Financial PerformanceThe company's blended product gross margin for the quarter decreased to 61%, a significant drop from 72% in 3Q23 and 75% in 2Q24.
Regulatory ChallengesThe primary focus of the company remains the submission of a 510(k) De Novo application to the FDA, which may also require an additional study to confirm the STAR-T study results.
RevenueThe company reported total revenues of $9.4M for the quarter, falling short of the consensus estimated revenue of $10.4M.