Oragenics Signs LOI to License CardioDialysis Technology for Brain Disorders

Oragenics Inc. has signed a letter of intent to license Sigyn Therapeutics' CardioDialysis blood purification technology, aiming to combine it with its intranasal neurosteroid candidate ONP-002 for a dual-modality approach to traumatic brain injury and neurodegenerative diseases.

May 7, 2026
Oragenics Signs LOI to License CardioDialysis Technology for Brain Disorders

Oragenics Inc. (NYSE American: OGEN) and Sigyn Therapeutics Inc. (OTCQB: SIGY) have announced the signing of a letter of intent (LOI) under which Oragenics expects to obtain an exclusive license to develop and commercialize Sigyn's CardioDialysis™ blood purification technology. This technology is intended for use in traumatic brain injury (TBI) and chronic neurodegenerative diseases, complementing Oragenics' Phase IIa intranasal neurosteroid candidate ONP-002 in a proposed dual-modality approach targeting inflammation on both sides of the blood-brain barrier.

The announcement marks a strategic expansion for Oragenics, which is currently developing ONP-002 as a potential first-in-class treatment for concussion and mild traumatic brain injury. The company is planning to commence clinical trials in Australia for ONP-002, with U.S. Phase 2b trials expected to follow. By incorporating CardioDialysis, Oragenics aims to address inflammation systemically, potentially enhancing therapeutic outcomes for patients with neurological conditions.

Sigyn's CardioDialysis technology is a blood purification platform designed to remove harmful inflammatory mediators from the bloodstream. This approach could be particularly relevant for TBI, where inflammation plays a critical role in secondary injury and long-term neurodegeneration. The dual-modality strategy combines systemic blood purification with intranasal delivery of ONP-002, which targets inflammation within the brain, offering a comprehensive treatment paradigm.

"This agreement represents a significant step forward in our mission to develop innovative therapies for neurological disorders," said a spokesperson for Oragenics. "By combining our intranasal delivery platform with Sigyn's CardioDialysis technology, we hope to create a new standard of care for patients suffering from traumatic brain injury and neurodegenerative diseases."

The LOI outlines the key terms for the exclusive license, but the final agreement is subject to negotiation and execution of definitive documents. The companies have not disclosed financial details of the proposed license. Oragenics' intranasal delivery platform has potential applications across multiple neurological conditions, including Parkinson's disease, Alzheimer's disease, PTSD, and anxiety disorders.

Investors can find the latest news and updates regarding OGEN in the company's newsroom at https://ibn.fm/OGEN. The full press release is available at https://ibn.fm/VD4RO.