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.
| NEW YORK, Dec. 6, 2019 /PRNewswire/ -- 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™ About 3DBio Therapeutics For more information visit: www.3dbiocorp.com Certain information set forth in this press release may constitute “forward-looking statements” under applicable securities laws. There are a number of factors that could cause actual results or outcomes to differ materially from those addressed in such forward-looking statements. Thus forward-looking statements are provided only as an opportunity to understand management’s beliefs and opinions in respect of the company’s future prospects.
SOURCE 3DBio Therapeutics |
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