BONESUPPORT, a Scandinavian medical technology company, announced recently that it received regulatory approval from the Central Drugs Standards Control Organization (CDSCO) and their Medical Device Approval Committee (MDAC) to market CERAMENT and CERAMENT BONE VOID FILLER to manage osteomyelitis in India.
CERAMENT, an injectable bone graft substitute is the first of its kind approved for the management of osteomyelitis (i.e., bone infection) in India. The injectable substance is composed of resorbable ceramic material, which is intended to fill gaps in bones and promote healing.
Injectable Substitute Reduces the Number of Surgical Procedures Required
Previously, autogenic bone grafts (i.e., grafts removed from healthy bone elsewhere in the body) were used, but with many possible disadvantages, including donor site pain, blood loss, infection, and slow incorporation rates. Additionally, bone tissue transplantation generally requires at least two surgeries and general anesthesia. In case studies, CERAMENT provides pain relief, full weight bearing recovery, and bone consolidation—as well as structural integrity and durability.
During surgical procedures, CERAMENT can also be used for filling voids, augmenting hardware and maintaining bone alignment. CERAMENT contains gentamicin – an antibiotic intended to prevent the colonization of gentamicin-sensitive microorganisms that can cause complicated infections that delay or prevent healing.
The standard treatment of complex osteomyelitis, or bone infection, can be frustrating for physicians and patients alike. Treatment includes oral—and sometimes intravenous—antibiotic therapy, multiple surgical interventions, and even amputation. The prevalence of osteomyelitis is increasing as a result of prosthetic infections, diabetic ulcers, war and sports injuries, and increasing antibiotic resistance.
Diabetes Is a Siginficant Cause of Lower Limb Amputation
In India, where BONESUPPORT recently received approval to market its CERAMENT product, the prevalence of diabetes is 8.56%, but is as high as 20% in some cities. Comparatively, the global prevalence of diabetes was 9%, or approximately 347 million people in 2014. 90% of these cases had type 2 diabetes generally caused by excess body weight and lack of physical activity.
Diabetes causes 40-70% of all lower limb amputations in the world. Of those, 85% begin with a foot ulcer. In India and other developing countries, a common cause of diabetic foot ulcers is wearing unsuitable shoes or walking barefoot, according to the World Diabetes Foundation. Low levels of health literacy and socioeconomic status are also exacerbating factors.
With more than 66 million adults diagnosed with diabetes and an estimated 35 million undiagnosed cases, India is an important market for BONESUPPORT. Vikram Johri, Executive Vice President International at BONESUPPORT, states that:
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. 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.
Revolutionizing Bone Transplantation
Based in Lund, Sweden, BONESUPPORT is an emerging leader of injectable bone graft substitutes for orthopedic trauma focusing on bone infection, instrument augmentation and spinal applications. Its CERAMENT product has been tested in over 45 pre-clinical, clinical, and animal studies, and is commercially available in the US and EUROPE. The company has subsidiary locations in the US and Germany.
According to the company’s press release, BONESUPPORT is working to revolutionize the treatment of fragility and other fractures caused by diseases, such as osteomyelitis, and trauma.
Besides producing an antibiotic-laced bone graft substitute, BONESUPPORT has developed a clinician-facing app called CERAMENT. Available on iTunes, the application gives access to clinical case studies, surgical x-rays, as well as mixing and handling instructions. The app can also be used in patient education, helping them to better understand the surgical procedure and how CERAMENT will heal into their own healthy bone during the recovery period.
Note: Feature image from Dr. PS Sahana via Creative Commons