Bluejay Diagnostics, Inc. - BJDX STOCK NEWS

Bluejay Diagnostics (NASDAQ: BJDX) reported financial results for Q2 2022, highlighting a net loss of $1.9 million, or $0.10 per share. Cash and cash equivalents fell to $15.3 million from $19.0 million at year-end 2021. The company is advancing its Symphony IL-6 Test, with plans for FDA marketing application submission in Q4 2022. Significant increases in R&D and G&A expenses reflect investment in clinical studies and scalable infrastructure. The Symphony System aims to deliver rapid testing results in 20 minutes, enhancing patient care for life-threatening diseases.

Bluejay Diagnostics (NASDAQ: BJDX) has completed its clinical studies for the Symphony IL-6 Test, a key milestone towards submitting a de Novo Marketing Application to the FDA by year-end. The studies included a reference range study and validation studies, the results of which will be revealed at the AACC Annual Scientific Meeting from July 26-28, 2022. The Symphony System aims to provide rapid, near-patient testing with results in approximately 20 minutes, enhancing decision-making in critical care settings.

Bluejay Diagnostics (NASDAQ: BJDX) announced that the FDA has agreed to consider its De Novo submission plan for the Symphony IL-6 Test. This follows feedback on a January 2022 pre-submission package indicating potential for the test's regulatory pathway. CEO Neil Dey expressed optimism about advancing the Symphony IL-6 Test towards FDA marketing application, expected by year-end 2022. The Symphony System aims to provide rapid, efficient patient testing with results in approximately 20 minutes, targeting improved disease management.

Bluejay Diagnostics (NASDAQ: BJDX) announced its financial results for Q1 2022, reporting a cash position of $17.1 million. This is down from $19.0 million at the end of 2021, but expected to support operations until the anticipated regulatory approval and launch of its Symphony IL-6 Test. The company saw a substantial rise in R&D expenses to $695,000 from $24,000 year-over-year, reflecting ongoing clinical studies. Net loss for the quarter was $2.0 million, or $0.10 per share, compared to $194,000, or $0.06 per share in Q1 2021.

Bluejay Diagnostics, Inc. (NASDAQ: BJDX) has appointed Edwin “Ed” E. Rule as Vice President of Regulatory, Quality, and Compliance. With over 15 years of experience in medical device regulations, Mr. Rule is expected to enhance the company's efforts towards its Symphony IL-6 Test marketing application to the FDA due later this year. The Symphony System aims to provide rapid, near-patient diagnostic testing to improve patient outcomes in critical care settings.

Mr. Rule's expertise will be pivotal in navigating regulatory processes and ensuring product compliance.

Bluejay Diagnostics, Inc. (NASDAQ: BJDX) announced the appointment of Kenneth Fisher as the new Chief Financial Officer (CFO), effective March 23, 2022, following the resignation of Gordon Kinder. Fisher, a Certified Public Accountant with over 20 years of experience, previously held senior executive positions in public accounting and finance. His role will focus on enhancing financial and operational infrastructure as the company advances its Symphony Test for IL-6 through regulatory processes toward commercial launch. Fisher expressed enthusiasm for contributing to the company's mission of improving patient outcomes.

Bluejay Diagnostics (NASDAQ: BJDX) reported Q4 and full-year 2021 financial results, highlighting a significant increase in cash to approximately $19 million, enabling operations beyond anticipated FDA approval for the Symphony IL-6 Test. The company is progressing towards its FDA Marketing Application planned for Q3 2022 and has initiated a comprehensive clinical testing program for the IL-6 Test in sepsis triage. Bluejay's net loss expanded to $3.49 million for 2021, up from $1.16 million in 2020, largely due to increased R&D and administrative costs.

Bluejay Diagnostics, Inc. (NASDAQ: BJDX) announced the successful filing of a Pre-Submission package for its Symphony IL-6 Test with the FDA. This filing aims to gather feedback before a formal marketing application, expected in Q3 2022. The Symphony IL-6 Test is designed to rapidly measure IL-6 levels in whole blood, assisting healthcare professionals in treating patients with severe diseases. Bluejay is developing this user-friendly testing system to provide results in approximately 24 minutes, enhancing patient care in critical settings.

Bluejay Diagnostics (NASDAQ: BJDX) announced the completion of a multicenter clinical study involving 90 subjects focused on a rapid IL-6 test for COVID-19 patients in critical care. Conducted at three hospitals in Dallas, Texas, this study validates the use of unprocessed whole blood for IL-6 measurement, positioning Bluejay for forthcoming FDA submissions. The Symphony System aims to provide quicker test results, essential for triaging patients. Bluejay plans to file a Pre-Submission application with the FDA by January 2022 and commence expanded clinical testing, with results supporting a 510(k) marketing application in Q3:22.