Expected Results

OSTEOGROW development will greatly help in overcoming currently present bottlenecks. Since there is no adequate therapy available so far that can accelerate long bone fractures, healing and present solutions in this therapeutic area rely on expensive and side-effects associated bone devices, OSTEOGROW brings new insight into application of potentially the most efficacious and safest therapy for biological bone regeneration.  

By developing OSTEOGROW device we’ll be able for the first time to enhance targeted acute long bone fractures and decrease the need for secondary interventions. OSTEOGROW will improve bone repair by utilizing autologous carrier and minimal quantities of recombinant BMP6, applying them directly on the fracture site, without potential undesirable effects.

Research indicators in the form of new, innovative clinical trial protocols and observations will enter into standardized procedures used by regulatory bodies and enhance the level of orthopedic trauma surgery evidence based medicine.

Project progress will be measured through main deliverables, of which the most important are:

  1. Improving GLP/GMP production of recombinant BMP6 for large scale needs
  2. Formulating the OSTEOGROW device
  3. Performing successful Phase I clinical trial
  4. Complete Phase II clinical trials in three different clinical centers on two different indications: i) healing of distal radius fractures, and ii) high tibial opening wedge osteoctomy

Commercial potential for OSTEOGROW is considerable. Today, there are 26 million registered fractures worldwide annually. Due to the increase of osteoporosis incidence it is estimated that the number of bone fractures will double until the year 2030. With the rate of secondary interventions of 5-11% the current eligible patient pool is 1.5-2.6 million and will grow to 3-5.2 million in the next 20 years. Increased safety and efficacy, and much lower price of OSTEOGROW will provide a strong competitive advantage over existing products currently on the market. Additional indications for OSTEOGROW in the future will increase the overall commercial potential of the product. It will become the first EU bone device with novel and superior biological characteristics.