What changed in this filing

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Item 1. Business

2024-03-28 compared with 2023-03-20 · 152 added, 126 removed, 215 unchanged (56% of the section changed)

22 unchanged sentences

Our operations to date have been funded primarily

through the proceeds of our initial public offering (the “IPO”) on November 2021 (the “IPO Date”).

We were incorporated

under the laws of Delaware on March 20, 2015.

through the proceeds of (i) our initial public offering (the “IPO”) on November 2021 (the “IPO Date”), (ii) the

registered direct offering of common stock and concurrent private placement of warrants that we completed on August 28, 2023, and (iii)

the public offering of common stock and warrants that we completed on January 2, 2024.

We were incorporated under the laws of Delaware

on March 20, 2015.

Our headquarters is located in Acton, Massachusetts.

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We intend to offer various financing options for the device itself.

As such, our business model should not require customers to incur

a significant capital outlay.

As such, our business model should not require customers to incur a significant capital outlay.

Recurring Revenue .

intend to sell single-use diagnostic test cartridges.

Our cartridges will create a growing and recurring revenue stream, as adoption

and utilization increase, and as we develop tests for additional indications.

We expect the sale of test cartridges to generate the majority

of our revenue and gross profit.

● Expand our Menu of Diagnostic

We intend to sell single-use diagnostic test cartridges.

Our cartridges will create a growing and recurring revenue stream, as adoption and utilization increase, and as we develop tests for additional indications.

We expect the sale of test cartridges to generate the majority of our revenue and gross profit.

Expand our Menu of Diagnostic Products .

As adoption increases, the average customer use of the Symphony platform should also increase.

As we expand our test menu,

we will be able to increase our annual revenue per customer through the resulting increase in utilization.

As we expand our test menu, we will be able to increase our annual revenue per customer through the resulting increase in utilization.

The Symphony Platform

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Manufacturing

We plan to manufacture both our devices and cartridges

through Contract Manufacturing Organizations (“CMOs”).

We plan to manufacture both our analyzers and

cartridges through Contract Manufacturing Organizations (“CMOs”).

We have contracts with Toray Industries, Inc (“Toray”),

to manufacture our cartridges and Sanyoseiko Co.

Ltd (“Sanyoseiko”) to manufacture both our device and cartridges.

our partners are well-established global manufacturing companies with capabilities to scale up, re-design and supply our devices and cartridges.

to license the intellectual property rights needed to manufacture our cartridges and Sanyoseiko Co.

(“Sanyoseiko”), to

manufacture both our analyzers and cartridges.

Each of our partners are well-established global manufacturing companies with capabilities

to scale up, re-design and supply our analyzers and cartridges.

Sanyoseiko had been selected as our CMO, though

in the near-term Toray will continue to develop, validate and manufacture our IL-6 cartridges as our pilot-manufacturing partner.

to meet the demands of our global market.

in the near-term Toray will continue to manufacture certain product intermediate components for use in cartridges being manufactured for

the Company by Sanyoseiko.

These cartridges made using Toray intermediates are for the purpose of obtaining FDA approval and not for commercial

We expect to meet the demands of our global market.

Both Toray’s and Sanyoseiko’s facilities are located in Japan.

We license the technology

for the Symphony cartridges from Toray.

license the technology for the Symphony cartridges from Toray.

Our license grants us exclusive global use, with the exception of Japan.

Regulatory Strategy

FDA Regulatory Strategy

Our current regulatory strategy is designed to

support commercialization of Symphony in the United States pending authorization from the FDA.

The FDA has identified Symphony as a de

novo device, and we are subject to the de novo authorization regulatory pathway, which includes expansion of our clinical studies.

We have several clinical studies currently active, all designed to support our de novo FDA submission.

We have targeted large,

well-known medical and academic institutions for our studies, which should also help support initial commercialization and market penetration.

This clinical trial expansion could also support additional indications.

The expansion also could delay obtaining marketing authorization

for the product.

support commercialization of Symphony in the United States pending marketing authorization from the FDA.

Previously, our regulatory strategy

involved clinical studies involving COVID-19 patients.

However, we have shifted our focus away from COVID-19 patients due to a significant

decline in the number of COVID-19 related hospitalizations.

Pursuant to this revised strategy, we are beginning to conduct a clinical

study to support an FDA regulatory submission with an initial indication for risk stratification of hospitalized sepsis patients.

a pre-submission application to the FDA presenting the new study design in May 2023 and participated in a pre-submission meeting on August

At the meeting, the FDA provided feedback on the new study design, determined that the submission of a 510(k) is the appropriate

premarket submission pathway, and requested that certain data be provided in the 510(k).

