Sigyn Therapeutics, Inc., a developer of dialysis-like therapies for cardiovascular disease and cancer, has issued a shareholder update outlining the clinical advancement of CardioDialysis and new corporate strategies. The update, authored by CEO Jim Joyce, clarifies the company's regulatory pathway, discloses exploration of Nasdaq merger opportunities, and reveals a plan to fund clinical progression with potentially reduced shareholder dilution.
Cardiovascular disease remains the leading cause of death worldwide, with treatment primarily focused on reducing major adverse cardiovascular events. While statin drugs reduce MACE incidence by approximately 25%, blood purification therapies like lipoprotein apheresis can achieve 75–95% reductions according to the American Heart Association, 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 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, 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 the pivotal study needed for FDA market clearance.
A significant advantage of CardioDialysis is that both feasibility and pivotal efficacy studies can be conducted in end-stage renal disease patients during regularly scheduled dialysis sessions at their clinics, rather than in hospital intensive care units. This addresses a historic logistical challenge for blood purification therapies. With approximately 550,000 ESRD patients in the U.S., most of whom have cardiovascular disease, the company anticipates efficient clinical study enrollment.
The commercial potential is substantial. Treating just 1% of the U.S. ESRD population could generate over $700 million in annual revenue based on one $2,500 treatment per week. Extending ESRD patient lives by one month could boost dialysis industry revenues by approximately $2.8 billion. Additional information about CardioDialysis is available through articles accessible at https://www.sigyntherapeutics.com/ceo-notes.
Concurrently, Sigyn is pursuing Nasdaq merger opportunities to elevate its trading from the OTC market. Nasdaq recently announced plans 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. The company believes this will create widespread pressure for non-compliant Nasdaq companies to identify merger candidates. Sigyn has initiated discussions with one at-risk Nasdaq company and is exploring other potential mergers with investment banks on a non-exclusive basis.
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 OTC securities. The company notes that three Nasdaq-listed blood purification companies have seen share prices decline 95%, 85%, and 34% respectively over the past year, with one seeing its market capitalization fall from approximately $800 million to $44 million. Meanwhile, a private pre-clinical stage blood purification company is raising capital at a $59 million valuation, exceeding the combined market cap of the three Nasdaq-listed companies.
This valuation variance raises questions about reducing shareholder dilution through private capital raises. A private subsidiary may also 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, may also be advanced within a private subsidiary that could become a valued asset on Sigyn's balance sheet.
