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PolyPid Launches Trial of BonyPid-1000 Antibiotic-Eluting Bone Void Filler

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PolyPid enrolled the 1st patient in a confirmatory clinical trial of BonyPid-1000™, a doxycycline-loaded synthetic bone substitute. The prospective, randomized study will assess the product's safety and performance in severe open tibial fractures as an adjunct to the standard of care and vs. standard of care alone. 

The study is expected to engage 64 patients at 5 sites in Israel and 3 in Asia, with follow-up at 6 and 12 months. 

BonyPid-1000 bone graft substitute has completed pilot clinical trials in an open fracture indication, demonstrating 0% infections in the target fracture and 0% amputations after 6 to 12 months follow-up (vs. an average of 25% and 7%, respectively, in a historical control group).

Sources: PolyPid Ltd., clinicaltrials.gov

Surgical site infections topped the list of reasons for hospital readmissions following TKA or THA, according to the American College of Surgeons, and DePuy Synthes leadership called out infection prevention specifically as an area of continued strategic focus in its 3Q15 earnings call.

Numerous approaches are in development to combat infection, including nanotechnology used on implant surfaces, polymer coatings, small molecule compounds, etc. BONESUPPORT claims that its CERAMENT|G is the 1st antibiotic-eluting bone substitute indicated to promote and protect bone healing in the management of osteomyelitis/bone infection.