Pipeline

3dBio Therapeutics Pipeline

Overview

3DBio’s technology platforms enable the creation of de novo, patient-specific living tissues as a therapeutic to treat disease and congenital medical conditions. Our products address a spectrum of different medical needs, including: replacing damaged tissue (e.g., DiscNovo™), preventing further degeneration (e.g., AnnuNovo™), and replacing congenitally absent tissue (e.g., AuriNovo™).

Our technology is capable of addressing a broad range of indications. The initial pipeline is focused on providing cartilage tissues for craniofacial and spinal conditions. Cartilage is an essential connective tissue, yet typically heals poorly — creating a particular need for regenerative approaches to treating cartilage-based medical conditions.

Indication: Microtia

Product: AuriNovoTM

Microtia is a congenital medical condition in which the auricle (“external ear”) is undeveloped, and in some cases results in anotia, or the complete absence of an auricle. There are currently no established treatments that enable a patient to regain an auricle comprising living tissue, other than rib grafts which are deficient in shape and consistency, and are associated with significant donor site morbidity. 3DBio’s AuriNovo™ is a living ear-shaped tissue that is 3D-bioprinted using 3DBio’s ColVivoTM bio-ink, seeded with the patient’s own auricular cartilage cells, and matched in shape precisely to the patient’s contralateral ear for implantation into the patient.

Indication: Herniated Intervertebral Disc

Product: AnnuNovoTM

Herniation of the intervertebral disc, sometimes referred to as a “slipped” disc, can occur when a tear develops in the intervertebral disc’s outer ring of tissue, called the annulus fibrosus (AF). This tear allows the core jelly-like tissue, called the nucleus pulposus (NP), to leak out of the disc and impinge nearby nerves. Each year, nearly 500,000 patients in the U.S. experience related pain, numbness or weakness in the back and limbs. The condition is surgically treated by removing the leaked NP to decompress the nearby nerves, but there is no widely accepted treatment to close and heal the hernia in the AF and prevent further leakage or re-herniation. 3DBio’s AnnuNovo™ uses our proprietary bio-ink (ColVivo™), formulated specifically for AF repair along with a proprietary delivery method to close the defect in the AF, support healing, and reduce the risk of re-herniation.

Indication: Degenerative Disc Disease

Product: DiscNovoTM

Degenerative Disc Disease (DDD) is a condition in which a damaged intervertebral disc causes back pain. The most common treatment is fusion, with approximately 200,000 patients in the U.S. having fusion on the cervical levels alone. Fusion’s limitations include risk of Adjacent Segment Disease (ASD) — is a condition in which neighboring discs begin fail due to the unnatural mechanics of the fused site. Some estimates suggest that up to 30% of patients will experience ASD within 10 years subsequent to a disc fusion. Synthetic implants do not remove ASD risk and also have other limitations and may pose risks related to degradation debris and bone erosion. 3DBio’s DiscNovo™ is living tissue, whole-disc implant 3D-biprinted in the shape of the patient’s intervertebral disc as a replacement.

Indication: Complex Nasal Defect

Product: NasaNovoTM

Severe nasal defects, and in particular those with large dorsal compromise, present serious challenges due to the complex shape, and general lack of availability of sufficient graft tissue. While grafts are sourced from the ear and rib of the patient, there can be donor site morbidity and these tissues are limited in quantity and can sometimes be difficult to carve into appropriate shapes. Synthetic solutions have limitations, including the risk of extrusion and contamination. 3DBio’s NasaNovo™ is similar to the AuriNovo™ product (i.e., a 3D-bioprinted living tissue implant from the patient’s own cells), but tailored specifically to nasal indications and printed to match the desired aesthetic outcome for each patient.