering, which included $1.5 million from the exercise by the underwriter of its full over-allotment option for the offering. On June 25, 2020, the U.S. Food and Drug Administration (FDA) granted InspireMD conditional approval of its Investigational Device Exemption (IDE) application to initiate a pivotal study of CGuard™ EPS. We are in the process of addressing the Agency’s remaining requests, specifically related to the stent-embolic protection device (EPD) compatibility performance testing that was previously conducted. Published 12-month PARDIGM trial results in the journal, EuroIntervention, a prestigious peer-reviewed publication covering the latest advancements in vascular intervention. The paper, titled “Routine MicroNET” details the results of 101 unselected consecutive real-life patients treated with the CGuard™ MicroNET covered stent for carotid stenosis and the 12-month prevention of post-procedural neurologic events. The results indicate that 12 months following carotid intervention the CGuard EPS MicroNET-covered stent delivers sustained protection against postprocedural neurologic events. Announced early results from the investigator-initiated SIBERIA randomized clinical trial of CGuard™ compared to Acculink™, evaluating 30-day silent brain infarcts in 100 patients who qualified for carotid revascularization with high risk for sur...