Sigyn Therapeutics has outlined its clinical development plan for CardioDialysis, a medical device designed to treat cardiovascular disease in dialysis patients, while disclosing corporate initiatives including the pursuit of a Nasdaq listing through merger opportunities. The company's CEO, Jim Joyce, detailed these plans in a shareholder update, emphasizing the potential impact on treating the leading cause of death worldwide.
Cardiovascular disease remains the primary cause of global mortality, 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, though access is limited to specialized centers. CardioDialysis addresses a broader range of cardiovascular targets and is designed for use on existing dialysis machines at approximately 50,000 clinics worldwide, potentially expanding treatment access significantly.
The commercialization pathway requires completing a feasibility safety study followed by a pivotal efficacy study. The company has developed its feasibility study protocol in collaboration with a leading dialysis company's clinical research division, with three clinical site locations identified for a 12-15 subject study costing approximately $1.25 million. Successful completion would enable the pivotal study needed for FDA market clearance.
A critical advantage of CardioDialysis is its ability to conduct clinical studies in dialysis clinic settings rather than hospital intensive care units. This addresses historical logistical challenges that have delayed other blood purification therapies. The company notes that treating cardiovascular disease allows studies to be conducted in end-stage renal disease patients during regular dialysis sessions, with approximately 550,000 U.S. ESRD patients representing a substantial potential study population, most of whom have cardiovascular disease.
The economic implications are substantial. Treating just 1% of the U.S. ESRD population could generate over $700 million in annual revenue based on one weekly treatment at $2,500 reimbursement. Extending patient lives by one month could add approximately $2.8 billion to dialysis industry revenues. Additional information about CardioDialysis is available through the company's website at https://www.sigyntherapeutics.com/ceo-notes, which includes articles discussing the therapy's clinical rationale and industry attributes.
Concurrently, Sigyn is exploring Nasdaq merger opportunities as an OTC-listed company. Nasdaq recently announced plans to increase minimum Market Value of Listed Securities requirements from $1 million to $5 million for Nasdaq Capital Market companies, a change awaiting SEC clearance. The company anticipates this will create merger opportunities with non-compliant Nasdaq companies and has initiated discussions with one such company while exploring other potential mergers with investment banking firms.
To fund clinical progression with reduced shareholder dilution, Sigyn plans to establish a private subsidiary that could raise capital at potentially more favorable valuations than its current public market value. This approach would also provide access to investment funds restricted from OTC securities. The company notes that three Nasdaq-listed blood purification companies have seen share price declines of 95%, 85%, and 34% in the past year, while a private preclinical company is raising capital at a $59 million valuation that exceeds their combined market capitalization.
This valuation variance suggests potential advantages to private funding. Additionally, a private subsidiary might be more attractive for acquisition by dialysis companies seeking to avoid inheriting public company liabilities and disclosure obligations. The company's oncology assets, including ImmunePrep, ChemoPrep, and ChemoPure, may also be advanced within such a private entity. These corporate strategies aim to advance CardioDialysis while managing shareholder value amid challenging market conditions for medical device developers.
