CERAMENT® V DE NOVO SUBMISSION UPDATE

Published: 2026-08-27

BONESUPPORT™, a leading company in orthobiologics for the management of bone injuries, today announces, that the FDA has extended the submission deadline for the additional data package for CERAMENT V. The revised timeline follows one specific request from the FDA for additional information on previously submitted biocompatibility data. The complete data package will be submitted to the FDA no later than October.

For more information contact:

BONESUPPORT AB
Torbjörn Sköld, 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 1,175 msek in 2025. Please visit www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.

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CERAMENT® V DE NOVO SUBMISSION UPDATE