Sigyn Therapeutics has provided a shareholder update outlining the clinical development pathway for CardioDialysis, a medical device designed to treat cardiovascular disease using existing dialysis clinic infrastructure. The company also disclosed initiatives to pursue a Nasdaq listing through potential mergers and establish a private subsidiary to fund clinical progression with potentially less shareholder dilution.
Cardiovascular disease remains the leading cause of death worldwide, with current statin drug therapies 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, but access is limited to specialized centers. CardioDialysis addresses a broader range of cardiovascular targets and is designed for use on dialysis machines located at approximately 50,000 dialysis clinics globally.
The commercialization pathway for CardioDialysis through the FDA requires completion of a feasibility safety study followed by a pivotal efficacy study. The company has developed a feasibility study protocol in collaboration with the clinical research division of a leading dialysis company, with three clinical site locations and principal investigators identified for a 12-15 subject study estimated to cost $1.25 million. This represents a significant inflection point as it allows studies to be conducted in dialysis clinics rather than hospital intensive care units, overcoming historical logistical challenges that have delayed other blood purification therapies for years.
The treatment of cardiovascular disease enables feasibility and efficacy studies to be conducted in end-stage renal disease patients during regularly scheduled dialysis sessions. With approximately 550,000 ESRD patients in the U.S., most of whom have cardiovascular disease and two-thirds expected to die from the condition, the company anticipates efficient clinical study enrollment. 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. 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 the company's CEO notes.
Concurrently, Sigyn is exploring Nasdaq merger opportunities as an OTC-listed company. 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 awaiting final SEC clearance. Approximately 235 companies were reported non-compliant with Nasdaq's continued listing requirements at the time of the announcement. The company has initiated discussions with a Nasdaq company at risk of falling below the new $5 million MVLS requirement and is exploring other potential merger opportunities with investment banking houses.
Independent of merger pursuits, Sigyn plans to establish a privately-owned subsidiary to fund CardioDialysis clinical progression at valuations potentially more favorable than its 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 therapy companies have seen share prices decline 95%, 85%, and 34% respectively in the past year, with one seeing its market capitalization descend 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.
This corporate strategy matters because it addresses both the clinical advancement of a potentially transformative cardiovascular treatment and the financial mechanisms needed to fund that development. The shift to dialysis clinic-based studies could accelerate regulatory approval timelines significantly compared to ICU-based studies that have taken other companies over a decade to complete. The financial strategies reflect adaptation to changing market conditions and exchange requirements that could impact shareholder value and the company's ability to access necessary capital.
The implications extend beyond Sigyn to the broader healthcare landscape. Successful development of CardioDialysis could provide dialysis clinics with new revenue streams while addressing the leading cause of death in ESRD patients. The treatment model leverages existing infrastructure rather than requiring specialized centers, potentially increasing patient access to advanced cardiovascular interventions. The corporate initiatives reflect broader trends in biotechnology financing and exchange listing requirements that may influence how emerging medical technology companies structure their development pathways.
