osur-20241219
FALSE000111646300011164632024-12-192024-12-19

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): December 19, 2024
OraSure Technologies, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware
001-16537
36-4370966
(State or Other Jurisdiction
of Incorporation)
(Commission
File Number)
(I.R.S. Employer
Identification No.)
220 East First Street
Bethlehem, Pennsylvania
18015-1360
(Address of Principal Executive Offices)
(Zip Code)
Registrant’s telephone number, including area code: 610-882-1820
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Trading
Symbol(s)
Name of each exchange on which registered
Common Stock, $0.000001 par value per share
OSUR
The Nasdaq Stock Market LLC
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Indicate by a 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 o
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. o



Item 7.01 – Regulation FD Disclosure.
OraSure Technologies, Inc. (the “Company”) hereby furnishes the Investor Presentation that the Company will present to analysts and investors on or after the date hereof, which is attached as Exhibit 99.1 to this Current Report on Form 8-K (“Current Report”), is incorporated herein by reference and will be available on the Company’s website at www.orasure.com.

The information in this Item and attached Exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that section, nor shall such information and Exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, except as shall be expressly set forth by specific reference in such a filing. The fact that the information and Exhibit are being furnished should not be deemed an admission as to the materiality of any information contained therein. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Current Report or attached Exhibit.

Item 8.01 Other Events.

On December 19, 2024, the Company issued a press release announcing the Company’s acquisition of Sherlock Biosciences, Inc (“Sherlock”). A copy of the press release is attached as Exhibit 99.2 to this Current Report and is incorporated herein by reference.

Forward Looking Statements

This Current Report contains certain “forward-looking statements” within the meaning of the Federal securities laws, including with respect to products, product development and manufacturing activities, the Company’s acquisition of Sherlock, revenue growth, cash flow, increasing margins and other matters. Words such as “expects,” “estimates,” “forecasts,” “intends,” “plans,” “projects,” “could,” “may,” “should,” “will” or other similar words and expressions are intended to identify these forward-looking statements. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: the Company’s ability to integrate Sherlock's business and achieve the intended benefits of the acquisition on the timeline expected or at all; Sherlock’s ability to seek and obtain regulatory approval for products in development; the Company’s ability to satisfy customer demand; ability to reduce the Company’s spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to achieve the anticipated cost savings as a result of the Company’s business restructuring, including from insourcing third party manufacturing and exiting microbiome services; ability to market and sell products, whether through the Company’s internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for the Company’s products; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on the Company’s business, supply chain, labor force, ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing, and demand for the Company’s COVID-19 testing products; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales and the ability to continue to reduce costs; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of the Company’s products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other



technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; cybersecurity breaches or other attacks involving the Company’s systems or those of the Company’s third-party contractors and IT service providers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including inflationary pressures and banking stability. These and other factors that could affect the Company’s results are discussed more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s registration statements, Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this Current Report and the Company undertakes no duty to update these statements.
Item 9.01 – Financial Statements and Exhibits.
(d)Exhibits
Exhibit
Number
Description
99.1
99.2
104
Cover Page Interactive Data File (embedded within the Inline XBRL document).



SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
ORASURE TECHNOLOGIES, INC.
Date: December 19, 2024By:/s/ Carrie Eglinton Manner
Carrie Eglinton Manner
President and Chief Executive Officer

exhibit991_projwatsoninv
OraSure Technologies ACQUISITION OF SHERLOCK BIOSCIENCES DECEMBER 19, 2024 EXHIBIT 99.1


 
© 2024 OraSure Technologies, Inc. 2 This presentation contains certain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including with respect to OraSure Technologies, Inc.’s (“OraSure”) acquisition of Sherlock Biosciences, Inc. (“Sherlock”), revenue growth, cash flow, increasing margins and other matters. Words such as “expects,” “estimates,” “forecasts,” “intends,” “plans,” “projects,” “could,” “may,” “should,” “will” or other similar words and expressions are intended to identify these forward-looking statements. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: OraSure’s ability to integrate Sherlock’s business and achieve the intended benefits of the acquisition on the timeline expected or at all, Sherlock’s ability to seek and obtain regulatory approval for products in development; OraSure’s ability to satisfy customer demand; ability to reduce OraSure’s spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to achieve the anticipated cost savings as a result of OraSure’s business restructuring; ability to market and sell products, whether through OraSure’s internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for OraSure’s products; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on OraSure’s business, supply chain, labor force, ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing, and demand for OraSure’s COVID-19 testing products; changes in relationships, including disputes or disagreements, with strategic partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for OraSure’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of OraSure to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales and the ability to continue to reduce costs; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of OraSure’s products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of OraSure’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; cybersecurity breaches or other attacks involving OraSure’s systems or those of OraSure’s third-party contractors and IT service providers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including inflationary pressures and banking stability. These and other factors that could affect OraSure’s results are discussed more fully in OraSure’s filings with the Securities and Exchange Commission (the “SEC”), including OraSure’s registration statements, Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward- looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this presentation and OraSure undertakes no duty to update these statements. Forward-Looking Statement


