3DBio Therapeutics and Microtia-Congenital Ear Deformity Institute Conduct Human Ear Reconstruction Using 3D Bio-Printed Living Tissue Implant in First-in-Human Clinical Trial

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-Auri Novo investigation, The 3D bio-printed implant was created using a proprietary process that leverages the patient’s own tissue to generate an implantable ear –

– Phase 1/2a clinical trial recruiting patients with microtia, a rare congenital disease where reconstruction options are limited –

– AuriNovo™ has been granted Orphan Drug and Rare Pediatric Disease Designations by the US FDA –

NEW YORK & SAN ANTONIO, June 02, 2022–(BUSINESS WIRE)–3DBio Therapeutics (3DBio), a clinical-stage regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute announced that they have conducted human ear reconstruction using the AuriNovo™ implant , an experimental living, patient-friendly and bio-printed 3D tissue ear implant. The revolutionary reconstruction procedure in the first phase 1/2a in humans clinical test is evaluating the safety and preliminary efficacy of AuriNovo™ for patients with microtia, a rare birth defect where one or both outer ears are absent or underdeveloped. Microtia affects approximately 1,500 babies born in the United States each year1.2. This transformational implant procedure was performed by a team led by Arturo Bonilla, MD, a pediatric reconstructive surgeon specializing in microtia and the founder and director of the Microtia-Congenital Ear Deformity Institute in San Antonio, Texas.

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AuriNovo™ is a patient-specific living tissue implant created using 3D bioprinting technology for surgical reconstruction of the outer ear in people born with grades II-IV microtia. AuriNovo™ is designed to provide a treatment alternative to costal cartilage grafts and synthetic materials traditionally used to reconstruct the outer ear of patients with microtia. The United States Food and Drug Administration (FDA) has granted AuriNovo™ Orphan Drug and Rare Pediatric Disease Designations.

“As a physician who has treated thousands of children with microtia across the country and around the world, I am inspired by what this technology can mean for microtia patients and their families,” said Dr Bonilla. “This study will allow us to investigate the safety and aesthetic properties of this new ear reconstruction procedure using the patient’s own cartilage cells. I hope that AuriNovo™ will one day become the standard of care replacing current surgical methods for ear reconstruction require the removal of costal cartilage or the use of porous polyethylene (PEP) implants.The AuriNovo™ implant requires less invasive surgery than the use of costal cartilage for reconstruction We also expect it will result in a more flexible ear than reconstruction with an EPI implant.The AuriNovo™ Living Tissue Implant is designed to provide a better solution for patients born with microtia by transforming their appearance. and boosting their confidence and self-esteem.”

Daniel Cohen, Ph.D., 3DBio The CEO and co-founder, and his team have built an exclusive and comprehensive technology platform to deliver living tissue implants to patients. “This is a truly historic moment for patients with microtia, and more broadly, for the field of regenerative medicine, as we begin to demonstrate the real-world application of the tissue engineering technology of new generation. It is the culmination of more than seven years of focused efforts by our company to develop a unique, differentiated technology platform that meets FDA requirements for the therapeutic manufacturing of reconstructive implants,” said Dr. Cohen. “We believe that the microtia clinical trial can provide us with not only strong evidence of the value of this innovative product and the positive impact it can have for patients with microtia, but also demonstrate the potential for the technology to provide living tissue implants in other therapeutic areas in the future.”

“Our initial indications are focused on cartilage in the areas of reconstructive and orthopedics, including the treatment of complex nasal malformations and spinal degeneration,” Dr. Cohen continued. “We look forward to leveraging our platform to solve other high-impact unmet medical needs, such as 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, California, led by John Reinisch, MDDirector of Craniofacial and Pediatric Plastic Surgery.

