GlobeNewswire Inc | Jan 5, 2022 08:15AM EST

January 05, 2022

ACTON, Mass., Jan. 05, 2022 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX) (Bluejay) a late-stage, pre-revenue diagnostics/medical device company focused on developing cost-effective, rapid, near-patient products for triage and monitoring of disease progression, today announced the appointment of Mark W. Feinberg, M.D. as Chief Medical Advisor. Dr. Feinberg will guide Bluejays clinical development programs and provide strategic medical and scientific leadership to the Company.

I am very pleased to welcome Mark on board as Chief Medical Advisor. I believe Marks expansive clinical background and strategic leadership skills will be invaluable as we seek to develop the Companys first product, the Symphony IL-6 Test to determine patient acuity for sepsis triage and monitoring (Symphony IL-6 Test), and to advance Bluejays pipeline, said Indranil Neil Dey, Bluejays Chief Executive Officer. Bluejay intends to file its Pre-Submission application with the FDA in January 2022 for the Symphony IL-6 Test and to initiate the expanded clinical testing program in Q3:22. The results from this clinical program will form the basis of the Companys planned 510(k) marketing application, intended to be submitted in Q3:22. I look forward to working together with Mark to advance this program and Bluejays cardiovascular disease programs and embark on the next phase of growth as a Company.

It is my pleasure to be joining Bluejay at this exciting time. Bluejays Symphony IL-6 Test was developed as a way to rapidly measure IL-6 levels in whole blood in a near-patient setting using the Symphony System, said Dr. Mark Feinberg, Bluejays Chief Medical Advisor. I believe this product, if cleared, could help medical professionals make better triage/treatment decisions. I am eager to work with the Bluejay Team to help guide development of this program and the Bluejay product pipeline.

Dr. Mark W. Feinberg is a cardiovascular medicine specialist at Brigham and Womens Hospital (BWH) and an associate professor of medicine at Harvard Medical School (HMS). He is also an affiliated faculty member at the Harvard Stem Cell Institute.

Dr. Feinberg received his medical degree from the Medical College of Pennsylvania. He completed an internal medicine residency at Duke University Medical Center and cardiology fellowships at Harvard School of Public Health and the Brigham and Womens Hospital. Dr. Feinberg is board certified in internal medicine and cardiology.

Dr. Feinbergs clinical interests include noninvasive clinical cardiology, vascular medicine, and cardiovascular disease prevention. Dr. Feinberg directs a basic science laboratory that investigates mechanisms leading to the development of atherosclerosis (coronary artery disease) and myocardial infarction (heart attack). These studies have revealed novel and unexpected pathophysiological roles for microRNAs and transcriptional regulators in vascular inflammation and repair, with therapeutic implications for ischemic cardiovascular disease and other acute and chronic inflammatory diseases. Dr. Feinberg has held various leadership roles in cardiovascular research including his service on national peer review study sections, editorial service, and as a Co-Chair of the Brigham Research Institutes CVDM Center.

Dr. Feinberg is Director of Cardiovascular RNA Biology Research at BWH. Dr. Feinbergs research has resulted in more than 100 peer-reviewed publications, seminars and invited lectures. Dr. Feinberg holds several patents or pending patents for diagnosing, monitoring, or treating inflammation. He has been involved with several clinical trials and has served as an advisor to a number of global pharmaceutical companies. Dr. Feinberg is an honorary member of the American Society of Clinical Investigation, and his research program has been supported by the American Heart Association and the US National, Heart, Lung, and Blood Institute.

About the SymphonySystem:Bluejays Symphony System is intended to address the need for simple, reliable, rapid near-patient testing. 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 system does not require any sample prep and was shown in published clinical studies to deliver results in about 24 minutes.

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 to determine patient acuity for sepsis triage and monitoring (Symphony IL-6 Test) is Bluejays lead product candidate. The Company intends to make a Pre-submission filing for the Symphony IL-6 Test in January, 2022.

About Bluejay Diagnostics:Bluejay Diagnostics, Inc. is a late-stage, pre-revenue diagnostics/medical device 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. Bluejays 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 at www.bluejaydx.com.

Symphony is a registered trade mark of Bluejay Diagnostics, Inc.

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 Companys filings with the Securities and Exchange Commission, including as set forth in the Risk Factors section of the Companys final prospectus, which was filed with the Securities and Exchange Commission on November 11, 2021, as updated by the Companys 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 Companys expectations of results or any change in events.

Investor Contact: Alexandra SchumanLifeSci Advisorsalex@lifesciadvisors.comt: 646-876-3647