Based on this feedback, we determined to proceed

on this basis, which considers the FDA’s feedback.

In the first quarter

of 2024, we initiated the study at multiple sites, which the study is intended to use the Symphony IL-6 test to monitor IL-6 concentrations

in patients who are diagnosed with sepsis or septic shock and are admitted or intended to be admitted to the ICU.

The objective of this

study is to establish IL-6 concentrations in these sepsis patients that best predict 28-day all-cause mortality.

We expect that we will

need to bring several additional sites into the study in the future, which we believe will help support initial commercialization and

market penetration.

We believe that this clinical trial expansion could also support additional indications, but that any such expansion

also could delay obtaining marketing authorization for the product.

As a result of our lack of cash resources, we have recently slowed

the timeline of this study to preserve cash resources in the near-term, and we expect that this will delay our Symphony platform regulatory

submission timeline until 2025.

Sales and Marketing

Until Symphony products are authorized by the FDA, we will focus our

sales and marketing efforts on brand awareness and market education to potential customers, emphasizing the value of monitoring a critical

care patient’s IL-6 levels to improve decision making and patient outcomes.

If cleared or approved by the FDA, we will target sales

to ERs and ICUs at United States hospitals, as well as to long-term acute care facilities.

We plan to establish a market presence by selling

Symphony devices and tests both directly and through various distribution channels to maximize sales volume and market penetration.

Until Symphony products are authorized by the

FDA, we will focus our sales and marketing efforts on brand awareness and market education to potential customers, emphasizing the value

of monitoring a critical care patient’s IL-6 levels to improve decision making and patient outcomes.

If cleared or approved by the

FDA, we will target sales to ERs and ICUs at United States hospitals, as well as to long-term acute care facilities.

We plan to establish

a market presence by selling Symphony devices and tests both directly and through various distribution channels to maximize sales volume

and market penetration.

License Agreement

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and sale of the products (as defined in the License Agreement).

We also have a nonexclusive license for the same purposes in Japan.

agreement terminates in 2029 upon expiration of the last of the patents included in the license.

In connection with entering into the License Agreement,

we are required to pay a 15% royalty fee for the period that any underlying patents exist or for five years after the first sale for the

licensed technology after obtaining regulatory approval based on a percentage of our “Net Sales” of products using these technologies

(as defined in the license Agreement) with a minimum royalty of $60,000 for the initial year that royalties are payable increasing to

a minimum of $100,000 thereafter.

On October 23, 2023, we entered into an Amended

and Restated License Agreement (the “New Toray License Agreement”) and a Master Supply Agreement (the “New Toray Supply

Agreement” and, together, the “Toray Agreements”) with Toray.

Under the New Toray License Agreement, we continue to

license from Toray intellectual property rights needed to manufacture single-use test cartridges, and we have received the right to sublicense

certain Toray intellectual property to Sanyoseiko in connection with our ongoing agreement with Sanyoseiko to manufacture our Symphony

analyzers and cartridges.

In addition, the New Toray License Agreement provides for the transfer of certain technology related to the

cartridges to Sanyoseiko.

The royalty payments we are required to pay Toray have been reduced under the New Toray License Agreement from

15% to 7.5% (or less in certain circumstances) of net sales of certain cartridges for a term of 10 years.

A 50% reduction in the royalty

rate applies upon expiry of applicable Toray patents on a product-by-product and country-by-country basis.

The New Toray License Agreement

contemplates that applicable royalty payment obligations from us to Toray for other products will be determined separately in the future.

Under the New Toray Supply Agreement, Toray will

manufacture in the near-term (through its wholly owned subsidiary Kamakura Techno-Science, Inc.) certain product intermediate components

for use in cartridges being manufactured for the Company by Sanyoseiko.

These cartridges made using Toray intermediates are for the purpose

of obtaining FDA approval and not for commercial sale.

The New Toray Supply Agreement has a term ending on the earlier of October 23,

2025 or the date that we obtain FDA approval for our product, and may be extended for up to six months by mutual agreement.

Once FDA approval

has been obtained, the intermediates and cartridges will be manufactured by Sanyoseiko under a separate supply agreement between us and

The FDA may not clear or approve these product submissions or applications on a timely basis or at all.

Such delays or refusals

could have a material adverse effect on our business, financial condition, and results of operations.

Intellectual Property, Proprietary Technology

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agreements, and contractual protection to establish and protect our proprietary rights.

Our primary competition in the IL-6 market is laboratory size equipment

including the Roche Cobas ® , Siemens ADVIA Centaur ® and Beckman Coulter Access 2 ® , which require

pre-processing of whole blood prior to performing their test.

