BONESUPPORT receives approval to market CERAMENT™ in India CERAMENT™IG is the first injectable antibiotic eluting bone substitute in India
Lund, Sweden, (PRNEWSWIRE) February 25, 2015 – BONESUPPORT, an emerging leader in injectable bone substitutes for orthopedic trauma, bone infections and instrument augmentation related to orthopedic surgery, announced that it has received regulatory approval from the CDSCO (Central Drugs Standards Control Organization) and their MDAC (Medical Device Approval Committee) to market CERAMENT™|BONE VOID FILLER and CERAMENT™|G in India. CERAMENT™|G is the first injectable antibiotic eluting bone substitute indicated to promote and protect bone healing being jeopardized by infection, and the first of its kind approved for the management of osteomyelitis in India. BONESUPPORT will work closely with regional distributors to launch CERAMENT™ to leading hospital groups in India.
Osteomyelitis, or Bone Infection is a $1.7 billion market where prolonged, long-term antibiotic therapy, multiple surgical interventions and the threat of amputation are the current standard of care. Rising prosthetic infections, diabetic ulcers, war injuries, sports injuries, and an increasing resistance to antibiotics contribute to this growing condition.
“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,” said Vikram Johri, Executive Vice President International at BONESUPPORT. “In a country where synthetic bone void fillers are widely accepted, quality is gaining importance as regulations increase. In addition, the combination of an antibiotic loaded product that promotes bone healing and remodeling presents an important clinical option in a country with a high rate of bone infection and limb salvage procedures.”
According to the 2014 IDF Diabetes Atlas, middle and low-income countries often have higher rates of adult diabetes compared to the world average. In India, more than 66 million adults have been diagnosed with the disease in addition to an estimated 35 million undiagnosed cases. It’s expected that more than 10% of diabetic sufferers will be afflicted with osteomyelitis due to diabetic foot ulcers.
“The CERAMENT™ platform has a long standing safety profile and we are pleased to see this once again confirmed by India’s approval,” said Lloyd Diamond, CEO of BONESUPPORT. “CERAMENT™|G is an important advancement in the management of bone infections and we are proud to be at the forefront in addressing an unmet need to patients in India.”
BONESUPPORT is an emerging leader of injectable bone graft substitutes for orthopedic trauma focusing on bone infection, instrument augmentation and spinal applications. CERAMENT™ is an injectable, synthetic bone substitute that mimics the properties of cancellous bone, allows for controlled resorption to support future bone ingrowth and is injectable under local anesthesia for minimally invasive surgery. CERAMENT’s unique biologic properties deliver a consistent, pre-packed and ready-to-use formulation to facilitate optimal delivery. CERAMENT™|G is the first CE-marked injectable antibiotic eluting ceramic bone graft substitute. CERAMENT™|G is indicated to promote and protect bone healing in the management of osteomyelitis, (bone infections) in CE marked countries. CERAMENT™|G is not available in the United States.
CERAMENT™ is a fully developed product platform that is commercially available in the U.S. and Europe and is revolutionizing the treatment of fragility and other fractures caused by disease and trauma. Scientific research of CERAMENT spans more than eleven years. Over forty-five pre-clinical, clinical and animal studies have been conducted and close to 9,000 patients have been treated with CERAMENT. The company was founded in 1999 and is based in Lund, Sweden with subsidiary locations in the US and Germany. To learn more about BONESUPPORT please visit www.bonesupport.com.
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