OYE has repurposed and reformulated a injectable drug product that accelerates emergence from anesthesia roughly 50% faster than the current standard of care. The downstream impact of the intervention is a 30-50% reduction in the length of stay in recovery of 30-90 minutes, reduction in uncompensated care, and improvements to delirium and cognitive deficit saving hospitals $3B annually in the USA. Patients are safely migrated from higher to lower cost centers and ultimately discharge.
The drug product is a 505(b)2 submission, thus significantly reducing the the time and cost as pre-clinical studies have been bridged to the previously approved drug.
Our regulatory and clinical investigational plan completes the products development with a single Phase III trial that is set to enroll the first patient Q2 2021. The Series A funds the Phase III and submission of the NDA.
All in, 505(b)2 at $23M to exit, achieves US FDA approval, and addresses a $2.2B Service Obtainable Market!
The drug product is a 505(b)2 submission, thus significantly reducing the the time and cost as pre-clinical studies have been bridged to the previously approved drug.
Our regulatory and clinical investigational plan completes the products development with a single Phase III trial that is set to enroll the first patient Q2 2021. The Series A funds the Phase III and submission of the NDA.
All in, 505(b)2 at $23M to exit, achieves US FDA approval, and addresses a $2.2B Service Obtainable Market!
Company Type:
Privately Funded Company
Company Website:
Company HQ State:
Indiana
Company HQ Country:
United States
Year Founded:
2019
Main Therapeutic Focus:
Other
Lead Product in Development:
OYE-0519
Development Phase of Primary Product:
Phase III
Number Of Unlicensed Products (For Which You Are Seeking Partners):
1
Speaker
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