Announcement • Jul 17
Sigyn Therapeutics, Inc. Files Form 15 Sigyn Therapeutics, Inc. has announced that it has filed a Form 15 with the Securities and Exchange Commission to voluntarily deregister its Common Stock, $0.0001 Par Value under the Securities Exchange Act of 1934, as amended. Announcement • Apr 01
Sigyn Therapeutics, Inc. announced delayed annual 10-K filing On 03/31/2026, Sigyn Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Aug 16
Sigyn Therapeutics, Inc. announced delayed 10-Q filing On 08/15/2025, Sigyn Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • May 16
Sigyn Therapeutics, Inc. announced delayed 10-Q filing On 05/15/2025, Sigyn Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Apr 01
Sigyn Therapeutics, Inc. announced delayed annual 10-K filing On 03/31/2025, Sigyn Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Mar 08
Sigyn Therapeutics, Inc. Announces CFO Changes Sigyn Therapeutics, Inc. announced On February 26, 2025, Chief Financial Officer, Mr. Gerald DeCiccio provided a notice of retirement, effective immediately. In Mr. DeCiccio’s notice of retirement, Mr. DeCiccio indicated his retirement was not the result of any disagreements. As a result of Mr. DeCiccio’s retirement, Mr. James Joyce, Chief Executive Officer, will serve as interim Chief Financial Officer. Announcement • Nov 16
Sigyn Therapeutics, Inc. announced delayed 10-Q filing On 11/15/2024, Sigyn Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Aug 15
Sigyn Therapeutics, Inc. announced delayed 10-Q filing On 08/14/2024, Sigyn Therapeutics, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Announcement • Dec 13
Sigyn Therapeutics, Inc. Appoints Jerry Deciccio as Chief Financial Officer Sigyn Therapeutics, Inc. announced the appointment of Jerry DeCiccio, CPA, MBA, as chief financial officer. Mr. DeCiccio brings more than 40 years of financial industry experience to the Company, which includes executive roles at publicly traded companies and Ernst &Young. Previously, he was CFO/COO at Intech Electromechanical, CFO/COO at GTC Telecom, CFO at Incomnet Communications, and President at Cerebain Biotech Corp. Mr. DeCiccio also served in senior financial roles at Parker Hannifin Corp., Waste Management Inc, and Newport Corp. In these roles, he managed finance, accounting, SEC reporting, treasury, human resources, investor relations, and legal departments. He has also been a member of the Board of Directors and Audit Committee for Interplay Entertainment, Inc., and GT Data Corp. Mr. DeCiccio earned a Bachelor of Science degree in Accounting and Business Administration from Loma Linda University and an MBA in Finance and Systems Technology from the University of Southern California. He is also a Certified Public Accountant in the State of California. Mr. DeCiccio succeeds Jeremy Farrell, who was previously appointed CFO in March of 2022. In conjunction with the appointment of a new Chief Financial Officer, the Company removed Jeremy Ferrell from his position as CFO of the Company, effective immediately. The circumstances surrounding Mr. Ferrell’s termination are not a result of any disagreements with the Company or any matter relating to the Company’s operations, policies, or practices. Announcement • May 18
Sigyn Therapeutics, Inc. Discloses "DEVICES FOR ENHANCING THE ACTIVITY OF THERAPEUTIC ANTIBODIES" Patent Submission and Related ImmunePrep Trademark Application Sigyn Therapeutics, Inc. disclosed 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 has also been filed with the USPTO. ImmunePrep 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 optimal 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 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 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. Announcement • Oct 07
