BONESUPPORT – CERAMENT® G RECEIVES FDA CLEARANCE FOR OPEN FRACTURES
Published: 2024-03-14
BONESUPPORT AB, a leading company in orthobiologics for the management of bone injuries, announces that the FDA has cleared the company’s 510(k) submission regarding the use of CERAMENT G in open fractures.
Open fractures are a consequence of trauma and carry a high risk of subsequent infection. The clearance more than doubles the US addressable market for CERAMENT G, which is the first and only combination product approved in the USA for this indication.
“Open fractures are one of the most common causes of a patient developing a bone infection, and we are very excited about this expanded indication. It means that American surgeons will have a new powerful tool to treat patients with skeletal injuries while simultaneously protecting the site from infection by local elution of antibiotics”, said Emil Billbäck, CEO of BONESUPPORT.
CERAMENT G is an orthopedic medical device combination matrix consisting of a resorbable synthetic bone graft substitute and the antibiotic gentamicin, which protects against colonization of bacteria sensitive to gentamicin.
For more information contact:
BONESUPPORT Holding AB
Emil Billbäck, CEO
+46 (0) 46 286 53 70
Håkan Johansson, CFO
+46 (0) 46 286 53 70
ir@bonesupport.com
Cord Communications
Charlotte Stjerngren
+46 (0) 708 76 87 87
charlotte.stjerngren@cordcom.se
www.cordcom.se
This information is information that BONESUPPORT Holding AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2024-03-14 08:45 CET.
About BONESUPPORT™
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 591 million in 2023. Please visit www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.
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