Biologics and bioprinting company 3DBio Therapeutics has secured rare paediatric disease status from the US Food and Drug Administration (FDA) for its AuriNovo living ear-shaped tissue.
AuriNova is an investigational combination product designed for the reconstruction of the outer ear in patients with microtia.
Microtia is a rare congenital disorder, which makes the outer ear (auricle) smaller than typical, misshapen, and sometimes missing at birth.
3DBio Therapeutics CEO Dr Daniel Cohen said: “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.”
AuriNovo is 3D-bioprinted by using ColVivo bio-ink and GMPrint bioprinter
AuriNovo integrates the auricular cartilage cells of the patient into a 3D-bioprinted, living and full-sized ear construct for the replacement of microtia-affected ear. Later, AuriNovo is implanted under the patient’s skin.
By using 3DBio’s ColVivo bio-ink and GMPrint bioprinter, AuriNovo is 3D-bioprinted. It will be matched in shape to the patient’s contralateral ear for implantation back into the patient
3DBio executive chairman Harlan Weisman said: “We are excited to achieve another important milestone in our first product’s development program as we approach clinical trials in 2020.”
With a focus on regenerative medicine, 3DBio is involved in the production of living tissues to enable replacement of each individual patient’s parts with tissues designed and created specifically for them.
The firm’s technology platform is comprised of a full suite of features to meet the FDA’s requirements for therapeutic manufacturing.
In November, Stryker secured FDA 510(k) clearance for its Sahara lateral 3D expandable interbody system.
Sahara Lateral 3D expandable interbody system, which features Lamellar 3D Titanium technology, is claimed to be the first-ever 3D-printed lateral expandable fusion device.
The device includes passive expansion capabilities that will help surgeons to achieve up to 30 degrees of sagittal spinal correction in skeletally mature patients.
