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BellaSeno Starts Two Clinical Trials of its Resorbable Breast and Chest Implants
Resorbable implants to treat pectus excavatum and silicone breast implant revision / congenital defect correction First patients treated in Australia BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, today announced the start of two clinical trials of its products in Australia, which are sponsored by its Australian subsidiary BellaSeno Pty. Already, recruiting has started in Brisbane, Australia. The first trial is expected to enroll 10 patients with pectus excavatum, a common congenital chest wall deformity in which the breastbone is sunken into the chest. Principal investigator of this trial is Dr. Michael Wagels, Director of the Herston Biofabrication Institute (HBI), Specialist Plastic and…
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BellaSeno Announces Publication of First-in-Human Data of its Lead Program Senella
Successful initial treatment of pectus excavatum patient in Australia Data published in the European Journal of Plastic Surgery confirms Bellaseno’s novel approach in soft tissue engineering BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, today announced the publication of first-in-human data of its lead program Senella® in the European Journal of Plastic Surgery. In the trial, a 22-year old patient with severe pectus excavatum received a custom-made, 3D-printed, biodegradable and highly porous Senella® scaffold filled with autologous fat graft to correct her chest deformation. The procedure was performed by Dr. Michael Wagels, Specialist Plastic and Reconstructive Surgeon at the Princess Alexandra Hospital and Senior…
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BellaSeno Appoints Tobias Grossner to Chief Medical Officer
BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, today announced the appointment of Dr. med. Tobias Grossner as Chief Medical Officer (CMO). Dr. Grossner brings strong clinical expertise in trauma surgery and regenerative medicine and has previously been working with BellaSeno as an independent consultant. In addition, Dr. Grossner has been working as a trauma surgery specialist at University Hospital Heidelberg since 2011, most recently as Senior Consultant Trauma Surgery. In 2020, he founded the SCABALLO5 Research Consortium focusing on novel biologic approaches to bone healing. The consortium currently consists of University Hospital Heidelberg, TICEBA GmbH (Germany), RehaCell (Germany), BellaSeno GmbH (Germany / Australia),…
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BellaSeno Receives Australian Public Grant Totaling AUD 1 Million
Winner of the Australian Global Innovation Linkages Program Funding dedicated to advancing regenerative scaffolds for breast reconstruction and large bone defects BellaSeno to lead consortium of renowned commercial and academic partners BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, today announced that its Australian subsidiary BellaSeno Pty Ltd has been granted AUD 1 million (EUR 625,600) for the development of regenerative scaffolds for breast reconstruction and large bone defects. The grant was provided under the Australian Global Innovation Linkages Program, which is dedicated to help Australian businesses and researchers collaborate with global partners. The funding will be used for the additive manufacturing of personalized…
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BellaSeno Initiates Scaffold Development Program for Tendon and Ligament Regeneration
. Collaboration with Fraunhofer IZI further expanded Funding provided by Sächsische Aufbaubank BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, today announced that the Company has initiated a program on tendon and ligament reconstruction funded by the State of Saxony´s Sächsische Aufbaubank (SAB). The program will be run in close collaboration with Fraunhofer Institute for Cell Therapy and Immunology (Fraunhofer IZI), which will be responsible for the development of an animal model for subsequent in vivo performance testing of the scaffolds. The goal of the program is to design and evaluate next-generation scaffolds for tendon and ligament reconstruction, incl. assessment of their biomechanical properties…
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BellaSeno Wins Prestigious German Innovation Award 2021
BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, today announced that the Company has received the German Innovation Award from the German Design Council for its Senella® technology in the category #W2 Excellence in Business to Business – Medical Technologies. BellaSeno has been chosen among about 700 applicants from 30 countries, covering both bluechip as well as innovative start-up companies. Senella® has been designed to alleviate the complications and risks found in current breast reconstruction and augmentation approaches. Based on a patented porous scaffold made of an absorbable biocompatible polymer that is FDA-approved and CE-marked for a variety of clinical applications and used routinely in…
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BellaSeno and Fraunhofer Institute for Production Technology IPT Receive EUR 1.4 Million BMBF Grant
Funding dedicated to the development of commercial-scale, fully automated additive manufacturing of resorbable medical implants First-ever industrial-scale, additive manufacturing platform of medical implants BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, and the Fraunhofer Institute for Production Technology IPT today announced that both parties have received a grant totaling EUR 1.4 million from Germany´s Federal Ministry of Education and Research (BMBF) under the funding program KMU-innovativ. BellaSeno and Fraunhofer IPT aim to develop a high-performance industrial scale-up process for its GMP-compliant manufacturing facilities, which include leading-edge features such as high-througput additive manufacturing based on the so-called no-touch approach to significantly improve the safety and…
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BellaSeno Establishes GMP-Compliant High-Throughput Additive Manufacturing Facility for Resorbable Medical Implants
. – Seamless transition from R&D to commercial-scale additive manufacturing – Leading-edge cleanroom, no-touch manufacturing – GMP capabilities for internal and contract manufacturing BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, today announced the establishment of a novel, leading-edge additive manufacturing facility for medical implants supported by the Fraunhofer Institute for Cell Therapy and Immunology IZI, Leipzig, Germany. It is the one of the first GMP-compliant manufacturing facilities worldwide to include innovative features such as high-througput additive manufacturing based on the so-called no-touch approach to significantly improve the safety and sterility of medical implants. Moreover, the facility allows for a seamless transition from R&D…
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BellaSeno Announces First-In-Human Trial of its Novel, Absorbable Soft Tissue Reconstruction Scaffold and Granting of Key U.S. Patent
First patient with Pectus Excavatum congenital defect has undergone surgery in Australia Minimally invasive procedure and fully absorbable scaffold expected to provide for improved safety and recovery Key U.S. patent granted for the design and porosity of Senella® platform BellaSeno GmbH, an ISO 13485-certified medtech company developing absorbable scaffolds using additive manufacturing technologies, today announced the initiation of a first-in-human trial of its novel, absorbable soft tissue reconstruction scaffold (Senella®). A patient with Pectus Excavatum congenital defect has undergone surgery at Princess Alexandra Hospital in Brisbane, Australia, earlier this month. The procedure was performed by Dr. Michael Wagels, Principal Investigator of the trial and Plastic and Reconstructive Surgeon at Princess…
