BONESUPPORT, a company based in Sweden, has received regularity approval from the Central Drugs Standards Control Organization and their Medical Device Approval Committee to sell CERAMENT Bone Void Filler and Cerament G in India.
BONESUPPORT Enters India Market
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According to BONESUPPORT, CERAMENT G is an injectable antibiotic eluting bone substitute developed for bone healing that is threatened by infection. It is also approved to treat osteomyelitis in India.
An MDBR staff writer quotes BONESUPPORT International Executive Vice-President Vikram Johri as saying: “With the population of India exceeding a billion people, this approval represents one of the more significant international markets for CERAMENT and is an important step in our geographic expansion plan.”
CERAMENT is commercially available in the US and Europe, to treat fragility and other fractures caused by disease and trauma.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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