3DBio Therapeutics Receives Orphan Drug Designation for AuriNovo™ for Ear Reconstruction in Microtia Patients
NEW YORK, Nov. 19, 2019 /PRNewswire/ -- 3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced it has received Orphan Drug Designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia. Microtia is a rare congenital disorder causing the outer ear (auricle) to be smaller than typical, misshapen, and sometimes missing at birth; most cases only affect one ear. AuriNovo™ incorporates the patient's own auricular cartilage cells into a 3D-bioprinted, living, full-sized ear construct designed to replace the patient's microtia-affected ear. AuriNovo™ is then implanted under the skin of the auricular region of the patient's head.
"We are very pleased to have received Orphan Drug Designation for AuriNovo™ as this designation underscores the critical need for better treatments for children with microtia," said Daniel Cohen, Ph.D., Chief Executive Officer of 3DBio Therapeutics. "This milestone reinforces our commitment to bring AuriNovo™ into the clinic."
Orphan Drug Designation is granted by the Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA). The purpose of this designation is to create financial incentives for companies to develop new drugs and biologics for rare diseases. In the U.S., Orphan Drug Designation means that the sponsor qualifies for certain benefits, including a partial tax credit for clinical trial expenditures, waived user fees, and eligibility for marketing exclusivity, protecting it from competitors during this time period.
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