The market submission for CERAMENT® V in the US will be a 510(k)
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| Tid* | ||
| 2025-10-23 | N/A | Kvartalsrapport 2025-Q3 |
| 2025-07-15 | N/A | Kvartalsrapport 2025-Q2 |
| 2025-04-24 | N/A | Kvartalsrapport 2025-Q1 |
| 2025-02-25 | N/A | Bokslutskommuniké 2024 |
| 2024-10-24 | - | Kvartalsrapport 2024-Q3 |
| 2024-07-11 | - | Kvartalsrapport 2024-Q2 |
| 2024-05-17 | - | X-dag ordinarie utdelning BONEX 0.00 SEK |
| 2024-05-16 | - | Årsstämma |
| 2024-04-25 | - | Kvartalsrapport 2024-Q1 |
| 2024-02-15 | - | Bokslutskommuniké 2023 |
| 2023-10-26 | - | Kvartalsrapport 2023-Q3 |
| 2023-07-13 | - | Kvartalsrapport 2023-Q2 |
| 2023-05-19 | - | X-dag ordinarie utdelning BONEX 0.00 SEK |
| 2023-05-17 | - | Årsstämma |
| 2023-04-27 | - | Kvartalsrapport 2023-Q1 |
| 2023-02-16 | - | Bokslutskommuniké 2022 |
| 2022-10-27 | - | Kvartalsrapport 2022-Q3 |
| 2022-07-14 | - | Kvartalsrapport 2022-Q2 |
| 2022-05-20 | - | X-dag ordinarie utdelning BONEX 0.00 SEK |
| 2022-05-19 | - | Årsstämma |
| 2022-05-04 | - | Kvartalsrapport 2022-Q1 |
| 2022-02-17 | - | Bokslutskommuniké 2021 |
| 2021-11-04 | - | Kvartalsrapport 2021-Q3 |
| 2021-07-15 | - | Kvartalsrapport 2021-Q2 |
| 2021-05-21 | - | X-dag ordinarie utdelning BONEX 0.00 SEK |
| 2021-05-20 | - | Årsstämma |
| 2021-05-06 | - | Kvartalsrapport 2021-Q1 |
| 2021-02-17 | - | Bokslutskommuniké 2020 |
| 2020-11-05 | - | Kvartalsrapport 2020-Q3 |
| 2020-07-17 | - | Kvartalsrapport 2020-Q2 |
| 2020-05-20 | - | X-dag ordinarie utdelning BONEX 0.00 SEK |
| 2020-05-19 | - | Årsstämma |
| 2020-05-08 | - | Kvartalsrapport 2020-Q1 |
| 2020-02-26 | - | Bokslutskommuniké 2019 |
| 2019-11-07 | - | Kvartalsrapport 2019-Q3 |
| 2019-07-25 | - | Kvartalsrapport 2019-Q2 |
| 2019-05-15 | - | X-dag ordinarie utdelning BONEX 0.00 SEK |
| 2019-05-14 | - | Årsstämma |
| 2019-05-02 | - | Kvartalsrapport 2019-Q1 |
| 2019-02-27 | - | Bokslutskommuniké 2018 |
| 2018-11-07 | - | Kvartalsrapport 2018-Q3 |
| 2018-07-26 | - | Kvartalsrapport 2018-Q2 |
| 2018-05-23 | - | X-dag ordinarie utdelning BONEX 0.00 SEK |
| 2018-05-22 | - | Årsstämma |
| 2018-05-04 | - | Kvartalsrapport 2018-Q1 |
| 2018-02-20 | - | Bokslutskommuniké 2017 |
| 2017-11-02 | - | Kvartalsrapport 2017-Q3 |
| 2017-08-17 | - | Kvartalsrapport 2017-Q2 |
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Mid Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Medicinteknik |
BONESUPPORT™, a leading company in orthobiologics for the management of bone injuries, today announces that the company’s submission for marketing authorization for its antibiotic eluting bone graft substitute, CERAMENT V (vancomycin), following discussions with the U.S. Food and Drug Administration (FDA), will proceed through a 510(k) pathway, instead of a De Novo application.
The marketing approval for CERAMENT® G in 2022 was based on extensive efficacy and patient safety data, with nearly 17,000 clinical data points. Since CERAMENT V shares the same mechanism of action as CERAMENT G, despite containing a different antibiotic, CERAMENT G can serve as a predicate device for CERAMENT V. The submission is still scheduled for the first quarter of 2025.
CERAMENT V has previously received “breakthrough device” designation from the FDA for the indication bone infection.
For more information contact:
BONESUPPORT 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 591 million in 2023. Please visit www.bonesupport.com for more information.
BONESUPPORT and CERAMENT are registered trademarks of BONESUPPORT AB.