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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):
September 1, 2026
BLUEJAY DIAGNOSTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
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| delaware |
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001-41031 |
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47-3552922 |
(State or Other Jurisdiction of
Incorporation or Organization) |
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(Commission File No.) |
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(I.R.S. Employer
Identification No.) |
360 Massachusetts Avenue, Suite 203
Acton, MA 01720
(Address of principal executive offices
and zip code)
(844) 327-7078
(Registrant’s telephone number, including
area code)
(Former
name or former address, if changed from 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 (see General Instruction A.2. below):
| ☐ |
Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14(c)) |
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.
Securities registered pursuant to Section 12(b)
of the Act:
| Title of each class |
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Trading Symbol (s) |
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Name of each exchange on which registered |
| Common Stock, par value $0.0001 per share |
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BJDX |
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The Nasdaq Stock Market LLC |
Item 1.01 Entry into a Material Definitive Agreement.
On September 1, 2026, Bluejay
Diagnostics, Inc. (the “Company”) entered into a Distribution, Co-Marketing & Strategic Partnership Agreement (the “Distribution
Agreement”) with Lovell Government Services, Inc. (“Lovell”), a Service-Disabled Veteran-Owned Small Business (“SDVOSB”)
specializing in federal healthcare distribution. The Distribution Agreement establishes the terms under which Lovell will serve as a distributor
of the Company’s medical diagnostic products to federal, state, and local government customers in the U.S. following applicable U.S.
Food and Drug Administration (“FDA”) clearance or other required regulatory authorization.
Under the Distribution Agreement,
the Company has granted Lovell (a) a non-exclusive right to list and resell the Company’s products on open-market (non-set-aside)
federal, state, and local government procurements in the U.S., and (b) a sole and exclusive right to distribute the Company’s products
for all federal procurement opportunities requiring or favoring SDVOSB set-aside status, including procurements by the U.S. Department
of Veterans Affairs (“VA”), Department of Defense (“DoD”), and Indian Health Service (“IHS”), whether
conducted through VA Federal Supply Schedule, GSA Advantage, GSA Multiple Award Schedule, ECAT, DAPA, or any successor contract vehicles.
During the term of the Distribution Agreement, the Company may not appoint, authorize, or permit any other set-aside distributor to list,
market, bid on, or resell the Company’s products within the exclusive set-aside territory.
Product pricing is subject
to change by the Company upon written notice, provided that all prices listed on Lovell’s federal contract catalogs remain fixed
for a minimum of twelve months from the original catalog listing date. The Company must provide Lovell at least ninety days’ advance
written notice of any proposed price increase to allow for federal contracting authority review, and the Company may submit up to two
price increase requests per calendar year. Lovell is required to remit full payment to the Company within three business days after receipt
of payment from the applicable federal government customer for the corresponding order, or within thirty days following Lovell’s receipt
of a valid invoice, whichever is later. Any undisputed amount not paid when due accrues interest at the lesser of 18% per annum or the
maximum rate permitted by applicable law.
In connection with the Distribution
Agreement, the Company paid a one-time discounted establishment fee of $5,500 for multi-contract vehicle setup. Lovell is entitled to
an approximate fifteen percent distribution fee on gross sales made through its federal catalogs, which amount is added to the Company’s
cost of goods sold and does not reduce the Company’s profit margin. In addition, a two percent fee on gross sales is allocated for
sales made through Lovell’s catalogs listed with DAPA prime vendors.
The Distribution Agreement
provides for a co-marketing and strategic partnership under which the parties will collaborate in good faith to develop awareness of the
Company’s products and technology among U.S. federal healthcare stakeholders, including the VA, DoD, Defense Health Agency, and
IHS, following applicable FDA clearance or other required regulatory authorization. Activities under the co-marketing arrangement may
include joint marketing plans, conferences, educational initiatives, product demonstrations, and digital campaigns.
The Distribution Agreement
has an initial term of two years and automatically renews for successive one-year terms unless either party provides at least ninety days’
advance written notice of non-renewal prior to the end of the then-current term. Either party may terminate the Distribution Agreement
immediately if the other party (i) is suspended, excluded, or sanctioned under a state or federal healthcare program or convicted of certain
criminal offenses, (ii) is subject to bankruptcy proceedings, (iii) has a final, non-appealable judgment entered against it in excess
of $100,000 that materially impairs its ability to perform, or (iv) permanently discontinues its operations. Either party may also terminate
the Distribution Agreement if the other party is in default of any obligation and fails to cure such default within thirty days after
receiving written notice of such default.
The foregoing description of
the Distribution Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Distribution
Agreement, a copy of which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Item 7.01 Regulation FD Disclosure.
