BONESUPPORT received market authorization from the FDA for Cerament G, the first and only bone graft with antibiotic elution that is approved for the US market.
Osteomyelitis is a bone infection caused by fungi or bacteria. Individuals at risk for developing osteomyelitis include those with a weak immune system, traumatic injury or wound, pressure injuries, artificial joints (like hip replacements) or metal implants in bone, blood infection and diabetes. Patients with osteomyelitis can have painful swelling of the bone marrow and are often prescribed antibiotics or recommended to have surgery.
BONESUPPORT is an orthobiologics company focused on the management of bone injuries. BONESUPPORT has recently received market authorization from the US Food and Drug Administration (FDA) for Cerament G, its bone graft with antibiotic elution.
Xtalks learned more about BONESUPPORT and its first FDA-approved drug-device combination product Cerament G through an email interview with BONESUPPORT’s CEO Emil Billbäck. Read on to learn more!
Please tell us about BONESUPPORT. What does this orthobiologics company do?
Billbäck: BONESUPPORT is a Swedish orthobiologics company that has sprung out of the extensive research and development in bone biology and bone healing done at the Department of Orthopedics at Lund University hospital.
The company has an injectable ceramic biocomposite, CERAMENT, which basically translates to “synthetic bone in a syringe.” CERAMENT is used to heal bone injuries that the body can’t manage to heal itself.
What is BONESUPPORT’s mission?
Billbäck: Restoring health to improve the quality of life for patients with bone disorders.
Can you discuss a bit about BONESUPPORT’s history? When was the company founded?
Billbäck: The company was founded in early 2000 by Professor Lars Lidgren. Professor Lidgren is a well renowned orthopedic clinician, researcher and scientist.
The idea of the technology came from a deep frustration with the historical standard of care for bone injuries, which left the patient with long-term pain and discomfort following an autograft (bone transplantation from the patient itself).
How does BONESUPPORT stand out from other orthobiologics companies?
Billbäck: BONESUPPORT has an industry-leading amount of clinical evidence validating the unique clinical benefits of CERAMENT.
CERAMENT has been shown to completely remodel into the patient’s own bone within six to 12 months: This is unique for CERAMENT.
CERAMENT G and V contain the antibiotics gentamicin and vancomycin, respectively, which elute from CERAMENT over the initial 30 days after implantation, protecting the bone healing from infection during the most critical phase of the bone healing: This is unique for CERAMENT.
Healing bone and eradicating bone infections usually takes many surgical procedures and extensive hospital stay for the patients. With the unique work mechanism of CERAMENT, the surgeon can perform a one-stage-procedure, saving valuable time in the surgical room and a faster recovery to normal life for the patient.
In May this year, BONESUPPORT received market authorization in the US for its drug-device combination product Cerament G. The authorization was for the indication of bone infection (osteomyelitis). How does osteomyelitis occur and what are the risk factors for it?
Billbäck: There are many different reasons for why a bone infection can occur. Most commonly, this occurs as an effect of a broken bone (trauma), for instance following a traffic accident. As a rule of thumb, one could say that the more severe the injury and the more exposed the injury has been to foreign material (i.e., due to a traffic accident), the more likely it is that an infection will develop. At a severe open fracture of the bone (“open” means that the tissue is perforated), the infection rate is as high as 52 percent.
Other reasons for bone infection are diabetic foot, tumor removal from the skeleton and hip or knee joint replacements.
On average, infections occur at 10 to 15 percent of the surgeries where bone injuries are managed.
How does the combination product Cerament G work?
Billbäck: CERAMENT undergoes a biphasic transformation. At the moment of application, CERAMENT has the properties of a paste, which makes it easy to inject. Nine to 15 minutes after it has been injected into the bone injury, CERAMENT goes hard and solid. As the healing process starts, CERAMENT transforms into a porous structure (a scaffold) into which the bone building cells (osteoblasts) can migrate and form new bone. It is through this phase, as the material becomes porous, that antibiotics are eluted from the material protecting against the potentially devastating effects of an infection.
As the bone forms, the porous structure/scaffold is resorbed by the body. After six to 12 months, this process is completed, and native bone has replaced CERAMENT.
What clinical value does Cerament G provide compared to existing treatment options?
Billbäck: A large clinical study material has been submitted to the FDA. Among others, a material showing that the occurrence of infection in a study population treated in a one-stage-procedure with CERAMENT G was 4.5 percent. The occurrence of infection in a similar study group treated with the reigning standard of care in the US was 13.3 percent.
The lower the infection occurrence, the better!
In a very large British study with over 25,000 patients that were analyzed and followed for two years after surgical treatment, it was shown that patients with bone infection treated with CERAMENT G in a one-stage-procedure spent 16 days less in the hospital compared to patients treated with any of the other treatment methods.
What was special about this latest FDA approval from the company’s (BONESUPPORT’s) commercial perspective?
Billbäck: BONESUPPORT already sells the “basic” CERAMENT without antibiotic elution. This product has quickly gotten to about $14 million USD in sales and an annual growth of more than 50 percent. The FDA approval of CERAMENT G gives BONESUPPORT the first ever synthetic bone graft with antibiotic elution on the market. This puts the company in a unique position to service an underdeveloped market opportunity of $450 million USD. The US Centers for Medicare & Medicaid Services (CMS) has awarded a New Technology Add-On Payment (NTAP) incremental reimbursement of $4,900 USD for procedures made with CERAMENT G on a CMS patient.