Sigyn Therapeutics explores NASDAQ merger, establishes clinical pathway

Sigyn Therapeutics Inc. (OTCQB: SIGY) announced plans to pursue merger opportunities with NASDAQ-listed companies and outlined a clinical pathway for its CardioDialysis device to treat cardiovascular disease.

The company said it has initiated discussions with a NASDAQ company that may fall below the exchange's new $5 million market value requirement. NASDAQ announced plans in September 2025 to increase the minimum market value of listed securities from $1 million to $5 million for Capital Market companies, pending SEC approval.

Sigyn outlined a two-phase clinical pathway for CardioDialysis, starting with a feasibility study estimated to cost $1.25 million. The company said it developed the study protocol with a dialysis company's clinical research division, which offered three clinical sites and investigators for a 12-15 subject study.

The device targets cardiovascular disease in end-stage renal disease patients during regular dialysis sessions. Sigyn estimates that treating 1% of the approximately 550,000 ESRD patients in the United States could generate over $700 million in annual revenue at $2,500 per weekly treatment.

Chief Executive Officer Jim Joyce said the company plans to establish a private subsidiary to fund clinical development at potentially higher valuations than its current public market value. This structure would also provide access to investment funds restricted from investing in over-the-counter securities.

Joyce noted that three NASDAQ-listed blood purification therapy companies have seen share price declines of approximately 95%, 85%, and 34% in the past year. He cited a private pre-clinical blood purification company raising capital at a $59 million valuation, exceeding the combined market capitalization of the three public companies.

The company's development pipeline includes CardioDialysis for cardiovascular disease and three cancer-related therapies: ImmunePrep, ChemoPrep, and ChemoPure.

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