VergenixBVF is a novel resorbable scaffold composed of our rhCollagen and synthetic minerals that mimics bone structure intended for use in posterolateral spinal fusion and trauma and other orthopedic applications. We intend to develop VergenixBVF as a product platform for the development of bone void filler products which can be used as a one time treatment that is easy to implant during open surgery and will cover a broad spectrum of bone repair indications.
The scaffold is designed to be charged with a growth factor which will stimulate bone growth and tissue growth in a controlled manner. The platform also has the potential to support additional product applications where it is charged with cells or therapeutics, further expanding the potential market for VergenixBVF related products.
The initial VergenixBVF product candidate is intended to be used as a bone void filler, initially targeting trauma. According to GlobalData, there were an estimated 414 million trauma‑related bone grafting procedures across 10 major markets in 2013, accounting for 22% of all bone grafting procedures.
This product candidate will have wide applicability in skeletal procedures, and we expect that it will be used in multiple markets, including spinal fusion. GlobalData estimates that a total of 1.8 million bone grafting procedures were performed in 2013 worldwide, with approximately one million related to spinal fusion. Spinal fusion procedures have the highest utilization rates of bone graft substitutes across all bone grafting procedures. We estimate the size of the worldwide target market for the initial VergenixBVF product candidate at one million procedures per year, representing a market size of approximately $3.5 billion.
VergenixBVF is currently under development and is not approved for sales in EU or in the USA