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
For more information contact:
Emil Billbäck, CEO
+46 (0) 46 286 53 70
Håkan Johansson, CFO
+46 (0) 46 286 53 70
ir@bonesupport.com
Charlotte Stjerngren
+46 (0) 708 76 87 87
charlotte.stjerngren@cordcom.se
www.cordcom.se
About BONESUPPORT(TM)
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
BONESUPPORT and CERAMENT are registered trademarks of
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https://mb.cision.com/Main/16090/3369484/1433426.pdf
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