Oragenics Inc. (NYSE American: OGEN) signed a letter of intent to license CardioDialysis technology from Sigyn Therapeutics Inc. (OTCQB: SIGY) for treating traumatic brain injury and other chronic neurodegenerative diseases, according to a company statement.

The proposed exclusive license would allow Oragenics to develop and commercialize the blood purification technology, which removes inflammatory and pathogenic molecules from the bloodstream. The company plans to combine this approach with its existing ONP-002 neurosteroid treatment, currently in Phase IIa clinical trials for concussion and mild traumatic brain injury.

Under the proposed terms, Oragenics would issue 3.25 million shares of restricted preferred stock to Sigyn, convertible to common stock on a one-to-one basis. The company would pay a 3% royalty on revenue from licensed technology sales for six years following FDA market clearance per approved indication and country.

The transaction targets closing within 90 days, subject to due diligence completion, board approvals, independent valuation, and other standard conditions. Sigyn agreed not to license the technology to third parties for the specified markets during the exclusivity period.

CardioDialysis is designed to filter blood plasma through a proprietary cartridge system, targeting inflammatory cytokines, endotoxins, and other pathogenic molecules. ONP-002 crosses the blood-brain barrier to address neuroinflammation directly within the brain tissue.

The letter of intent contains non-binding provisions except for exclusivity, confidentiality, and governing law terms. Completion of a definitive agreement requires satisfactory due diligence, board approvals from both companies, NYSE American compliance, and other customary closing conditions.

No FDA-approved pharmacological treatments currently exist for concussion or mild traumatic brain injury, which affects an estimated 69 million individuals worldwide annually.