MedTech Business - March 23, 2020
Bonesupport submits De Novo application to the FDA
The company will submit a De Novo application to the US Food and Drug Administration (FDA) to obtain a market approval for the company’s antibiotic–releasing product CERAMENT G. The application is specified for the indication osteomyelitis (bone infection) and can potentially result in an approval at the latter end of 2020. “The benefits of CERAMENT […]
Clinical Trials Medtech - November 19, 2018
Positive results from Bonesupport
The company has announced new data from the CERTiFy (CERAMENT Treatment of Tibia Plateau Fracture defects) study comparing CERAMENT|BVF with autologous iliac bone graft (autograft). “Successfully completing the ground-breaking CERTiFy study, to demonstrate CERAMENT BVF is non-inferior to autograft in treating tibia plateau fracture defects, is a major milestone for BONESUPPORT. We expect the results from the study […]
In a new job - January 23, 2018
New CEO of Bonesupport
The Board of Directors at Bonesupport has appointed Emil Billbäck as the new CEO. Billbäck, who lives in Malmö and is a Swedish citizen, will join from Essity where he was Senior Advisor following its acquisition of BSN Medical from the Swedish private equity group EQT in 2017. Prior to this, he was a member […]
MedTech Business - January 22, 2018
Publication highlights Bonesupport’s technology
The paper “Gelatin- hydroxyapatite-calcium sulphate based biomaterial for long term sustained delivery of bone morphogenic protein-2 and zoledronic acid for increased bone formation: In-vitro and in-vivo carrier properties, – D Raina et al 2018 -shows that a novel macro-porous biomaterial, Gelatin/CERAMENT, is an efficient carrier for the long-term, sustained delivery of recombinant bone morphogenic protein […]
Clinical Trials Medtech - December 14, 2017
Bonesupport recruits 136 patients into their CERTiFy study
CERTiFY is a prospective, randomized, controlled clinical study designed to compare the differences in pain, quality of life, and cost of care in the treatment of tibia plateau fracture-associated bone defectsusing either CERAMENT|BONE VOID FILLER (CERAMENT BVF) or autologous bone grafting (autograft). Autograft is the current gold standard for bone graft procedure for the management of […]
Agreement - November 24, 2017
Bonesupport in commercialization agreement
BONESUPPORT has signed a second distribution agreement for Italy with Citieffe Srl to strengthen its access to trauma and orthopaedic surgeons in this market. Citieffe is a trauma implant manufacturer based in Bologna. It is part of the Medistream Group, owned by ArchiMed an independent French Healthcare Investment Firm. Citieffe, which has a direct sales force in Italy […]
