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Traumatic Brain Injury

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Introduction

Intranasal administration via the Shenocatheter allows exosomes to bypass the blood–brain barrier through the olfactory and trigeminal pathways. Neural exosomes may support neuroinflammation reduction, neuronal repair and signaling.

Indications and Viable Conditions

  • Mild, moderate, or severe traumatic brain injury

  • Post-concussive syndrome

  • Chronic neurologic symptoms following head trauma

  • Cognitive dysfunction, headaches, mood or sleep disturbance related to TBI

Contraindications

  • Active sinus or nasal infection

  • Severe nasal septal deviation

  • Active intracranial hemorrhage (relative contraindication)

Dosing Considerations

Total Dose: 2.0 cc EXO-NeuralTM

  • 1.0 cc per nostril

    Procedure:

    1. Position patient supine with slight neck extension.

    2. Prime SphenoCatheter® per manufacturer guidelines.

    3. Advance catheter along nasal floor to posterior nasopharynx.

    4. Deliver 1.0 cc EXO-NeuralTM slowly.

    5. Repeat on contralateral side.

    6. Maintain supine position for 10–15 minutes post-procedure.

Treatment Frequency

Initial Series: Every 2 weeks for 4–8 weeks (2–4 treatments)

Maintenance: Every 4–8 weeks as clinically indicated

Regulatory Disclaimer

This therapy is investigational. Exosome-based products are not FDA-approved for the treatment of traumatic brain injury. This protocol is not intended to diagnose, treat, cure, or prevent disease.

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