AXDX Accelerate Diagnostics Inc

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported)

March 21, 2025

 

Accelerate Diagnostics, Inc.

(Exact name of registrant as specified in its charter)

 

Delaware

(State or other jurisdiction of incorporation)

 

001-31822		84-1072256
(Commission File Number)		(IRS Employer Identification No.)

 

3950 South Country Club Road, Suite 470, Tucson, Arizona		85714
(Address of principal executive offices)		(Zip Code)

 

(520) 365-3100

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, $0.001 par value per share	AXDX	The Nasdaq Stock Market LLC (The Nasdaq Capital Market)

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

 

Emerging growth company ¨

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

 

 

 

Item 8.01.

Other Events.

 

On March 21, 2025, Accelerate Diagnostics, Inc. (the “Company”) issued a press release announcing the submission of its Accelerate WAVE™ system and positive blood culture gram-negative test kit to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference in its entirety.

 

Item 9.01.

Financial Statements and Exhibits.

 

(d)           Exhibits.

 

Exhibit
Number		Description
99.1		Press Release, dated March 21, 2025
104		Cover Page Interactive Data File (cover page XBRL tags are embedded within the Inline XBRL document)

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

	ACCELERATE DIAGNOSTICS, INC.
	(Registrant)
Date: March 21, 2025
	/s/ David Patience
	David Patience
	Chief Financial Officer

 

 

Exhibit 99.1

 

Accelerate Diagnostics Submits WAVE System and Gram-Negative Positive Blood Culture Menu to the FDA for 510(k) Clearance

 

TUCSON, Ariz., March 21, 2025 (NASDAQ: AXDX), an innovator in rapid in vitro diagnostics for microbiology, today announced the submission of its Accelerate WAVE™ system and positive blood culture gram-negative test kit to the U.S. Food and Drug Administration (FDA) for 510(k) clearance.

 

The Accelerate WAVE system is designed to provide rapid antimicrobial susceptibility testing (AST) directly from positive blood culture bottles and bacterial isolate colonies. The WAVE system is designed to deliver accurate results in an average of 4.5 hours, enabling same shift targeted antimicrobial therapy for patients with serious infections.

 

With a user-friendly workflow, high throughput capacity, and scalable design, once approved by the FDA, the WAVE system will offer microbiology laboratories a comprehensive AST solution to meet a wide range of testing demands and hospital formulary needs.

 

According to the World Health Organization, sepsis affects an estimated 49 million people globally each year, resulting in approximately 11 million deaths.¹ Of those, around 1.32 million deaths² are attributed to bacterial antimicrobial resistance. Sepsis also represents the most significant cost burden to the U.S. healthcare system, with an estimated annual expense of $62 billion.³

 

By delivering rapid AST results, the WAVE system is designed to support earlier, targeted antimicrobial therapy—improving patient outcomes, reducing hospital costs, and helping combat antimicrobial resistance.

 

References:

 

1. Rudd KE, Johnson SC, Agesa KM, Shackelford KA, Tsoi D, Kievlan DR, Colombara DV, Ikuta KS, Kissoon N, Finfer S, Fleischmann-Struzek C, Machado FR, Reinhart KK, Rowan K, Seymour CW, Watson RS, West TE, Marinho F, Hay SI, Lozano R, Lopez AD, Angus DC, Murray CJL, Naghavi M. Global, regional, and national sepsis incidence and mortality, 1990-2017: analysis for the Global Burden of Disease Study. Lancet. 2020 Jan 18;395(10219):200-211. doi: 10.1016/S0140-6736(19)32989-7.

 

2. Murray CJ. Global Burden of Bacterial Antimicrobial Resistance in 2019: A Systematic Analysis. The Lancet. 2022;399(10325):629-655. doi:https://doi.org/10.1016/S0140-6736(21)02724-0.

 

3. (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7017950/)

 

 

About Accelerate Diagnostics, Inc.

 

Accelerate Diagnostics, Inc. is an in-vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. Accelerate Diagnostics’ current portfolio of FDA-cleared platforms include the Accelerate Pheno system and Accelerate PhenoTest® BC kit as well as the Accelerate Arc™ system and BC kit. The Accelerate Pheno system and Accelerate PhenoTest® BC kit combine several technologies aimed at reducing the time clinicians must wait to determine the most optimal antibiotic therapy for deadly infections. This system fully automates sample preparation, identification and phenotypic antibiotic susceptibility testing in approximately seven hours directly from positive blood cultures. Recent external studies indicate this solution offers results 1-2 days faster than existing methods, enabling clinicians the ability to optimize antibiotic selection and dosage specific to the individual patient days earlier. Further, the Accelerate Arc™ system and BC kit provide a novel, automated positive blood culture sample preparation platform for use with Bruker’s MALDI Biotyper® CA System (MBT-CA System) and MBT-CA Sepsityper® software extension. Designed for clinical laboratories, the Accelerate Arc system has a simple workflow that automates positive blood culture sample preparation for direct downstream microbial identification using Bruker’s MBT-CA System. This innovation eliminates the need for overnight culture methods, reducing the wait time for microbial identification results, which is critical in the fight against sepsis.

 

© Copyright 2025 Accelerate Diagnostics, Inc. All Rights Reserved. The "ACCELERATE DIAGNOSTICS," "ACCELERATE PHENO," "ACCELERATE PHENOTEST," "ACCELERATE ARC" and "ACCELERATE WAVE" diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc. All other trademarks are the property of their respective owners.

 

For more information about the company, its products and technology, or recent publications, visit axdx.com.

 

Forward-Looking Statements

 

Certain statements made in this press release and the related conference call are forward-looking or may have forward-looking implications within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and the company intends that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements, which can be identified by the use of words such as "may," "will," "expect," "believe," "anticipate," "estimate," or "continue," or variations thereon or comparable terminology, include but are not limited to, statements about: the WAVE system’s expected performance, effectiveness, hospital and patient benefits, market interest, and eventual commercialization; FDA approval for the WAVE system, including our ability to fund operations through the commercial launch of the Wave system. Actual results or developments may differ materially from those projected or implied in these forward-looking statements due to significant risks and uncertainties, including, but not limited to: difficulties in resolving the company's continuing financial condition and ability to obtain additional capital to meet its financial obligations; and the company's ability to obtain any regulatory approvals in a timely manner. Other important factors that could cause the company's actual results to differ materially from those in its forward-looking statements include those discussed in the company's filings with the Securities and Exchange Commission (the "SEC"), including in the "Risk Factors" sections of the company's most recently filed periodic reports on Form 10-K and Form 10-Q and subsequent filings with the SEC. Except as required by federal securities laws, the company undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies. Forward-looking statements speak only as of the date they are made and should not be relied upon as representing the company's plans and expectations as of any subsequent date.

 

 

v3.25.1

Cover	Mar. 21, 2025
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Mar. 21, 2025
Entity File Number	001-31822
Entity Registrant Name	Accelerate Diagnostics, Inc.
Entity Central Index Key	0000727207
Entity Tax Identification Number	84-1072256
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	3950 South Country Club Road
Entity Address, Address Line Two	Suite 470
Entity Address, City or Town	Tucson
Entity Address, State or Province	AZ
Entity Address, Postal Zip Code	85714
City Area Code	520
Local Phone Number	365-3100
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.001 par value per share
Trading Symbol	AXDX
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false

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