Pipeline of innovative projects to address unmet patient needs
GRFT-R02 is a unique, highly osteogenic putty.
This patented biomaterial is expected to allow surgeons to address difficult surgical situations like acetabular reconstruction, spinal postero-lateral fusion, non-union or complex cases of fracture healing with poor vascularization. GRFT-R02 shows osteoinductive properties to enhance bone regeneration and is able to repair a critical and segmental bone defects in animal models.
This biomaterial has demonstrated comparable efficacy to autograft in animal models and offers an alternative to expensive and higher risk bone morphogenetic proteins (BMPs).
GRFT-R02 is a combination of patented Bi-CaP Microparticules with whole blood. Once clotted, the material creates a fibrin mesh and acts like a hydrogel. The BiCaP technology includes controlled particle sizes (ranging from 80 to 200μm) and is composed of 60% Hydroxyhapatite and 40% βTCP. BiCaP Microparticules are enriched with Calcium ions, which facilitate blood clot formation.
GRFT-M03 is a new generation of highly injectable calcium phosphate cement designed to boost bone reconstruction (with high resorption properties).
GRFT-M03 is a unique calcium phosphate composition to be mixed with autologous blood. GRFT-M03 technology is expected to provide an osteogenic performance comparable to those of autologous bone and BMPs (bone remodeling and reconstruction), with an improved safety profile.
The targeted clinical indications are orientated to “salvage” situations (osteonecrosis, non-unions, revision on elderly patients, large bone defect (e.g. acetabular reconstruction), bone anchorage augmentation (high injectability, plasticity), minimally invasive injection in fusion cages for intervertebral body fusion after placement of cage, minimally invasive procedures requiring higher pressure and lower viscosity, such as bone marrow lesions and tibioplasty.
The first CE-mark and FDA clearance are planned for early 2018.
GRFT-M04 project is a combination device associating a bone resorption inhibitor (bisphosphonate), a highly injectable calcium phosphate cement and a radio opacifier for the spinal applications. This R&D project is aiming at therapeutic and prophylactic applications for osteoporotic patients:
- short-term expected benefit is an enhanced strength and resistance in fragile bone at high risk of fracture.
- long term expected benefit is the optimization of the reconstruction of healthy bone at the site of implantation throughout the resorption process of the device followed by its replacement bynatural bone, through inhibition of the excessive and unbalanced osteoclastic activity.
The targeted indications include bone anchorage augmentation and secondary fracture prevention in the proximal femur or in the spine in osteoporotic patients.
This proprietary and patented technology is a unique combination device to propose local therapeutic or prophylactic solutions for osteoporotic patients.
Preclinical data show significant reinforcement and effective secondary action on trabecular bone structure. Regulatory route has been confirmed, and a first market introduction is expected in 2020-2021.
GRF-M05 project features an innovative Gallium-doped calcium phosphate cement with antitumoral and antimicrobial properties.
Targeted indications include bone tumors resections and bone metastases.
This project is based upon a next generation technology where the therapeutic agent is included in the crystal structure of the biomaterial.
- Gallium is a semi-metallic element with anti-tumoral, anti-resorptive and anti-microbial properties.
- Combination of Gallium in the calcium phosphate crystal structure has given evidence of bioavailability and proof of action.
For this proprietary and patented technology, biological properties are being tested in animal models. The market release is expected in 2021.