We believe that our technology, which uses whole blood, provides us with

a substantial competitive advantage over our existing competition that will sustain through commercialization, despite the major life

science companies and consistent entry of innovative start-ups that define our competitive landscape.

Our primary competition in the IL-6 market is

laboratory size equipment including the Roche Cobas ® , Siemens ADVIA Centaur ® and Beckman Coulter Access

2 ® , which require pre-processing of whole blood prior to performing their test.

We believe that our technology, which uses

whole blood, provides us with a substantial competitive advantage over our existing competition that will sustain through commercialization,

despite the major life science companies and consistent entry of innovative start-ups that define our competitive landscape.

Government Regulation

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are necessary to reasonably ensure their safety and effectiveness:

general controls, such

as labeling and adherence to quality system regulations;

special controls,

premarket notification (often referred to as a 510(k)), specific controls such as performance standards, patient registries, post-market

surveillance, additional controls such as labeling and adherence to quality system regulations;

special controls

and requires a premarket approval (“PMA”).

general controls, such as labeling and adherence to quality system regulations;

special controls, premarket notification (often referred to as a 510(k)), specific controls such as performance standards, patient registries, post-market surveillance, additional controls such as labeling and adherence to quality system regulations;

special controls and requires a premarket approval (“PMA”).

FDA Premarket Clearance and Approval Requirements

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application, or approval of a premarket approval (PMA).

While most Class I devices are exempt from the 510(k) premarket

notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket notification under

Section 510(k) of the FDCA requesting permission to commercially distribute the device.

The FDA’s permission to commercially

distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

Devices deemed by the FDA to pose

the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new intended use, or

use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III, requiring

approval of a PMA.

Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance process

in order to be commercially distributed.

While most Class I devices are exempt from

the 510(k) premarket notification requirement, manufacturers of most Class II devices are required to submit to the FDA a premarket

notification under Section 510(k) of the FDCA requesting permission to commercially distribute the device.

The FDA’s permission

to commercially distribute a device subject to a 510(k) premarket notification is generally known as 510(k) clearance.

Devices deemed

by the FDA to pose the greatest risks, such as life sustaining, life supporting or some implantable devices, or devices that have a new

intended use, or use advanced technology that is not substantially equivalent to that of a legally marketed device, are placed in Class III,

requiring approval of a PMA.

Some pre-amendment devices are unclassified, but are subject to FDA’s premarket notification and clearance

process in order to be commercially distributed.

Our initial product is a Class II device subject to 510(k) clearance.

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subjects outweigh the anticipated benefits.

Sponsors of applicable clinical trials of devices

also are required to register with www.clinicaltrials.gov, a public database of clinical trial information.

Information related to

the device, patient population, phase of investigation, study sites and investigators and other aspects of the clinical trial is made

public as part of the registration.

Although the QSR does not fully apply to investigational devices, the requirement for controls on

design and development does apply.

Sponsors of applicable clinical trials of

devices also are required to register with www.clinicaltrials.gov, a public database of clinical trial information.

related to the device, patient population, phase of investigation, study sites and investigators and other aspects of the clinical

trial is made public as part of the registration.

Although the FDA’s Quality System Regulation (QSR) does not fully apply to

investigational devices, the requirement for controls on design and development does apply.

Post-market Regulation

After a device is cleared or approved for marketing, numerous and pervasive

regulatory requirements continue to apply.

After a device is cleared or approved for marketing,

numerous and pervasive regulatory requirements continue to apply.

These include:

● establishment

registration and device listing with the FDA;

requirements, which require manufacturers, including third-party manufacturers, to follow

stringent design, testing, control, documentation and other quality assurance procedures

during all aspects of the design and manufacturing process;

regulations and FDA prohibitions against the promotion of investigational products, or the

promotion of ‘‘off-label’’ uses of cleared or approved products;

● requirements

related to promotional activities;

or approval of product modifications to 510(k)-cleared devices that could significantly affect

safety or effectiveness or that would constitute a major change in intended use of one of

our cleared devices, or approval of certain modifications to PMA-approved devices;

device reporting regulations, which require that a manufacturer report to the FDA if a device

it markets may have caused or contributed to a death or serious injury, or has malfunctioned

and the device or a similar device that it markets would be likely to cause or contribute

to a death or serious injury, if the malfunction were to recur;

● correction,

removal and recall reporting regulations, which require that manufacturers report to the

FDA field corrections and product recalls or removals if undertaken to reduce a risk to health

posed by the device or to remedy a violation of the FDCA that may present a risk to health;

FDA’s recall authority, whereby the agency can order device manufacturers to recall

from the market a product that is in violation of governing laws and regulations;

