This Study performs unique rapid on-site measurements of interleukin-6 (IL-6) and positions Company to move forward with multiple initiatives.
“Sepsis is a leading cause of hospitalization and mortality, with about 1.7 million people developing sepsis in the US alone,” said Dr.
This study will use the Symphony IL-6 test to monitor IL-6 concentrations in patients who are diagnosed with sepsis or septic shock and are admitted or intended to be admitted to the ICU. The objective of this study is to establish IL-6 concentrations in these sepsis patients that best predict 28-day mortality. The study design incorporates feedback from the pre-submission meetings with the FDA held earlier this year. The details of this clinical study are listed on clinicaltrials.gov (NCT06181604) and will be updated as more clinical study sites are brought into the study.
“We are very excited to start these important studies,” said
Interleukin-6 (IL-6) is an established biomarker of immune system activation. It is elevated in sepsis, infection, inflammation, and cancer. IL-6 presents in blood circulation as an early “first responder” in conditions which cause inflammation, such as sepsis, and needs to be measured quickly and reliably.
About the Symphony™ System:
Bluejay’s Symphony System (the “Symphony System”) is designed to address the need for simple, reliable, rapid, near-patient testing by providing quantitative measurements of specific biomarkers to determine the need for additional patient care and monitoring. The user-friendly Symphony System will not require any sample preparation or dedicated staff and was shown in published clinical studies to deliver results in approximately 20 minutes.
The Symphony IL-6 Test is a development stage product candidate for investigational use only. It is limited by
This press release contains statements that the Company believes are “forward-looking statements” within the meaning of the Private Litigation Reform Act. Forward-looking statements in this press release include, without limitation, the Company’s expectations for conducting and completing clinical trials, including planned expansion to additional testing locations, the expected nature and timing of the Company’s planned FDA submission, 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, and whether such regulatory approval will actually occur. Forward-looking statements may be identified by words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “may,” “plans,” “projects,” “seeks,” “should,” “suggest”, “will,” and similar expressions. 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 under item 1A. “Risk Factors” in our most recently filed Form 10-K filed with the
Source: Bluejay Diagnostics