US FDA approves bioprinted solution for pediatric microtia

Written by Georgi Makin

3DBio Therapeutics (NY, USA) has announced US FDA rare pediatric disease designation for ear reconstruction in microtia patients. 3DBio Therapeutics (NY, USA) has received US FDA rare pediatric disease designation for AuriNovoTM, a living ear-shaped bioprinted tissue, custom developed by seeding the device with the patient's own auricular cartilage cells. A 'rare pediatric disease' is defined by the FDA as 'a serious or life-threatening disease primarily affecting individuals age 18 years or younger that impacts fewer than 200,000 individuals in the United States'. Microtia is a rare congenital condition characterized by a misshapen, smaller or often missing auricle (outer ear)...

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