Sigyn Therapeutics Explores Strategic Options Amid Nasdaq Listing Challenges

Sigyn Therapeutics, Inc., a developer of dialysis-like therapies targeting cardiovascular disease and cancer, has issued a shareholder update detailing strategic initiatives including a potential merger and asset sales. The company's CEO, Jim Joyce, outlined these plans while explaining challenges related to the company's OTCQB listing status and failed attempt to uplist to Nasdaq. Joyce previously founded Aethlon Medical, where he oversaw development of the Aethlon Hemopurifier, which received multiple FDA Breakthrough Device designations and was named by TIME magazine as a Top 25 Invention and Top Eleven Medical Breakthrough.

The company's lead therapeutic candidate, CardioDialysis, addresses therapeutic targets underlying life-threatening conditions including cardiovascular disease, sepsis, and traumatic brain injury. For cardiovascular disease, CardioDialysis targets cholesterol-transporting lipoproteins plus inflammatory molecules and is designed for use on existing dialysis machines at more than 7,500 U.S. dialysis clinics. This represents a significant opportunity since lipoprotein apheresis devices that reduce cholesterol-transporting lipoproteins demonstrate greater reduction of major adverse cardiovascular events than drugs, but are only available at fewer than 60 specialized centers in the United States.

Regarding sepsis, there is currently no approved therapy, though the PMX hemoadsorption device being developed by Spectral Medical has shown promise. CardioDialysis has been validated to reduce sepsis-inducing bacterial toxins including endotoxin and inflammatory mediators from human blood plasma. Spectral Medical, a Toronto Stock Exchange company, has a market value of approximately $300 million, indicating the potential market for sepsis treatments.

Joyce explained that Sigyn Therapeutics became public through a merger with an established OTC company but failed to execute an uplist to Nasdaq financing due to regulatory complications. The financing was a firm commitment offering led by a FINRA member broker-dealer, but Nasdaq requested to review and approve investors prior to SEC effectiveness of the registration statement, creating what Joyce described as a catch-22 situation. The company eventually withdrew the registration statement. While share price and exchange listing don't impact therapeutic efficacy, Joyce noted they have affected the company's ability to raise capital without harming shareholder value.

The company is now pursuing strategies to move forward with reduced shareholder dilution, including asset sales and a potential merger with a Nasdaq-listed company at risk of not meeting the forthcoming $5 million minimum market value of listed securities requirement. Joyce referenced his January 15th shareholder update which details these strategies available at https://www.sigyntherapeutics.com/investors/news-events/press-releases/detail/118/sigyn-therapeutics-issues-shareholder-update-highlighting. The company's traumatic brain injury indication has recently emerged as an asset whose value they hope to leverage through strategic transactions. As of March 11, 2026, Sigyn Therapeutics has 2,330,042 shares outstanding.