BONESUPPORT: CERAMENT V to enter the US in Q2 2025 instead of H2
Yesterday, during trading hours, BONESUPPORT announced that CERAMENT V will follow the 510(k) FDA path instead of De Novo, positively shortening the time to market to Q2 2025 instead of YE 2025. Such a decision coming from the FDA is backed by the fact that CERAMENT V (vancomycin), despite having aBonesupport Holding AB is a Sweden-based orthobiologics company. It develops and commercialize injectable bioceramic bone graft substitutes which remodel to host bone and have the capability to elute drugs directly into the bone void. The marketed synthetic bone graft substitutes are CERAMENT BVF, CERAMENT G and CERAMENT V, which are based on the CERAMENT technology platform. The products are commercially available in Europe and the United States, as well as in India, Malaysia, Oman and Singapore. The products are developed to treat patients with fractures and bone voids caused by trauma and related surgery, as well as caused by infection or diseases, such as chronic osteomyelitis, revision arthroplasty and infected diabetic foot.
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