Sigyn Therapeutics, Inc. Announces Cancer-Related Patent Submission Sigyn Therapeutics, Inc. announced that a provisional patent application entitled: “SYSTEM AND METHODS TO ENHANCE CHEMOTHERAPY DELIVERY AND REDUCE TOXICITY” has been filed with the United States Patent and Trademark Office (“USPTO”). Cancer is the second leading cause of death in the United States. Despite therapeutic advances, treatment toxicity, drug resistance and inadequate tumor site delivery restrict the benefit of chemotherapeutic agents administered to cancer patients. More specifically, less than 5% of systemically administered chemotherapeutic agents are reported to reach their target tumor site. Off-target chemotherapeutic agents contribute to treatment toxicity2,3 and may promote the spread of cancer metastasis. To overcome these challenges, Sigyn’s patent submission describes a therapeutic device system whose primary objective is to enhance chemotherapy delivery and reduce its toxicity. A secondary objective of the therapeutic system is to reduce treatment dosing without sacrificing patient benefit, or conversely increase chemotherapy dosing without added toxicity. In concert with these objectives, the therapeutic system offers to reduce drug resistance and inhibit the potential spread of cancer metastasis induced by the administration of chemotherapeutic agents. On September 14, 2022, the Company announced plans to initiate first-in-human studies of Sigyn Therapy in End-Stage Renal Disease (ESRD) patients suffering from excess inflammation and/or endotoxemia. Sigyn Therapy is a broad-spectrum blood purification technology designed to treat pathogen-associated inflammatory disorders that are not addressed with approved drug therapies. Candidate treatment indications for Sigyn Therapy also include sepsis, community acquired pneumonia and emerging pandemic threats. Announcement • Oct 05
Sigyn Therapeutics, Inc. Announces Board Changes, Effective October 10, 2022 Sigyn Therapeutics, Inc. announced the appointment of Richa Nand, B.S., J.D.; Jim Dorst, B.S., M.S.; and Christopher Wetzel, B.S., M.B.A. to its Board of Directors, effective October 10, 2022. Richa Nand is a senior legal executive with more than 20 years of experience as an intellectual property (“IP”) attorney and strategic business advisor for biotechnology and medical device companies. She is the founder of Insight Patents, a legal and consulting firm providing IP and transactional corporate services for the life sciences industry. Ms. Nand previously served as Vice President of Corporate Development and Legal at Bird Rock Bio – a Johnson & Johnson-backed biopharmaceutical company in San Diego – and Vice President of Intellectual Property and Licensing; Director of Business Development; and In-House Patent Counsel at Cytori Therapeutics. Prior to law school, she was a biomedical researcher at Cedars Sinai Medical Center in Beverly Hills, California. Ms. Nand received a Bachelor of Science degree in Microbiology and Molecular Genetics from the University of California, Los Angeles, and a Juris Doctor degree from Boston University School of Law. Jim Dorst has more than 30 years of senior management experience in finance, operations, planning and business transactions at both private and public companies. He was most recently Director of Corporate Development at SYNNEX/Concentrix, where he was primarily responsible for mergers and acquisitions. Mr. Dorst was previously Chief Operating Officer (“COO”) and Chief Financial Officer (“CFO”) at SpectraScience, Inc.; CFO of Aethlon Medical, Inc. and Vice President of Finance and Operations for Verdisoft Corporation. In addition, he previously served as Senior Vice President of Finance and Administration at SeeCommerce; CFO and COO of Omnis Technology Corp; and CFO and Senior Vice President of Information Technology at Savoir Technology Group, Inc.Mr. Dorst practiced as a Certified Public Accountant with Coopers & Lybrand (now PricewaterhouseCoopers LLP); and holds a Master of Science degree in Accounting and a Bachelor of Science degree in Finance from the University of Oregon. Christopher Wetzelhas more than 25 years of leadership experience in various aspects of the healthcare delivery system and since 2004, has served as Chief Executive Officer for the Surgery Center at Hamilton in New Jersey. His career has focused on building organizations, increasing operational efficiency, increasing profitability, maximizing revenue, and managing change in the complex and high-growth healthcare environment. Mr. Wetzel applied his broad background in strategy, finance, and operations to guide various entities starting new ventures, entering new markets, and reengineering business processes. He is a long-term investor in the extracorporeal therapy space. Mr. Wetzel received a Master of Business Administration degree in Healthcare Management and a Bachelor of Science degree in Nursing from Thomas Jefferson University (formerly Philadelphia University). Announcement • Sep 15
