Microtia is a rare congenital deformity where one or both outer ears are absent or underdeveloped and affects approximately 1,500 babies born in the US annually. In a transformational implant procedure, a team of pediatric ear reconstructive surgeons specializing in microtia has conducted a human ear reconstruction using an investigational, patient-matched, 3D-bioprinted living tissue ear implant.

3DBio Therapeutics (3DBio, Long Island City, NY, USA) and the Microtia-Congenital Ear Deformity Institute (San Antonio, TX, USA) performed the groundbreaking reconstructive procedure in the first-in-human Phase 1/2a clinical trial evaluating the safety and preliminary efficacy of the AuriNovo implant, a living tissue ear implant for surgical reconstruction of the external ear in patients born with unilateral microtia. The Phase 1/2a clinical trial is a multicenter, single arm, prospective, open-label, staged study of the AuriNovo living tissue ear implant for surgical reconstruction of the external ear in patients born with unilateral microtia.

AuriNovo is a patient-specific, living tissue implant created using 3D-bioprinting technology for surgical reconstruction of the outer ear in people born with microtia Grades II-IV. It is designed to provide a treatment alternative to rib cartilage grafts and synthetic materials traditionally used to reconstruct the outer ear of microtia patients. Following 3D scanning of the opposite ear to specifically match the patient’s ear geometry, 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 was granted Orphan Drug and Rare Pediatric Disease Designations by the FDA for reconstruction of the outer ear in patients with microtia.

“My hope is that AuriNovo will one day become the standard-of-care replacing the current surgical methods for ear reconstruction requiring the harvesting of rib cartilage or the use of porous polyethylene (PPE) implants,” said Arturo Bonilla, M.D., a leading pediatric ear reconstructive surgeon specializing in microtia and the founder and director of the Microtia-Congenital Ear Deformity Institute. “The AuriNovo implant requires a less invasive surgical procedure than the use of rib cartilage for reconstruction. We also expect it to result in a more flexible ear than reconstruction with a PPE implant.”

“We believe that the microtia clinical trial can provide us not only with robust evidence about the value of this innovative product and the positive impact it can have for microtia patients, but also demonstrate the potential for the technology to provide living tissue implants in other therapeutic areas in the future,” said Daniel Cohen, Ph.D., 3DBio Chief Executive Officer and Co-founder. “Our initial indications focus on cartilage in the reconstructive and orthopedic fields including treating complex nasal defects and spinal degeneration. We look forward to leveraging our platform to solve other high impact, unmet medical needs like lumpectomy reconstruction and eventually expand to organs.”

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