Asep Medical Holdings is delighted to announce the successful approval of a patent for its revolutionary AI-powered sepsis diagnostic technology, SepsetER TM, in the United States. This achievement serves as a pivotal moment for the company, establishing a strong foundation for its business as it progresses into advanced development and prepares for formal clinical 510(k) studies in the U.S.

The SepsetER signature has undergone thorough validation and refinement through extensive testing on over 700 cases involving sepsis and severe COVID-19 patients. Building on these validated results, the company is now gearing up for a formal trial to further substantiate its efficacy. The 510(k) pathway in the field of diagnostics involves a single clinical study, with successful completion leading to approval by the US Food & Drug Administration (FDA). Upon approval, the diagnostic test will be made available globally for use in emergency rooms and intensive care units, empowering physicians to make swift, well-informed decisions that can significantly improve prognosis and enhance survival rates.

What sets SepsetER TM apart is its ability to identify the dysfunctional immune response at the onset of sepsis when patients first present in the emergency room. This blood-based gene expression assay is designed for straightforward implementation using standard hospital lab equipment, producing results within 60-90 minutes. In contrast, current diagnostic tools often take 8-36 hours, potentially causing delays in crucial treatment initiation. SepsetER TM is strategically crafted to provide physicians with rapid insights into the severity of the disease, allowing them to initiate urgent and personalized patient treatment promptly.

Source: prnewswire.com