Tensive Srl reported positive data from its pivotal trial confirming the safety profile of Regenera, its bioabsorbable breast implant, and its potential to transform breast reconstruction. The pivotal trial, evaluating the Regenera in patients undergoing lumpectomy, found it to be safe, biocompatible and feasible for volume replacement in breast-conserving surgery.
Bellaseno GmbH and Evonik Industries AG joined forces to commercialize 3D-printed scaffolds used in bone regeneration. The scaffolds are made with Evonik’s Resomer polymers to address large and complex bone defects as an alternative to frequently less stable conventional methods.
Bellaseno GmbH began recruiting patients in Australia for two clinical trials of its resorbable breast scaffold products on Aug. 4. The company expects to enroll 10 patients with pectus excavatum, a structural deformity of the chest in which the breastbone presses inwards.
PARIS – Bellaseno GmbH reported publication of first-in-human data for its 3D-printed biodegradable and highly porous Senella scaffold filled with autologous fat graft to correct a chest deformation in a 22-year-old patient with severe pectus excavatum. The article was published in the European Journal of Plastic Surgery.
PARIS – Bellaseno GmbH recently completed a phase I trial of its Senella absorbable soft tissue reconstruction scaffold on an Australian patient with congenital pectus excavatum.