• Login
    • Join
  • FOLLOW:
  • Subscribe Free
    • Magazine
    • eNewsletter
    Checkout
    • Magazine
    • News
    • Opinions
    • Top 30
    • Research
    • Supply Chain
    • Device Sectors
    • Directory
    • Events
    • Resources
    • Microsites
    • More
  • Magazine
  • News
  • Opinions
  • Top 30
  • Research
  • Supply Chain
  • Device Sectors
  • Directory
  • Events
  • Resources
  • Microsites
  • Current / Back Issues
    Features
    Editorial
    Digital Edition
    eNewsletter Archive
    Our Team
    Editorial Guidelines
    Reprints
    Subscribe Now
    Advertise Now
    Top Features
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    OEM News
    Supplier News
    Service / Press Releases
    Online Exclusives
    Press Releases
    People in the News
    Product & Service Releases
    Supplier News
    Medtech Makers
    Technical Features
    International News
    Videos
    Product & Service Releases
    Live From Shows
    Regulatory
    Financial/Business
    Top News
    BMP Medical Expands Sterling, Massachusetts Facility

    Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy

    Environmental Sustainability Becoming Increasingly Important to Medtech Industry

    Duane DiFranco Joins Harvard MedTech’s Medical Advisory Board

    Lionel Bonte Named President of Mativ’s Healthcare and Wellness Business Unit
    From the Editor
    Blogs
    Guest Opinions
    Top Opinions
    Deep (Brain) Thoughts with Medtronic's Neuromodulation President

    Grab and Go: Examining the Thrombectomy Device Market

    Fine Print: A Discourse on Additive Manufacturing

    MPO's 2022 Medtech Industry Year in Review

    Micro Molding for Medtech Is Miniature Magic
    Top 30 Medical Device Companies
    Market Data
    White Papers
    Top Research
    Reflections on 2022 and What’s Ahead for Medtech: MPO Sounding Board

    3 Ways to Prepare for ISO 13485/Part 820 Harmonization

    A New Home for Theranos' Elizabeth Holmes?

    Health Cost Drivers for Large Employers

    Braving Change: Facing Fears in the Midst of Major Transitions
    3D/Additive Manufacturing
    Contract Manufacturing
    Electronics
    Machining & Laser Processing
    Materials
    Molding
    Packaging & Sterilization
    R&D & Design
    Software & IT
    Testing
    Tubing & Extrusion
    Cardiovascular
    Diagnostics
    Digital Health
    Neurological
    Patient Monitoring
    Surgical
    Orthopedics
    All Companies
    Categories
    Company Capabilities
    Add New Company
    Outsourcing Directory
    Paragon Medical

    Providence Enterprise USA Inc.

    Medbio LLC

    Fusion Biotec Inc.

    Halkey-Roberts Corporation
    MPO Summit
    Industry Events
    Webinars
    Live From Show Event
    Industry Associations
    Videos
    Career Central
    eBook
    Slideshows
    Top Resources
    How Artificial Intelligence Can Combat Key Issues Impacting Healthcare

    Why Advanced Sensors Are Crucial Within Medical Pumps

    How Artificial Intelligence Could Help Prevent 80% of Chronic Diseases

    4 Ways to Use Injection Molding in Medical Device Manufacturing

    Telemedicine and Connectivity to Drive Material Innovation in the Near Future
    Companies
    News Releases
    Product Releases
    Press Releases
    Product Spec Sheets
    Service Releases
    Case Studies
    White Papers
    Brochures
    Videos
    Outsourcing Directory
    Paragon Medical

    Providence Enterprise USA Inc.

    Medbio LLC

    Fusion Biotec Inc.

    Halkey-Roberts Corporation
    • Magazine
      • Current/Back Issues
      • Features
      • Editorial
      • Columns
      • Digital Editions
      • Subscribe Now
      • Advertise Now
    • News
    • Directory
      • All Companies
      • ALL CATEGORIES
      • Industry Associations
      • Company Capabilities
      • Add Your Company
    • Supply Chain
      • 3D/Additive Manufacturing
      • Contract Manufacturing
      • Electronics
      • Machining & Laser Processing
      • Materials
      • Molding
      • Packaging & Sterilization
      • R&D & Design
      • Software & IT
      • Testing
      • Tubing & Extrusion
    • Device Sectors
      • Cardiovascular
      • Diagnostics
      • Digital Health
      • Neurological
      • Patient Monitoring
      • Surgical
      • Orthopedics
    • Top 30 Company Report
    • Expert Insights
    • Slideshows
    • Videos
    • eBook
    • Resources
    • Podcasts
    • Infographics
    • Whitepapers
    • Research
      • White Papers
      • Case Studies
      • Product Spec Sheets
      • Market Data
    • MPO Summit
    • Events
      • Industry Events
      • Live From Show Events
      • Webinars
    • Microsite
      • Companies
      • Product Releases
      • Product Spec Sheets
      • Services
      • White Papers / Tech Papers
      • Press Releases
      • Videos
      • Literature / Brochures
      • Case Studies
    • About Us
      • About Us
      • Contact Us
      • Advertise with Us
      • eNewsletter Archive
      • Privacy Policy
      • Terms of Use
    Breaking News

    3D Bioprinted Ear Implanted in Clinical Trial

    3DBio Therapeutics used a proprietary process leveraging the patient’s own tissue to generate an implantable ear, AuriNovo.

