Asep Medical Holdings Inc. (“Asep Inc.” or the “Company“) (CSE: ASEP) (OTCQB: SEPSF) (FSE: JJ8) is pleased to announce that the Company’s AI-based sepsis diagnostic technology, called SepsetER TM, has received successful patent approval in the United States. The Company received confirmation from its attorneys of its US Patent Application No. 16/279788, which has been subsequently validated in the US, representing 332 million people. This patent is in addition to the successful European and Australian patents awarded to the Company in November of 2022, which represent approximately 400 million people.
The US patent, granted on August 18, 2023, is exclusively licensed to Asep Inc.’s subsidiary Sepset Biosciences Inc. and validates the Company’s unique AI-based approach to sepsis diagnosis, a disease that globally causes more than 11 million deaths annually. SepsetER TM is a blood-based gene expression assay developed under the direction of leading UBC microbiologist and Asep Inc.’s Founder, Chair & CEO, Dr. Robert E. W. Hancock. The test enables earlier and faster risk assessment of sepsis and enables targeted treatment. Sepsis is also the cause of death in most patients with severe COVID-19.
The patents also provide a solid foundation for the Company’s business since the test is in advanced development and in preparation for formal clinical 510(k) studies in the United States. Since the SepsetER signature has already been validated and refined in more than 700 sepsis and severe COVID-19 patients to date, the Company is looking to duplicate this in a formal trial. In the diagnostics area, the 510(k) route involves a single clinical study that, if successful, will lead to approval by the US Food & Drug Administration (FDA). Once approved, the test will be marketed for use in emergency rooms and intensive care units worldwide, enabling physicians to make early informed decisions about patient care that will improve prognosis and survival.
The SepsetER TM test senses the dysfunctional immune response underlying sepsis when patients first enter the emergency room. The test is a blood-based gene expression assay that is straightforward to implement using equipment available in most hospital labs, and results are obtained in about 60-90 minutes. Current diagnostic tools deliver results after approximately 8-36 hours, often delaying the initiation of treatment. SepsetER TM is designed to enable physicians to quickly predict how severe the disease will become and thus trigger urgent patient treatment.
CEO Dr. Robert E. W. Hancock stated, “Patents are the lifeblood of biotechnology companies like ours. This new patent in the US once again validates the novelty of our technology in major markets, which now represents over 700 million people.”