SAN DIEGO, CA - (NewMediaWire) - May 17, 2023 - Sigyn Therapeutics, Inc. (“Sigyn” or the “Company”) (OTCQB: SIGY), a development-stage medical technology company, disclosed today that it has submitted a provisional patent application entitled: “DEVICES FOR ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES” to the United States Patent and Trademark Office (“USPTO”). Associated with this patent submission, the Company further disclosed that a trademark application to register ImmunePrep^TM has also been filed with the USPTO.

ImmunePrep^TM is a development-stage commercialization platform for antibody-based immunotherapies and their corresponding biosimilars. The platform is designed to permit the potential creation of selective plasma depletion devices that enhance the delivery of therapeutic antibodies without increasing drug toxicity.

Therapeutic antibodies are market-cleared to treat a variety of indications, including but not limited to Alzheimer’s disease, autoimmune disorders, and cancer.  However, patient response to these therapies is often suboptimal as just a small portion of infused antibodies reach their intended therapeutic target.  In many cases, infused antibodies are bound by drug decoys that display the antibody’s antigen binding site on their surface.  As a result, these decoys are empowered to bind and sequester antibodies from being delivered to their therapeutic targets (such as cancer cells). 

ImmunePrep^TM is designed to allow for a monoclonal antibody to be the active component of a selective plasma depletion device that preemptively eliminates bloodstream decoys that would subsequently block the infused delivery of the same antibody.  The mechanistic objective of this pre-treatment strategy is to increase the availability of antibodies to interact with their intended therapeutic targets without increasing drug toxicity. Concurrently, the ability of therapeutic targets to evade antibody interactions would be diminished.

The Company believes that the ImmunePrep^TM platform establishes a novel strategy to create selective plasma depletion therapies that incorporate either market-approved or clinical-stage monoclonal antibodies.  As of June 30, 2022, the Umabs antibody database reported 162 antibody therapies to be market-approved by at least one regulatory agency, including 122 approvals in the US, followed by 114 in Europe, 82 in Japan and 73 in China. In December 2022, the Antibody Society reported nearly 1200 therapeutic antibodies to be in clinical studies.

The World Health Organization’s (WHO) International Agency for Research on Cancer projects the market for therapeutic monoclonal antibodies will grow from $208.68 billion (USD) in 2023 to $566.72 billion (USD) in 2032.

About Sigyn Therapeutics™

Sigyn Therapeutics is a development-stage medical technology company headquartered in San Diego, California. The Company’s therapeutic candidates include Sigyn Therapy™, ChemoPrep™, ChemoPure™, and future products that may evolve from the ImmunePrep^TM platform.

Sigyn Therapy^TM is a candidate to treat pathogen-associated inflammatory disorders. The therapeutic blood purification technology has been proven to deplete a broad-spectrum of inflammatory cytokines, viral pathogens, and bacterial toxins from human blood plasma.  First-in-human clinical studies are being directed toward the enrollment of end-stage renal disease patients with endotoxemia and concurrent inflammation.

ChemoPrep^TM is a candidate to enhance the targeted delivery of chemotherapeutic drug agents and its system component ChemoPure^TM is designed to reduce the post-treatment toxicity of chemotherapy.

ImmunePrep^TM is a development-stage commercialization platform for antibody-based immunotherapies and their corresponding biosimilars. The platform allows the potential creation of selective plasma depletion devices that enhance the delivery of therapeutic antibodies without increasing drug toxicity.

To learn more about Sigyn Therapeutics, visit: www.SigynTherapeutics.com.

Cautionary Note Regarding Forward-Looking Statements

This information in this press release contains forward-looking statements of Sigyn Therapeutics, Inc. (“Sigyn”) that involve substantial risks and uncertainties. All statements contained in this summary are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that involve risks and uncertainties. Statements containing words such as "may," "believe," "anticipate," "expect," "intend," "plan," "project," "will," "projections," "estimate," "potentially" or similar expressions constitute forward-looking statements. Such forward-looking statements are subject to significant risks and uncertainties and actual results may differ materially from the results anticipated in the forward-looking statements. These forward-looking statements are based upon Sigyn's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Factors that may contribute to such differences may include, without limitation, the Company's ability to clinically advance Sigyn Therapy in human studies required for market clearance, the Company's ability to manufacture Sigyn Therapy, the Company's ability to raise capital resources, and other potential risks. The foregoing list of risks and uncertainties is illustrative but is not exhaustive. Additional factors that could cause results to differ materially from those anticipated in forward-looking statements can be found under the caption "Risk Factors" in the Company's Annual Report on Form 10-K for the year ended December 31, 2022, and in the Company's other filings with the Securities and Exchange Commission, including its quarterly Reports on Form 10-Q. All forward-looking statements contained in this report speak only as of the date on which they were made. Except as may be required by law, the Company does not intend, nor does it undertake any duty, to update this information to reflect future events or circumstances.

Contact:

Jim Joyce

Chairman, CEO

Phone/Text: 619.368.2000

Email: jj@SigynTherapeutics.com

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