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Oragenics and BRAINBox Solutions Partner to Develop First Integrated Concussion Diagnosis and Treatment Platform

  • Oragenics and BRAINBox Solutions have formed a strategic partnership to create the first comprehensive concussion management platform, combining diagnostic biomarkers with intranasal therapy ONP-002.

  • The collaboration integrates BRAINBox's AI-driven diagnostic platform using neurological biomarkers and assessments with Oragenics' intranasal therapeutic candidate for improved concussion care.

  • Initial clinical results show promise, with ONP-002 demonstrating good tolerability in Phase I trials, while addressing a significant market need of over 5 million annual concussion cases in the US alone.

Oragenics, Inc. (NYSE American: OGEN) and BRAINBox Solutions have announced a groundbreaking partnership aimed at transforming the landscape of concussion diagnosis and treatment. The collaboration combines BRAINBox's advanced diagnostic capabilities with Oragenics' innovative therapeutic development to create the first comprehensive test-to-treat platform for mild traumatic brain injury (mTBI).

Innovative Diagnostic-Therapeutic Integration

The partnership leverages BRAINBox's proprietary diagnostic platform, which utilizes a sophisticated combination of neurological biomarkers, neuropsychological assessments, and AI-driven analytics. This technology will be integrated with Oragenics' ONP-002, an intranasal therapeutic candidate designed specifically for concussion treatment.
"This collaboration represents a significant step forward in concussion care," said Janet Huffman, Interim Chief Executive Officer of Oragenics. "By combining our innovative intranasal therapeutic with BRAINBox's state-of-the-art diagnostic product platform, we hope to offer a comprehensive solution that addresses both the identification and treatment of mTBI, ultimately improving patient outcomes."

Clinical Progress and Market Potential

ONP-002, developed as an intranasal neurosteroid therapeutic, has shown promising results in preclinical studies for reducing brain injury effects and supporting recovery. The Phase I clinical trial demonstrated that ONP-002 is well-tolerated, with patients successfully operating the novel intranasal delivery device.
Donna Edmonds, Chief Executive Officer of BRAINBox Solutions, emphasized the partnership's potential: "Partnering with Oragenics allows us to enhance the impact of our diagnostic technology by linking it directly to a promising therapeutic option. Together, we aim to set a new standard in the management of brain injuries."

Advanced Diagnostic Capabilities

BRAINBox's testing platform provides both diagnostic and prognostic insights, crucial for identifying patients at higher risk for long-term symptoms. The platform includes:
  • Point-of-care blood biomarker analysis
  • Comprehensive neuropsychological assessments
  • AI-driven analytics for accurate TBI assessment
  • Real-time monitoring capabilities for therapeutic efficacy

Market Impact and Future Directions

With over 5 million concussions occurring annually in the United States alone, the partnership addresses a significant unmet medical need. The integrated platform aims to streamline the path from diagnosis to treatment, potentially revolutionizing how concussions are managed in clinical settings.
The collaboration will play a crucial role in Oragenics' upcoming Phase IIa trials, where BRAINBox's diagnostic tools will facilitate precise patient selection and monitoring of treatment effectiveness. This integrated approach represents a significant advancement in the field of traumatic brain injury care, offering healthcare providers a comprehensive solution for improved patient outcomes.
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