{"success":true,"data":{"pressRelease":{"id":"26478","rtpr_id":"nGNX64BHnj","ticker":"BJDX","exchange":"NASDAQ","all_tickers":["BJDX"],"title":"Bluejay Diagnostics Provides First Quarter 2026 Corporate Update","author":"Globe Newswire","published_at":"2026-05-07T20:01:01.848Z","article_body":"ACTON, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc.\n(“Bluejay” or the “Company”), a medical diagnostics company focused on\nimproving patient outcomes in critical care settings, today provided a\ncorporate update highlighting progress achieved during the first quarter of\n2026 and recent operational developments related to its Symphony™\nnear-patient diagnostic platform.\n\nDuring the first quarter of 2026, Bluejay continued advancing the clinical,\nmanufacturing, and regulatory activities supporting the development of its\nSymphony IL-6 test for sepsis patient monitoring and risk assessment in\ncritical care settings.\n\nQ1 2026 and Recent Highlights\n\n• Continued enrollment progress in the ongoing SYMON-II pivotal clinical\nstudy evaluating the role of IL-6 in sepsis and septic shock patients. As of\nMay 5, 2026, approximately 680 patients have been enrolled toward the target\nenrollment of 750 patients across participating clinical sites.\n\n• Advanced manufacturing readiness activities for Symphony cartridges in\ncollaboration with Sanyoseiko Co. Ltd., Bluejay’s contract manufacturing\norganization. The Company successfully resolved technical issues related to\nthe Symphony cartridge manufacturing process and is progressing toward\nanalytical and clinical validation activities intended to support future\nregulatory submission.\n\n• Continued execution of Bluejay’s FDA-focused regulatory strategy for\nSymphony IL-6, with the Company maintaining its objective of preparing for a\nfuture 510(k) submission following completion of required analytical and\nclinical validation activities.\n\n• Continued development activities related to Bluejay’s broader Symphony\nplatform strategy, which includes future potential applications in additional\ncritical care biomarkers and cardiovascular disease monitoring.\n\nNeil Dey, President and Chief Executive Officer of Bluejay Diagnostics,\ncommented, “We believe the first quarter of 2026 represented meaningful\noperational progress across several key areas of our Symphony program. Most\nimportantly, we continued strong enrollment momentum in our SYMON-II pivotal\nstudy while also advancing manufacturing readiness activities intended to\nsupport future analytical and clinical validation. We are encouraged by the\nprogress our team and partners have made in positioning Symphony toward the\nnext phase of development.”\n\nMr. Dey continued, “We believe Symphony has the potential to address an\nimportant unmet need in critical care by enabling rapid, near-patient\nbiomarker testing where time-sensitive clinical decisions are essential. As we\ncontinue executing our clinical and manufacturing roadmap, we remain focused\non progressing toward regulatory readiness and future commercialization\nopportunities.”\n\nFinancial Highlights\n\nAs of March 31, 2026, Bluejay reported cash and cash equivalents of\napproximately $3.7 million. The Company reported a net loss of approximately\n$1.9 million for the first quarter of 2026, compared to approximately $1.9\nmillion for the same period in 2025.\n\nThe Company believes it has continued to manage operating expenses with\nfinancial discipline while prioritizing critical clinical, manufacturing, and\nregulatory activities supporting the Symphony program.\n\nAbout the Symphony IL-6 Test:\n\nThe Symphony(TM) Test platform is designed to determine patient acuity for\ntriage and monitoring based on the measurement of a specific biomarker. The\nSymphony(TM) IL-6 Test to determine patient acuity for sepsis triage and\nmonitoring (“Symphony(TM) IL-6 Test”) is currently Bluejay’s lead\nproduct candidate.\n\nNote: Investigational device. Limited by United States law to investigational\nuse.\n\nAbout the SYMON Clinical Study Program:\n\nThe SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov ID\nNCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is\na pilot study to determine IL-6 levels associated with various endpoints,\nincluding, but not limited to 28-day all-cause mortality and in-hospital\nmortality. The SYMON-II study is the pivotal study to validate the outcomes of\nthe SYMON-I study, which the Company plans to use to support a 510(k)\napplication to the FDA. The SYMON-III study is a pilot study to determine IL-6\nlevels associated with patients presenting with increasing severity of\ninfection in the emergency department and risk of developing sepsis.\n\nAbout Bluejay Diagnostics:\n\nBluejay Diagnostics, Inc. is a medical diagnostics company focused on\nimproving patient outcomes using its Symphony System, a cost-effective, rapid,\nnear-patient testing system for sepsis triage and monitoring of disease\nprogression. Bluejay does not yet have regulatory clearance for the Symphony\nSystem, and we will need to receive regulatory authorization from the U.S.