Bluejay Announces Abstract Accepted for Presentation at the 2025 Society of Academic Emergency Medicine (SAEM) Annual Meeting
Bluejay Diagnostics (NASDAQ: BJDX) has announced the acceptance of an abstract for presentation at the 2025 Society of Academic Emergency Medicine (SAEM) Annual Meeting in Philadelphia. The presentation will showcase new clinical data from the SYMON-I study, which evaluated the Symphony IL-6 Test in sepsis patients.
The study assessed IL-6 as a prognostic indicator for 28-day mortality, 7-day mortality, and microbiological positivity in patients intended or admitted to intensive care units. Dr. Nathan Shapiro from Beth Israel Deaconess Medical Center highlighted that early IL-6 testing shows promise in predicting short-term and mid-term mortality in sepsis patients.
The company is currently conducting the SYMON-II validation clinical study to further establish IL-6 as a prognostic biomarker. The presentation, titled 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)', will be delivered by Dr. John H. Lee and Dr. Nathan Shapiro on May 14, 2025.
Bluejay Diagnostics (NASDAQ: BJDX) ha annunciato l'accettazione di un abstract per la presentazione al Meeting Annuale 2025 della Society of Academic Emergency Medicine (SAEM) a Philadelphia. La presentazione mostrerà nuovi dati clinici derivati dallo studio SYMON-I, che ha valutato il test Symphony IL-6 in pazienti con sepsi.
Lo studio ha analizzato l'IL-6 come indicatore prognostico per la mortalità a 28 giorni, a 7 giorni e per la positività microbiologica in pazienti destinati o ricoverati in unità di terapia intensiva. Il dott. Nathan Shapiro del Beth Israel Deaconess Medical Center ha sottolineato come il test precoce dell'IL-6 mostri potenzialità nella previsione della mortalità a breve e medio termine nei pazienti con sepsi.
L'azienda sta attualmente conducendo lo studio clinico di validazione SYMON-II per consolidare ulteriormente l'IL-6 come biomarcatore prognostico. La presentazione, intitolata 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)', sarà tenuta dal dott. John H. Lee e dal dott. Nathan Shapiro il 14 maggio 2025.
Bluejay Diagnostics (NASDAQ: BJDX) ha anunciado la aceptación de un resumen para su presentación en la Reunión Anual 2025 de la Society of Academic Emergency Medicine (SAEM) en Filadelfia. La presentación mostrará nuevos datos clínicos del estudio SYMON-I, que evaluó la prueba Symphony IL-6 en pacientes con sepsis.
El estudio evaluó la IL-6 como indicador pronóstico para la mortalidad a 28 días, a 7 días y la positividad microbiológica en pacientes que estaban por ingresar o ya ingresados en unidades de cuidados intensivos. El Dr. Nathan Shapiro del Beth Israel Deaconess Medical Center destacó que la prueba temprana de IL-6 muestra potencial para predecir la mortalidad a corto y mediano plazo en pacientes con sepsis.
La compañía está llevando a cabo actualmente el estudio clínico de validación SYMON-II para establecer aún más la IL-6 como biomarcador pronóstico. La presentación, titulada 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)', será impartida por el Dr. John H. Lee y el Dr. Nathan Shapiro el 14 de mayo de 2025.
Bluejay Diagnostics (NASDAQ: BJDX)가 2025년 Society of Academic Emergency Medicine (SAEM) 연례회의에서 발표할 초록이 필라델피아에서 채택되었다고 발표했습니다. 이번 발표에서는 SYMON-I 연구의 새로운 임상 데이터를 소개할 예정이며, 이 연구는 패혈증 환자에서 Symphony IL-6 검사를 평가했습니다.
이 연구는 중환자실 입원 예정 또는 입원한 환자들의 28일 사망률, 7일 사망률, 미생물 양성 여부에 대한 예후 지표로서 IL-6를 평가했습니다. Beth Israel Deaconess Medical Center의 Nathan Shapiro 박사는 조기 IL-6 검사가 패혈증 환자의 단기 및 중기 사망률 예측에 유망하다고 강조했습니다.
