Revolutionizing the standard of care for patients across multiple life changing programs
Our vision is to repair or replace human tissues and organs, that are individually designed for each patient. We aim to treat a wide range of conditions, from congenital to traumatic, as well as injuries subsequent to degeneration and cancer.
At 3DBio, we always keep the patient in mind. Our products are engineered to support potentially life-long reconstruction and/or replacement with living tissue and organ implants. We are turning our vision into reality as we continue clinical testing of our AuriNovo ear implant in patients born with microtia.
As we develop our products, we put patient safety first. We start with guidance from the world’s top reconstructive surgeons to better understand what the greatest patient needs are with an eye to transform reconstructive surgeries using 3D-printed living tissues and organs.
Our design and manufacturing processes are conducted under a stringent quality system required by the U.S. Food and Drug Administration for medical product manufacturing of cell- or tissue-based medical products. Our clinical trials follow Good Clinical Practice (GCP), an international quality standard provided by the International Conference on Harmonisation (ICH) that is accepted worldwide. This standard protects patient privacy, patient safety, and clinical trial data quality.
Our first clinical program is evaluating AuriNovo™ and provides a patient-specific, living-tissue implant for use in the surgical reconstruction of the external ear in people born with microtia Grades II-IV.
A Phase 1/2A study is being conducted to collect preliminary safety data on microtic ear reconstruction using AuriNovo; fine-tune technical, logistical, surgical, and post-surgical care aspects related to implantation; and to gather preliminary efficacy data including short- and longer-term in vivo duration and biological status of the implant. See full details below.
A Multicenter, Single Arm, Prospective, Open-Label, Staged Study of the Safety and Efficacy of the AuriNovo™ Construct for Auricular Reconstruction in Subjects With Unilateral Microtia.
Phase 1/2A Clinical Study Open for Enrollment
Study title: A Multicenter, Single Arm, Prospective, Open-Label, Staged Study of the Safety and Efficacy of the AuriNovo Construct for Auricular Reconstruction in Subjects with Unilateral Microtia
Investigational Product: The investigational product is called AuriNovo™ and it is not currently approved by the U.S. Food and Drug Administration (FDA). AuriNovo is a patient-specific, biologic implant for use in surgical reconstruction of the external ear (auricle) in people born with microtia Grades II-IV. It is 3D-bioprinted using the patient’s own auricular cells combined with collagen. It includes a biodegradable Overshell made of polydioxanone. The study is being conducted under the FDA’s Investigational New Drug/Biologic (IND) program.
Purpose of the study: This is a first-in-human (Phase 1/2a) study being conducted to collect preliminary safety and efficacy data on AuriNovo. Data also are being collected on technical, logistical, surgical, and post-surgical care aspects related to implantation of AuriNovo
Protocol Summary: The surgeon (Principal Investigator) will work with 3DBio manufacturing to design an AuriNovo implant that is sized and shaped specifically for a given patient. At the time of the microtia reconstruction surgery, the surgeon will place the Overshell component parts around the biologic components, suture the outside Overshell parts together, and implant the entire AuriNovo product (Overshell and biologic components) under the skin or skin flap. The implantation procedure varies based on the surgeon’s chosen technique.
The study subject, subject’s caretaker (if the subject is not an adult), and the surgeon will complete questionnaires indicating their level of satisfaction with the AuriNovo™ implant. Safety data will be collected at each visit.
Enrollment for the entire study is limited to 11 subjects aged 6-25 years old. Since the study is small, enrollment is largely by invitation from the surgeon (Principal Investigator).
It is anticipated that it will take approximately 18 to 21 months to recruit the targeted number of subjects due to staged (spread out over time) enrollment and up to 5 additional years to complete the long-term follow up.
Basic Study Eligibility Criteria
Below is a partial list of study eligibility criteria.
- 6-25 years old, inclusive
- Born with unilateral microtia Grade II, III, or IV
- No previous surgical procedure for auricular reconstruction
- Have undergone an audiological assessment prior to enrollment and surgeon confirmation that study participation will not preclude future hearing correction options
- Normal or near normal hairline position
- Healthy subjects with no history of cancer, problematic wound healing, or immune disorders
Patients who meet any of the following exclusion criteria are not eligible for the study:
- Previous cochlear implant surgery
- Prior surgery in the temporal, parietal, or mastoid regions of the affected side that resulted in scarring that may affect the outcome of microtia reconstruction surgery.
- Sensitivity to broad-spectrum aminoglycoside antibiotics containing any of the following: streptomycin, gentamycin tobramycin, amikacin, kanamycin, neomycin, or plazomicin.
- Sensitivity to materials of porcine origin including pork products. For subjects with no known exposure to porcine materials including pork products, sensitivity as confirmed at baseline through a positive porcine skin sensitivity test.
- Patients previously diagnosed/evaluated for any of the following syndromes:
- CHARGE (Coloboma, Heart defect, choanal Atresia, Retarded growth and development, Genital hypoplasia, Ear anomalies) syndrome,
- Branchio-oto-renal (BOR) syndrome
- Patients with renal dysfunction of any etiology
- There are additional inclusion and exclusion criteria.
More information about the trial can be found at ClinicalTrials.gov
This is Just the Beginning
At 3DBio, we know 3D-printing of human tissues and organs is achievable. We know because we’ve done it. Our first patient-matched, patient tissue-derived product, AuriNovo, is being evaluated in a clinical study in adults and children. Learn more about our ongoing clinical study evaluating 3D-printed ears manufactured using 3DBio’s living tissue implant platform.
“I’ve been waiting over 30 years to give my patients a natural ear. Finally, the future may be here.”
Dr. John Reinisch has been reconstructing the ears of children and adults born with microtia (missing or malformed outer ear) for over 35 years. He is known for developing a procedure that is done in a single, outpatient surgery using a porous polyethylene implant. He has long hoped to give his patients a “real” flexible ear grown from their own cartilage.
“I am very excited to be participating in the AuriNovo clinical study. We may finally have the chance to reconstruct an ear that matches the look and feel of a normal ear.”
United States, California
Cedars-Sinai Pediatric Plastic Surgery
Beverly Hills, California, United States, 90211
United States, Texas
Microtia-Congenital Ear Deformity Institute
San Antonio, Texas, United States, 78240