On September 8, 2026, the
Company issued a press release in connection with the matters discussed herein under item 1.01. A copy of that press release is furnished
with this report as Exhibit 99.1.
The information contained in
Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be “filed” for the
purpose of the Securities Exchange Act of 1934, as amended, nor shall it be incorporated by reference in any filing under the Exchange
Act or the Securities Act of 1933, as amended, unless specifically identified therein as being incorporated by reference.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| 10.1 |
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Distribution, Co-Marketing & Strategic Partnership Agreement dated September 1, 2026, between Bluejay Diagnostics, Inc. and Lovell Government Services, Inc. |
| 99.1 |
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Press Release, dated September 8, 2026. |
| 104 |
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Cover Page Interactive Data File (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.
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Bluejay Diagnostics, Inc. |
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By: |
/s/ Neil Dey |
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Neil Dey |
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President and Chief Executive Officer |
Date: September 8, 2026
Exhibit 99.1
Bluejay Diagnostics and Lovell Government Services Announce Partnership
to Expand Access to U.S. Federal Healthcare Markets
Partnership Establishes Federal Distribution and Co-Marketing
Framework Across VA, DoD, Military Health Systems and Other Government Healthcare Channels
ACTON, Mass. and PENSACOLA, Fla. — September 8, 2026 —
Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (“Bluejay” or the “Company”), a medical diagnostics company focused on
improving patient outcomes through its Symphony™ near-patient diagnostic platform, and Lovell Government Services, Inc. (“Lovell”),
a Service-Disabled Veteran-Owned Company (“SDVOSB”) specializing in federal healthcare distribution, today announced a distribution,
co-marketing and strategic partnership designed to support the introduction of Bluejay’s products into the U.S. federal healthcare
market following applicable U.S. Food and Drug Administration (“FDA”) clearance or other required regulatory authorization.
The partnership is designed to establish a scalable federal market
access and procurement infrastructure in advance of potential commercialization, positioning Bluejay to efficiently pursue opportunities
across some of the largest government-operated healthcare systems in the United States, subject to applicable FDA clearance or other required
regulatory authorization for its products.
Under the agreement, Lovell will serve as Bluejay’s exclusive
distributor for federal procurement opportunities requiring or favoring SDVOSB set-aside and preferred status, including opportunities
within the U.S. Department of Veterans Affairs (“VA”), Department of Defense (“DoD”), Military Health Systems
(“MHS”) and Indian Health Service (“IHS”). Lovell will also have non-exclusive rights to participate in open-market
federal, state and local government procurement opportunities.
Strategic Access to a Large Federal Healthcare Market
The partnership provides Bluejay with a strategic framework to access
and pursue opportunities across the significant U.S. federal healthcare market, creating a potential pathway for commercial expansion
if and when its devices receive applicable FDA clearance or approval and are commercially launched in the United States.
The Veterans Health Administration (“VHA”), the largest
integrated healthcare system in the United States, encompasses approximately 170 major medical centers and 1,193 outpatient clinics, with
a proposed FY2026 budget of approximately $165.1 billion. The broader federal healthcare opportunity includes approximately 45 U.S. military
hospitals and 572 military medical clinics within the DoD healthcare system, with the Defense Health Agency (“DHA”) having
a proposed FY2026 budget of approximately $64 billion. The Indian Health Service (“IHS”), with a proposed FY2026 budget of
approximately $8.1 billion, serves approximately 2.8 million American Indians and Alaska Natives through approximately 170 IHS and tribally
managed service units.
Together, these federal healthcare systems represent an extensive network
of hospitals, medical centers, outpatient clinics and other care settings in which timely access to clinically relevant information may
be important.
“We believe this partnership represents an important step in
building Bluejay’s commercial infrastructure well ahead of potentially marketing medical devices in the US.” said Neil Dey,
Chief Executive Officer of Bluejay Diagnostics. “The scale of the federal healthcare system is significant, and establishing a pathway
into these markets could provide Bluejay with an important future commercialization channel.”
Dey continued, “We believe regulatory, manufacturing and commercial
readiness should advance in parallel. Lovell brings established federal contracting infrastructure, SDVOSB capabilities and experience
navigating government procurement pathways that would be difficult and time-consuming for Bluejay to develop independently.”
Lovell Brings Established Federal Market Infrastructure
Lovell Government Services specializes in helping medical and healthcare
companies navigate the U.S. federal marketplace. Its experience includes working with VA medical centers, military hospitals and clinics,
IHS facilities and other federal healthcare organizations.
