James A. Joyce
Co-founder, Chairman, and CEO
James “Jim” Joyce has 30+ years of diverse public market experience, which includes two decades of public company CEO and Corporate Board leadership roles. He is also an inventor or co-inventor underlying 18 pending or issued patents.
Prior to establishing Sigyn Therapeutics, Mr. Joyce was the founder and former Chairman and CEO of Aethlon Medical, a therapeutic technology company that he navigated from single shareholder start-up to Nasdaq-traded Company with 8000+ shareholders. During his tenure at Aethlon, Mr. Joyce oversaw the development of the Hemopurifier®, a first-in-class blood purification technology to address life-threatening viruses and cancer-promoting exosomes. Under his leadership, the Hemopurifier® became the first therapeutic candidate to be awarded two FDA “Breakthrough Device” designations and was the first and only device to receive “Emergency Use Authorization” (EAU) approval from both the FDA and Health Canada to treat Ebola virus. Time Magazine named the Hemopurifier® one of the “11 Most Remarkable Advances in Healthcare” and designated the device to its “Top 25 Best Inventions” award list. The Hemopurifier® has since been cleared by the FDA to treat severe COVID-19 infections in a clinical setting.
Under Mr. Joyce’s leadership, the Hemopurifier® was the subject of two Department of Defense (DOD) contract awards and a National Cancer Institute (NCI) contract. Mr. Joyce led the completion of approximately $100 million of equity financings on behalf of Aethlon Medical and established preclinical and clinical collaborations with more than twenty government and non-government research institutes.
Based on the use of the Hemopurifier® to treat HIV and Hepatitis-C infected individuals in India, Mr. Joyce was the recipient of the “Spirit of India Award” sponsored by the Bill & Melinda Gates Foundation and awarded each year by the American India Foundation to the American business leader who has demonstrated a commitment to accelerate social and economic change in India.
Mr. Joyce testified before Congress and lobbied Capitol Hill to promote the Hemopurifier® as a broad-spectrum countermeasure against bioterror and pandemic threats, which contributed to expanding the government-wide definition of treatment countermeasure to be inclusive of medical devices under U.S. law.
Mr. Joyce is also the founder and former Executive Chairman of Exosome Sciences, Inc. (ESI), a company focused on the discovery of exosomal biomarkers to diagnose and monitor cancer and neurological disorders. Inspired by the death of a former teammate, Mr. Joyce established a collaboration with the Boston University CTE Center to test his hypothesis that circulating exosomes transported tau protein cargos (exosomal tau or TauSome) that could provide a basis for a non-invasive blood test to diagnose and monitor neurological tauopathies, including chronic traumatic encephalopathy (CTE) and Alzheimer’s disease. As a result, ESI was invited to participate in the first NIH funded clinical study of CTE, which revealed TauSome levels to be approximately 9x higher in 78 former NFL players as compared to the same age group control subjects. The study results (co-authored by Mr. Joyce) were published in the Journal of Alzheimer’s Disease. Follow-on clinical studies are being conducted. Mr. Joyce established a collaboration with the Boston University Alzheimer’s Disease Center that also demonstrated TauSome levels to be significantly elevated in diagnosed Alzheimer’s patients.
Prior to founding Aethlon Medical and Exosome Sciences, Mr. Joyce operated James Joyce & Associates. He was the founder and former CEO of Mission Labs, Inc. and a principal at London Zurich Securities. Upon graduating from the University of Maryland, Mr. Joyce was first employed as a member of the Denver Broncos Football Club of the National Football League.
Craig P. Roberts
Co-founder and Chief Technology Officer
Mr. Roberts is an inventor of several life-saving therapeutic technologies. This includes the Percutaneous Adult Extracorporeal Membrane Oxygenation (ECMO) system, which was licensed and subsequently sold to C.R. Bard. During the COVID-19 pandemic, ECMO has been broadly deployed to treat critically ill COVID-19 patients. Additionally, Mr. Roberts is the inventor of the IMPACT System, which received CE Mark clearance in the European Union and was subsequently registered in 32 countries and deployed to treat cytokine storm-related conditions, including sepsis, acute respiratory distress syndrome (ARDS), acute liver failure, severe pneumonia, and H5N1 bird flu virus infection. The IMPACT system was comprised of multiple cartridges and designed to reduce the presence of inflammatory cytokines from human blood plasma. The active cartridge component of the IMPACT system was recently incorporated into an extracorporeal system that received FDA Emergency Use Authorization (EAU) to treat severe COVID-19 infections.
As a Clinical Perfusionist, Craig has conducted more than 4,000 extracorporeal procedures, including adult and pediatric cardiopulmonary bypass, cardiac assist devices, ECMO (artificial lung), vascular access catheter systems, and CRRT. He is a nominee to receive the 2020 John H. Gibbon, Jr. Award from the American Society of Extracorporeal Technology (AmSECT). The award is the industry’s highest achievement.
Director of Clinical Affairs
Mr. Lynam has played key roles in developing, contracting and conducting over 190 clinical trials and will oversee clinical studies of Sigyn Therapy™ 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. While at Pharmatech, Mr. Lynam pioneered a high efficiency, patient centered clinical trials system, providing on-demand trial access to a network of more than 1,500 investigators.
Charlene R. Owen
Director of Operations
Charlene Owen has over two decades of complex administrative and operations experience at publicly-traded Biotechnology and Medical Device organizations. In her previous role at Aethlon Medical, Ms. Owen supported all C-Suite professionals while managing the smooth flow of corporate activities, including Human Resources, Facilities, and Information Technology (IT). At Hollis-Eden Pharmaceuticals, Ms. Owen was the Executive Administrator to the founder and CEO and played a critical role in the growth and expansion of the company as the fifth (#5) employee hired. Widely seen as a problem solver and key “corporate in-filler,” Charlene’s versatility and collaborative nature make her a valued part of our team.
Charlene holds a Bachelor of Arts degree in Communications /Psychology from Western Washington University, as well as significant post-baccalaureate work in Instructional Technology.