 
© 2024 OraSure Technologies, Inc. 3 Executive Summary • Sherlock expands OTI's portfolio with next-generation molecular diagnostics at the point-of-need (PON) • OTI gains … + Scalable platform for disposable, instrument-free Molecular self-tests with strong clinical performance + Addition of Sherlock CT/NG molecular self-test, if approved by the FDA, is expected to contribute to OTI’s revenue beginning in 2026 • Transaction structure: majority of transaction consideration dependent on CT/NG FDA approvals Transaction Overview • Innovation: next phase of OTI’s innovation strategy … instrument-free molecular platform that delivers lab-like accuracy – sensitivity & specificity – in a rapid, disposable format • Talent: strong team scientifically, technically, culturally - brings expertise & additional capabilities to OTI • Portfolio expansion: adds rapid testing in areas of existing strength - sexual health, infectious disease - leverages OTI’s infrastructure, strong customer relationships & commercial capabilities • Channel expansion: opens opportunities to build our presence as provider of content serving growing consumer-facing channels • Purpose: amplifies OTI’s opportunity to improve access, quality, & affordability of healthcare All products are subject to receipt of regulatory approvals in applicable markets. Strategic Alignment


 
© 2024 OraSure Technologies, Inc. 4 Acquisition of Sherlock aligns with OTI’s mission & vision Growth of precision medicine Connecting the needs of the user directly to healthcare Move to point-of-need (PON) & self-testing diagnostics OTI is Focused on Where the Future of Healthcare is Going…


 
© 2024 OraSure Technologies, Inc. 5 Diagnostics (Dx) Actionable point-of-need & self-testing increases access & affordability of care  Best-in-class portfolio of tests in infectious disease – sexual health & respiratory … ex. HIV, HCV, Syphilis, COVID-19, Ebola, Marburg others Sample Management Solutions (SMS) Molecular sample collection & stabilization innovation drives access & discovery  Best-in-class tools & chemistries to collect, stabilize, transport, store … More sample types, analytes & applications … plus, value chain expansion Powering the Shift that Connects People to Healthcare Wherever They Are Improving access, quality, and value of healthcare with innovation in effortless tests and sample management solutions More tests … priority on “instrument-free”


 
© 2024 OraSure Technologies, Inc. 6 Power the Industry with Infrastructure + Innovation “OTI”


 
© 2024 OraSure Technologies, Inc. 7 OTI Portfolio – Diagnostics Sherlock accelerates our innovation pipeline with next-gen molecular platform & new test expansion OTI Diagnostics Actionable point-of need & self-testing increases affordability & access to care Broad array of infectious disease – sexual health & respiratory … ex. HIV, HCV, Syphilis, COVID-19, Ebola, Marburg … others Clinical lab molecular Increasing performance Increasing cost / challenge to access Lateral flow Self-tests Visual & digital “Molecular-like” Self-tests Molecular Self-tests Current Future PON Molecular InstrumentInstrument-free, disposable GOAL More tests … priority on “instrument-free”


 
© 2024 OraSure Technologies, Inc. 8 Sherlock Disposable Self-Test (in clinical trial) Next-Gen Technologies (in development) Sherlock Technology Platforms Molecular testing to strengthen and broaden our diagnostic portfolio • Single-use, over-the-counter • Easy to use at point-of-need • Focused on STIs initially • Flexibility to multiplex • Platform for other swab- based assays CRISPR Detection Ambient Temperature Amplification


 
© 2024 OraSure Technologies, Inc. 9 OTI strengths Infrastructure & commercial reach Infectious disease portfolio breadth Sexual health expertise Attractive segments CT/NG: $1.5B & growing market1 Patients desire privacy & speed for STI testing Sherlock Enables Entry into Large Addressable Markets while Leveraging OTI’s Existing Strengths 1. Based on Company projections, modeling and external research


 
© 2024 OraSure Technologies, Inc. 10 Investments in innovation Scale-up for launch Advance differentiated platform & pipeline of molecular tests Growth potential Clinical trial underway Anticipate submission to FDA by end of 2025 Revenue Growth from Sherlock Powered by NT Investments


