Sigyn Therapeutics, Inc. (OTCQB: SIGY) released a shareholder update on March 13, 2026, authored by CEO Jim Joyce, detailing the company's strategic initiatives to address financial constraints and advance its pipeline of dialysis-like therapies for cardiovascular disease and cancer.
Joyce, who previously founded Aethlon Medical and led the development of the Hemopurifier—a device that received multiple FDA Breakthrough Device designations and was named a TIME Top 25 Invention—acknowledged the challenges facing Sigyn as an OTC-traded company. The company had intended to uplist to Nasdaq but failed to execute a firm commitment offering due to a regulatory catch-22 involving Nasdaq and SEC requirements. As a result, Sigyn is exploring alternative strategies to capitalize its endeavors without diluting shareholder value.
Key among these strategies is a potential merger with a Nasdaq-listed company at risk of not meeting the forthcoming $5 million minimum market value of listed securities (MVLS) requirement. Joyce also noted the possibility of selling certain assets, including the company's traumatic brain injury (TBI) indication, which has recently emerged as a valuable asset. The full shareholder update is available on the company's website at https://www.sigyntherapeutics.com/investors/news-events/press-releases/detail/118/sigyn-therapeutics-issues-shareholder-update-highlighting.
Sigyn's lead candidate, CardioDialysis, targets cholesterol-transporting lipoproteins and inflammatory molecules to address cardiovascular disease, the leading cause of death worldwide. Unlike existing lipoprotein apheresis devices limited to fewer than 60 specialized centers in the U.S., CardioDialysis is designed for use on dialysis machines at over 7,500 clinics. In vitro studies also suggest potential for treating sepsis and TBI. The company's pipeline includes ImmunePrep, ChemoPrep, and ChemoPure for cancer therapy.
Joyce highlighted the significance of the cardiovascular disease opportunity, noting that lipoprotein apheresis reduces major adverse cardiovascular events (MACE) more effectively than drugs, yet remains underutilized. For sepsis, where no approved therapy exists, CardioDialysis has been shown to reduce endotoxin and inflammatory mediators, positioning it alongside Spectral Medical's PMX device, which has a market value of approximately $300 million.
Despite the therapeutic promise, Joyce emphasized that the company's OTC status has hampered its ability to raise capital. He encouraged shareholders to review his earlier January 15th update for further details on navigating forward with reduced dilution. As of March 11, 2026, Sigyn had 2,330,042 shares outstanding.
The update underscores Sigyn's efforts to leverage its technology through strategic transactions while facing the realities of a challenging financial environment. The company's ability to execute a merger or asset sale will be critical to advancing its therapies toward clinical studies and eventual market clearance.
