Sigyn Therapeutics, Inc., a developer of dialysis-like therapies for cardiovascular disease and cancer, has outlined its clinical pathway to commercialize CardioDialysis through the FDA while disclosing exploration of Nasdaq merger opportunities and a strategy to fund clinical progression with reduced shareholder dilution. The company's CEO, Jim Joyce, emphasized that cardiovascular disease remains the leading cause of death worldwide, with current statin treatments reducing major adverse cardiovascular events by approximately 25%, while blood purification therapies like lipoprotein apheresis can achieve 75–95% reductions according to the American Heart Association.
The commercialization pathway for CardioDialysis requires completion of a feasibility study and subsequent pivotal efficacy study. The company has developed its feasibility study protocol 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 estimated to cost $1.25 million. The recent rebranding to CardioDialysis represents a critical inflection point, unlocking a clinical pathway that allows studies to be conducted in dialysis clinic settings rather than hospital intensive care units, overcoming historical logistical challenges that have delayed other blood purification therapies for years.
CardioDialysis addresses a broader range of cardiovascular disease targets compared to lipoprotein apheresis and is designed for use on existing dialysis machines at approximately 50,000 dialysis clinics worldwide. The treatment of cardiovascular disease allows for clinical studies to be conducted in end-stage renal disease patients during regularly scheduled dialysis sessions, with the company anticipating efficient enrollment since approximately 550,000 ESRD patients in the U.S. have cardiovascular disease and two-thirds are expected to die from the condition. If commercialized, treating just 1% of the U.S. ESRD population could generate over $700 million in annual revenue based on one treatment per week at $2500 per treatment, while extending patient lives by one month could boost dialysis industry revenues by approximately $2.8 billion. Additional information about CardioDialysis is available through articles accessible at https://www.sigyntherapeutics.com/ceo-notes.
Concurrently, the company is pursuing Nasdaq merger opportunities as an OTC-listed entity, recognizing that a Nasdaq listing would expand access to capital markets, improve share liquidity, and increase visibility. Nasdaq announced plans in September 2025 to increase the minimum "Market Value of Listed Securities" requirement for continued listing from $1 million to $5 million for Nasdaq Capital Market companies, a change expected to be formalized following SEC clearance. Approximately 235 companies were reported non-compliant with continued listing requirements at the time of the announcement. Sigyn has initiated discussions with a Nasdaq company at risk of falling below the $5 million MVLS requirement and is exploring other potential merger opportunities with investment banking houses on a non-exclusive basis.
Independent of merger pursuits, Sigyn plans to establish a privately-owned subsidiary to fund CardioDialysis clinical progression at potentially more favorable valuations compared to current public market value, while also accessing investment funds restricted from OTC securities. The company notes that three Nasdaq-listed blood purification therapy companies have seen share prices decline 95%, 85%, and 34% respectively in the past year, with one company's market capitalization descending from approximately $800 million to $44 million. Currently, a private pre-clinical stage blood purification company is raising capital at a $59 million valuation, exceeding the combined market capitalization of the three Nasdaq-listed companies, raising questions about reducing shareholder dilution through private funding. A private subsidiary may also be more attractive as an acquisition candidate since acquirers could avoid inheriting legacy liabilities, public disclosure obligations, and non-core assets of a public parent company.
