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.
There are currently no established treatments for microtia that enable a patient to regain an auricle comprising living tissue, other than rib grafts which are limited in shape and consistency, and are associated with significant donor site morbidity. 3DBio’s AuriNovo™ is a living ear-shaped tissue that is 3D-bioprinted using 3DBio’s ColVivo™ bio-ink, seeded with the patient’s own auricular cartilage cells, and matched in shape to the patient’s contralateral ear for implantation back into the patient.
About 3DBio Therapeutics
3DBio Therapeutics is a biologics and bioprinting company with a focus on regenerative medicine that manufactures living tissues to allow replacement of each individual patient’s parts with tissues designed and created specifically for them. 3DBio has developed unique capabilities toward the creation of living tissue implants for therapeutic applications. The technology platform includes a full suite of features to meet the FDA’s requirements for therapeutic manufacturing, including novel and proprietary 3D-bioprinter (GMPrint™), bio-ink (ColVivo™), and cell processes. In pre-clinical studies the platform has demonstrated the ability to generate functioning living tissues.