\nFood and Drug Administration before Symphony can be marketed as a diagnostic\nproduct in the United States. Bluejay’s first product candidate, an IL-6\nTest for sepsis, is designed to provide accurate, reliable results in\napproximately 20 minutes from ’sample-to-result’ to help medical\nprofessionals make earlier and better triage/treatment decisions. More\ninformation is available at www.bluejaydx.com.\n\nForward-Looking Statements:\n\nThis press release contains statements that the Company believes are\n“forward-looking statements” within the meaning of the Private Litigation\nReform Act. Forward-looking statements may be identified by words such as\n“anticipates,” “believes,” “estimates,” “expects,”\n“intends,” “may,” “plans,” “projects,” “seeks,”\n“should,” “suggest,” “will,” and similar expressions. The Company\nhas based these forward-looking statements on its current expectations and\nprojections about future events, nevertheless, actual results or events could\ndiffer materially from the plans, intentions and expectations disclosed in, or\nimplied by, the forward-looking statements the Company makes. These statements\nare only predictions and involve known and unknown risks, uncertainties, and\nother factors, including market and other conditions and those discussed under\nitem 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for\nthe fiscal year ended December 31, 2025, and in Part II, Item 1A, “Risk\nFactors” in its Quarterly Report on Form 10-Q for the fiscal quarter\nended March 31, 2026. You should not place undue reliance on these\nforward-looking statements, as they are subject to risks and uncertainties,\nand actual results and performance in future periods may not occur or may be\nmaterially different from any future results or performance suggested by the\nforward-looking statements in this release. This press release speaks as of\nthe date indicated above. The Company undertakes no obligation to update any\nforward-looking statements, whether as a result of new information, future\nevents, or otherwise, except as required by law. The Company expressly\ndisclaims any obligation to update or revise any forward-looking statements\nfound herein to reflect any future changes in the Company’s expectations of\nresults or any future change in events, except as required by law.\n\nInvestor Contact: \nNeil Dey\nBluejay Diagnostics, Inc.\nir@bluejaydx.com\n978-631-0310\n\nWebsite: www.bluejaydx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/d0d4a766-5115-448d-ba8a-d522100949f1)\n\n\n\nGlobeNewswire, Inc. 2026","article_body_html":"","raw_payload":{"data":{"id":"nGNX64BHnj","title":"Bluejay Diagnostics Provides First Quarter 2026 Corporate Update","author":"Globe Newswire","ticker":"BJDX","created":"2026-05-07T20:01:01.848Z","tickers":["BJDX"],"exchange":"NASDAQ","article_body":"ACTON, Mass., May 07, 2026 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc.\n(“Bluejay” or the “Company”), a medical diagnostics company focused on\nimproving patient outcomes in critical care settings, today provided a\ncorporate update highlighting progress achieved during the first quarter of\n2026 and recent operational developments related to its Symphony™\nnear-patient diagnostic platform.\n\nDuring the first quarter of 2026, Bluejay continued advancing the clinical,\nmanufacturing, and regulatory activities supporting the development of its\nSymphony IL-6 test for sepsis patient monitoring and risk assessment in\ncritical care settings.\n\nQ1 2026 and Recent Highlights\n\n• Continued enrollment progress in the ongoing SYMON-II pivotal clinical\nstudy evaluating the role of IL-6 in sepsis and septic shock patients. As of\nMay 5, 2026, approximately 680 patients have been enrolled toward the target\nenrollment of 750 patients across participating clinical sites.\n\n• Advanced manufacturing readiness activities for Symphony cartridges in\ncollaboration with Sanyoseiko Co. Ltd., Bluejay’s contract manufacturing\norganization. The Company successfully resolved technical issues related to\nthe Symphony cartridge manufacturing process and is progressing toward\nanalytical and clinical validation activities intended to support future\nregulatory submission.\n\n• Continued execution of Bluejay’s FDA-focused regulatory strategy for\nSymphony IL-6, with the Company maintaining its objective of preparing for a\nfuture 510(k) submission following completion of required analytical and\nclinical validation activities.\n\n• Continued development activities related to Bluejay’s broader Symphony\nplatform strategy, which includes future potential applications in additional\ncritical care biomarkers and cardiovascular disease monitoring.\n\nNeil Dey, President and Chief Executive Officer of Bluejay Diagnostics,\ncommented, “We believe the first quarter of 2026 represented meaningful\noperational progress across several key areas of our Symphony program. Most\nimportantly, we continued strong enrollment momentum in our SYMON-II pivotal\nstudy while also advancing manufacturing readiness activities intended to\nsupport future analytical and clinical validation. We are encouraged by the\nprogress our team and partners have made in positioning Symphony toward the\nnext phase of development.”