Accelerate Diagnostics Announces Certain Preliminary Fourth Quarter and Full-Year 2024 Results

Company Performance and Operational Highlights - The company announced preliminary, unaudited results for Q4 and full-year 2024, showing progress in its innovation pipeline, including the Accelerate WAVE™ system and Gram-Negative assay clinical trials [1][2] - The WAVE system clinical trial demonstrated consistent performance with pre-clinical data, offering the largest Gram-Negative bug-drug combination for rapid PBC AST with a time-to-result of approximately 4.5 hours [5] - The company maintained approximately 350 clinically live Pheno® revenue-generating instruments in the US, consistent with its commercial strategy [5] - Contract extensions were secured with over 75% of US Pheno customers, ensuring continuity through the anticipated WAVE commercial launch [5] - The company received 510(k) clearance for the Accelerate Arc system and BC kit, an automated positive blood culture sample preparation platform [5] Financial Results - Preliminary revenue for 2024 was approximately $11.7 million, down from$12.1 million in the prior year, primarily due to lower capital sales of Pheno instruments [5] - Consumable product revenue increased by approximately 3% year-over-year [5] - Cash and cash equivalents decreased by $4.5 million in Q4 2024, ending the year with$16.3 million, reflecting continued reductions in operating cash use [5] Product Development and Regulatory Progress - The company is close to finalizing enrollment for the WAVE system clinical trial, with encouraging results and anticipates FDA submission shortly after enrollment completion [2] - The WAVE system is expected to be submitted for FDA approval in Q1 2025, with a commercial launch anticipated in late 2025 [5] - The company contracted a large US reference lab for the Accelerate Arc™ system, highlighting its utility for cost-effective, rapid, and automated microbial identification [5] Industry and Market Context - The company focuses on addressing global challenges of antibiotic resistance and sepsis through its in vitro diagnostics solutions, including the Accelerate Pheno system and Accelerate PhenoTest® BC kit [8] - Recent external studies indicate that the company's solutions offer results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage earlier [8]