3DBio Therapeutics issued the following announcement on Dec. 6.
3DBio Therapeutics, an emerging leader in the field of 3D-bioprinting for human therapeutic use, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease designation for AuriNovo™, an investigational combination product for reconstruction of the outer ear in patients with microtia.
"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," said Daniel Cohen, Ph.D., Chief Executive Officer of 3DBio Therapeutics.
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 patient's skin.
"We are excited to achieve another important milestone in our first product's development program as we approach clinical trials in 2020," added 3DBio's Executive Chairman Harlan Weisman, M.D., formerly Chief Science and Technology Officer of Johnson & Johnson Medical Devices & Diagnostics.
The U.S. FDA defines a "rare pediatric disease" 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. The Rare Pediatric Disease designation provides incentives to advance the development of drugs and biologics to treat rare diseases. Through the FDA's Rare Pediatric Disease Priority Review Voucher Program a sponsor who receives marketing approval for a product with a Rare Pediatric Disease designation may be eligible for a voucher that can be redeemed to obtain priority review for any subsequent marketing application.
About AuriNovo™
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 and GMPrint™ bioprinter, 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.
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