Through the partnership, Lovell will leverage its SDVOSB status, federal
contracting capabilities and industry relationships to support market development, facilitate appropriate introductions and pursue federal
procurement opportunities for Bluejay. The parties may also collaborate on educational initiatives, conferences, customer engagement and
other federal market-development activities.
Lovell’s established federal procurement infrastructure includes
access to contract vehicles such as the VA Federal Supply Schedule (“FSS”), GSA Advantage, GSA Multiple Award Schedule (“MAS”),
Defense Logistics Agency (“DLA”) DAPA and Electronic Catalog (“ECAT”). ECAT is a preferred DoD procurement vehicle
for medical supplies and devices and is also utilized by the VA and IHS.
Lovell also participates in the Association of Military Surgeons of
the United States (“AMSUS”), providing potential exposure to more than 8,000 federal health professionals through publications,
meetings and conferences.
“We are proud to partner with Bluejay Diagnostics as they prepare
to bring the Symphony platform to market. At Lovell, our mission is to connect innovative healthcare technologies with the federal healthcare
providers serving our Veterans, active-duty service members, and their families. By establishing the necessary contracting and procurement
pathways now, we can help position Bluejay to efficiently reach these critical healthcare systems following applicable FDA clearance,”
said Chris Lovell, Major, USMC (Ret.), CEO of Lovell Government Services.
Building Commercial Readiness in Parallel With Regulatory Development
The partnership reflects Bluejay’s broader strategy of building
commercialization capabilities while advancing its clinical, regulatory and manufacturing programs. Bluejay and Lovell may jointly pursue
federal market-development initiatives and engage appropriate healthcare, clinical, innovation and procurement stakeholders in preparation
for potential future commercialization.
Note: The Company’s Symphony™ rapid diagnostic platform
is an investigational device and is limited by United States law to investigational use.
About the SYMON Clinical Study Program:
The SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov
ID NCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is a pilot study to determine IL-6 levels associated with
various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal
study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA. The SYMON-III
study is a pilot study to determine IL-6 levels associated with patients presenting with increasing severity of infection in the emergency
department and risk of developing sepsis.
About Bluejay Diagnostics:
Bluejay Diagnostics, Inc. is a medical diagnostics
company focused on improving patient outcomes using its Symphony System, a cost-effective, rapid, near-patient testing system for sepsis
triage and monitoring of disease progression. Bluejay does not yet have regulatory clearance for the Symphony System, and we will need
to receive regulatory authorization from the U.S. Food and Drug Administration before Symphony can be marketed as a diagnostic product
in the United States. Bluejay’s first product candidate, an IL-6 Test for sepsis, is designed to provide accurate, reliable results
in approximately 20 minutes from ’sample-to-result’ to help medical professionals make earlier and better triage/treatment
decisions. More information is available at www.bluejaydx.com.
About Lovell Government Services
Lovell Government Services has been a trusted Service-Disabled Veteran-Owned
Small Business (SDVOSB) vendor since 2013 with a proven track record of helping suppliers successfully navigate the federal marketplace.
As a five-time Inc. 5000 honoree, Lovell partners with medical, dental, pharmaceutical, and healthcare technology companies to expand
access to federal healthcare systems while helping agencies streamline procurement and improve patient care for Veterans, military personnel,
and other federal beneficiaries.
Learn more at www.lovellgov.com.
Forward-Looking Statements:
This press release contains statements that
the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking
statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,”
“intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest,”
“will,” and similar expressions. The Company has based these forward-looking statements on its current expectations and projections
about future events, nevertheless, actual results or events could differ materially from the plans, intentions and expectations disclosed
in, or implied by, the forward-looking statements the Company makes. These statements are only predictions and involve known and unknown
risks, uncertainties, and other factors, including market and other conditions and those discussed under item 1A. “Risk Factors”
in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025, and in Part II, Item 1A, “Risk
Factors” in its Quarterly Reports on Form 10-Q for the fiscal quarters ended March 31, 2026 and June 30, 2026. You should
not place undue reliance on these forward-looking statements, as they are subject to risks and uncertainties, and actual results and performance
in future periods may not occur or may be materially different from any future results or performance suggested by the forward-looking
statements in this release. This press release speaks as of the date indicated above. The Company undertakes no obligation to update any
forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. The Company
expressly disclaims any obligation to update or revise any forward-looking statements found herein to reflect any future changes in the
Company’s expectations of results or any future change in events, except as required by law.
Investor Contact:
Neil Dey
Bluejay Diagnostics, Inc.
ir@bluejaydx.com
Website: www.bluejaydx.com
Lovell Government Services Contact:
Jeff
McKay Lovell Government Services
media@lovellgov.com
850-912-4680