0001104659-23-121120.txt : 20231127 0001104659-23-121120.hdr.sgml : 20231127 20231127091513 ACCESSION NUMBER: 0001104659-23-121120 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20231127 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20231127 DATE AS OF CHANGE: 20231127 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Accelerate Diagnostics, Inc CENTRAL INDEX KEY: 0000727207 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 841072256 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31822 FILM NUMBER: 231437499 BUSINESS ADDRESS: STREET 1: 3950 S. COUNTRY CLUB ROAD #470 STREET 2: BUILDING 3-307 CITY: TUCSON STATE: AZ ZIP: 85714 BUSINESS PHONE: 303-863-8088 MAIL ADDRESS: STREET 1: 3950 S. COUNTRY CLUB ROAD #470 STREET 2: BUILDING 3-307 CITY: TUCSON STATE: AZ ZIP: 85714 FORMER COMPANY: FORMER CONFORMED NAME: ACCELR8 TECHNOLOGY CORP DATE OF NAME CHANGE: 19920703 FORMER COMPANY: FORMER CONFORMED NAME: HYDRO SEEK INC DATE OF NAME CHANGE: 19880802 8-K 1 tm2331535d1_8k.htm FORM 8-K
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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) November 27, 2023

 

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 November 27, 2023, Accelerate Diagnostics, Inc. (the “Company”) issued a press release announcing the signing of a collaboration and quality agreement with Bruker Corporation relating to Accelerate Diagnostics’ Arc™ system. 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 November 27, 2023
     
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: November 27, 2023  
   
  /s/ David Patience
  David Patience
  Chief Financial Officer

 

 

 

 

 EX-99.1 2 tm2331535d1_ex99-1.htm EXHIBIT 99.1

 

Exhibit 99.1

 

 

 

Accelerate Diagnostics Announces Collaboration for the Use of the Arc™ System in Combination With Bruker´s MALDI Biotyper®

 

Working together to bring rapid, automated microbial identification directly from positive blood culture samples

 

Tucson, Ariz. (November 27, 2023) – Accelerate Diagnostics, Inc. (NASDAQ: AXDX) an innovator of rapid in vitro diagnostics in microbiology, announced the signing of a collaboration and quality agreement with Bruker Corporation (NASDAQ: BRKR), the provider of the market-leading MALDI Biotyper system for microbial identification. This agreement enables both companies to validate the use of Accelerate Diagnostics’ Arc™ system, an innovative, automated positive blood culture sample preparation platform, with Bruker’s MALDI Biotyper® sirius instruments and Sepsityper® software for subsequent registration in both the US and EMEA markets.

 

Designed for clinical laboratories, the Arc™ system has a simple load-and-go workflow that automates direct from positive blood culture sample preparation for downstream microbial identification using Bruker’s MALDI Biotyper system. The Arc™ system enables on-demand processing of samples without the need for an overnight culture incubation, reducing the wait time for identification results. Labs will be able to leverage the breadth of their Bruker MALDI-Biotyper identification library in combination with rapid phenotypic antibiotic susceptibility results using the Accelerate Pheno® system, as well as with the Accelerate WAVE™ system which is currently under development and planned for future release.

 

The Arc™ system is designed to compete with molecular positive blood culture identification solutions. Namely, utilization of Bruker’s Biotyper system, in conjunction with the Arc™ system, offers the potential to reduce the likelihood of cross reactivity and false positive results that come with rapid molecular tests. In addition, the platform economics are more favorable with the Arc™ system as compared to on-market molecular platforms, especially when laboratories consider that approximately 30% of results are blood culture contaminants resulting in wasted expense. Finally, clinical laboratories are under pressure to run FDA cleared devices with increased legislation and enforcement of laboratory developed tests. As such, Accelerate has already initiated a clinical trial with intent to submit to the FDA over the coming months with the goal of seamless laboratory adoption.

 

“The total cost to rapidly identify organisms from positive blood cultures is significantly lower than what labs are paying today for a rapid molecular ID solution,” said Jack Phillips, President and CEO of Accelerate Diagnostics. “When you think of the extreme demand that labs are under today, the Arc™ system is a fast and inexpensive diagnostic tool which frees up technician hands and lab budgets to deliver actionable results in the race against sepsis. We look forward to working with Bruker, the recognized leader in mass spectrometry-based microbial identification, to bring this much needed solution to laboratories.”

 

“The combination of Bruker’s MALDI Biotyper with Accelerate Diagnostics’ Arc™ system to automate positive blood culture sample preparation and rapid microbial identification will be a valuable addition to many laboratories. Bruker welcomes this collaboration with Accelerate Diagnostics as both companies are committed to help laboratories in the important fight against sepsis with their leading products,” said Wolfgang Pusch, President, Bruker Microbiology & Infection Diagnostics.

 

 

 

 

About Accelerate Diagnostics, Inc. (Nasdaq: AXDX)

 

Accelerate Diagnostics, Inc. is an in vitro diagnostics company dedicated to providing solutions for the global challenges of antibiotic resistance and sepsis. In addition to its Arc™ system, 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. The FDA cleared Pheno® system and kit fully automate the sample preparation steps to report phenotypic antibiotic susceptibility results in approximately 7 hours direct from positive blood cultures. Recent external studies indicate the solution offers results 1–2 days faster than existing methods, enabling clinicians to optimize antibiotic selection and dosage specific to the individual patient days earlier.

 

The "ACCELERATE DIAGNOSTICS" and "ACCELERATE PHENO" and "ACCELERATE PHENOTEST" and diamond shaped logos and marks are trademarks or registered trademarks of Accelerate Diagnostics, Inc.

 

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

 

Forward-Looking Statements

 

Certain of the statements made in this press release are forward looking or may have forward-looking implications, such as, among others: intentions and expectations relating to the collaboration and quality agreement with Bruker, including that the agreement will enable both companies to validate the use of Accelerate Diagnostics’ Arc™ system with Bruker’s MALDI Biotyper® sirius instruments and Sepsityper® software for subsequent registration in both the US and EMEA markets, as well as the anticipated benefit for laboratories using the platforms in conjunction; expectations regarding the potential or benefits of Accelerate Diagnostics’ products and technologies; expectations regarding new or planned products and technologies, including the anticipated timing of any releases, such as with respect to the Accelerate WAVE™ system currently under development; and intentions and plans relating to regulatory approvals or submission, including with respect to the U.S. Food and Drug Administration (FDA). 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 general industry and market conditions, such as volatility throughout the global economy and the related impacts to the businesses of suppliers and customers, whether due to customer demand fluctuations, supply chain constraints and inflationary pressures or otherwise, as well as Accelerate Diagnostics’ ability to obtain any regulatory approvals. Other important factors that could cause Accelerate Diagnostics’ 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, Accelerate Diagnostics undertakes no obligation to update or revise these forward-looking statements to reflect new events, uncertainties or other contingencies.

 

SOURCE Accelerate Diagnostics, Inc.

 

 

 

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Cover
Nov. 27, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Nov. 27, 2023
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
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