Sigyn Therapeutics, Inc. (OTCQB: SIGY), the developer of CardioDialysis, a medical device designed for continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the bloodstream, today announced the launch of an initiative to evaluate emerging medical technologies in former NFL players at risk of chronic traumatic encephalopathy (CTE). Former NFL players experience significantly higher rates of neurodegenerative diseases such as amyotrophic lateral sclerosis (ALS), Parkinson’s disease, and CTE, which has been diagnosed post-mortem in a majority of former NFL players.
While repetitive head trauma is a known trigger for CTE initiation, chronic inflammation has been discovered to be the principal driver of disease progression. Last month, researchers at Trinity College Dublin reported that the protective blood-brain barrier (BBB) can be compromised by chronic inflammation and remain leaky for decades after an athlete retires from a sport involving repetitive head trauma. As a result, inflammatory and pathogenic molecules can leak into the brain, triggering neuroinflammation that accelerates abnormal accumulation of tau-protein, the hallmark indicator of CTE. Based on this discovery, it is anticipated that many former NFL players could be living in a persistent state of hyper-inflammation that increases their risk for CTE.
In response, Sigyn Therapeutics is establishing a collaborative initiative to evaluate emerging medical technologies in former NFL players that have the potential to diagnose, monitor, or treat CTE. The initiative plans to evaluate the feasibility of CardioDialysis, an extracorporeal blood purification technology, to reduce the circulating presence of key inflammatory and pathogenic molecules that fuel CTE progression. Additionally, the initiative will complete an evaluation of blood-based neuron-derived exosome assays that offer to monitor CTE progression, response to therapies, and provide potential insight into changes in BBB permeability. Other candidate therapies to be evaluated include a tau vaccine and a brain-delivered anti-inflammatory drug agent.
“Based on my previous participation in two landmark studies of CTE in former NFL players, the knowledge that the brains of collision sport athletes can remain permeable for decades opens the door to new strategies to diagnose CTE in the living and for treating the disease through a targeted control of inflammation,” said Jim Joyce, CEO of Sigyn Therapeutics.
CardioDialysis is the first technology to integrate plasma separation and therapeutic adsorption into a single device, enabling continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the bloodstream. This includes the clearance of inflammatory cytokines TNF-alpha, IL-1 beta, IL-6, as well as bacterial endotoxin, which are among the most relevant BBB-crossing contributors to CTE progression. Related to CTE, excessive inflammatory cytokine production also increases gut permeability, allowing bacterial endotoxin to leak into the bloodstream, further amplifying inflammation into the chronic self-perpetuating loop of neuroinflammation observed by the Trinity College researchers.
Sigyn Therapeutics is the developer of CardioDialysis, a next-generation blood purification technology. Within the emerging field of subtractive medicine, CardioDialysis aims to reduce the circulating presence of inflammatory mediators that fuel cardiovascular disease progression while simultaneously lowering levels of cholesterol-transporting lipoproteins that contribute to heart attacks, strokes, and other Major Adverse Cardiovascular Events (MACE). Based on its underlying mechanism, CardioDialysis is also being explored as a potential treatment for sepsis, life-threatening viral infections, and neurological disorders associated with systemic inflammation. The Company’s development pipeline also includes ImmunePrep to optimize the delivery of immunotherapeutic antibodies to treat cancer; ChemoPrep to enhance the targeted delivery of chemotherapy; and ChemoPure to reduce the toxicity of chemotherapy. To learn more about Sigyn Therapeutics, visit SigynTherapeutics.com.
