{"id":191179,"date":"2022-05-23T00:00:00","date_gmt":"2022-05-23T00:00:00","guid":{"rendered":"https:\/\/facfox.com\/news\/3dbio-therapeutics-reconstructs-human-ear-using-bioprinted-living-tissue-bioprinting\/"},"modified":"2022-07-19T07:09:17","modified_gmt":"2022-07-19T07:09:17","slug":"3dbio-therapeutics-reconstructs-human-ear-using-bioprinted-living-tissue-bioprinting","status":"publish","type":"post","link":"https:\/\/facfox.com\/news\/3dbio-therapeutics-reconstructs-human-ear-using-bioprinted-living-tissue-bioprinting\/","title":{"rendered":"3DBio Therapeutics reconstructs human ear using bioprinted living tissue Bioprinting"},"content":{"rendered":"

3DBio Therapeutics, a clinical-stage regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute have conducted a human ear reconstruction using the AuriNovo implant \u2013 an investigational, patient-matched, 3D bioprinted living tissue ear implant.<\/p>\n

This groundbreaking reconstructive procedure, which is in the first-in-human Phase 1\/2a clinical trial, is evaluating the safety and preliminary efficacy of AuriNovo for patients with microtia, a rare congenital deformity where one or both outer ears are absent or underdeveloped. Microtia affects approximately 1,500 babies born in the US, annually.<\/p>\n

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.<\/p>\n

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AuriNovo is a patient-specific, living tissue implant \u2013 created using 3D bioprinting technology \u2013 for surgical reconstruction of the outer ear in people born with microtia Grades 2 to 4. AuriNovo is designed to provide a treatment alternative to rib cart<\/a>ilage 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.<\/p>\n

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Following the 3D scanning of the opposite ear to specifically match the patient\u2019s ear geometry, AuriNovo incorporates the patient\u2019s own auricular cart<\/a>ilage cells into a 3D bioprinted, living, full-sized ear construct designed to replace the patient\u2019s microtia-affected ear.<\/p>\n

3DBio Therapeutics has developed unique capabilities enabling the creation of living tissue implants for therapeutic application<\/a>s. In addition to creating the first 3D bioprinted living tissue implant, 3DBio Therapeutics 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\u2019s 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.<\/p>\n

\u201cAs 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,\u201d said Dr. Bonilla. \u201cThis study will allow us to investigate the safety and aesthetic properties of this new procedure for ear reconstruction using the patient\u2019s own cart<\/a>ilage 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 cart<\/a>ilage or the use of porous polyethylene (PPE) implants. The AuriNovo implant requires a less invasive surgical procedure than the use of rib cart<\/a>ilage 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.\u201d<\/p>\n

<\/p>\n

Daniel Cohen, Ph.D., 3DBio Therapeutics Chief Executive Officer, and Co-founder, and his team have built a comprehensive, proprietary technology platform to deliver living tissue implants to patients. \u201cThis 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<\/a> of next-generation tissue engineering technology. It is the culmination of more than seven years of our company\u2019s focused efforts to develop a uniquely differentiated technology platform meeting the FDA\u2019s requirements for therapeutic manufacturing of reconstructive implants,\u201d said Dr. Cohen. \u201cWe 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.\u201d<\/p>\n

\u201cOur initial indications focus on the cart<\/a>ilage in the reconstructive and orthopedic fields including treating complex nasal defects and spinal degeneration,\u201d continued Dr. Cohen. \u201cWe look forward to leveraging our platform to solve other high impact, unmet, medical<\/a> needs like lumpectomy reconstruction and eventually expand to organs.\u201d<\/p>\n

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* This article is reprinted from 3D Printing Media Network<\/a>. If you are involved in infringement, please contact us to delete it.<\/p>\n

<\/i> Author: Edward Wakefield<\/p>\n","protected":false},"excerpt":{"rendered":"

3DBio Therapeutics, a clinical-stage regenerative medicine company, and the Microtia-Congenital Ear Deformity Institute have conducted a human ear reconstruction using the AuriNovo implant \u2013 an investigational, patient-matched, 3D bioprinted living tissue ear implant.<\/p>\n","protected":false},"author":3,"featured_media":191645,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0,"fifu_image_url":"\/wp-content\/uploads\/2022\/06\/7666602064867569276.jpeg","fifu_image_alt":"","footnotes":""},"categories":[195],"tags":[4782],"class_list":["post-191179","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-medical","tag-biomaterialsbioprintingcellular-agriculturemedicalmedical-researchpersonalized-medicineprosthetics"],"yoast_head":"\n3DBio 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