SAN DIEGO, CA - March 12, 2025 (NEWMEDIAWIRE) - Sigyn Therapeutics, Inc. ("Sigyn" or the "Company") (OTCQB: SIGY) today released the following note authored by its CEO, Jim Joyce.
Dear Reader,
Blood purification technologies have emerged to become leading post-exposure countermeasures to treat emerging pandemic viruses. When properly designed, these devices can also serve a dual-use purpose in everyday medicine. In this regard, Sigyn TherapyTM is a candidate first-line countermeasure to address viral threats, yet it also offers a mechanism to potentially enhance and prolong the lives of the 550,00 end-stage renal disease (ESRD) patients who rely on dialysis for survival in the United States. Additionally, Sigyn Therapy(TM) is able to target circulating factors underlying sepsis, a currently untreatable condition that is a leading cause of U.S. hospital deaths.
The U.S. Government has supported the development of blood purification therapies through the Defense Advanced Research Projects Agency (DARPA). If you're unfamiliar, the EconomistMagazine describes DARPA as "the agency that shaped the modern world," having contributed to groundbreaking innovations such as GPS, drones, stealth technology, the personal computer, and even the internet.
DARPA Dialysis-Like Therapeutics Program
DARPA also has a long history of supporting breakthrough advances in medicine. In 2010, the agency launched a five-year program entitled Dialysis-Like Therapeutics (DLT) to advance blood purification technologies to treat bloodstream infections and sepsis.
Among the recipients of a DLT program contract was Aethlon Medical. As the founder of Aethlon, I oversaw development of the Hemopurifier(TM), a broad-spectrum virus clearance device that became the first blood purification technology to receive FDA Emergency-Use Authorization (EUA) to treat an emerging pandemic virus. In this case, Ebola virus, which occurred during the DLT program and under my leadership. Subsequently, blood purification therapies developed by two other members of the DARPA DLT team would be among the first therapies to receive EUA approval from FDA to treat COVID-19.
Note: As compared to the Hemopurifier(TM), we designed Sigyn Therapy(TM) with the intent to process the bloodstream more efficiently; to have a greater capacity to capture therapeutic targets; to addresses viral pathogens plus a wide range of inflammatory targets; and to improve scalability with lower production costs.
mRNA Vaccine Research Initiatives
Not long after the launch of its DLT program, DARPA initiated a rapid mRNA vaccine development program that would play pivotal role in the development of the Moderna COVID-19 vaccine.
When COVID-19 spread across the globe five years ago, the world faced an urgent need for a vaccine. At the time, the record for the fastest development of a vaccine to address a new virus was four years. In a groundbreaking achievement, mRNA-based vaccines from Moderna and Pfizer/BioNTech were available within a year of COVID-19 being declared a global health emergency by the World Health Organization. A study published in the journal The Lancet Infectious Diseases; estimated that these vaccines prevented between 14.4 to 19.8 million deaths worldwide in just their first year of distribution.
This unprecedented speed in vaccine development may have shifted the historic focus of post-exposure treatment countermeasures from single-target antiviral drugs to broad-spectrum blood purification technologies. Especially as preventative vaccines can be developed and distributed in a mere fraction of the time it takes to bring a post-exposure antiviral drug to market. Whereas blood purification therapies can be available at the outset of a viral outbreak.
Potential Advantages of Sigyn Therapy
As compared to a post-exposure antiviral drug, Sigyn Therapy(TM) offers several key advantages. Unlike antiviral drugs, our technology provides an expansive mechanism of action to reduce the circulating presence of viruses, toxins, inflammatory cytokines, and other deleterious factors from the bloodstream of infected individuals. While antiviral drugs can target a specific type of virus, Sigyn Therapy(TM) offers a broad-spectrum strategy to potentially address different strains, species, and families of viruses.
In closing, Sigyn Therapy(TM) is a candidate first-line countermeasures to address emerging viral threats. The continued convergence of global warming, urban crowding, and international travel will fuel new outbreaks. The question is not if, but how often these outbreaks will occur, how many lives will be lost, and what will be the global economic impact as emerging viral threats will not be constrained by borders.
In the meantime, the expansive mechanism of Sigyn Therapy(TM) allows for its potential dual use in everyday medicine. Our lead clinical opportunity incorporates Sigyn Therapy(TM) in series with regularly scheduled dialysis treatments to reduce endotoxemia and concurrent inflammation that contributes to shorten the lives of end-stage renal disease (ESRD) patients. Extending the lives of those suffering from ESRD could establish a strategic competitive advantage within the dialysis industry.
Thank you for taking the time to read my note.
Sincerely, Jim
About Sigyn Therapeutics(TM)
Sigyn Therapeutics is developing next-generation blood purification therapies to address life-threatening infectious disease disorders. Sigyn Therapy(TM) has been demonstrated to reduce the presence of viral pathogens, bacterial toxins, inflammatory cytokines, and other relevant therapeutic targets from human blood plasma. Based on these capabilities, Sigyn Therapy(TM) is a candidate to treat life-threatening viruses, endotoxemia, and sepsis, the leading cause of death in U.S. hospitals. The clinical protocol of first-in-human studies incorporates Sigyn Therapy into regularly scheduled dialysis treatments to address endotoxemia and concurrent inflammation, which are highly prevalent disorders that shorten the lives of end-stage renal disease (ESRD) patients. The value of extending ESRD patient lives is quantifiable based its potential impact on dialysis industry revenues.
The Company also has an oncology pipeline comprised of ImmunePrep(TM), a platform to enhance the delivery of immunotherapeutic antibodies; ChemoPrep(TM) to improve the delivery of chemotherapeutic agents; and ChemoPure(TM) to reduce chemotherapy toxicity. If successfully advanced, the Company's therapies offer to provide strategic value to the dialysis and biopharmaceutical industries.
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, 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.
