3DBio Therapeutics (3DBio), a clinical-stage regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute announce that they have conducted a human ear reconstruction using the AuriNovo implant, an investigational, patient-matched, 3D-bioprinted living tissue ear implant. 

The reconstructive procedure in the first-in-human Phase 1/2a clinical trial is evaluating the safety and preliminary efficacy of AuriNovo™ for patients with microtia, a rare congenital deformity where one or both outer ears are absent or underdeveloped. Microtia affects approximately 1,500 babies born in the US annually. This transformational implant procedurewas performed by a team led by Arturo Bonilla, MD, a pediatric ear reconstructive surgeon specializing in microtia and the founder and director of the Microtia-Congenital Ear Deformity Institute in San Antonio..

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. AuriNovo is designed to provide a treatment alternative to rib cartilage grafts and synthetic materials traditionally used to reconstruct the outer ear of microtia patients. The U.S. FDA has granted AuriNovo Orphan Drug and Rare Pediatric Disease Designations.

“As a physician who has treated thousands of children with microtia from across the country and around the world, I am inspired by what this technology may mean for microtia patients and their families,” says Bonilla. “This study will allow us to investigate the safety and aesthetic properties of this new procedure for ear reconstruction using the patient’s own cartilage cells.”

Bonilla adds, “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. 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.”

3D Bio CEO and Co-Founder Daniel Cohen, PhD, and his team have built a proprietary technology platform to deliver living tissue implants to patients. “This is a truly historic moment for patients with microtia, and more broadly, for the regenerative medicine field as we are beginning to demonstrate the real-world application of next-generation tissue engineering technology.” 

“Our initial indications focus on cartilage in the reconstructive and orthopedic fields including treating complex nasal defects and spinal degeneration,” continues Cohen. “We look forward to leveraging our platform to solve other high impact, unmet medical needs like lumpectomy reconstruction and eventually expand to organs.”

In addition to the Microtia-Congenital Ear Deformity Institute, the AuriNovo Phase 1/2a clinical trial is enrolling patients at Cedars-Sinai Medical Center in Los Angeles under the direction of John Reinisch, MD, Director of craniofacial and pediatric plastic surgery.