회사는 현재 IL-6를 예후 바이오마커로 확립하기 위한 SYMON-II 검증 임상 연구를 진행 중입니다. 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)'라는 제목의 발표는 2025년 5월 14일 John H. Lee 박사와 Nathan Shapiro 박사가 진행할 예정입니다.
Bluejay Diagnostics (NASDAQ : BJDX) a annoncé l'acceptation d'un résumé pour une présentation lors de la réunion annuelle 2025 de la Society of Academic Emergency Medicine (SAEM) à Philadelphie. La présentation mettra en avant de nouvelles données cliniques issues de l'étude SYMON-I, qui a évalué le test Symphony IL-6 chez des patients atteints de sepsis.
L'étude a évalué l'IL-6 comme indicateur pronostique de la mortalité à 28 jours, à 7 jours, ainsi que de la positivité microbiologique chez des patients destinés ou admis en unité de soins intensifs. Le Dr Nathan Shapiro du Beth Israel Deaconess Medical Center a souligné que le test précoce de l'IL-6 présente un potentiel prometteur pour prédire la mortalité à court et moyen terme chez les patients septicémiques.
La société mène actuellement l'étude clinique de validation SYMON-II afin de confirmer davantage l'IL-6 comme biomarqueur pronostique. La présentation, intitulée « Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I) », sera donnée par le Dr John H. Lee et le Dr Nathan Shapiro le 14 mai 2025.
Bluejay Diagnostics (NASDAQ: BJDX) hat die Annahme eines Abstracts für die Präsentation auf dem Jahrestreffen 2025 der Society of Academic Emergency Medicine (SAEM) in Philadelphia bekanntgegeben. Die Präsentation wird neue klinische Daten aus der SYMON-I Studie vorstellen, die den Symphony IL-6 Test bei Patienten mit Sepsis bewertet hat.
Die Studie untersuchte IL-6 als prognostischen Indikator für die 28-Tage-Mortalität, 7-Tage-Mortalität und mikrobiologische Positivität bei Patienten, die für die Intensivstation vorgesehen oder aufgenommen wurden. Dr. Nathan Shapiro vom Beth Israel Deaconess Medical Center hob hervor, dass ein früher IL-6 Test vielversprechend ist, um die kurzfristige und mittelfristige Sterblichkeit bei Sepsispatienten vorherzusagen.
Das Unternehmen führt derzeit die SYMON-II Validierungsstudie durch, um IL-6 weiter als prognostischen Biomarker zu etablieren. Die Präsentation mit dem Titel 'Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)' wird am 14. Mai 2025 von Dr. John H. Lee und Dr. Nathan Shapiro gehalten.
- Clinical data shows promising results for IL-6 as prognostic biomarker in sepsis patients
- Ongoing enrollment in SYMON-II validation study indicates progress in product development
- None.
Insights
Bluejay's abstract acceptance for the SAEM conference represents incremental clinical progress for their Symphony IL-6 Test in sepsis management. The SYMON-I pilot study results appear to show promise for IL-6 as a biomarker to prognosticate mortality and predict microbiological culture positivity in sepsis patients.
The involvement of prominent researchers from Beth Israel Deaconess Medical Center and Harvard Medical School lends credibility to this early-stage work. Dr. Nathan Shapiro's commentary suggests potential clinical utility for IL-6 measurement in emergency departments to guide early sepsis management decisions.
Most significantly, Bluejay has advanced to their SYMON-II validation study with active enrollment underway. This represents a structured clinical development pathway for their lead product candidate. The validation study will help further define IL-6's role as a prognostic biomarker for mortality and other critical care endpoints.
For a microcap company with approximately
The presentation on May 14th may provide more detailed data points and statistical significance measures that aren't included in this announcement. The sepsis diagnostics market remains challenging with regulatory hurdles, making the timeline to potential commercialization still uncertain despite this positive progression.
New clinical data from the SYMON-I study to evaluate IL-6 in sepsis patients to be presented.
