3DBio Therapeutics announced today that the FDA granted it rare pediatric disease designation for the AuriNovo outer ear reconstruction system for patients with microtia.
According to the New York–based company, there are currently no other established treatments for microtia that allow a patient to regain an auricle comprising living tissue aside from limited rib grafts that are associated with significant donor site morbidity.
The AuriNovo living ear-shaped tissue is designed to be implanted under the patient’s skin to replace the microtia-affected ear. It is 3D-bioprinted with 3DBio’s ColVivo bio-ink and GMPrint bioprinter and seeded with the patient’s auricular cartilage cells. The tissue is matched in shape to the patient’s contralateral ear for implantation.
FDA rare pediatric disease designation is awarded to devices designed to treat a serious or life-threatening disease that primarily affects individuals aged 18 or under and that impacts fewer than 200,000 individuals in the U.S.
“We are pleased to have received rare pediatric disease designation, as it highlights the seriousness of microtia and the impact it has on children born with the condition,” 3DBio Therapeutics CEO Daniel Cohen said in a news release.
“We are excited to achieve another important milestone in our first product’s development program as we approach clinical trials in 2020,” added 3DBio executive chairman Dr. Harlan Weisman.