ProChon Biotech Ltd. expanded a clinical trial of its Biocart knee cartilage regeneration system from one medical center to 10, a move that CEO Patrick O’Donnell told MassDevice puts ProChon on track to bring the technology to market in the U.S. and the European Union in 2014.
O’Donnell, who heads up a new management team that took over in January, said the expansion will also help raise the profile of a company that’s largely flown under the radar until now.
“When the new management took over in January, there was one study site and it was in New York. There are now 10 study sites, seven in the U.S. and three in Israel. There was one patient in the study and we’ve enrolled our 11th patient today. It’s exciting because we want to be enrolling in the Phase III study beginning in 2011 and we’re on track to achieve that milestone,” he told us. “It puts us on track to get into the U.S. and EU markets in 2014, which isn’t that far away in a lot of respects. … This just brings harder data and validation to what were trying to accomplish as a company, because a lot of people haven’t heard about our company and our technology.”
Woburn, Mass.-based ProChon is developing biologic knee repair technology that using a proprietary fibroblast growth factor variant.*
The Phase II study will compare the Biocart treatment with microfracture in repairing symptomatic cartilage defects. Microfracture uses the body’s bone marrow stem cells to create a patch of scar tissue to repair damaged cartilage.
The BioCart system, which cultures a healthy sample of knee cartilage and implants it back into the damaged knee, uses the FGF2v product to stimulate cartilage growth on an implant scaffold.