Full Press Release Details
Date: January 31, 2022
Bluejay Diagnostics,
Inc. Announces its Pre-Submission Filing Package for the Symphony IL-6
Test is with the FDA
Acton, Massachusetts,
January 31, 2022 - Bluejay Diagnostics, Inc. (NASDAQ: BJDX) ("Bluejay", "the Company") a late-stage, pre-revenue
diagnostics company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression,
today announced that it has filed a Pre-Submission package for the Symphony IL-6 Test with the U.S. Food and Drug Administration
("FDA" or "the agency"). The purpose of this filing is to request feedback from the agency prior to submitting
a medical device marketing application. The pre-submission package will allow the FDA to review and comment on the Company's plans
for clinical trials and analytical testing.
Neil Dey, Bluejay's Chief Executive Officer
commented "I am very pleased to announce that Bluejay successfully met its goal of filing the pre-submission package with the FDA
for the Symphony IL-6 Test by the end of January, 2022. Bluejay is developing the Symphony IL-6 Test to rapidly measure IL-6 in whole
blood in a near-patient setting that is intended to help healthcare professionals make better treatment decisions for patients with life
threatening diseases. The pre-submission filing an important milestone for Bluejay as we will receive important feedback from the FDA
for our planned marketing submission for the Symphony IL-6 Test, planned for Q3:22."
Interleukin-6 (IL-6) is an established biomarker
of immune system activation. It is elevated in infection, inflammation, and cancer. IL-6 presents as an early "first responder"
and needs to be measured quickly and reliably.
About the Symphony IL-6 Test Program
Bluejay's initial testing program is proceeding
as planned to support the Pre-Submission filing with the FDA, as announced today, and the overall product development program. This testing
program includes multiple studies, all intended to demonstrate the performance and safety of the IL-6 test. This clinical program will
continue in anticipation of the company's planned marketing application.
About the SymphonyTM System:
Bluejay's Symphony System (the Symphony
System) is intended to address the need for simple, reliable, rapid near-patient testing. The Symphony System is designed to provide quantitative
measurements of specific biomarkers to determine the need for additional patient care and monitoring, when used in combination with other
test and laboratory measurements. The system does not require any sample prep and was shown in published clinical studies to deliver results
in about 24 minutes.
This user-friendly system is expected to fit into
ICU/near-patient settings without the need for dedicated staff to run a test. The system has been designed to measure test analytes using
whole blood. Samples are collected and loaded into proprietary, test-specific cartridges.
The Symphony System is based on a well-accepted
test method (ELISA, Enzyme-Linked Immunosorbent Assay) using advances in nanotechnology and new approaches to microfluidics. Bluejay has
an exclusive license to the Symphony System from Toray Industries (Toray), a multinational company with more than 96 years of manufacturing
experience, located in Japan. The product is manufactured by Toray and Sanyoseiko. Sanyoseiko is an FDA-registered manufacturer with more
than 50 years of global experience in medical devices manufacturing, located in Japan.
The Symphony IL-6 Test ("Symphony IL-6 Test")
is currently Bluejay's lead product candidate. The Company completed a Pre-submission filing for the Symphony IL-6 Test on January
The Symphony IL-6 Test is a development stage product candidate
for investigational use only. It is limited by United States law to investigational use.
About Bluejay Diagnostics:
Bluejay Diagnostics, Inc. is a late-stage, pre-revenue
diagnostics company focused on improving patient outcomes through the Symphony System, a more cost-effective, rapid, near-patient product
candidate for triage and monitoring of disease progression in hospital and long-term acute care (LTAC) settings. Bluejay's first
product candidate, an IL-6 test for sepsis triage, is designed to provide accurate, reliable results in approximately 24 minutes from
sample-to-result' to help medical professionals make earlier and better triage/treatment decisions. More information is available
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. These statements
include, but are not limited to, statements relating to the expected timeline for the Pre-Submission application with the FDA, planned
clinical studies and the planned 510(k) marketing application submission. Forward-looking statements are usually identified by the use
of words such as "anticipates," "believes," "estimates," "expects," "intends,"
"may," "plans," "projects," "seeks," "should," "suggest", "will,"
and variations of such words or similar expressions or their negatives (as well as other words and expressions referencing future events,
conditions, or circumstances). 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 those discussed in the Company's filings with the Securities and Exchange Commission,
including as set forth in the "Risk Factors" section of the Company's final prospectus, which was filed with the Securities
and Exchange Commission on November 11, 2021, as updated by the Company's subsequent Quarterly Reports on Form 10-Q. You should
not place undue reliance on these statements, as they are subject to risks and uncertainties, and actual results and performance in future
periods 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. The Company expressly disclaims any obligation to update or revise
any forward looking statements found herein to reflect any changes in the Company's expectations of results or any change in events.