Accelerate Diagnostics, Inc. (NASDAQ:AXDX) Q3 2024 Earnings Conference Call November 7, 2024 4:30 PM ET
Company Participants
Laura Pierson - Investor Relations Officer
Jack Phillips - President and Chief Executive Officer
David Patience - Chief Financial Officer
Conference Call Participants
Operator
Good day, and welcome to the Accelerate Diagnostics Inc. Third Quarter 2024 Earnings Conference Call.
All participants will be in a listen-only mode. [Operator Instructions] Today’s remarks will be followed by a question-and-answer session with covering analysts. And, please note that this event is being recorded.
I would now like to turn the conference over to Laura Pierson. Please go ahead.
Laura Pierson
Before we begin, it is important to share that information presented during this call may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.
Forward-looking statements include projections, statements about our future and those that are not historical facts. All forward-looking statements that are made during this conference call are subject to risks, uncertainties and other factors that could cause our actual results to differ materially. These are discussed in greater detail in our annual report on Form 10-K for the year ended December 31, 2023, and other reports we file with the SEC.
It is my pleasure to now introduce the company’s President and CEO, Jack Phillips.
Jack Phillips
Thank you, Laura. Good afternoon, everyone, and welcome to our third quarter earnings call.
We’re excited to share some significant milestones from this past quarter, which underscores our commitment to advancing innovation, growing our market leadership and securing long-term financial stability.
Beginning with an update on WAVE, we’re pleased to report that our clinical trial for the WAVE system and Gram-Negative testing menu is on track with external site enrollments meeting our expectations. The trial’s clinical performance at all four external laboratories meets our expectations thus far. In addition, the WAVE systems are demonstrating strong reliability and laboratorians like the ease of use and workflow.
We anticipate submitting to the FDA in Q1 of 2025 with a review timeline of approximately nine months. The promising progress here reinforces our belief in WAVE’s potential to significantly improve patient outcomes by enabling timely accurate diagnostics.
Another major achievement this quarter was obtaining FDA 510(k) clearance for our Accelerate Arc system, including the blood culture kit. This automated platform designed for use with Bruker’s MALDI Biotyper CA System brings us a step closer to reducing diagnostic turnaround times in clinical settings.