AuriNovo™ clinical trial

The Phase 1/2a clinical trial is a multicenter, single-arm, prospective, open-label, staged study of the AuriNovo™ living tissue ear implant for surgical reconstruction of the outer ear in patients born with unilateral microtia. The clinical trial will collect safety data on microtic ear reconstruction using AuriNovo™ and evaluate preliminary efficacy data which will be measured by overall satisfaction scores of surgical outcomes and FACE- questionnaires. QKids. Following 3D scanning of the opposite ear to specifically match the geometry of the patient’s ear, AuriNovo™ incorporates the patient’s own auricular cartilage cells into a live, full-size, bio-printed 3D ear construct , designed to replace the ear affected by the patient’s microtia. The trial plans to enroll 11 patients and is taking place at sites in Los Angeles, California, and San Antonio, Texas. For more information about the clinical trial, visit clinicaltrials.gov.

Exclusive 3D bioprinting technology

3DBio has developed unique capabilities allowing the creation of living tissue implants for therapeutic applications. The company not only created the first 3D bio-printed living tissue implant, but it also created a comprehensive suite of engineering processes and solutions needed to support the technology platform. The platform is specifically designed to meet FDA requirements for therapeutic manufacturing and includes: proprietary cellular processes to rapidly grow cells in sufficient quantities; ColVivo™ therapeutic grade biological ink to preserve key biological and rheological properties; GMPrint™ 3D-bioprinter to enable sterile workflow combined with exceptional quality and speed; and Overshell technology to add non-permanent structural support to biological implants.

About AuriNovo™

AuriNovo™ is a patient-specific supportive living tissue implant created using 3D bioprinting technology for surgical reconstruction of the outer ear (atrium) in people born with grades II-IV microtia. The construct is a 3D bio-printed collagen hydrogel scaffold encapsulating the patient’s own ear cartilage cells (chondrocytes). The construct is printed in a size and shape to match the patient’s opposite ear for implantation. AuriNovo™ has been granted Orphan Drug and Rare Pediatric Disease Designations by the FDA for reconstruction of the outer ear in patients with microtia.

About Microtia-Congenital Ear Deformity Institute

Founded in 1996 by Dr. Arturo Bonilla, the Microtia-Congenital Ear Deformity Institute helps children born with microtia and other ear deformities. It is one of the largest clinics in the world specializing in pediatric reconstruction surgeries for microtia and has performed thousands of procedures to help children born with this ear deformity. The Microtia-Congenital Ear Deformity Institute is based in San Antonio, Texas. For more information visit: https://www.microtia.net/.

About 3DBio Therapeutics

3DBio Therapeutics (3DBio) is a clinical-stage regenerative medicine company solving medical challenges by creating personalized, patient-specific, 3D bioprinted living tissue implants. 3DBio’s breakthrough approach develops living tissue implants with structural and functional integrity using a comprehensive suite of features to meet FDA requirements for therapeutic manufacturing, including a new and proprietary 3D bioprinter (GMPrint ™), a bio-ink (ColVivo™), a specialized cell culture system, and implantable protective Overshell technology. 3DBio’s first investigational product, AuriNovo™, is currently being evaluated in a Phase 1/2a clinical trial for ear reconstruction in patients with microtia and has received orphan drug and rare pediatric disease designation by the FDA. For more information visit: www.3dbiocorp.com

REFERENCES:

1 Lucetti, DV, et al., Microtia: epidemiology and genetics. American Journal of Medical Genetics, Part A, 2012. 158(1): p. 124-139.
2 Lucetti, DV, E. Leoncini and P. Mastroiacovo, Microtia-anotia: a global review of prevalence rates. Birth defects Res A Clin Mol Teratol, 2011. 91(9): p. 813-22.

Certain information contained in this press release may constitute “forward-looking statements” under applicable securities laws. There are a number of factors that could cause actual results to differ materially from those discussed in these forward-looking statements. Accordingly, forward-looking statements are provided solely as an opportunity to understand management’s beliefs and opinions regarding the company’s future prospects.

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contacts

Investors 3DBio Therapeutics:
Colin McDonough, Chief Financial Officer
Email: [email protected]

Media:
Shani Lewis
TheWayHealthScience
Email: [email protected]
Phone: 617-865-5554

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