\n\nMr. Dey continued, “We believe Symphony has the potential to address an\nimportant unmet need in critical care by enabling rapid, near-patient\nbiomarker testing where time-sensitive clinical decisions are essential. As we\ncontinue executing our clinical and manufacturing roadmap, we remain focused\non progressing toward regulatory readiness and future commercialization\nopportunities.”\n\nFinancial Highlights\n\nAs of March 31, 2026, Bluejay reported cash and cash equivalents of\napproximately $3.7 million. The Company reported a net loss of approximately\n$1.9 million for the first quarter of 2026, compared to approximately $1.9\nmillion for the same period in 2025.\n\nThe Company believes it has continued to manage operating expenses with\nfinancial discipline while prioritizing critical clinical, manufacturing, and\nregulatory activities supporting the Symphony program.\n\nAbout the Symphony IL-6 Test:\n\nThe Symphony(TM) Test platform is designed to determine patient acuity for\ntriage and monitoring based on the measurement of a specific biomarker. The\nSymphony(TM) IL-6 Test to determine patient acuity for sepsis triage and\nmonitoring (“Symphony(TM) IL-6 Test”) is currently Bluejay’s lead\nproduct candidate.\n\nNote: Investigational device. Limited by United States law to investigational\nuse.\n\nAbout the SYMON Clinical Study Program:\n\nThe SYMON Clinical Study Program includes SYMON-I (clinicaltrials.gov ID\nNCT06181604), SYMON-II (NCT06654895), and SYMON-III (NCT07425587). SYMON-I is\na pilot study to determine IL-6 levels associated with various endpoints,\nincluding, but not limited to 28-day all-cause mortality and in-hospital\nmortality. The SYMON-II study is the pivotal study to validate the outcomes of\nthe SYMON-I study, which the Company plans to use to support a 510(k)\napplication to the FDA. The SYMON-III study is a pilot study to determine IL-6\nlevels associated with patients presenting with increasing severity of\ninfection in the emergency department and risk of developing sepsis.\n\nAbout Bluejay Diagnostics:\n\nBluejay Diagnostics, Inc. is a medical diagnostics company focused on\nimproving patient outcomes using its Symphony System, a cost-effective, rapid,\nnear-patient testing system for sepsis triage and monitoring of disease\nprogression. Bluejay does not yet have regulatory clearance for the Symphony\nSystem, and we will need to receive regulatory authorization from the U.S.\nFood and Drug Administration before Symphony can be marketed as a diagnostic\nproduct in the United States. Bluejay’s first product candidate, an IL-6\nTest for sepsis, is designed to provide accurate, reliable results in\napproximately 20 minutes from ’sample-to-result’ to help medical\nprofessionals make earlier and better triage/treatment decisions. More\ninformation is available at www.bluejaydx.com.\n\nForward-Looking Statements:\n\nThis press release contains statements that the Company believes are\n“forward-looking statements” within the meaning of the Private Litigation\nReform Act. Forward-looking statements may be identified by words such as\n“anticipates,” “believes,” “estimates,” “expects,”\n“intends,” “may,” “plans,” “projects,” “seeks,”\n“should,” “suggest,” “will,” and similar expressions. The Company\nhas based these forward-looking statements on its current expectations and\nprojections about future events, nevertheless, actual results or events could\ndiffer materially from the plans, intentions and expectations disclosed in, or\nimplied by, the forward-looking statements the Company makes. These statements\nare only predictions and involve known and unknown risks, uncertainties, and\nother factors, including market and other conditions and those discussed under\nitem 1A. “Risk Factors” in the Company’s Annual Report on Form 10-K for\nthe fiscal year ended December 31, 2025, and in Part II, Item 1A, “Risk\nFactors” in its Quarterly Report on Form 10-Q for the fiscal quarter\nended March 31, 2026. You should not place undue reliance on these\nforward-looking statements, as they are subject to risks and uncertainties,\nand actual results and performance in future periods may not occur or may be\nmaterially different from any future results or performance suggested by the\nforward-looking statements in this release. This press release speaks as of\nthe date indicated above. The Company undertakes no obligation to update any\nforward-looking statements, whether as a result of new information, future\nevents, or otherwise, except as required by law. The Company expressly\ndisclaims any obligation to update or revise any forward-looking statements\nfound herein to reflect any future changes in the Company’s expectations of\nresults or any future change in events, except as required by law.\n\nInvestor Contact: \nNeil Dey\nBluejay Diagnostics, Inc.\nir@bluejaydx.com\n978-631-0310\n\nWebsite: www.bluejaydx.com\n\n(https://www.globenewswire.com/NewsRoom/AttachmentNg/d0d4a766-5115-448d-ba8a-d522100949f1)\n\n\n\nGlobeNewswire, Inc. 2026"},"type":"article","timestamp":"2026-05-07T20:01:02.138801425Z","server_sent_at_ms":1778184062138},"received_at":"2026-05-07T20:01:02.268Z","source_url":null},"analysis":null,"durationMs":null,"modelName":null}}