Asep Inc. is Granted Patent Approval for its Sepsis Diagnostic Technology in 13 European Countries and Australia

Rhea-AI Summary

Asep Medical Holdings Inc. (CSE: ASEP; OTCQB: SEPSF) announced that its sepsis diagnostic technology, Sepset^ER, has received patent approval in 13 European countries and Australia. This patent validates Asep's AI-based approach to diagnosing sepsis, which claims over 11 million lives annually. The test, developed under CEO Dr. Robert E. W. Hancock, enables rapid diagnosis with results in 60-90 minutes, significantly faster than existing methods. Asep is preparing for formal clinical studies aiming for FDA approval, potentially leading to marketing in emergency and intensive care settings.

Positive

• Patent approval in 13 European countries and Australia enhances market potential.
• Sepset^ER provides accurate diagnosis within 60-90 minutes, improving patient outcomes.
• Technology developed under experienced leadership with strong clinical validation.

Negative

• Dependence on successful completion of clinical 510(k) studies for FDA approval.
• High competitive landscape in sepsis diagnostic market may pose challenges.

VANCOUVER, BC, Nov. 7, 2022 /PRNewswire/ - Asep Medical Holdings Inc. ("Asep Inc." or the "Company") (CSE: ASEP) (OTCQB: SEPSF) is very pleased to announce that the Company's sepsis diagnostic technology, called Sepset^{ER TM}, has received successful patent approval in 13 European countries as well as in Australia. The Company received confirmation of its European Patent (EP) 3117030 from its patent lawyers on August 29, 2022, and this patent was subsequently validated in Belgium, Denmark, Finland, France, Germany, Ireland, Italy, Netherlands, Norway, Spain, Sweden, Switzerland and the UK, representing 400 million people. The Company also was awarded a patent in Australia (Australian Patent No. AU2020201564B2), issued on July 16, 2022.

The patents, exclusively licensed to Asep Inc.'s subsidiary Sepset Biosciences Inc., validate the Company's unique and clinically feasible AI-based approach to sepsis diagnosis, a disease that globally causes more than 11 million deaths annually. The technology, named Sepset^ER, is a blood-based gene expression assay developed under the direction of leading UBC microbiologist and Asep Inc.'s Founding Director and current CEO, Dr. Robert E. W. Hancock. The test enables early and accurate diagnosis of severe incidences of the deadly disease sepsis, which 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. Since the Sepset^ER 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 Sepset^ER 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. Sepset^ER is designed to enable physicians to quickly predict how severe the disease will become and thus trigger urgent patient treatment. The patent licensing arrangement gives Asep Inc.'s subsidiary, Sepset Biosciences Inc., exclusive worldwide rights to develop the sepsis severity signature into a diagnostic test and bring the test to market.

CEO Dr. Robert E. W. Hancock stated, "Patents are the lifeblood of biotech. This validates the novelty of our technology in major markets."

Tim Murphy, the COO, commented, "The expansion of Asep Inc.'s patent coverage in Europe and Australia represents an important step for the company towards commercialization of the Sepset^ER test."

ABOUT ASEP MEDICAL HOLDINGS INC.

Asep Medical Inc. (asepmedical.com) is dedicated to addressing antibiotic failure by developing novel solutions for significant unmet medical needs. The Company is a consolidation of two existing private companies (Sepset Biosciences Inc. and ABT Innovations Inc.) that are both in the advanced development of both proprietary diagnostic tools, enabling the early and timely identification of severe sepsis as well as broad-spectrum therapeutic agents to address multidrug-resistant biofilm infections.

Sepset Biosciences Inc. (sepset.ca) is developing a diagnostic technology that involves a patient gene expression signature that predicts severe sepsis, one of the significant diseases leading to antibiotic failure since antibiotics are the primary treatment for sepsis. Despite this, sepsis is responsible for nearly 20% of all deaths on the planet. The Sepset^ER test is a blood-based gene expression assay that is straightforward to implement, and results are obtained in about an hour in the emergency room or intensive care unit. This proprietary diagnostic technology differs from current diagnostic tests in enabling diagnosis of severe sepsis within 1-2 hours of first clinical presentation (i.e., in the emergency room), while other diagnostics only provide diagnosis after 24-36 hours. Asep Inc. believes this will enable critical early decisions to be made by physicians regarding appropriate therapies and reduce overall morbidity and mortality due to sepsis.

ABT Innovations Inc.'s (abtinnovations.ca) peptide 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.

FORWARD-LOOKING STATEMENTS —

This news release contains certain "forward-looking statements" within the meaning of such statements under applicable securities law. Forward-looking statements are frequently characterized by words such as "anticipates", "plan", "continue", "expect", "project", "intend", "believe", "anticipate", "estimate", "may", "will", "potential", "proposed", "positioned" and other similar words, or statements that certain events or conditions "may" or "will" occur. These statements include but are not limited to the completion of successful clinical testing of our Sepsis diagnostic test and its intended filing for regulatory approval; and the undertaking of pre-clinical studies on our lead therapeutic, with the expectation that this will lead to fast-track clinical trials. Various assumptions were used in drawing conclusions or making the predictions contained in the forward-looking statements throughout this news release. Forward-looking statements are based on the opinions and estimates of management at the date the statements are made and are subject to a variety of risks (including those risk factors identified in the Asep Medical Inc.'s prospectus dated November 9, 2021) available for review under the Company's profile at www.sedar.com and uncertainties and other factors that could cause actual events or results to differ materially from those projected in the forward-looking statements. Asep Medical Inc. is under no obligation, and expressly disclaims any intention or obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by applicable law.

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SOURCE ASEP Medical Holdings Inc.

FAQ

What recent patent approvals did Asep Medical receive for SEPSF?

Asep Medical received patent approvals for its sepsis diagnostic technology Sepset^ER in 13 European countries and Australia.

What is the significance of the Sepset^ER test for SEPSF?

The Sepset^ER test enables fast and accurate sepsis diagnosis, which can reduce mortality rates associated with the disease.

Who is the CEO leading Asep Medical Holdings Inc. (SEPSF)?

Dr. Robert E. W. Hancock is the CEO of Asep Medical Holdings Inc.

What are the next steps for Asep Medical Holdings (SEPSF) regarding its sepsis technology?

Asep Medical is preparing for formal clinical 510(k) studies to obtain FDA approval for the Sepset^ER test.

How does Sepset^ER compare to traditional sepsis diagnostic methods?

Sepset^ER delivers results in 60-90 minutes, compared to 8-36 hours for traditional methods, enabling quicker treatment decisions.