Sigyn Therapeutics has provided a comprehensive update on the advancement of CardioDialysis, its medical device designed to treat cardiovascular disease through dialysis-like blood purification. The company detailed its clinical pathway through the U.S. Food and Drug Administration, disclosed exploration of Nasdaq merger opportunities, and outlined strategies to fund clinical progression with reduced shareholder dilution.
Cardiovascular disease remains the leading cause of death worldwide, with current statin drug treatments reducing major adverse cardiovascular events by approximately 25%. In contrast, blood purification therapies like lipoprotein apheresis can achieve 75-95% reductions in MACE according to the American Heart Association, though access is limited to specialized centers. CardioDialysis addresses a broader range of cardiovascular disease targets and is designed for use on existing dialysis machines located at approximately 50,000 dialysis clinics globally.
The commercialization pathway for CardioDialysis requires completion of a feasibility study followed by a pivotal efficacy study. The feasibility study protocol was developed 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. Successful completion would enable a pivotal efficacy study necessary for FDA market clearance.
A significant advantage of CardioDialysis is its ability to conduct both feasibility and pivotal efficacy studies in dialysis clinic settings rather than hospital intensive care units. This approach overcomes historical challenges of conducting blood purification studies in ICU environments, where similar studies have taken more than a decade to complete enrollment. The treatment of cardiovascular disease allows studies to be conducted in end-stage renal disease patients during regularly scheduled dialysis sessions.
Clinical study enrollment is anticipated to be efficient since approximately 550,000 ESRD patients in the U.S. have cardiovascular disease, with two-thirds 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 $2,500 per treatment. Extending the lives of U.S. ESRD patients by one month could boost dialysis industry revenues by approximately $2.8 billion. Additional information about CardioDialysis is available through https://www.sigyntherapeutics.com/ceo-notes.
As an OTC-listed company, Sigyn is pursuing potential Nasdaq merger opportunities to expand access to capital markets, improve share liquidity, and increase visibility. Nasdaq announced plans in September 2025 to increase minimum Market Value of Listed Securities requirements from $1 million to $5 million for Nasdaq Capital Market companies, with approximately 235 companies reported non-compliant at that time. The company has initiated discussions with a Nasdaq company at risk of falling below the new requirement and is exploring other potential merger opportunities with investment banking houses.
Independent of merger pursuits, Sigyn plans to establish a private subsidiary to fund CardioDialysis clinical progression at potentially more favorable valuations compared to current public market value. This approach would also provide access to investment funds restricted from investing in OTC-listed securities. The company notes that three Nasdaq-listed blood purification companies have experienced share price declines of 95%, 85%, and 34% respectively in the past year, with one seeing its market capitalization descend from approximately $800 million to $44 million.
A private preclinical stage blood purification company is currently raising capital at a $59 million valuation, exceeding the combined market capitalization of the three Nasdaq-listed companies. This valuation variance raises questions about reducing shareholder dilution through private funding. CardioDialysis offers potential strategic value to the dialysis industry, and a private subsidiary may 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.
The company's oncology assets, including ImmunePrep, ChemoPrep, and ChemoPure, are not contributing quantifiable value at present but may be advanced within a private subsidiary that could become a valued asset on Sigyn's balance sheet. The update emphasizes the company's commitment to advancing therapeutic and corporate endeavors while addressing the global burden of cardiovascular disease through innovative blood purification technology.
