Sigyn Therapeutics, Inc. (OTCQB: SIGY) released a shareholder update from CEO Jim Joyce, outlining key milestones for its CardioDialysis therapy, corporate initiatives including potential Nasdaq mergers, and a strategy to fund clinical progress with reduced shareholder dilution.
The company emphasized that cardiovascular disease is the leading cause of death globally, and current statin therapies reduce major adverse cardiovascular events (MACE) by only about 25%. In contrast, blood purification therapies like lipoprotein apheresis can achieve 75–95% reductions in MACE, but access is limited to specialized centers. CardioDialysis targets a broader range of cardiovascular disease targets and is designed for use on dialysis machines at approximately 50,000 clinics worldwide.
Sigyn clarified its FDA clinical pathway: a feasibility (safety) study followed by a pivotal efficacy study. The feasibility study protocol was developed with a leading dialysis company's clinical research division, offering three clinical sites and principal investigators for a 12–15 subject study at an estimated cost of $1.25 million. Successful completion would enable the pivotal efficacy study for FDA market clearance. The company noted that focusing on cardiovascular disease allows studies to be conducted in ESRD patients during regular dialysis sessions, avoiding the logistical challenges of ICU-based studies that have taken over a decade for other companies.
If commercialized, treating just 1% of the U.S. ESRD population (approximately 550,000 patients) could generate over $700 million annually, based on one treatment per week at $2,500 reimbursement. Additional details are available in a series of articles accessible at https://www.sigyntherapeutics.com/ceo-notes.
Regarding Nasdaq listing, Sigyn acknowledged the need to elevate its trading to a major exchange. However, Nasdaq's increasing listing requirements—including a planned increase in the minimum Market Value of Listed Securities from $1 million to $5 million for Capital Market companies—have prompted the company to initiate discussions with a Nasdaq company at risk of non-compliance and explore merger opportunities with investment banks. There is no assurance a merger will be completed.
Independent of a merger, Sigyn plans to establish a private subsidiary to fund CardioDialysis clinical progression at potentially higher valuations than its current public market value. This approach also opens access to investment funds restricted from OTC securities. The company noted that three Nasdaq-listed blood purification companies have seen share price declines of 34% to 95% in the past year, while a private preclinical-stage blood purification company is raising capital at a $59 million valuation—exceeding the combined market cap of those three Nasdaq firms. This disparity suggests that funding through a private entity could reduce shareholder dilution. Additionally, a private subsidiary may be a more attractive acquisition target for dialysis companies, though no acquisition discussions are currently underway.
Sigyn also plans to assess advancing its oncology assets—ImmunePrep, ChemoPrep, and ChemoPure—within a private subsidiary that could become a valued balance sheet asset. The company concluded by thanking shareholders and directing further inquiries to the CEO at jj@sigyntherapeutics.com.
