FDA Market Authorization for BONESUPPORT’s CERAMENT G

By Julie A. Vetalice

FDA Market Authorization for BONESUPPORT’s CERAMENT G

BONESUPPORT received market authorization from FDA for the company's antibiotic eluting product CERAMENT G, for the indication bone infection (osteomyelitis).

CERAMENT G previously received Breakthrough Device Designation in 2021. As what is reportedly the first injectable combination antibiotic bone graft substitute, CERAMENT G can be delivered in a single-stage procedure to simultaneously support bone remodeling and locally elute Gentamicin to protect bone healing.

BONESUPPORT’s CERAMENT G is an implantable device/drug combination bone void filler that provides a pathway for a one-stage approach to the management of bone infection with its dual mode of action that delivers bone remodeling with reliable and safe local elution of a broad-spectrum antibiotic.

BONESUPPORT reports that CERAMENT technology has the largest amount of pre-clinical and clinical data to prove bone remodeling and is the only bone graft substitute technology with patient-reported outcome measures.

“This is a significant recognition for the power and promise of our technology, as we are the first-to-market in the U.S. with this breakthrough combination device/drug bone graft,” said Emil Billbaeck, CEO of BONESUPPORT. “Our years of success in Europe have validated the unique benefits and superior outcome that CERAMENT G brings - and we’re excited to address proven demand for a better way to treat patients with bone infections in the U.S. market.”

Source: BONESUPPORT

Product Labels: Bone Graft Materials/DBM

Tags: Regulatory