Sigyn Therapeutics Announces First-In-Human Clinical Strategy to Address Inflammation and Endotoxemia in End-Stage Renal Disease Patients Sigyn Therapeutics, Inc. announced that it plans to pursue first-in-human feasibility studies of Sigyn Therapy in End-Stage Renal Disease (ESRD) patients suffering from excess inflammation and/or endotoxemia. Inflammation and endotoxemia are prevalent conditions associated with increased mortality in dialysis dependent ESRD patients. According to the United States Renal Data System (USRDS), there are more than 550,000 individuals with ESRD, which results in approximately 85 million dialysis treatments being administered in the United States each year. At present, there are no approved drugs to treat ESRD related inflammation and endotoxemia. In this regard, Sigyn Therapy offers a candidate strategy to improve the health and quality-of-life of ESRD patients. In the Company’s proposed study, Sigyn Therapy will be combined in series with enrolled subjects regularly scheduled dialysis treatment. Sigyn Therapy is broad-spectrum blood purification technology that isolates and extracts pathogen sources of life-threatening inflammation in concert with the depletion of proinflammatory cytokines from the bloodstream. In addition to evaluating the safety of Sigyn Therapy in health compromised ESRD patients, the Company plans to quantify changes in circulating levels of endotoxin (gram-negative bacterial toxin) and inflammatory cytokines including, tumor necrosis factor-a (TNF-a), interleukin-1b (IL-1-b), and interleukin-6 (IL-6) before and after each administration of Sigyn Therapy. Previously conducted in vitro studies have validated the ability of Sigyn Therapy to address each of these therapeutic targets, which are also associated with sepsis (leading cause of hospital deaths worldwide), community-acquired pneumonia (a leading cause of death among infectious diseases) and emerging pandemic threats. Based on its disclosed intent to enroll ESRD patients, the Company is updating an Investigational Device Exemption (IDE) that it drafted for submission to the U.S. Food and Drug Administration (“FDA”) related to the potential initiation of human feasibility studies. However, there is no assurance that human feasibility or pivotal studies will demonstrate Sigyn Therapy to be a safe and efficacious treatment for any candidate treatment indication. The Company further reported that it has downgraded its clinical interest in treating hepatic encephalopathy and other liver-associated disorders at this time. Announcement • Jun 24
Sigyn Therapeutics, Inc. has filed an IPO. Sigyn Therapeutics, Inc. has filed an IPO.
Security Name: Class A Units
Security Type: Equity/Derivative Unit
Security Name: Class B Units
Security Type: Equity/Preferred Unit Announcement • Apr 27
Sigyn Therapeutics Appoints Donald J. Hillebrand, M.D. to its Scientific Advisory Board Sigyn Therapeutics, Inc. announced the appointment of Donald J. Hillebrand,M.D. to its Scientific Advisory Board. Dr. Hillebrand is the Associate Medical Director of Liver Transplantation at Saint Luke's Hospital of Kansas City and Associate Professor of Medicine at the University of Missouri Kansas City (UMKC). He is a recognized leader in the field of Hepatology and Liver Transplantation. In addition to his academic and clinical contributions, Dr. Hillebrand has served as a Principal Investigator in clinical studies of extracorporeal technologies to treat patients suffering from severe liver disorders. Dr. Hillebrand has authored more that 20 Papers Published or In Press/Preparation and 7 books and/or book chapters. He is currently on the Editorial Board, ASAIO Journal, Section Editor ASATO Journal-Liver Transplantation, Website Editor ASAIO Artificial Liver Section and Reviewer, European Journal of Gastroenterology & Hepatology. Dr. Hillebrand graduated with distinction in Microbiology from Iowa State University. He did his residency in Internal Medicine at Iowa State University Hospitals and Clinics and fellowships in Gastroenterology/Hepatology and Liver Transplantation at Iowa State University Hospitals and Clinics. Announcement • Apr 01
