Sweden-based BoneSupport has obtained regulatory approval from the Central Drugs Standards Control Organization (CDSCO) and their Medical Device Approval Committee (MDAC) to commercialize Cerement Bone Void Filler and Cerament G in India.
Cerament G is claimed to be the first injectable antibiotic eluting bone substitute developed for bone healing that is threatened by infection, as well as first of its kind to be approved to treat osteomyelitis in the country.
BoneSupport international executive vice-president Vikram Johri said: "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."
Cerement is a fully developed product platform, which is commercially available in the US and Europe, to treat fragility and other fractures caused by disease and trauma.
As per the 2014 IDF Diabetes Atlas, middle and low-income countries have higher rates of adult diabetes compared against the world average, while about 66 million adults in India were diagnosed with the disease in addition to an estimated 35 million undiagnosed cases.
The company develops injectable bone graft substitutes for orthopedic trauma, focusing on bone infection, instrument augmentation and spinal applications.