InflammaSense Information

One liner: InflammaSense is building the VITAL-X-PATCH it records a new vital sign termed Autonomic Neurography or ANG; it immediately transmits disease severity to a clinician with millisecond precision. With the developed VITAL-X-PATCH InflammaSense is in process with FDA for clearances expected in 6 months time. Our novel and purpose-made machine-learning algorithms drive high quality and reproducible data analyses with continuous stratification of autonomic and inflammation states across nth number of diseases. The company has successfully navigated the regulatory landscape, obtaining a Non-Significant Risk (NSR) determination and completing key Pre-Submissions for the envisioned clinician decision support system; it focused on sepsis diagnostics using wearable Autonomic Neurography (ANG). The 510(k) clearance process is underway (Q-submission complete and Clinical Testing Plan in process), while progress continues towards DeNovo and PMA approval are scoped for the current raise. InflammaSense has filed multiple patents, with licensing complete and or licensure agreements from UCSD and Duke University in progress. The company has secured $1.65 million in dilutive funding, combining a Seed round of $1.4 million and an additional $250K in pre-seed funding. This funding has supported the development of its wearable sensor patch & InflammaSense has also attracted substantial backing from key government agencies, including BARDA, DARPA/ARPA-H, and NIH, totaling $4.05 Mil which have funded important projects in sepsis and inflammatory response diagnostics. With these milestones in place, the company is well-positioned to pursue its $7.5 million Series A raise to further advance its technologies, aiming for FDA approvals and commercial rollout by 2029.