 
© 2024 OraSure Technologies, Inc. 11 Sherlock Enhances Key Elements for OTI’s Long-Term Success Key Elements Sherlock Contributes Product portfolio & pipeline • CT/NG disposable Molecular self-test offers fast results, lab-like accuracy​ • Clinical trial for CT/NG test is on-going, OTI plans for FDA submission by end of 2025 • Expanded test pipeline in development Platform for the future • Technology enables molecular performance in a rapid, low-cost, disposable format • Design is open to other swab-based assays, with ability to multiplex • Next-gen technologies in development: ambient temperature amplification, CRISPR Commercial fit • Access to Molecular Diagnostics platform in large, attractive markets • Addition of molecular CT/NG self-test expands OTI’s portfolio of rapid diagnostics in sexual health • Leverages OTI’s strengths, including in distribution & customer relationships Financials • Expected to contribute to OTI’s revenue growth following regulatory approval • Attractive purchase; majority of transaction consideration dependent on FDA approvals Human capital & culture • Talented technical team with deep experience, expertise in research & development • Adds new expertise & capabilities in isothermal amplification technologies, fluidics, electronics & CRISPR


 
Document

https://cdn.kscope.io/d2db6216dc199924026ce957e8bdb0f7-image_0a.jpg
EXHIBIT 99.2

Investor Contact:                        Media Contact:
Jason Plagman                            Amy Koch
VP, Investor Relations                        Director, Corporate Communications
investorinfo@orasure.com                    media@orasure.com


OraSure Technologies Acquires Sherlock Biosciences

BETHLEHEM, PA, December 19, 2024 (GLOBE NEWSWIRE) -- OraSure Technologies, Inc. (“OTI”) (NASDAQ: OSUR), a leader in point-of-need and home diagnostic tests and sample management solutions, today announced the acquisition of Sherlock Biosciences, Inc., a global health company bringing next-generation diagnostics to consumers and healthcare providers.

This acquisition expands OraSure’s innovation pipeline with the addition of Sherlock’s molecular diagnostics platform, which is able to provide rapid results with strong sensitivity and specificity in a disposable format that is well-suited for over-the-counter usage. Sherlock’s first molecular self-test is for Chlamydia Trachomatis (CT) and Neisseria Gonorrhoeae (NG) which will expand OraSure’s portfolio of rapid diagnostics for sexually transmitted infections (STIs), subject to regulatory approvals. Test results are expected to be provided in under 30 minutes by analyzing DNA and RNA from self-collected swabs using isothermal amplification. In addition, Sherlock has been developing a pipeline of other molecular tests, along with several next-generation technology platforms, including Ambient Temperature Amplification and CRISPR-based technologies that have the potential to further reduce costs and improve performance of its platforms.

Sherlock’s CT/NG self-test is in clinical studies and is expected to be submitted to the FDA by the end of 2025 for review. Subject to regulatory approvals, revenue from Sherlock’s CT/NG test is expected to contribute to OTI’s growth beginning in 2026, benefiting from OraSure’s existing infrastructure, commercial capabilities, and strong customer relationships.

OTI estimates that testing for CT/NG represents a total addressable market of more than $1.5 billion. The vast majority of CT/NG tests in the U.S. are processed in a centralized lab, and the introduction of an affordable, rapid self-test has the potential to drive significant incremental market expansion. Additionally, public health channels play a key role in STI screening, which is an area where OraSure has a strong presence.

“The acquisition of Sherlock represents the next step in OTI’s innovation strategy,” said Carrie Eglinton Manner, President and CEO of OraSure. “Sherlock brings valuable capabilities with an advanced molecular platform that aims to deliver lab-like accuracy in a format that expands access to diagnostic insights through convenient, effortless tests. We are excited to welcome Sherlock’s talented team to OTI and believe that Sherlock’s unique capabilities will contribute significantly to the expansion of our pipeline of diagnostic tests in infectious disease, sexual health, and beyond.”






Conference Call Information
OraSure will host a conference call to discuss the acquisition of Sherlock Biosciences at 5:00 p.m. ET on Thursday, Dec. 19, 2024. A webcast of the conference call will be available on the investor relations page of OraSure’s website at https://orasure.gcs-web.com/events-and-presentations. Please click on the webcast link and follow the prompts for registration and access at least 10 minutes prior to the call. The webcast will be archived on OraSure’s website shortly after the call has ended and will be available for approximately 90 days.

To participate in the live conference call, please follow the link below to pre-register. After registering, you will be provided with access details via email.

https://register.vevent.com/register/BIb938f5bae2a442d9acdb83f4bdd9286d

About OraSure Technologies, Inc. 
OraSure Technologies, Inc. (“OraSure) transforms health through actionable insight and powers the shift that connects people to healthcare wherever they are. OraSure improves access, quality, and value of healthcare with innovation in effortless tests and sample management solutions. OraSure, together with its wholly-owned subsidiary, DNA Genotek Inc., is a leader in the development, manufacture, and distribution of rapid diagnostic tests and sample collection and stabilization devices designed to discover and detect critical medical conditions. OraSure’s portfolio of products is sold globally to clinical laboratories, hospitals, physician’s offices, clinics, public health and community-based organizations, research institutions, government agencies, pharmaceutical companies, and direct to consumers. For more information on OraSure Technologies, please visit www.orasure.com.

