West Sacramento Biotech Firm Wins FDA Clearance For Bone Graft Substitute
Molecular Matrix, a Sacramento-area biotech firm, has won an important Food and Drug Administration clearance, 510(K), for Osteo-P, its synthetic bone-void-filler product. The clearance is an important step toward bringing the product to market.
A 510(K) is a premarket submission made to the FDA to demonstrate a device is at least as safe and effective as a legally marketed device that is not subject to premarket approval.
Founded 2011 in Davis, Molecular Matrix now takes space at 3410 Industrial Blvd. in West Sacramento. The company is preparing to grow on the basis of Osteo-P, which will to be used in surgery to spur the growth of new, healthy bone.
Based on proprietary research, Osteo-P is intended for the filling of bone defects created surgically or through traumatic injury. When packed into bone voids, Osteo-P supports and guides the growth of new bone across the graft site, after which it is replaced by newly formed bone.
According to Molecular Matrix, the polymer technology offers several advantages over current bone-graft substitutes, including exceptional bone formation and implant resorption, real-time fusion monitoring and the ability to hold a suture.
Biotech is a growth sector of the Sacramento economy, with the University of California, Davis anchoring much of that growth. Lab, office and residential space is cheaper in the region than San Francisco, driving growth as well.
According to Select Sacramento, the region’s biotechnology and life science industries include more than 100 biotechnology and medical device companies with more than 141,000 life sciences employees.