San Diego, December 17, 2021 (Global News Agency)-Through NewMediaWire-Sigyn Therapeutics, Inc. (OTC: "SIGY"), a medical technology company focused on the treatment of pathogen-related diseases that cause sepsis, The following note written by its chairman and CEO Jim Joyce was released today.

On March 24, 2020, the U.S. Department of Health and Human Services (HHS) announced that the emergence of COVID-19 proves that the emergency use authorization (EUA) of drugs, biological products, and medical devices is to fight the pandemic.

Within one month of the HHS statement, the U.S. Food and Drug Administration (FDA) issued EUAs to industry colleagues at Terumo BCT, ExThera Medical Corporation, CytoSorbents, Inc., and Baxter Healthcare Corporation. The therapeutic products provided by these organizations are not drugs or biological agents, but blood purification technologies.

In terms of these EUA awards, the FDA issued a statement stating that blood purification equipment may effectively treat certain confirmed COVID-19 patients by reducing various pathogens, cytokines and other inflammatory mediators in the blood.

Consistent with the FDA's statement, we have been advancing Sigyn Therapy, a dual-function blood purification technology. We created this technology to address the source of life-threatening inflammation and at the same time broadly eliminate cytokines and other inflammatory mediators.

Starting in December 2020, we have reported the results of a series of in vitro blood purification studies. These studies have verified the ability of Sigyn Therapy to extract a broad spectrum of viral pathogens (including COVID-19), Gram-negative and Gram-positive bacteria. Toxins, liver toxins, cell vesicles and pro-inflammatory cytokines in plasma.

While we are interested in participating in the emerging blood purification industry, COVID-19 has revealed the pros and cons of the government's prepared plans at the beginning of the pandemic.

In this regard, the development, clinical testing, market licensing, and global delivery of multiple vaccines to prevent severe COVID-19 infection are unprecedented. Less than a year after HHS authorization, vaccines from Janssen, Moderna, and Pfizer-BioNTech were approved under emergency use authorization. In addition to the continuing need to prevent COVID-19, the business environment for protective vaccines should continue to be strong, as the convergence of global warming, urban congestion, and intercontinental travel may contribute to the continuation of future epidemics.

In contrast, 5.3 million COVID-19 deaths and the global economic shutdown have exposed the futile effort of aligning post-exposure antiviral drugs with emerging pandemic threats. Especially if preventive messenger RNA (mRNA) vaccines can be put on the market earlier than the development of antiviral drugs after exposure. Between the aforementioned EUA approvals for blood purification and vaccine technologies, Remdesivir (Gilead Sciences) is a drug repurposed from the 2014 Ebola virus outbreak and is the only antiviral drug approved under the EUA.

Therefore, more and more attention should be paid to blood purification technology as a post-exposure strategy for the treatment of hospitalized patients with severe infections. Finally, considering that a properly designed blood purification device can perform functions that drugs cannot achieve, and in addition to treating pandemic viruses, it will also have a wide range of commercial applications.

Happy holidays, Jim

Sigyn Therapeutics is a medical technology company that focuses on the treatment of pathogen-related diseases that cause sepsis, which is the number one cause of death in hospitals worldwide. Sigyn Therapy™ is a dual-function blood purification technology that can extract the source of life-threatening inflammatory pathogens and eliminate inflammatory mediators in the blood with a broad spectrum.

Starting in December 2020, a series of in vitro blood purification studies have verified that Sigyn Therapy solves endotoxin (Gram-negative bacterial toxin), peptidoglycan and lipoteichoic acid (Gram-positive bacterial toxin), viral pathogens (including COVID-19), liver toxins (ammonia, bile acid and bilirubin), cell vesicles that transport inflammatory substances, and related pro-inflammatory cytokines (TNF-a, IL-1b, IL-6), they are causing The basis of the cytokine storm of sepsis.

Sigyn Therapy's treatment opportunities include, but are not limited to, emerging bioterrorism and pandemic threats, drug-resistant pathogens, hepatic encephalopathy, and community-acquired pneumonia, which are the main cause of death in infectious diseases and the main cause of death in children. 5 years old is the catalyst for about 50% of sepsis and septic shock cases.

To support widespread implementation, Sigyn Therapy is a disposable device designed to be used in the established infrastructure of hemodialysis and continuous renal replacement therapy (CRRT) machines in hospitals and clinics around the world. Sigyn Therapy contains a formula of adsorbent components that can provide a surface area of ​​more than 200,000 square meters (approximately 50 acres) for adsorption and removal of blood flow targets. Unlike devices that focus treatment targets in the blood path, Sigyn Therapy extracts targets from the bloodstream, which eliminates their ability to interact with blood cells during treatment.

To learn more, please visit www.SigynTherapeutics.com

Note on forward-looking statements

The information in this press release contains forward-looking statements by Sigyn Therapeutics, Inc. ("Sigyn"), which involve significant risks and uncertainties. All statements contained in this summary are forward-looking statements referred to in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and involve risks and uncertainties. Contain statements such as "may", "believe", "anticipate", "anticipate", "intend", "plan", "project", "will", "forecast", "estimate", "may" or similar words The statements constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties, and actual results may differ materially from the expected results in the forward-looking statements. These forward-looking statements are based on Sigyn's current expectations and involve assumptions that may never be realized or may prove to be incorrect. Factors that may cause this difference may include, but are not limited to, the company's ability to clinically advance Sigyn therapy in human studies required for market clearing, the company's ability to produce Sigyn therapy, the company's ability to raise capital resources, and other potential risks. The above list of risks and uncertainties is illustrative but not exhaustive. Other factors that may cause the results to differ materially from those expected in the forward-looking statements can be found under the heading “Risk Factors” in the company’s annual report on Form 10-K for the year ended December 31, 2020, and in the company’s Other documents filed with the US Securities and Exchange Commission, including its quarterly report on Form 10-Q. All forward-looking statements contained in this report represent only the conditions as of the date they are made. Except as required by law, the company does not intend and does not assume any responsibility to update this information to reflect future events or circumstances.

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