 In the second quarter the Company was granted approval to market its CGuardTM MicroNet stent in Brazil and completed an 11.5 million capital raise; reported outstanding results in studies treating patients with the CGuardTM MicroNET stent Management to host investor conference call today, August 5, 2020 at 8:30am ETTEL AVIV, Israel, Aug. 05, 2020 GLOBE NEWSWIRE -- InspireMD, Inc. NYSE American: NSPR, developer of the CGuardTM 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 CGuardTM 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 CGuardTM EPS. We are in the process of addressing the Agencys 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 CGuardTM 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 CGuardTM compared to AcculinkTM, evaluating 30-day silent brain infarcts in 100 patients who qualified for carotid revascularization with high risk for surgery. The results indicated that significantly fewer silent brain infarcts were associated with CGuardTM EPS versus AcculinkTM at 30 days post-procedure.COVID-19 placed significant pressure on the operations of healthcare facilities worldwide, resulting in interruptions in elective procedure volumes, including critical carotid artery treatments. However, we are encouraged by the gradual resumption of these crucial procedures in a growing number of our key markets in Europe and other territories, and we look forward to this expansion taking hold in South America as well. We are also buoyed by the scientific validation we continue to receive in both peer-reviewed publications and opportunities to present at medical conferences where our CGuard MicroNet technology is being recognized as a valued advancement in the carotid stent category, said Marvin Slosman, InspireMDs Chief Executive Officer. Our expansion strategy continues to progress, with our recent Brazilian approval for CGuardTM MicroNet introducing us to the largest market for medical devices in Latin America and one of the top overall global markets for carotid artery disease. We believe this approval will set the stage for continued expansion into other countries in South America.We are in the process of addressing the agencies remaining requests, specifically related to the stent-embolic protection device EPD compatibility performance testing to gain full FDA approval of our Investigational Device Exemption IDE application to initiate a pivotal study of CGuardTM EPS. We have already completed the testing of additional stents according to the FDAs specifications, and have employed alternative visualization modalities that, we believe, will ultimately allow us to gain full approval. Having an approved IDE is an extremely significant step towards enabling us to initiate a pivotal trial in the United States, clearly one of the worlds most important markets for carotid artery disease and other vascular treatments. We previously indicated that the FDA has concurred with our clinical study design and data requirements to support the market approval of the device. Accordingly, we believe that we are well positioned from a regulatory perspective in terms of our ability to initiate a trial.In addition, we believe the completion of our 11.5M financing will help ensure we are capable of advancing our commercial expansion and research and development activities as a pillar of our growth objectives. Although the pandemic has put a spotlight on the supply chain infrastructure challenges many in our field are facing, we stand at the ready to fulfill the needs of physicians and their patients for these serious and lifesaving procedures, Mr. Slosman concluded.Financial Results for the Second Quarter and Six Months ended June 30, 2020For the three months ended June 30, 2020, revenue decreased by 1,041,000, or 76.9, to 313,000, from 1,354,000 during the three months ended June 30, 2019. This decrease was predominantly driven by a 75.7 decrease in sales volume of CGuard EPS from 1,116,000 during the three months ended June 30, 2019, to 271,000 during the three months ended June 30, 2020. This decrease was mainly due to the fact that procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, were mostly postponed as hospitals shifted resources to patients affected by COVID-19. The decrease was also due to the large shipments of CGuard EPS that we made during the three months ended June 30, 2019 of backlog that accumulated in the three months ended March 31, 2019 that we were unable to ship previously due to our former third-party sterilizer equipment failures. Those large shipments did not recur during the three months ended June 30, 2020. In addition, there was an 82.4 decrease in sales volume of MGuard Prime EPS, from 238,000 during the three months ended June 30, 2019, to 42,000 during the three months ended June 30, 2020, mainly due to similar reasons as mentioned above.The company recorded a gross loss for the quarter ended June 30, 2020 of 120,000, compared to a gross profit of 442,000 for the same period in 2019. This decrease in gross profit resulted primarily from a 448,000 decrease in revenues as described above, less the related material and labor costs, and a decrease following a receipt of 135,000 compensation received in the quarter ended June 30, 2019 from our former third-party sterilizer for the delays related to the product sterilization interruption during the three months ended March 31, 2019, which did not reoccur in the three months ended June 30, 2020, offset by a 21,000 decrease in miscellaneous expenses. Gross margin gross profits as a percentage of revenue decreased to 38.3 during the three months ended June 30, 2020 from 32.6 during the three months ended June 30, 2019, driven by the reasons mentioned above.Total operating expenses for the quarter ended June 30, 2020 were 2,326,000, a decrease of 11.4 compared to 2,625,000 for the same period in 2019. This decrease was primarily due to a reduction of 382,000 in clinical expenses associated with CGuard EPS, mainly related to the IDE approval process, 235,000 in compensation related to temporary salary reductions due to the immediate impact of COVID-19 on cash flow, and 82,000 of miscellaneous expense reductions offset by an increase of 400,000 due to a settlement agreement with the underwriter of our prior offerings.Financial expenses for the quarter ended June 30, 2020 were 34,000 compared to 23,000 for the same period in 2019. Net loss for the second quarter of 2020 totaled 2,480,000, or 0.20 per basic and diluted share, compared to a net loss of 2,206,000, or 1.59 per basic and diluted share, for the same period in 2019.For the six months ended June 30, 2020, revenue decreased by 422,000, or 23.9, to 1,347,000, from 1,769,000 during the six months ended June 30, 2019. This decrease was predominantly driven by a 16.8 decrease in sales volume of CGuard EPS from 1,492,000 during the six months ended June 30, 2019, to 1,242,000 during the six months ended June 30, 2020, mainly due to the postponement of procedures with CGuard EPS, which are generally scheduled or non-emergency procedures, as hospitals shifted resources to patients affected by COVID-19. In addition, there was a 62.1 decrease in sales volume of MGuard Prime EPS from 277,000 during the six months ended June 30, 2019, to 105,000 during the six months ended June 30, 2020, mainly due to the impact of COVID-19, as mentioned above.For the six months ended June 30, 2020, gross profit decreased by 194,000, or 52.6, to 175,000 from 369,000 for the same period in 2019. This decrease in gross profit resulted primarily from a 225,000 decrease in revenues as mentioned above, less the related material and labor costs and a 61,000 increase in write-offs driven by a non-recurring component supply issue. This decrease was partially offset by a decrease of 69,000 of expenses related to upgrades made to our production facilities during the six months ended June 30, 2019, which did not reoccur during the six months ended in June 30, 2020 and a decrease of 23,000 in miscellaneous expenses during the six months ended June 30, 2020. Gross margin gross profits as a percentage of revenue decreased to 13.0 during the six months ended June 30, 2020 from 20. 