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U.S. FDA grants market authorization for BONESUPPORT's CERAMENT G (Gentamicin)

·3 min read

First Injectable Combination Antibiotic Bone Graft Substitute

BOSTON, May 19, 2022 /PRNewswire-PRWeb/ -- BONESUPPORT ™, an emerging leader in orthobiologics for the management of bone injuries, today announced that the company has received market authorization from the US Food and Drug Administration (FDA), for the company's antibiotic eluting product CERAMENT G, for the indication bone infection (osteomyelitis). CERAMENT G has previously received Breakthrough Device Designation, an FDA categorization reserved for devices that treat serious and life-threatening conditions and which have demonstrated substantial improvement over other treatments and/or is the first of its kind. As 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 (antibiotic) to protect bone healing.

"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."

Bone infection can arise from fractures, orthopedic implants and diabetic foot ulcers. It can often be irreversibly debilitating, is susceptible to infection recurrence, and can lead to limb amputations.

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 unique dual mode of action that delivers proven bone remodeling with reliable and safe local elution of a broad-spectrum antibiotic.

"Bone infection is a complex condition and a challenge for clinicians and patients," said Kent Ellington, MD, FAAOS, Medical Director of the Foot and Ankle Institute, OrthoCarolina and Associate Professor of Orthopaedics at Atrium. "Access to CERAMENT G is a potentially limb saving advancement that will provide an additional and viable option to cure bone infections, save mobility, improve patient quality of life, and reduce costs by preventing recurrence of infection."

The 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. No other bone graft comes close to this level and quality of clinical data.

"Our mission is to help healthcare providers innovate the way they manage bone infection to increase the rate of success and decrease a patient's time in the hospital. This market authorization from the FDA allows us to bring our technology to even more surgeons who are looking for ways to evolve the way they manage this debilitating disease," added Billbaeck.

For more information about BONESUPPORT, visit http://www.bonesupport.com.

BONESUPPORT (Nasdaq Stockholm: BONEX) develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient's own bone and have the capability of eluting drugs. BONESUPPORT's bone graft substitutes are based on the patented technology platform CERAMENT. The company is conducting several clinical studies to further demonstrate the clinical and health economic benefits its products deliver. The company is based in Lund, Sweden, and the net sales amounted to SEK 213 million in 2021. Please visit http://www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.

Media Contact

Aimee Eichelberger, Superior PR, (312) 952-1528, aimee@superior-pr.com