In the face of a pandemic that paused and shuttered numerous clinical research programs, we translated our vision for Sigyn Therapy from conceptual design to clinical application in 2021.
Milestone achievements in the past year establish Sigyn Therapy as an emergent strategy to address a wide-range of pathogen-related conditions that precipitate sepsis, the #1 cause of hospital deaths worldwide.
Building off preclinical observations first reported in
Concurrent with these achievements, we established manufacturing procedures to support a final design of Sigyn Therapy that improved bloodstream turnover efficiency and expanded our capacity to extract therapeutic targets.
As a result, up to seven additional passes of a patient’s entire bloodstream can now be achieved during a single four-hour treatment. Regarding capacity, we incorporated an increased quantity of adsorbent components that now provide more than 200,000 square meters (~50 acres) of surface area on which to adsorb and bind bloodstream targets.
To demonstrate the feasibility and safety of our device, we initiated and successfully completed a pilot animal study in two porcine (pig) subjects that received six-hour administrations of Sigyn Therapy. Based on these results, we expanded our porcine studies and have now treated five subjects in an eight-subject study. The successful completion of this study will set the stage for the potential advancement of human clinical studies.
As referenced at the outset of this note, we advanced Sigyn Therapy from conceptual design to clinical application in 2021. In this regard, I am proud to share the following link, which provides access to images of Sigyn Therapy in clinical action during treatments administered on the 10th and 14th of December.
https://tinyurl.com/Sigyn-Therapy-in-Action-Link
2022 – Clinical Progression
In 2022, we will navigate the next phase of our clinical endeavors. First and foremost, we have been drafting an Investigational Device Exemption (IDE) that we plan to submit to the
Beyond this clinical objective, we plan to expand our board of directors, augment our senior management team, and establish a scientific advisory board with industry thought leaders. To leverage our status as a fully reporting public company, we are taking steps to comply with the requirements necessary to list our securities on a major exchange.
In our quest to address unmet needs in global health, we envisioned a medical technology that could overcome the limitations of previous blood purification therapies and perform functions that were beyond the reach of drugs. In 2022, we will continue our efforts to transform this vision into a reality.
Sincerely, Jim
About Sigyn Therapeutics™
Beginning in December of 2020, a series of invitro blood purification studies have validated the ability of Sigyn Therapy to address endotoxin (gram-negative bacterial toxin), peptidoglycan and lipoteichoic acid (gram-positive bacterial toxins), viral pathogens (including COVID-19), hepatic toxins (ammonia, bile acid & bilirubin), cytovesicles that transport inflammatory cargos, and relevant proinflammatory cytokines (TNF-a, IL-1b, IL-6) that underlie the cytokine storm that precipitates sepsis.
Therapeutic opportunities for Sigyn Therapy include but are not limited to emerging bioterror and pandemic threats, drug-resistant pathogens, hepatic encephalopathy, and community-acquired pneumonia, which is a 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.
To support widespread implementation, Sigyn Therapy is a single-use disposable device designed for use on the established infrastructure of hemodialysis and continuous renal replacement therapy (CRRT) machines located in hospitals and clinics worldwide. Incorporated within Sigyn Therapy is a formulation of adsorbent components that provide more than 200,000 square meters (~50 acres) of surface area on which to adsorb and remove bloodstream targets. Unlike devices that concentrate therapeutic targets in the blood-path, Sigyn Therapy extracts targets from the bloodstream, which eliminates their ability to interact with blood cells during treatment.
To learn more, visit www.SigynTherapeutics.com
Cautionary Note Regarding Forward-Looking Statements
This information in this press release contains forward-looking statements of
Contacts:
Investor Relations
(646) 274-3580
stephen@sigyntherapeutics.com
Media Contacts:
(212) 845-4271
David.Schull@russopartnersllc.com
(212) 845-4242
Nic.Johnson@russopartnersllc.com
![](https://ml.globenewswire.com/media/ODE2MWNmZWEtNzg0Mi00YjNmLThhOWQtYWViNWQwMjMwMWUyLTUwMDAzMjA5OA==/tiny/Sigyn-Therapeutics-Inc-.png)
2022 GlobeNewswire, Inc., source