Asep Medical Holdings Inc. at the request of IIROC the Company would like to provide clarification on the disclosure regarding the diagnostic and therapeutic technologies of the Company and its subsidiaries Sepset Biosciences Inc. that was included in a news release dated December 23, 2022. The Company is addressing antibiotic failure on two fronts -- a novel diagnostic assay that detects severe sepsis in the emergency room (ER) and a peptide technology that combats hard-to-treat infections known as biofilms. Antibiotic failure is generally referred to as any situation where bacteria survive antibiotic treatment, and the clinical symptoms of the infection persist(1) . With around 49 million sepsis cases per year worldwide and over 11 million deaths(2), faster and more accurate sepsis detection will save lives.

In addition, there are currently no approved treatments for biofilm infections, which is alarming since 65%(3) of all infections are biofilms.Asep Inc.'s diagnostic technology, Sepset(ER) ((TM)), is a blood-based gene expression assay that can provide an early and accurate diagnosis of severe incidences of the deadly disease sepsis. Sepset(ER) can deliver a sepsis diagnosis within 60-90 minutes (based on internal laboratory testing at UBC), whereas conventional blood culture testing often takes, on average, 15 hours but can be as long as five days(4) . Early detection of sepsis, along with timely, appropriate treatments, increases the probability of survival for patients(5) significantly.

The diagnostic test, developed under the direction of leading UBC microbiologist and the Company's Founder, Chairman and CEO, Dr. Robert E.W. Hancock, enables early and accurate diagnosis of the deadly disease sepsis, which caused 11 million deaths globally in 2017(2) . The diagnostic test builds off of a 2014 eBioMedicine paper(6) that identified a sepsis gene expression signature among severely ill sepsis patients. It should be noted that the Company's sepsis diagnostic technology is patented in China, Australia, and 13 European countries.

A patent is pending in North America. In addition to speeding up the process of sepsis detection, Asep Inc. also offers a patented peptide technology that targets and suppresses biofilm regrowth and reduces inflammation, addressing the ineffectiveness of current treatments for a wide range of hard-to-treat infections. The technology covers a broad range of therapeutic applications, including bacterial biofilm infections (medical device infections, chronic infections, lung, bladder, wound, dental, skin, ear- nose and throat, sinusitis, orthopaedic, etc.), anti-inflammatories, anti-infective immune-modulators and vaccine adjuvants.

The peptide technology is in advanced development through collaboration with its pre-clinical partner, iFyber, LLC. iFyber is a preclinical contract research organization based in Ithaca, NY, with expertise in antimicrobial wound dressings, biomaterials and wound care management. The Company believes that once the necessary regulatory approvals have been achieved and the requisite product testing has been completed, there will be various paths for the Company to consider with respect to monetizing this product and generating revenue.

The diagnostic assay is proceeding towards a definitive trial in the USA for 510(k) (FDA) approval, with trials currently anticipated to start mid-2023 and completed to allow application for regulatory 510(k) approval by year's end. Successful approval will enable the company to start selling diagnostic assays for sepsis in early 2024. The Company is currently developing the final diagnostic assay format.

The peptide therapeutic technology is in advanced pre-clinical testing, having been proven in relevant animal models. Its use in dental practice mouthwashes has been demonstrated in a small number of human volunteers, and a larger trial will be performed with Bohai in 2023. If successful this anti-biofilm hygiene treatment will be marketed, estimated in late 2023.

Advanced anti-biofilm bandages have demonstrated efficacy in animal models and are estimated to start the 510(k) clinical process in late 2023.