Will Osiris Be an Orthopedics Company?
Largely focused on using stem cells to treat inflammation and cardiovascular disease, the modest leverage Osiris is creating in the bone-growth market may ultimately argue in favor of a more traditional device-company model for growth.
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Stem-cell-related strategies may predominate these days in tissue engineering, but cell therapy companies know that providing the right microenvironment for nurturing tissue growth remains a difficult and essential challenge. Thus, start-ups remain committed to the developent of cellular matrices that provide the appropriate structure, environment, and bioactivity to encourage tissue growth. The four start-ups profiled in this issue represent a cross-section of strategies.
Orthobiologics are now on the horizon, driving suppliers to increase R&D spending. The goal is to develop high-margin products that will actively promote bone formation. Has the slow progress to commercialization of the first two products--bone morphogenic proteins developed by the collaborations of Stryker Corp/Creative Biomolecules and Genetics Institute/Sofamor Danek--helped prime the market to accept a new technology? Or has the perception of delay dampened enthusiasm and scared off some of the big orthopedics players?
The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).