BONESUPPORT receives “breakthrough device designation” for CERAMENT® V for the indication of bone infection
Published: 2023-10-16
BONESUPPORT™, an emerging leader in orthobiologics for the management of bone injuries, today announces that the company’s antibiotic eluting product CERAMENT® V has received categorization as a “breakthrough device” for the indication bone infection by the American Food and Drug Administration (FDA).
The categorization breakthrough device is assigned to products that are considered to provide a more effective treatment of severe medical conditions, where there is no comparable equivalent on the market. The categorization has been added to expedite the regulatory review of new medical devices and give patients faster access to new treatment options. CERAMENT® G has previously received breakthrough device designation for the indication’s bone infection and trauma.
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
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 329 million in 2022. Please visit www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.
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