BONESUPPORT was founded by a group of dedicated researchers and the well-recognized professor in orthopedics Lars Lidgren, with the purpose to develop a synthetic bone graft substitute to replace autograft (transplantation of bone from other parts of the body to the affected area) in surgeries caused by a bone injury. The autograft procedure may have serious impact on patients’ well-being and cause significant side effects such as daily live impact and long-term chronic pain. The idea was to create an easy to use “on the shelf solution” to improve patient outcomes and simplify the life for the surgeons.
The idea was well acknowledged by the innovative Swedish market and the company received investments from for ex HealthCap among other investment institutes. The strong financial support enabled the research, development, and commercialization of the CERAMENT platform. Since the commercialization started the company has experienced strong growth and has today an annual sale of approximately SEK 230 million.
BONESUPPORT has two different product categories, a pure synthetic bonegraft substitute, CERAMENT® BONE VOID FILLER and a combination product which is a bone graft substitute that contains two different kind of antibiotics, CERAMENT® G (gentamicin) and CERAMENT® V (vancomycin). These products have been available in Europe for a long time and for a wide range of indications, where CERAMENT® G is the most used alternative. The US market has only have had access to CERAMENT® BONE VOID FILLER although now access to CERAMENT G for the indication osteomyelitis (bone infection) will be possible.
The advantage of CERAMENT® G is that the local antibiotic eluting capability help protect the bone healing process from reinfection at site in a single stage procedure. Patients that suffer from bone infection very often get reinfected and requires several surgeries to get cured, and there is also a high risk of amputation. The US is the world’s largest market for a product like this and there is no other similar product on the market right now.
CERAMENT G has been approved by the FDA through their quite new regulatory route called De Novo. A De Novo application can be made when there is no comparable established alternative (“predicate device”) on the market. This means that CERAMENT® G is the first bone graft substitute ever with antibiotics that has received market authorization by the FDA and the first combination product (Medical device & drug) that FDA has approved through DeNovo.
” CERAMENT G is the first combination product which has successfully navigated the DeNovo process, it’s exciting that a Swedish company will be the first in the world with such incredible recognition”.
Emil Billbäck, CEO BONESUPPORT
One of the major milestones in this approval, is that now American patients who have previously been forced to either go through several surgeries or have had their leg amputated will have a bigger chance to limb salvage and quicker recovery. There is therefore a strong ethical aspect to this and a value for those patients who have not previously received the latest technology. The CERAMENT G will be launched in the US, this autumn.