Sigyn Therapeutics, Inc. Appoints Ajay Verma, M.D., Ph.D. to its Scientific Advisory Board Sigyn Therapeutics, Inc. announced the appointment of Ajay Verma, M.D., Ph.D.to its Scientific Advisory Board. Dr. Verma is a neurologist, neuroscientist, drug developer, inventor, and biotech science advisor. Dr. Verma most recently headed R&D efforts at Yumanity Therapeutics, developing drugs against novel targets for treating neurodegenerative diseases. Prior to that he was the EVP of Research and Experimental Medicine at Codiak Biosciences. Announcement • Mar 04
Sigyn Therapeutics, Inc. Appoints Jeremy Ferrell as Chief Financial Officer, Effective March 9, 2022 Sigyn Therapeutics, Inc. announced the appointment of Jeremy Ferrell, CPA, MBA as Chief Financial Officer (“CFO”), effective March 9, 2022. As CFO, Mr. Ferrell will have overall responsibility for operational finance, budgeting, and financial reporting, as well as helping to manage Sigyn’s relationships and interactions with the investment community. Mr. Ferrell has more than 25 years of finance and operations leadership experience, with expertise in venture capital; mergers and acquisitions; due diligence; initial public offerings; strategic alliance negotiation; and financial planning and reporting. He was most recently CFO at Miku, Inc, a privately held consumer hardware and tele-health company, where he managed a successful seed financing round and led Miku’s transition from its parent to an independent company. Announcement • Feb 24
Sigyn Therapeutics Announces Completion of Animal Studies Sigyn Therapeutics, Inc. reported the successful completion of an in vivo animal study that demonstrated Sigyn Therapy to be safe and well tolerated. Sigyn Therapy is a novel blood purification technology designed to perform functions that are beyond the reach of drugs and overcome the limitations of current devices to treat life-threatening inflammatory conditions, including sepsis, the leading cause of hospital deaths. Data resulting from the in vivo study will be incorporated into an Investigational Device Exemption (IDE) that the Company plans to submit to the U.S. Food and Drug Administration (FDA) to support the potential initiation of human clinical studies. In the study, an adult version of Sigyn Therapy was administered via standard dialysis machines utilizing conventional blood-tubing sets, for periods of up to six hours in eight (8) porcine (pig) subjects, each weighing approximately 40-45 kilograms. The study was comprised of a pilot phase (two subjects), which evaluated the feasibility of the study protocol in the first-in-mammal use of Sigyn Therapy; and an expansion phase (six subjects) to further assess treatment safety and refine pre-treatment set-up and operating procedures. Overall, Sigyn Therapy was well tolerated by all eight animal subjects and no serious adverse events were reported in any treated animal. Important criteria for treatment safety – including hemodynamic parameters, serum chemistries and hematologic measurements – were stable across all subjects. Of the eight treatments, seven were administered for the entire six-hour treatment period. One treatment was halted early due to the observation of a clot in the device, which was believed to be the result of a procedural deviation from the device priming instructions in the pre-treatment set-up. In another treatment, a decrease in activated clotting time values to below prescribed levels resulted in additional anticoagulant dosing during a completed six-hour treatment. No serious adverse events were observed in either of these two treatments. In parallel with conducting these in vivo studies, the Company reported the completion of in vitro blood plasma studies that validated the ability of Sigyn Therapy to address a broad-spectrum of relevant therapeutic targets, which included endotoxin (gram-negative bacterial toxin); peptidoglycan and lipoteichoic acid (gram-positive bacterial toxins); viral pathogens (including SARS-CoV-2); hepatic toxins (ammonia, bile acid & bilirubin); CytoVesicles (extracellular vesicles that transport inflammatory cargos); and tumor necrosis factor alpha (TNF alpha), interleukin-1 beta (IL-1b), and interleukin 6 (IL-6), which are pro-inflammatory cytokines whose dysregulated production can induce sepsis and other life-threatening inflammatory conditions. Announcement • Dec 02
