The USA's BioMimetic Therapeutics has reported promising interim results for the use of its growth-promoting surgical implant GEM OS1 Bone Graft in the product's first orthopedic clinical trial in Canada for foot and ankle fusion indications.
According to the lead investigator on the study, Timothy Daniels, the results so far with GEM OS1 have been "at least comparable to autograft," a process that involves harvesting bone from elsewhere in the patient's own body, currently considered the gold standard but, however, without the pain and morbidity associated with harvesting the autograft material.
Following GEM OS1 treatment, a blinded independent radiologist found that, by 12 weeks, 85% of patients had some degree of fusion and 67% achieved greater than 50% osseous bridging as measured by computer tomography scans. Dr Daniels noted that these results are similar to recently-published data using autograft, where 48% of patients demonstrated greater than 50% fusion mass at 12 weeks on CT scans.
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