PolyPid announces positive preliminary results of clinical trial with BonyPid
PolyPid Ltd. announced positive preliminary results of a first-in-man clinical trial with its BonyPid™ product.
BonyPid™ is a combined drug and medical device product integrating bone filler and a substantial antibiotic release platform. The bone filler is resorbed and replaced by the bone during healing process. The antibiotic release rate is controlled by PolyPid's drug delivery platform over a prolonged period of several weeks, allowing eradication or prevention of bone infections. The prolonged and sustained antibacterial activity, concomitantly with the bone osteoconductive activity exerted by the bone filler, contributes to bone healing.
The clinical trial was conducted in 16 males and females, aged 18-70, who experienced major trauma associated with severely open long-bone fractures. Upon administration, patients were treated according to the hospital standard of care treatment. BonyPid™ was implanted in the first surgical procedure, immediately after irrigation, debridement and bone fracture fixation.
"The preliminary results clearly demonstrated that BonyPid™ significantly reduced or prevented bone infection, and facilitated bone recovery. In addition, BonyPid™ enabled one surgical procedure and immediate closure of the open wound in most cases," said Dr. Noam Emanuel, PolyPid's CTO.
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