Strong Revenue Growth
Total CGuard revenue of $1.81 million, representing growth of more than 16% over the third quarter of last year. Sales of over 3,100 CGuard implants during the quarter, representing growth of nearly 14% over the same period last year.
U.S. Market Entry Prospects
Submission of PMA to the FDA for CGuard Prime, with a decision anticipated in early 2025. Potential U.S. market launch could generate significant revenue growth.
Pipeline Development and Strategic Initiatives
Approval of investigational device exemption by the FDA for CGuardians 2 pivotal study. Strategic agreement with the Jacobs Institute for an early feasibility study of CGuard Prime.
Financial Position
Cash, cash equivalents, and marketable securities were $40.4 million as of September 30, 2024, compared to $39 million as of December 31, 2023.
New Headquarters Facility
Seamless transition to new headquarters in Miami, Florida to support anticipated U.S. launch and commercialization.