Image: Actual image of the 3D printed AuriNovo “living” ear for reconstruction in patients with microtia (Photo courtesy of 3DBio Therapeutics)
Microtia is a rare birth defect where one or both outer ears are missing or underdeveloped and affects approximately 1,500 babies born in the United States each year. In a transformational implant procedure, a team of pediatric reconstructive surgeons specializing in microtia performed a reconstruction of the human ear using an experimental, patient-fitted, bioprinted living tissue ear implant. In 3D.
3DBio Therapeutics (3DBio, Long Island City, NY, USA) and the Microtia-Congenital Ear Deformity Institute (San Antonio, TX, USA) performed the breakthrough reconstructive procedure in the first Phase 1/2a clinical trial in humans evaluating the safety and preliminary efficacy of the AuriNovo implant, a living tissue ear implant for surgical reconstruction of the outer 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 outer 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 grades II-IV microtia. It is designed to provide a treatment alternative to costal cartilage grafts and synthetic materials traditionally used to reconstruct the outer ear of patients with microtia. Following 3D scanning of the opposite ear to specifically match the geometry of the patient’s ear, AuriNovo incorporates the patient’s own auricular cartilage cells into a live, full-size, 3D bio-printed ear construct, designed to replace the ear affected by the patient’s microtia. AuriNovo has been granted Orphan Drug and Rare Pediatric Disease designations by the FDA for reconstruction of the outer ear in patients with microtia.
“I hope that AuriNovo will one day become the standard of care replacing current surgical methods of ear reconstruction requiring the removal of costal cartilage or the use of porous polyethylene (PPE) implants,” said Arturo Bonilla. , MD, a leader. pediatric reconstructive ear surgeon specializing in microtia and founder and director of the Microtia-Congenital Ear Deformity Institute. “The AuriNovo implant requires less invasive surgery than using costal cartilage for reconstruction. We also expect this to result in a more flexible ear than reconstruction with an EPI implant.
“We believe that the microtia clinical trial can not only provide us with strong evidence of the value of this innovative product and the positive impact it can have for patients with microtia, but also demonstrate the potential for the technology to deliver living tissue implants in other therapeutics. areas in the future,” said Daniel Cohen, Ph.D., CEO and co-founder of 3DBio. “Our initial indications focus on cartilage in the areas of reconstruction and orthopedics, including the treatment of complex nasal malformations and spinal degeneration. We look forward to leveraging our platform to solve other high-impact unmet medical needs, such as lumpectomy reconstruction, and eventually expanding to organs. »
Microtia-Congenital Ear Deformity Institute