    Michael Barbella, Managing Editor07.07.22
    Now hear this: 3DBio Therapeutics (3DBio) and the Microtia-Congenital Ear Deformity Institute have reconstructed a human ear from 3D bioprinted living tissue. 

    The two organizations reconstructed the body's hearing organ via the AuriNovo implant during a first-in-human Phase 1/2a clinical trial. The study is evaluating AuriNovo's safety and preliminary efficacy for patients with microtia, a rare congenital deformity where one or both outer ears are absent or underdeveloped. Microtia affects approximately 1,500 U.S. babies annually.1,2 This transformational implant procedure was performed by a team led by Arturo Bonilla, M.D., a leading pediatric ear reconstructive surgeon specializing in microtia and the founder and director of the Microtia-Congenital Ear Deformity Institute in San Antonio, Texas.

    “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,” said Bonilla. “This study will allow us to investigate the safety and aesthetic properties of this new procedure for ear reconstruction using the patient’s own cartilage cells. 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. The AuriNovo™ living tissue implant is designed to provide a better solution for patients born with microtia by transforming their appearance and building their confidence and self-esteem.”
     
    AuriNovo is a patient-specific, living tissue implant created using 3D-bioprinting technology for surgical reconstruction of the outer ear in people born with microtia Grades II-IV. The construct is a 3D-bioprinted collagen hydrogel scaffold encapsulating the patient’s own auricular cartilage cells (chondrocytes). The construct is printed in a size and shape matching the patient’s opposite ear for implantation. AuriNovo 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 U.S. Food and Drug Administration (FDA) has granted AuriNovo Orphan Drug and Rare Pediatric Disease Designations.

    The AuriNovo Phase 1/2a clinical trial is a multicenter, single arm, prospective, open-label, staged study of the living tissue ear implant for surgical reconstruction of the external ear in patients born with unilateral microtia. The clinical trial will collect safety data on microtic ear reconstruction using AuriNovo and assess preliminary efficacy data which will be measured by overall satisfaction scores from Surgical Outcomes and FACE-Q Kids questionnaires. Following 3D scanning of the opposite ear to specifically match the patient’s ear geometry, AuriNovo incorporates the patient’s own auricular cartilage cells into a 3D-bioprinted, living, full-sized ear construct designed to replace the patient’s microtia-affected ear. The trial expects to enroll 11 patients and is being conducted in sites in Los Angeles and San Antonio. In addition to the Microtia-Congenital Ear Deformity Institute, the AuriNovo trial is enrolling patients at Cedars-Sinai Medical Center in Los Angeles under the direction of John Reinisch, M.D., director of Craniofacial and Pediatric Plastic Surgery.

    3DBio has developed unique capabilities enabling the creation of living tissue implants for therapeutic applications. The company not only created the first 3D-bioprinted living tissue implant, but it also created an entire suite of processes and engineering solutions required to support the technology platform. The platform is purpose-built 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 exceptional 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. It is the culmination of more than seven years of our company’s focused efforts to develop a uniquely differentiated technology platform meeting the FDA’s requirements for therapeutic manufacturing of reconstructive implants,” said Daniel Cohen, Ph.D., 3DBio CEO and co-founder. “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.”

    3DBio Therapeutics (3DBio) is a clinical-stage regenerative medicine company pioneering custom-engineered, patient-specific, 3D-bioprinted, living tissue implants. 3DBio’s approach develops living tissue implants with structural and functional integrity using a full suite of features to meet the FDA’s requirements for therapeutic manufacturing including novel and proprietary 3D-bioprinter, bio-ink, specialized cell culture system, and implantable protective Overshell technology. 
     
    Founded in 1996 by 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 microtia reconstruction surgeries 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. 

    References
    1 Luquetti, D.V., et al., Microtia: epidemiology and genetics. American Journal of Medical Genetics Part A, 2012. 158(1): p. 124-139.
    2 Luquetti, D.V., 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.
    Related Searches
    • 3D/Additive Manufacturing
    Related Knowledge Center
    • 3D/Additive Manufacturing
      Loading, Please Wait..