Sigyn Therapeutics, Inc. Reports the Successful Completion of A Study to Address Gram-Positive Bacterial Toxins Associated with Sepsis Sigyn Therapeutics, Inc. announced that preclinical invitro studies have validated the ability of Sigyn Therapy to deplete the presence of gram-positive bacterial toxins from human blood plasma. Sigyn Therapy is a dual-function blood purification technology that extracts pathogen sources of life-threatening inflammation in concert with the broad-spectrum elimination of inflammatory mediators that fuel sepsis, the leading cause of hospital deaths worldwide. Candidate pathogen-associated indications for Sigyn Therapy include but are not limited to the treatment of emerging bioterror and pandemic threats, drug-resistant pathogens, hepatic encephalopathy, and community-acquired pneumonia, which is the leading cause of death among infectious diseases, the leading cause of death in children under 5 years of age, and a catalyst for ~50% of sepsis and septic shock cases. In the bacterial toxin study, the Company is reporting that clinically relevant levels of the gram-positive bacterial toxins peptidoglycan (PG) and lipoteichoic acid (LTA) were infused into 1000ml of human blood plasma and circulated through an adult version of Sigyn Therapy at normal treatment blood-flow rates. The invitro clearance of both targets was rapid, with an ~50% reduction of PG at one hour and a ~70% reduction of LTA at two hours. In addition to being potent activators of sepsis, there is a heightened interest in gram-positive pathogens based on the continuing emergence of drug resistant species, including antibiotic-resistant Staphylococcus aureus (MRSA). The data resulting from the study will be incorporated into an Investigational Device Exemption (IDE) that the Company is preparing for submission to the United States Food and Drug Administration (FDA) to support the initiation of human clinical studies. Announcement • Jul 16
Sigyn Therapeutics, Inc. Announces Rapid Elimination of Hepatic Toxins from Human Blood Plasma Sigyn Therapeutics, Inc. announced the completion of a study that demonstrated the broad-spectrum ability of Sigyn Therapy to eliminate hepatic toxins from human blood plasma. In the study, Sigyn Therapy depleted the circulating presence of bile acid, bilirubin and ammonia, which are toxins commonly associated with Hepatic Encephalopathy, a neurological disorder that occurs in individuals suffering from chronic forms of liver disease and acute liver failure. Sigyn Therapy is a proprietary blood purification technology designed to deplete pathogens, toxins and inflammatory targets from the bloodstream of treated patients. Hepatic Encephalopathy is induced when toxins accumulate in the bloodstream and then cross through the blood brain barrier. Severe cases of HE can cause serious, life-threatening complications that range from decreased consciousness to coma. 30-day mortality rates of 38% have been reported in cirrhotic patients suffering from grade 3 and 4 Hepatic Encephalopathy. In the study, clinically relevant levels of bile acid, bilirubin and ammonia were spiked into 1000ml of human blood plasma, which was then circulated through an adult version of Sigyn Therapy at normal treatment blood-flow rates. The study was conducted in triplicate over four-hour time periods. The in vitro clearance of bile acid from human blood plasma was rapid, with an average reduction of 80.6% in one hour and 99% at the completion of the four-hour study. Average bilirubin reduction at one hour was 55% and 69.5% at four hours. 32% of ammonia was eliminated from human blood plasma in one hour and an average elimination of 37% was reported at four hours. Beyond the accumulation of hepatic toxins in the bloodstream, excessive inflammatory cytokine and endotoxin production contribute to increase the permeability of the blood brain barrier in those suffering from HE. Thus, enabling the direct interaction of hepatic toxins with brain tissue. Among the most prominent HE related cytokines are tumor necrosis factor-a (TNF-a), interleukin 6 (IL-6) and interleukin 1 beta (IL-1b). In previous studies, Sigyn Therapy demonstrated the simultaneous depletion of endotoxin, TNF-a, IL-6 and IL-1b from human blood plasma. The resulting data from these studies will be incorporated into an Investigational Device Exemption that Sigyn Therapeutics plans to submit to the United States Food and Drug Administration prior to year-end 2021. Announcement • Jul 15