ACTON, Mass., April 15, 2025 (GLOBE NEWSWIRE) -- Bluejay Diagnostics, Inc. (NASDAQ: BJDX), today announced acceptance of an abstract related to the Symphony IL-6 Test, the company’s lead product candidate, for presentation at the Society of Academic Emergency Medicine (SAEM) Annual Meeting, taking place in Philadelphia May 13-16, 2025. Results from SYMON-I, a pilot clinical study of interleukin-6 (IL-6) in sepsis patients intended or admitted for the intensive care unit (ICU), will be presented. SYMON-I evaluated IL-6 as a prognosticator for 28-day mortality and exploratory endpoints including 7-day mortality and microbiological positivity.
“Early use of IL-6 in sepsis and septic shock patients shows promise in prognosticating short-term and mid-term mortality, and in predicting the development of microbiological positive cultures,” said Nathan Shapiro, M.D., Vice Chairman of Emergency Medicine Research at Beth Israel Deaconess Medical Center and Professor of Emergency Medicine at Harvard Medical School. “The findings from SYMON-I raise the potential to use IL-6 measured in the emergency department for early prognosis and to guide management in sepsis.”
“The 2025 SAEM Annual Meeting provides a timely opportunity to engage with emergency medicine professionals and share important information related to the role of IL-6 as an early biomarker for the inflammatory response and in the management of sepsis patients,” said Mark Feinberg, M.D., Chief Medical Advisor at Bluejay Diagnostics and Professor of Medicine at Harvard Medical School. “Enrollment in our SYMON-II validation clinical study is underway, which will help define IL-6 as a prognostic biomarker for mortality and other impactful critical care endpoints.”
Details of the presentation:
Title: Multicenter Symphony IL-6 Monitoring Sepsis ICU Validation Study (SYMON I)
Presenters: John H. Lee, M.D., Ph.D. and Nathan Shapiro, M.D.
Presentation Date: May 14, 2025
About the Symphony IL-6 Test:
The Symphony Test platform is designed to determine patient acuity for triage and monitoring based on the measurement of a specific biomarker. The Symphony IL-6 Test to determine patient acuity for sepsis triage and monitoring (“Symphony IL-6 Test”) is currently Bluejay’s lead product candidate.
About the SYMON Clinical Study Program:
The SYMON Clinical Study Program includes SYMON-I I (clinicaltrials.gov ID NCT06181604) and SYMON-II (NCT06654895). SYMON-I is a pilot study to determine IL-6 levels associated with various endpoints, including, but not limited to 28-day all-cause mortality and in-hospital mortality. The SYMON-II study is the pivotal study to validate the outcomes of the SYMON-I study, which the Company plans to use to support a 510(k) application to the FDA.
About Bluejay Diagnostics: Bluejay Diagnostics, Inc. is committed to advancing healthcare by developing accessible, affordable, rapid and direct biomarker testing, in whole blood, near patient. Bluejay’s first product candidate, an IL-6 test for sepsis triage, is designed to provide accurate, reliable results in approximately 20 minutes from ‘Sample-To-Result’ to help medical professionals make earlier and better triage/treatment decisions. Based in Acton, Massachusetts, Bluejay aims to improve clinical outcomes through timely and precise diagnostic tests.
Symphony is a registered trademark 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 nature and timing of the Company’s planned FDA submissions and related plans for clinical study completion, whether the Company’s cash position will be sufficient to fund operations needed to achieve regulatory approval and initial commercialization of the Symphony IL-6 Test, whether such regulatory approval will actually occur, and the continuation of the Company as a going concern. 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 Annual Report on Form 10-K for the fiscal year ended December 31, 2024. You should not rely 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.
Investor Contact:
Investor Relations
Bluejay Diagnostics, Inc.
ir@bluejaydx.com
Website: www.bluejaydx.com
FAQ
What are the key findings of Bluejay Diagnostics' (BJDX) SYMON-I study for sepsis patients?
When and where will BJDX present their SYMON-I study results?
What is the current status of Bluejay Diagnostics' (BJDX) SYMON-II validation study?
How could BJDX's Symphony IL-6 Test impact sepsis patient management?
