Sigyn Therapeutics ™ reveals an in-vitro study of a viral pathogen

Sigyn Therapy ™ demonstrates the ability to address viral pathogens, including SARS-CoV-2 (COVID-19)

SAN DIEGO, April 21, 2021 (GLOBE NEWSWIRE) – by road NewMediaWire – Sigyn Therapeutics, Inc. (OTCMarkets: SIGY), a medical technology company focused on treating life-threatening inflammatory conditions precipitated by Cytokine Storm syndrome, today unveiled initial in vitro studies that demonstrated Sigyn Therapy’s ability to adsorb viral pathogens, including SARS -CoV-2 (COVID-19).

Cytokine storm syndrome is an overreaction of the immune system caused by infectious and non-infectious conditions. An indicator of cytokine storm syndrome is the excessive or uncontrolled release of proinflammatory cytokines, which can lead to multiple organ failure and cause death. The annual market opportunity to address Cytokine-related indications exceeds $ 20 billion and includes sepsis, the most common cause of death in hospitals worldwide. Virus-induced cytokine storm syndrome is the leading cause of death due to severe SARS-CoV-2 infections (COVID-19).

In an in vitro study, Sigyn reported the ability of adsorbent components incorporated in Sigyn Therapy to address viral pathogens, including COVID-19. As a result of two hours of exposure to Sigin components of the adsorbent, the presence of the pseudotypic lentivirus SARS-CoV-2 was reduced by 68.8% from plasma. Pseudotyped lentivirus SARS-CoV-2 established a model previously used to study the development of antiviral drugs for the treatment of COVID-19 and to evaluate the efficacy of vaccines against variants of COVID-19.

Sigyn Chairman and CEO Jim Joyce said: “While our first observation of viral depletion may be convincing, we recognize that this is the first of several steps to confirm viral depletion combined with the elimination of proinflammatory cytokines as effective strategies to mitigate viral cytokine storms. “

Sigyn Therapeutics further announced that it had filed a provisional patent application with the United States Patent and Trademark Office (USPTO) to protect this new discovery.

Sigyn Therapy is a proprietary blood purification technology designed to overcome the limitations of previous candidates for drugs and devices to treat acute inflammatory conditions. Included in Sigyn Therapy cocktail is an adsorbent component with unique binding and trapping characteristics to optimize the depletion of broad-spectrum inflammatory targets from the bloodstream. The disposable medical device is designed for use on the established infrastructure of dialysis and CRRT devices that are already in hospitals and clinics around the world.

As of December 1, 2020, the company reported the results of several in vitro studies created to test the ability of Sigyn therapy to address a wide range of inflammatory targets.

Among these studies were the simultaneous capture of endotoxins and relevant proinflammatory cytokines, which included Interleukin-1 Beta (IL-1B), Interleukin-6 (IL-6), and Tumor Necrosis Factor alpha (TNF-a). Endotoxin (lipopolysaccharide or LPS) is a potent mediator involved in the pathogenesis of sepsis and septic shock. Unregulated overproduction of IL-1B, IL-6, and TNF can cause organ failure and cause death. The aim of this study was to balance elevated cytokine levels and optimize the elimination of endotoxins from human blood plasma. The study was conducted in triplicate over four-hour time periods with the pediatric version of Sigyn Therapy. The average endotoxin load reduction reached 83% during the studies. The mean decrease in IL-1B was 69%, the decrease in IL-6 was 59%, and the decrease in TNF-α was 57% during the four-hour studies.

Sigyn Therapeutics also reported the results of an in vitro pilot study that modeled the ability of Sigyn Therapy ™ to address CytoVesicles that transport inflammatory cytokine cargo into the bloodstream. CytoVesicles (extracellular vesicles that carry the inflammatory burden of cytokines) participate in agreement with free-circulating cytokines to further escalate cytokine storm syndrome. CytoVesicles were previously an unattainable target because they can be 20-60 times larger than the cytokines themselves. In an in vitro pilot study, 104 nm liposomes were used as a model system to assess the ability of Sigyn Therapy adsorbent components to deplete CytoVesicles from human blood plasma. After two hours of interaction with Sigyn components of the adsorbent, liposome concentrations in human blood plasma were reduced by 9090%. Previously published studies have validated liposomes as a model for isolating extracellular vesicles from blood based on the similarity of their size and structural characteristics.