Sigyn Therapeutics, Inc. Reports Preliminary Results of Hepatic Encephalopathy Toxin Study Sigyn Therapeutics, Inc. announced the completion of an invitro blood purification study that validated the ability of Sigyn Therapy to eliminate bloodstream toxins associated with Hepatic Encephalopathy, a neurological disorder that occurs in individuals suffering from chronic forms of liver (hepatic) disease and acute liver failure. Sigyn Therapy is a proprietary blood purification technology designed to deplete a broad-spectrum of pathogens, toxins and inflammatory targets from the bloodstream of treated patients. Hepatic Encephalopathy (HE) is induced when toxins (normally removed by a healthy liver) accumulate in the bloodstream and then cross through the blood brain barrier. Severe cases of HE (grade 3 and 4) can cause serious, life-threatening complications that range from decreased consciousness to coma. 30-day mortality rates of 38% have been reported in cirrhotic patients suffering from grade 3 and 4 Hepatic Encephalopathy. The goal of the hepatic toxin study was to collect supporting data that would expand the potential use of Sigyn Therapy to include chronic liver disease and acute liver failure indications, including HE. Announcement • Apr 02
Sigyn Therapeutics, Inc. announced delayed annual 10-K filing On 03/31/2021, Sigyn Therapeutics, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Announcement • Jan 28
Sigyn Therapeutics, Inc. Appoints Eric Lynam as Head of Clinical Affairs Sigyn Therapeutics, Inc. announced the appointment of Eric Lynam as Head of Clinical Affairs. Lynam, who has played key roles in developing, contracting and conducting over 190 clinical trials, will oversee clinical studies of Sigyn Therapy(TM) in the United States and abroad. Previously, Mr. Lynam was the Director of Scientific and Medical Affairs for Pharmatech Incorporated until its recent acquisition by Caris Life Sciences. Announcement • Jan 08
Sigyn Therapeutics, Inc. Reports Results of Pilot Study to Address Inflammatory CytoVesicles Sigyn Therapeutics, Inc. announced the results of an in vitro pilot study that successfully modeled the ability of Sigyn Therapy™ to address CytoVesicles that transport inflammatory cytokine cargos in the bloodstream. Cytokine Storm Syndrome is an excessive response of the immune system that is induced by infectious and non-infectious conditions. A hallmark indicator of Cytokine Storm Syndrome is the excessive or uncontrolled release of pro-inflammatory cytokines, which can lead to multiple organ failure and cause death. The annual market opportunity to address Cytokine Storm related indications exceeds $20 billion and includes sepsis, the most common cause of hospital deaths worldwide. Virus-induced Cytokine Storm Syndrome is a leading cause of death resulting from severe SARS-CoV-2 (COVID-19) infections. Sigyn Therapy is a proprietary blood purification technology designed to overcome the limitations of previous drug and device candidates to treat acute inflammatory conditions. Incorporated within Sigyn Therapy is a cocktail of adsorbent components with unique binding and capture characteristics to optimize the broad-spectrum depletion of inflammatory targets from the bloodstream. These targets include pro-inflammatory cytokines, endotoxin and CytoVesicles (extracellular vesicles that transport inflammatory cytokine cargos) that participate in concert with freely circulating cytokines to further escalate the Cytokine Storm. CytoVesicles are an important yet previously elusive target as they can be 20-60 times larger than cytokines themselves. In the in vitro pilot study, 104nm liposomes were utilized as a model system to assess the ability of Sigyn Therapy’s adsorbent components to deplete CytoVesicles from human