Archive: Company News
New investigator-initiated clinical trials of BellaSeno´s resorbable tissue regeneration scaffolds to be conducted in Europe
— New clinical trial site opened in Italy for pectus excavatum and planned in Germany for bone reconstruction
— Company aims to expand EU market authorization from custom-made to off-the-shelf products and and to pursue market approval in the USA
BellaSeno GmbH, an ISO 13485-certified medtech company developing resorbable scaffolds using additive manufacturing technologies, today announced that additional, investigator-initiated clinical trials of its novel regenerative scaffolds for bone reconstruction and chest-wall defects (pectus excavatum) will be conducted in Germany and Italy, respectively. In 2023, BellaSeno had received market authorization for its custom-made, resorbable bone and pectus excavatum scaffolds in Europe.