Sacramento, Calif.-based Molecular Matrix received FDA 510(k) clearance for Osteo-P, a bone graft substitute technology.
Here are six things you need to know:
1. Osteo-P is a non-mineralized, synthetic bone void filler made of a hyper-crosslinked carbohydrate polymer. It is highly porous, biocompatible and biodegradable.
2. It is intended for filling bone defects created through traumatic injury or surgery. When placed or gently packed into bone voids, Osteo-P guides the ingrowth of new bone across the graft site, after which it is resorbed and replaced by newly formed bone during the healing process.
"Osteo-P provides an optimal microenvironment for infiltration of bone precursors such as osteoblasts that have been known to play a key role in bone regeneration," said Charles Lee, PhD, Molecular Matrix founder and CEO. "This microenvironment includes a significant surface area that allows the flow of fluids and metabolites, leading to the formation of healthy bone."
3. The polymer technology is designed to offer advantages over current bone graft substitutes, including real-time fusion monitoring, exceptional bone formation and implant resorption and the ability to hold a suture.
4. Osteo-P is available in large pore granules, sheets, cubes, wedges and cylinders offering greater application, flexibility and handling characteristics. Customized products are frequently manufactured for collaborative research projects and may be used to correct complex anatomic defects.
5. Osteo-P is intended for single patient use only and provided in a one-time use with double sterile packaging. It is not indicated for use as a structural support in load bearing applications.
6. It is delivered in ready-to-use sterile packaging and stored at room temperature. The technology is not subject to degradation through hydrolysis, making shipping easier; Osteo-P is not indicated for use as a structural support in load bearing applications.
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