Clinical Trial Progress for WAVE System
The clinical trial for the WAVE system and Gram-Negative testing menu is on track with external site enrollments meeting expectations. Submission to the FDA is anticipated in Q1 of 2025 with a review timeline of approximately 9 months.
FDA 510(k) Clearance Obtained for Arc System
The Arc system, which includes the blood culture kit, received FDA 510(k) clearance. This platform is designed to reduce diagnostic turnaround times in clinical settings, especially for conditions like sepsis.
Increased Gross Margin
Gross margin was approximately 29% for the quarter, a significant increase from approximately 3% in the same period in the prior year. This was driven by product mix and an inventory write-down in the prior period.
Reduction in SG&A and R&D Expenses
SG&A expenses were reduced to approximately $5.6 million from $7.8 million, and R&D expenses were reduced to $3.8 million from $7 million compared to the same period in the prior year.
Strong Reduction in Cash Used
Cash used for the quarter was approximately $5.5 million, with a strong reduction in cash used from operations down over $2 million quarter-over-quarter.