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FAQ: Sigyn Therapeutics' CardioDialysis™ Advancement and Corporate Initiatives
TL;DR
Sigyn Therapeutics' CardioDialysis offers a potential $700+ million revenue model by treating cardiovascular disease in dialysis patients, outperforming statins with 75-95% MACE reduction.
Sigyn's CardioDialysis uses dialysis machines at 50,000 clinics worldwide, requiring FDA feasibility and efficacy studies in ESRD patients during regular dialysis sessions.
CardioDialysis could extend lives of ESRD patients by reducing cardiovascular deaths, potentially adding $2.8 billion to dialysis industry revenues through improved patient outcomes.
Sigyn explores Nasdaq mergers due to new $5 million MVLS rules while creating a private subsidiary to fund CardioDialysis with less shareholder dilution.
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The update aims to clarify the FDA clinical pathway to commercialize CardioDialysis™, disclose investigation of Nasdaq merger opportunities, and reveal a strategy to advance therapies with less shareholder dilution.
Cardiovascular disease is the #1 cause of death worldwide, and while current drug treatments reduce major adverse cardiovascular events by about 25%, blood purification therapies can achieve 75-95% reductions, though access is limited to specialized centers.
CardioDialysis™ addresses a broader range of cardiovascular disease targets and is designed for use on existing dialysis machines at approximately 50,000 dialysis clinics worldwide, unlike lipoprotein apheresis which is limited to specialized apheresis centers.
The pathway requires completing a feasibility (safety) study costing approximately $1.25 million, followed by a pivotal efficacy study, both of which can be conducted in dialysis clinic settings rather than hospital ICUs.
The feasibility study protocol was developed in collaboration with the clinical research division of a leading dialysis company, which offered three clinical site locations and principal investigators for a 12-15 subject study.
Studies will be conducted in end-stage renal disease (ESRD) patients during regularly scheduled dialysis sessions at dialysis clinics, avoiding the logistical challenges of ICU-based studies.
Treating just 1% of the U.S. ESRD population (approximately 550,000 patients) could generate $700+ million in annual revenue based on one treatment per week.
Previous proposed indications included hepatic encephalopathy, sepsis, life-threatening virus and drug-resistant bacterial infections, but these would have required ICU-based studies that present significant logistical challenges.
Sigyn Therapeutics is investigating Nasdaq merger opportunities and implementing a strategy to advance therapies with less shareholder dilution.
Curated from NewMediaWire