Forward Looking Statements
This press release contains certain “forward-looking statements” within the meaning of the Federal securities laws, including with respect to products, product development and manufacturing activities, the Company’s acquisition of Sherlock, revenue growth, cash flow, increasing margins and other matters. Words such as “expects,” “estimates,” “forecasts,” “intends,” “plans,” “projects,” “could,” “may,” “should,” “will” or other similar words and expressions are intended to identify these forward-looking statements. Forward-looking statements are not guarantees of future performance or results. Known and unknown factors that could cause actual performance or results to be materially different from those expressed or implied in these statements include, but are not limited to: the Company’s ability to integrate Sherlock's business and achieve the intended benefits of the acquisition on the timeline expected or at all; Sherlock’s ability to seek and obtain regulatory approval for products in development; the Company’s ability to satisfy customer demand; ability to reduce the Company’s spending rate, capitalize on manufacturing efficiencies and drive profitable growth; ability to achieve the anticipated cost savings as a result of the Company’s business restructuring, including from insourcing third party manufacturing and exiting microbiome services; ability to market and sell products, whether through the Company’s internal, direct sales force or third parties; impact of significant customer concentration in the genomics business; failure of distributors or other customers to meet purchase forecasts, historic purchase levels or minimum purchase requirements for the Company’s products; ability to manufacture or have manufactured products in accordance with applicable specifications, performance standards and quality requirements; ability to obtain, and timing and cost of obtaining, necessary regulatory approvals for new products or new indications or applications for existing products; ability to comply with applicable regulatory requirements; ability to effectively resolve warning letters, audit observations and other findings or comments from the FDA or other regulators; the impact of the novel coronavirus (“COVID-19”) pandemic on the Company’s business, supply chain, labor force, ability to successfully develop new products, validate the expanded use of existing collector products, receive necessary regulatory approvals and authorizations and commercialize such products for COVID-19 testing, and demand for the Company’s COVID-19 testing products; changes in relationships, including disputes or disagreements, with strategic



partners or other parties and reliance on strategic partners for the performance of critical activities under collaborative arrangements; ability to meet increased demand for the Company’s products; impact of replacing distributors; inventory levels at distributors and other customers; ability of the Company to achieve its financial and strategic objectives and continue to increase its revenues, including the ability to expand international sales and the ability to continue to reduce costs; impact of competitors, competing products and technology changes; reduction or deferral of public funding available to customers; competition from new or better technology or lower cost products; ability to develop, commercialize and market new products; market acceptance of oral fluid or urine testing, collection or other products; market acceptance and uptake of microbiome informatics, microbial genetics technology and related analytics services; changes in market acceptance of products based on product performance or other factors, including changes in testing guidelines, algorithms or other recommendations by the Centers for Disease Control and Prevention or other agencies; ability to fund research and development and other products and operations; ability to obtain and maintain new or existing product distribution channels; reliance on sole supply sources for critical products and components; availability of related products produced by third parties or products required for use of the Company’s products; impact of contracting with the U.S. government; impact of negative economic conditions; ability to maintain sustained profitability; ability to utilize net operating loss carry forwards or other deferred tax assets; volatility of the Company’s stock price; uncertainty relating to patent protection and potential patent infringement claims; uncertainty and costs of litigation relating to patents and other intellectual property; availability of licenses to patents or other technology; ability to enter into international manufacturing agreements; obstacles to international marketing and manufacturing of products; ability to sell products internationally, including the impact of changes in international funding sources and testing algorithms; adverse movements in foreign currency exchange rates; loss or impairment of sources of capital; ability to attract and retain qualified personnel; exposure to product liability and other types of litigation; changes in international, federal or state laws and regulations; customer consolidations and inventory practices; equipment failures and ability to obtain needed raw materials and components; cybersecurity breaches or other attacks involving the Company’s systems or those of the Company’s third-party contractors and IT service providers; the impact of terrorist attacks, civil unrest, hostilities and war; and general political, business and economic conditions, including inflationary pressures and banking stability. These and other factors that could affect the Company’s results are discussed more fully in the Company’s filings with the Securities and Exchange Commission (the “SEC”), including the Company’s registration statements, Annual Report on Form 10-K for the year ended December 31, 2023, Quarterly Reports on Form 10-Q, and other filings with the SEC. Although forward-looking statements help to provide information about future prospects, readers should keep in mind that forward-looking statements may not be reliable. Readers are cautioned not to place undue reliance on the forward-looking statements. The forward-looking statements are made as of the date of this press release and the Company undertakes no duty to update these statements.

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