Sigyn Therapeutics Outlines Clinical Pathway for CardioDialysis and Corporate Strategy to Reduce Shareholder Dilution

Sigyn Therapeutics, Inc., a developer of dialysis-like therapies for cardiovascular disease and cancer, released a shareholder update authored by CEO Jim Joyce, outlining the company's clinical pathway, corporate initiatives, and funding strategy. Cardiovascular disease remains the leading cause of death worldwide, with current treatments like statins reducing major adverse cardiovascular events by approximately 25%. In contrast, blood purification therapies such as lipoprotein apheresis can achieve 75–95% reductions, though access is limited to specialized centers.

The company's CardioDialysis technology addresses a broader range of cardiovascular disease targets and is designed for use on dialysis machines at approximately 50,000 clinics globally. The commercialization pathway through the FDA requires completing a feasibility safety study and a subsequent pivotal efficacy study. The feasibility study protocol was developed with a leading dialysis company's clinical research division, which offered three clinical site locations and principal investigators for a 12-15 subject study estimated to cost $1.25 million. Successful completion would enable a pivotal efficacy study for FDA market clearance.

CardioDialysis represents a critical inflection point, allowing studies in dialysis clinics rather than hospital intensive care units, overcoming historical logistical challenges. The treatment of cardiovascular disease enables studies in end-stage renal disease patients during regular dialysis sessions. With about 550,000 ESRD patients in the U.S., most have cardiovascular disease, and two-thirds are expected to die from it, facilitating efficient clinical enrollment. Treating just 1% of the U.S. ESRD population could generate over $700 million annually, based on one weekly treatment at $2,500 reimbursement. Extending patient lives by one month could boost dialysis industry revenues by approximately $2.8 billion. More information on CardioDialysis is available through articles accessible at https://www.sigyntherapeutics.com/ceo-notes.

As an OTC-listed company, Sigyn is pursuing Nasdaq merger opportunities to enhance market access, liquidity, and visibility. Nasdaq plans to increase the minimum Market Value of Listed Securities requirement from $1 million to $5 million for Capital Market companies, potentially affecting about 235 non-compliant companies. In anticipation, Sigyn has initiated discussions with a Nasdaq company at risk and is exploring other merger opportunities with investment banks, though no assurance of completion exists.

To fund clinical progression with reduced shareholder dilution, Sigyn plans to establish a private subsidiary, potentially raising capital at more favorable valuations than its current public market value and accessing investment funds restricted from OTC securities. This strategy is informed by valuation disparities: three Nasdaq-listed blood purification companies have seen share price declines of 95%, 85%, and 34% in the past year, with one dropping from an $800 million peak to about $44 million. In contrast, a private pre-clinical stage company is raising capital at a $59 million valuation, exceeding the combined market cap of the three Nasdaq companies. A private subsidiary may also be more attractive for acquisition, avoiding legacy liabilities and public disclosure obligations. Sigyn's oncology assets, including ImmunePrep, ChemoPrep, and ChemoPure, may be advanced within this subsidiary to potentially enhance the company's balance sheet.