BONESUPPORT Announces First Patient Enrolled in FORTIFY Trial With CERAMENT G, a Novel Injectable, Antibiotic-eluting Bone Graft Substitute

LUND, Sweden, May 22, 2017 /PRNewswire/ --

BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone substitute products to treat bone voids caused by trauma, infection, disease or related surgery, today announced that the first patient has been enrolled by Dr Ravi Karia at the University of Texas Health Science Center at San Antonio into the company's pivotal Investigational Device Exemption (IDE) trial: A Prospective, Randomized, Multicenter Controlled Trial of CERAMENT G as Part of Surgical Repair of Open Diaphyseal Tibial Fractures (the FORTIFY trial: ClinicalTrials.gov Identifier: NCT02820363).

CERAMENT G is an injectable antibiotic-eluting bone graft substitute that has proven remodeling capabilities and provides local sustained delivery of gentamicin. The data from the trial will support BONESUPPORT's PMA (Premarket Approval) filing for CERAMENT G in the US.

In spite of modern day care of open tibial fractures, bone loss coupled with wound contamination and soft tissue damage continue to impair healing and recovery, particularly if infection develops. In addition, open tibial fractures result in a general infirmity, long-term disability and reduction in quality of life for patients, and a significant clinical challenge for orthopedic surgeons.

The FORTIFY trial will assess CERAMENT G's ability to improve on the standard-of-care management of patients with open fractures of the tibial diaphysis. The primary endpoints of the trial will include the absence of deep infection at the fracture site and the lack of secondary procedures intended to promote fracture union. The trial will also evaluate the safety of CERAMENT G in these patients. The trial will enroll upto 230 patients at upto 30 centers in the US and Europe.

Dr. Douglas Dirschl, the trial's Principal Investigator, said: "I am excited to take part in the FORTIFY clinical trial. The open tibial fracture remains the most common and one of the most troublesome open fractures managed by orthopedic surgeons. Even with modern treatment protocols, patients suffering this fracture continue to be at substantial risk of infection, fracture non-union, and prolonged disability. A product that could be inserted into the fracture site at the time of definitive treatment that could promote bone formation at the same time as reducing the risk of subsequent infection, would be a major advance in the treatment of these troublesome fractures and would have the potential to provide benefit to thousands of patients each year in the United States."