blood plasma. After a two-hour interaction with Sigyn’s adsorbent components, liposome concentrations in human blood plasma were reduced ~90%. Previously published studies have validated liposomes as a model for the isolation of extracellular vesicles from blood based on the similarity of their size and structural characteristics. Sigyn Therapy is a single-use device designed for use on the established infrastructure of dialysis and CRRT machines already located in hospitals and clinics worldwide. On December 1, 2020, the Company reported the results of an in vitro study that validated the ability of Sigyn Therapy to simultaneously reduce the presence of endotoxin and relevant pro-inflammatory 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 implicated in the pathogenesis of sepsis and septic shock. The dysregulated over-production of IL-1B, IL-6 and TNF-a can lead to organ failure and cause death. An objective of the study was to rebalance elevated cytokine levels and optimize the elimination of endotoxin from human blood plasma. The study was conducted in triplicate over four-hour time periods with a pediatric version of Sigyn Therapy. Average reduction of endotoxin load peaked at 83% during the studies. The average reduction of IL-1B was 69%, IL-6 reduction was 59% and TNF-a reduction was 57% during the four-hour studies. The resulting data from each of these studies will be incorporated into an Investigational Device Exemption (IDE) that Sigyn Therapeutics plans to submit to the United States Food and Drug Administration (FDA) in 2021. Announcement • Dec 03
Sigyn Therapeutics, Inc. Reports Simultaneous Clearance of Endotoxin and Inflammatory Cytokines from Human Blood Plasma Sigyn Therapeutics, Inc. announced the completion of an in vitro study that demonstrated the ability of Sigyn Therapy to clear both endotoxin and inflammatory cytokines from human blood plasma. Sigyn Therapy is a novel blood purification technology designed to mitigate cytokine storm syndrome, which precipitates a wide-range of life-threatening conditions, including sepsis, the most common cause of hospital deaths. Virus induced cytokine storm is associated with high mortality and currently is a leading cause of SARS-CoV-2 (COVID-19) deaths. Sigyn Therapy is a single-use device designed for use on the established infrastructure of dialysis and CRRT machines located in hospitals and clinics worldwide. In the in vitro study, Sigyn Therapy simultaneously reduced the presence of endotoxin and relevant pro-inflammatory 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 implicated in the pathogenesis of sepsis and septic shock. The dysregulated over-production of IL-1B, IL-6 and TNF-a can lead to organ failure and cause death. An objective of the study was to rebalance elevated cytokine levels and optimize the elimination of endotoxin from human blood plasma. The study was conducted in triplicate over four-hour time periods with a pediatric version of Sigyn Therapy. Average reduction of endotoxin load peaked at 83% during the studies. The average reduction of IL-1B was 69%, IL-6 reduction was 59% and TNF-a reduction was 57% during the four-hour studies. The resulting data will be incorporated into an Investigational Device Exemption (IDE) that Sigyn plans to submit to the United States Food and Drug Administration (FDA) in 2021. At present, the CytoSorb device from CytoSorbents Corporation and the Toraymyxin device from Toray Industries are market cleared and broadly administered to treat a wide-range of life-threatening inflammatory conditions outside of the United States. In regards to mechanism, the Toraymyxin device has a high specificity to bind circulating endotoxin, but does not address inflammatory cytokines. Conversely, the CytoSorb device depletes inflammatory cytokines from circulation, but does not address endotoxin. In addition to reporting the dual clearance of endotoxin and inflammatory cytokines, the Company further disclosed that it plans to evaluate the ability of Sigyn Therapy to address other inflammatory targets, including CytoVesicles that transport inflammatory cytokine cargos throughout the bloodstream. The Company believes that Sigyn Therapy is the first therapeutic candidate to target circulating CytoVesicles. 
