Business
InspireMD Reports Fourth Quarter and Year-End 2022 Financial Results and Provides Business Update
- 2022 CGuard EPS revenue of $5.1 million increased 18.9% over 2021 - - Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical
About this update from Inspiremd Inc.
[{"type":"text","content":"- 2022 CGuard EPS revenue of $5.1 million increased 18.9% over 2021 - - Resumed shipments of CGuard EPS to CE Mark territories under the pre-existing Medical Device Directive (MDD) regulatory framework; Company anticipates re-certification under new Medical Device Regulation (MRD) framework in coming weeks - - Continued enrollment in the C-Guardian US IDE trial, with 20 sites currently enrolling patients; on track to complete enrollment by approximately end of Q2 2023 - --Management to host investor conference call today, March 30, at 8:30am ET-- TEL AVIV, Israel, March 30, 2023 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR), developer of the CGuard™ Embolic Prevention System (EPS) for treatment of carotid artery disease (CAD) and prevention of stroke today announced financial and operating results for the fourth quarter ended December 31, 2022. Fourth Quarter 2022 and Recent Developments: Generated CGuard revenues for the fourth quarter 2022 of $1,026,000, a 20.6% decrease from $1,291,000 for the fourth quarter of 2021. The decrease was caused by reduced shipments due to the temporary expiration of the Company’s CE Mark for the second half of the fourth quarter, due to delays in the European regulatory bodies in the Medical Device Regulation (MDR) recertification process.In mid-March 2023, resumed shipments of CGuard EPS to CE Mark territories on a temporary basis under the pre-existing Medical Device Directive (MDD) regulatory framework while awaiting final re-certification under MDR.Hired medical device commercial veteran Shane Gleason as General Manager of North America and Vice President of Global Marketing to position InspireMD to capitalize on the US market upon expected FDA approval.Promoted the Company’s Vice President of Global Sales and Marketing, Andrea Tommasoli, to Chief Operating Officer to meet the Company’s increasing demand for CGuard.Delivered multiple presentations highlighting the superior safety of CGuard, and resulting positive patient outcomes, at the 2022 VEITH Symposium in November.Continued enrollment in the C-Guardian Investigational Device Exemption (IDE) Clinical Trial. The Company currently has 20 trial sites enrolling patients. The Company anticipates completing enrollment by approximately the end of Q2 2023. Marvin Slosman, CEO of InspireMD, commented: “We are very pleased to have resumed shi...