The data obtained from each of these studies will be incorporated into the Investigative Device Exemption (IDE) that Sigyn Therapeutics plans to submit to the U.S. Food and Drug Administration (FDA) in 2021.

About Sigyn Therapeutics

Sigyn Therapeutics ™ is a therapeutic technology development company based in San Diego, California, USA. Our focus is on significant unmet needs in global health; treatment of life-threatening inflammatory conditions that are precipitated by cytokine storm syndrome and that are not addressed by approved therapy. Our mission is to save lives.

Sigyn Therapy ™ is a new blood purification technology designed to alleviate cytokine storm syndrome through the depletion of a wide range of inflammatory targets from the bloodstream. Cytokine storm syndrome is a feature of sepsis, which is the most common cause of death in the hospital and takes more lives each year than all forms of cancer combined. Storm caused by cytokine viruses (VICS) is associated with high mortality and is the leading cause of death from SARS-CoV-2 (COVID-19). Other therapeutic options include, but are not limited to, bacterial-induced cytokine storm (BICS), acute respiratory distress syndrome (ARDS), and acute forms of liver failure, such as hepatic encephalopathy.

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Note regarding future statements

This press release contains statements from Sigyn Therapeutics, Inc. (“Sigyn”) involving significant risks and uncertainties. All statements contained in this press release are statements provided for in the meaning of the Private Securities Litigation Reform Act 1995. The words “could”, “will”, “plan”, “intend”, “anticipate”, “approximately”, ”“ Expect, ”“ potentially, ”or negatively from these terms or other similar terms are intended to identify forward-looking statements, although they do not contain all forward-looking statements. These forward-looking statements include, but are not limited to, statements about Sigyn’s future financial results, the effect of management changes, any proposed organizational restructuring, business results, capital resources to finance the business; statements of Sigyn’s expectations regarding the capitalization, resources and ownership structure of the combined company; statements of potential benefits of the transaction; expected completion and timing of the transaction and other information related to the transaction; and any statements other than statements of historical facts. Actual results or events could differ materially from the plans, intentions and expectations disclosed in future statements by Sigyn due to a number of important factors, including (i) the risk that the transaction may not be executed on time or at all, which could adversely affect Sigyn’s business. and the price of Sigyn ordinary shares, (ii) failure to complete the transaction, (iii) the occurrence of any event, change or other circumstance that could lead to termination of the merger agreement, (iv) risks associated with the ability to realize the expected benefits of the transaction, including the risk that the entity will not successfully integrate, (v) the effect of announcing or delaying the transaction on Sigyn’s business relationships, business results and operations in general, (vi) risking the proposed transaction disrupting current plans and operations, (vii) risks associated with the combined entity’s ability to be listed on the national stock exchange, (viii) risks associated with the combined entity’s access to existing capital and the prospect of raising funds to finance its day-to-day operations, (ix) risks associated with diverting management’s attention from Sigyn’s current operations, (x) other business effects, including industry, market, economic, political or regulatory conditions, future foreign exchange and interest rates and changes in tax and other laws, regulations, rates and policies; and (xi) associated risks to the inability to produce Sigyn therapy, risks associated with clinical progress of Sigyn therapy with regulatory agencies, and no guarantee that Sigyn will therapy prove to be a safe and effective treatment for any condition. The statements in this statement for the future represent Sigyn’s views at the date of this statement. Sigyn predicts that later events and happenings could lead to a change in his attitudes. However, although at some point in the future it may be decided to update these forward-looking statements, it expressly waives any obligation to do so. Therefore, you should not rely on these forward-looking statements to represent Sigyn’s views on any date after the date of this press release.

Contact Sigyn Therapeutics, Inc.

Jim Joyce

Chairman, CEO

(619) 368-2000

[email protected]