Sigyn Therapeutics, Inc., a developer of dialysis-like therapies for cardiovascular disease and cancer, has outlined its clinical and corporate strategy in a shareholder update. The company's primary focus is CardioDialysis, a medical device designed to treat cardiovascular disease by reducing inflammatory molecules and cholesterol-transporting lipoproteins during dialysis sessions. Cardiovascular disease remains the leading cause of death worldwide, with current statin drugs reducing major adverse cardiovascular events by approximately 25%. In contrast, blood purification therapies like lipoprotein apheresis can achieve 75–95% reductions, according to the American Heart Association, but access is limited. CardioDialysis is designed to address a broader range of targets and be used on existing dialysis machines at approximately 50,000 clinics globally.
The company clarified its FDA pathway, which requires a feasibility safety study followed by a pivotal efficacy study. The feasibility study protocol was developed with a leading dialysis company's clinical research division, which offered three clinical sites. The study, estimated to cost $1.25 million and involve 12-15 subjects, would be conducted in a dialysis clinic setting rather than a hospital ICU. This represents a significant logistical advantage, as ICU-based studies for other blood purification indications have historically taken over a decade to complete. By focusing on end-stage renal disease patients with cardiovascular disease during regular dialysis sessions, Sigyn anticipates efficient enrollment. Approximately 550,000 ESRD patients in the U.S. have cardiovascular disease, with two-thirds expected to die from it. The company projects that treating just 1% of this population could generate over $700 million in annual revenue, based on one weekly treatment at $2,500 per session. Extending patient lives by one month could add approximately $2.8 billion to dialysis industry revenues. More information on CardioDialysis is available at https://www.sigyntherapeutics.com/ceo-notes.
Concurrently, Sigyn is pursuing Nasdaq merger opportunities. As an OTC-listed company, it recognizes that a Nasdaq listing would improve capital market access, share liquidity, and visibility. However, Nasdaq's listing requirements have become more stringent. In September 2025, Nasdaq announced plans to increase the minimum "Market Value of Listed Securities" requirement for continued listing on the Nasdaq Capital Market from $1 million to $5 million. This change, awaiting final SEC clearance, is expected to create merger opportunities for non-compliant companies. Sigyn has initiated discussions with one such company and is exploring other potential mergers with investment banks. To fund clinical progression with reduced shareholder dilution, Sigyn plans to establish a private subsidiary. This strategy aims to raise capital at potentially more favorable valuations than its current public market value and access investment funds restricted from OTC securities. The company noted that three Nasdaq-listed blood purification companies have seen share prices decline significantly in the past year, with one falling from an $800 million market capitalization to approximately $44 million. In contrast, a private pre-clinical stage company is raising capital at a $59 million valuation. A private subsidiary could also be a more attractive acquisition candidate for dialysis companies, avoiding legacy liabilities and public disclosure obligations. Sigyn's oncology assets, including ImmunePrep, ChemoPrep, and ChemoPure, may also be advanced within this private structure.
