Bonesupport Holding

ISS • Dec 2, 2025

CERAMENT® V application in the U.S. transferred to the De Novo process

BONESUPPORT™, a leading company in orthobiology for the treatment of skeletal injuries, announced today a change in the regulatory process for the company's market application to the U.S. Food and Drug Administration (FDA) for CERAMENT® V for the indication of bone infection.

During the review process of the company's 510(k) application, it has become clear that CERAMENT V (vancomycin), if granted market authorization, may come to establish an entirely new product category. The De Novo process allows for this opportunity, but 510(k) does not. This follows the same principle as when CERAMENT G (gentamicin), upon its market authorization in May 2022, established a new regulatory category. The decision to change the regulatory process is being made in close and constructive dialogue with the FDA.

A large amount of reviewed clinical documentation, process descriptions, and pharmacological data will therefore be transferred to the De Novo process, which is expected to occur in December 2025. Instead of the 90-day review period for a 510(k), the De Novo process has a 150 day review period.

"We see great potential in the opportunity to set the standard for yet another product category. The 510(k) pathway to market authorization is somewhat shorter, but with a potential De Novo approval, we stand significantly stronger in the long term when CERAMENT V becomes the sole product in a new category. Our ambition is that the transfer to the De Novo process will take place before year-end, and we are optimistic about the continued handling and review. Our dialogue with the FDA is very good" says Torbjörn Sköld, CEO of BONESUPPORT.

CERAMENT V has previously been granted "breakthrough device" designation for the indication of bone infection by the FDA.

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

Press Release 02 December 2025 08:13:00 CET

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 2025-12-02 08:13 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 899 million in 2024. Please visit www.bonesupport. com for more information.

BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.

Attachments

CERAMENT® V application in the U.S. transferred to the De Novo process