      Trending
      • Study: Catheter Ablation Significantly Lowers Dementia Risk In AFib Patients
      • Tandem Diabetes Completes Deal For AMF Medical
      • BMP Medical Expands Sterling, Massachusetts Facility
      • The Future Of Biomedical Engineering Advancements
      • Abbott's Proclaim XR SCS OK'ed For Diabetic Neuropathy
      Breaking News
      • BMP Medical Expands Sterling, Massachusetts Facility
      • Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy
      • Environmental Sustainability Becoming Increasingly Important to Medtech Industry
      • Duane DiFranco Joins Harvard MedTech’s Medical Advisory Board
      • Lionel Bonte Named President of Mativ’s Healthcare and Wellness Business Unit
      View Breaking News >
      CURRENT ISSUE

      November 2022

      • MPO's 2022 Year in Review
      • Fine Print: A Discourse on Additive Manufacturing
      • Grab and Go: Examining the Thrombectomy Device Market
      • View More >

      Cookies help us to provide you with an excellent service. By using our website, you declare yourself in agreement with our use of cookies.
      You can obtain detailed information about the use of cookies on our website by clicking on "More information”.

      • About Us
      • Privacy Policy
      • Terms And Conditions
      • Contact Us

      follow us

      Subscribe
      Nutraceuticals World

      Latest Breaking News From Nutraceuticals World

      Vitamin D Supplementation Reduces Risk of Dynapenia
      Sustained-Release Caffeine Ingredient Offers Mood, Performance Benefits
      Multi-Strain Probiotic Improves Self-Reported Mood, Sleep, Serotonin Levels
      Coatings World

      Latest Breaking News From Coatings World

      Epoxytec Announces New Website Launch
      Paints and Coatings Market Worth $212B by 2026: MarketsandMarkets
      Axalta Releases Fourth Quarter and Full Year 2022 Results
      Medical Product Outsourcing

      Latest Breaking News From Medical Product Outsourcing

      BMP Medical Expands Sterling, Massachusetts Facility
      Abbott's Proclaim XR SCS OK'ed for Diabetic Neuropathy
      Environmental Sustainability Becoming Increasingly Important to Medtech Industry
      Contract Pharma

      Latest Breaking News From Contract Pharma

      Pasithea Signs CMC Development and Manufacturing Agreement
      Experic Expands Analytical Capabilities and Facilities
      List Labs Expands Manufacturing Capacity
      Beauty Packaging

      Latest Breaking News From Beauty Packaging

      Haircare Brand Uncle Funky’s Daughter Announces Retail Expansion
      TRESemmé Introduces New Pro Infusion Collection
      Walgreens Boots Alliance Shares 2022 ESG Report
      Happi

      Latest Breaking News From Happi

      KimChi Beauty Launches Spinning Hearts Love 02 Ahead of Valentine’s Day
      Dark & Lovely Names Actress Meagan Good Brand Ambassador
      Natural Household Care Company Tru Earth Adds Dishwasher Detergent Tablets
      Ink World

      Latest Breaking News From Ink World

      Xerox Releases 4Q, Full-Year 2022 Results
      Electronics For Imaging Names Frank Pennisi as CEO
      Fiery to Separate from EFI, Remain Wholly-Owned by Siris
      Label & Narrow Web

      Latest Breaking News From Label & Narrow Web

      EFI appoints Frank Pennisi CEO, Fiery now an independent business
      Bobst boosts senior sales team with Keith Nagle
      Penmar Industries adds Screen Truepress Jet L350UV SAI digital press
      Nonwovens Industry

      Latest Breaking News From Nonwovens Industry

      Essity’s Sales Grow
      Thinx to Pay up to $5 million to Settle Class Action Suit
      Typar Highlighting New Building Innovations
      Orthopedic Design & Technology

      Latest Breaking News From Orthopedic Design & Technology

      Orthofix Launches the Mariner Deformity System
      Tyber Medical Hires 2 New Execs
      Miach Ortho Raises $40M in Series B Funding
      Printed Electronics Now

      Latest Breaking News From Printed Electronics Now

      Smart Devices with Privacy Focus Have More Consumer Appeal
      Siman Group Partners with SML to Unlock Full Retail Potential with RFID
      Brewer Science Presents Optics Integration Solutions at SPIE Photonics West

      Copyright © 2023 Rodman Media. All rights reserved. Use of this constitutes acceptance of our privacy policy The material on this site may not be reproduced, distributed, transmitted, or otherwise used, except with the prior written permission of Rodman Media.

      AD BLOCKER DETECTED

      Our website is made possible by displaying online advertisements to our visitors.
      Please consider supporting us by disabling your ad blocker.


      FREE SUBSCRIPTION Already a subscriber? Login