InspireMD Gains Registration Clearance of its CGuard Embolic Prevention System (EPS) in Brazil

TEL AVIV, Israel, July 23, 2020 (GLOBE NEWSWIRE) -- InspireMD, Inc. (NYSE American: NSPR), the developer of the CGuard Embolic Prevention System (EPS) for the prevention of stroke caused by carotid artery disease (CAD), today announced it has obtained registration from the Brazilian registration authority, Agéncia Nacional de Vigiláncia Sanitária (ANVISA), for its CGuard MicroNet- covered stent, clearing it for sale and distribution in Brazil.

“As the largest market for medical devices in Latin America and one of the top overall global markets for carotid artery disease, the Brazilian registration clearance for CGuard is an important accomplishment for our company and represents a significant opportunity to serve an emerging healthcare system. The global carotid artery disease market is expected to reach up to $11.6 billion by 2023, and with an expected 12% CAGR in the overall stent market in Brazil, it is a pillar of our 2020 and 2021 growth strategy,” said Marvin Slosman, InspireMD’s CEO. “We look forward to working with our Brazilian partner, SUPRI Artigos Médicos Hospitalares Ltda, to reach and serve this crucial market with our advanced technology.”

Regulatory approval of CGuard EPS in Brazil reflects not only the ANVISA'S recognition of CGuard’s differentiating features versus conventional carotid stents, but also the need for safer treatments for carotid artery disease. Brazil ranks as the sixth largest populated country in world and the largest healthcare market in Latin America. With a population over 213 million, Brazil represents an important step toward expanding commercial availability of InspireMD products into new territories.

“The Brazilian clearance further supports our goals of broader expansion into South America, particularly into adjacent markets such as Argentina, Mexico and Columbia, and as part of our global expansion strategy, capitalizing on the potential of CGuard EPS – and its novel MicroNet technology – to fundamentally disrupt the current standard of care in carotid artery disease. While the COVID-19 related interruptions have had an impact on elective surgeries worldwide, we expect a resumption in elective procedures as the healthcare system gains a foothold in returning to more normalized operations, as is occurring in our key markets in Europe and other parts of the world. The Brazilian clearance for our CGuard EPS represents a milestone in our broader strategy to continue growing our market share in existing markets while expanding in growth markets such as South America, Asia/Pacific, and the U.S. We are also continuing our concerted focus on numerous opportunities for growing our pipeline, leveraging new indications for use of CGuard and MicroNet along with our research into a peri procedural protection device technology as we seek to build upon our strong growth performance in the first quarter of 2020,” Mr. Slosman concluded.