BONESUPPORT announced that the company's antibiotic eluting product CERAMENT G has been categorized as a breakthrough device for the indication trauma by FDA.
The categorization “breakthrough device” can be assigned to products that are considered to provide a more effective treatment of severe disease states, where there is no comparable equivalent on the market. The categorization is intended to expedite the regulatory review of medical devices so that patients receive faster access to new treatment options.
"We will submit a regulatory application including trauma by the end of 2021. The decision from the FDA is of course important regarding the upcoming reimbursement process and with which priority our application will be processed," said Emil Billbäck, CEO of BONESUPPORT.
CERAMENT G has been classified as a breakthrough device for the indication osteomyelitis (bone infection) since March 2020 and BONESUPPORT is currently working to supplement previously submitted application, with the aim of reaching a potential approval for bone infection during the first quarter of 2022. A potential approval for the indication trauma may become effective at the end of 2022.