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Sigyn CEO Note: An Emerging New Industry, 15 Years in the Making
Sigyn CEO Note: An Emerging New Industry, 15 Years in the Making

Associated Press

time12-03-2025

  • Health
  • Associated Press

Sigyn CEO Note: An Emerging New Industry, 15 Years in the Making

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 Economist Magazine 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. Sigyn Therapeutics, Inc. Johan Louw Senior Vice President of Strategic Programs 281.660.1815 [email protected] CEO, Inventor 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, 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.

Sigyn Therapeutics to be Featured in Fireside Chat With Zacks Healthcare Analyst
Sigyn Therapeutics to be Featured in Fireside Chat With Zacks Healthcare Analyst

Associated Press

time25-02-2025

  • Business
  • Associated Press

Sigyn Therapeutics to be Featured in Fireside Chat With Zacks Healthcare Analyst

The Exclusive Event Kicks-Off Tomorrow February 26th at 4pm Eastern SAN DIEGO - February 25, 2025 ( NEWMEDIAWIRE) - Sigyn Therapeutics, Inc. ('Sigyn' or the 'Company') (OTCQB: SIGY), a developer of next-generation blood purification devices to treat cancer and life-threatening infectious disease disorders, disclosed today that Company CEO, Jim Joyce, will participate in a Fireside Chat tomorrow with Zacks Senior Healthcare Analyst, John Vandermosten. Zacks is a leading investment research firm focusing on stock research, analysis and recommendations. This exclusive event is being hosted by Force Family Office, the largest network of family offices in the United States with a substantial and growing presence internationally. The Fireside Chat will review the emergence of blood purification therapies to address life-threatening infectious disease conditions that are beyond the reach of drugs and additionally will discuss the development of devices to synergistically optimize the benefit of leading drugs to treat cancer. Event Details Date: February 26th Time: 4pm Eastern (1pm Pacific) Force Family Office Event Description Healthcare is driven by innovation. New discoveries, technologies, applications, molecules, devices, and formulations are at the heart of an industry that never stands still. Which are the experts watching? One of those is Sigyn Therapy, a blood purification therapy with applications in infectious disease, oncology, dialysis and organ transplantation. Register now to join this Fireside Chat with Zacks Senior Healthcare Analyst, John Vandermosten, and Jim Joyce, CEO of Sigyn Therapeutics, for a discussion of innovations on the horizon that will be creating value in the healthcare sector. About Sigyn Therapeutics(TM) Sigyn Therapeutics is developing next-generation blood purification therapies to address cancer and life-threatening infectious disease disorders that are not treatable with drugs. The Company's lead product candidate, Sigyn Therapy(TM) has been demonstrated to reduce the presence of viral pathogens, bacterial toxins, and pro-inflammatory cytokines from human blood plasma. Based on these capabilities, Sigyn Therapy(TM) is a candidate to treat life-threatening viral pathogens, antibiotic-resistant bacterial infections, endotoxemia, and sepsis, which is the leading cause of death in U.S. hospitals. The clinical protocol of first-in-human studies incorporates Sigyn Therapy with 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. Extending the lives of those with ESRD could significantly impact dialysis industry revenues. The Company's oncology pipeline is 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 industry. CONTACTS: Sigyn Therapeutics, Inc. Johan Louw Senior Vice President of Strategic Programs 281.660.1815 [email protected] CEO, Inventor 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, 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.

Sigyn Therapeutics Announces the Appointment of Michael Ryan to Its Board of Directors
Sigyn Therapeutics Announces the Appointment of Michael Ryan to Its Board of Directors

Associated Press

time29-01-2025

  • Business
  • Associated Press

Sigyn Therapeutics Announces the Appointment of Michael Ryan to Its Board of Directors

NEWMEDIAWIRE) - Sigyn Therapeutics, Inc. ('Sigyn' or the 'Company') (OTCQB: SIGY), a developer of blood purification technologies to treat life-threatening conditions, today announced the appointment of Michael Ryan to its Board of Directors. Mr. Ryan is a seasoned executive, entrepreneur and investor within the early-stage technology and life science industry. Mr. Ryan is a Founding Director of Irrus Investments, Ltd., a role he has held since 2011. Irrus Investments is the largest angel investment syndicate in Ireland with an emphasis on life science companies. To date, Irrus has invested over $50 million in 40 early-stage life science and technology companies in Ireland, UK, Sweden and the United States. Mike brings a wealth of medical technology industry experience and investment expertise to our Board,' stated Sigyn Therapeutics CEO, Jim Joyce. 'He is a valued supporter of our endeavors, whose contributions as a board member will help us achieve our mission to develop blood purification technologies that save lives.' Mr. Ryan previously served as Chief Executive Officer and Board Member of Sedana Medical, from 2011 until shortly before the Company launched on the Nasdaq owned First North stock exchange in Stockholm in 2017. Prior to this, he was the main shareholder and Chief Executive Officer of Artema Medical AB, where he helped orchestrate the Company's acquisition by Datascope Corporation. Mr. Ryan holds a in Mechanical Engineering and a Masters in Industrial Engineering from University College Dublin. 'I am excited to join the Sigyn Therapeutics Board of Directors,' stated Mr. Ryan. 'The Company has established a compelling clinical and commercialization strategy to advance Sigyn Therapy, whose expansive capabilities introduce a strategy to treat infectious disease disorders that are significant global health challenges.' About Sigyn Therapeutics(TM) Sigyn Therapeutics is developing blood purification technologies to enhance the benefit of cancer therapies and to address life-threatening infections that are not treatable with drugs. The Company's lead product candidate, Sigyn TherapyTM has been demonstrated to reduce the presence of viral pathogens, bacterial toxins, and pro-inflammatory cytokines from human blood plasma. Based on these capabilities, Sigyn TherapyTM is a candidate to treat life-threatening viruses, antibiotic-resistant bacterial infections, endotoxemia, and sepsis, which is the leading cause of death in U.S. hospitals. The clinical protocol of first-in-human studies incorporates Sigyn Therapy in series with regularly schedule dialysis treatments to address endotoxemia and concurrent inflammation, which contribute to shortening the lives of end-stage renal disease (ESRD) patients. Extending the lives of individuals with ESRD would boost dialysis industry revenues. The Company has also established an oncology pipeline comprised of ImmunePrepTM, a platform to enhance the delivery of immunotherapeutic antibodies; ChemoPrepTM to improve the delivery of chemotherapeutic agents; and ChemoPureTM to reduce chemotherapy toxicity. If successfully advanced, the Company's therapies offer to provide strategic value to the dialysis and biopharmaceutical industry. 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, 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. Contacts: Johan Louw 281.660.1815 Chairman, CEO

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