Human ear reconstructed with 3D-bioprinted implant

Regenerative medicine company 3DBio Therapeutics, together with the Microtia - Congenital Ear Deformity Institute, has announced a groundbreaking human ear reconstruction utilising an investigational, patient-matched, 3D-bioprinted living tissue ear implant known as AuriNovo.

AuriNovo is a patient-specific, living tissue implant created using 3D-bioprinting technology for surgical reconstruction of the outer ear (auricle) in people born with microtia, a rare congenital deformity where one or both outer ears are absent or underdeveloped. The construct is a 3D-bioprinted collagen hydrogel scaffold encapsulating the patient’s own auricular cartilage cells (chondrocytes), and is printed in a size and shape matching the patient’s opposite ear for implantation. 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.

The recent reconstructive procedure was carried out as part of a first-in-human Phase 1/2a clinical trial that is evaluating the safety and preliminary efficacy of AuriNovo for patients with microtia. The trial expects to enrol 11 patients and is being conducted in sites in California and Texas. The implant procedure was performed by a team led by Dr Arturo Bonilla, the founder and Director of the Microtia - Congenital Ear Deformity Institute.

“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,” Bonilla said.

“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.”

In addition to AuriNovo, 3DBio has created an entire suite of processes and engineering solutions required to support the technology platform. The platform has been purpose-built over the past seven-plus years to meet the FDA’s requirements for therapeutic manufacturing, and includes proprietary cell processes to rapidly expand cells in sufficient quantity; ColVivo therapeutic-grade bio-ink to preserve key biological and rheological properties; GMPrint 3D-bioprinter to enable a sterile workflow combined with high quality and speed; and Overshell technology to add non-permanent structural support to biological implants.

“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,” said 3DBio CEO and co-founder Dr Daniel Cohen.

“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.

“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.”

Image caption: The reconstructed ear before surgery (left) and 30 days post-surgery (right); follow-on surgeries will form the ear lobe and projection. Photos courtesy of Dr Arturo Bonilla, Microtia - Congenital Ear Deformity Institute.

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