● post-market

surveillance activities and regulations, which apply when deemed by the FDA to be necessary

to protect the public health or to provide additional safety and effectiveness data

for the device.

establishment registration and device listing with the FDA;

QSR requirements, which require manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the design and manufacturing process;

labeling regulations and FDA prohibitions against the promotion of investigational products, or the promotion of ‘‘off-label’’ uses of cleared or approved products;

requirements related to promotional activities;

clearance or approval of product modifications to 510(k)-cleared devices that could significantly affect safety or effectiveness or that would constitute a major change in intended use of one of our cleared devices, or approval of certain modifications to PMA-approved devices;

medical device reporting regulations, which require that a manufacturer report to the FDA if a device it markets may have caused or contributed to a death or serious injury, or has malfunctioned and the device or a similar device that it markets would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur;

correction, removal and recall reporting regulations, which require that manufacturers report to the FDA field corrections and product recalls or removals if undertaken to reduce a risk to health posed by the device or to remedy a violation of the FDCA that may present a risk to health;

the FDA’s recall authority, whereby the agency can order device manufacturers to recall from the market a product that is in violation of governing laws and regulations;

post-market surveillance activities and regulations, which apply when deemed by the FDA to be necessary to protect the public health or to provide additional safety and effectiveness data for the device.

Once we have a commercialized product, our manufacturing

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enforcement actions, which may result in any of the following sanctions:

letters, warning letters, fines, injunctions, consent decrees and civil penalties;

● unanticipated

expenditures to address or defend such actions;

notifications or repair, replacement, refunds, recall, detention or seizure of our products;

restrictions, partial suspension or total shutdown of production;

or delaying our requests for regulatory approvals or clearances of new products or modified

● withdrawing

a PMA that has already been granted;

to grant export approval for our products;

As of December 31, 2022, we have sixteen full-time

We also contract with several consultants and contractors performing regulatory advisory, investor relations and manufacturing

scale-up support.

untitled letters, warning letters, fines, injunctions, consent decrees and civil penalties;

unanticipated expenditures to address or defend such actions;

customer notifications or repair, replacement, refunds, recall, detention or seizure of our products;

operating restrictions, partial suspension or total shutdown of production;

refusing or delaying our requests for regulatory approvals or clearances of new products or modified products;

withdrawing a PMA that has already been granted;

refusal to grant export approval for our products;

criminal prosecution.

As of March 28, 2024, we have 10 full-time

We also contract with several consultants and contractors performing finance, accounting, regulatory advisory, investor relations

and manufacturing scale-up support.

None of our employees are represented by labor unions or covered by collective bargaining agreements.

Reverse Stock Split

On July 24, 2023, we effected a reverse stock

split of our shares of common stock at a ratio of 1-for-20 (the “Reverse Stock Split”), with a corresponding reduction in

the number of authorized outstanding number of shares of common stock from 100,000,000 to 7,500,000.

The Reverse Stock Split became effective

on July 24, 2023, when the Company’s common stock opened for trading on Nasdaq on a post-split basis under the Company’s existing

trading symbol, “BJDX.” All historical share and per share amounts reflected throughout this prospectus have been adjusted

to reflect the Reverse Stock Split.

However, our periodic and current reports, and all other documents incorporated by reference into

this prospectus that were filed prior to July 24, 2023, do not give effect to the Reverse Stock Split.

Available Information

principal executive offices are located at 360 Massachusetts Avenue, Suite 203, Acton, MA 01720 and our telephone number is (844) 327-7078.

Our principal executive offices are located at

360 Massachusetts Avenue, Suite 203, Acton, MA 01720 and our telephone number is (844) 327-7078.

Our website address is www.bluejaydx.com.

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K

and all amendments to those reports, proxy statements and other information about us are made available, free of charge, through the Securities

and Exchange Commission (“SEC”) Filings section of our website at www.ir.bluejaydx.com/financial-information/sec-filings and

at the SEC’s website at www.sec.gov as soon as reasonably practicable

after such material is electronically filed with or furnished to the SEC.

We include our website address in this report only as an inactive

textual reference and do not intend it to be an active link to our website.

The contents of our website are not incorporated into this

Our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and all amendments to those reports, proxy

statements and other information about us are made available, free of charge, through the Securities and Exchange Commission (“SEC”)

Filings section of our website at www.ir.bluejaydx.com/financial-information/sec-filings and at the SEC’s website at www.sec.gov

as soon as reasonably practicable after such material is electronically filed with or furnished to the SEC.

We include our website address

in this report only as an inactive textual reference and do not intend it to be an active link to our website.

The contents of our website

are not incorporated into this report.

In addition, our Board of Directors has adopted

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business