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Interim results from study of BonyPid®-1000 in the treatment of open tibial fractures indicate that the bone substitute met performance and safety endpoints in first patients at 6 months.
The 64-patient trial is a randomized, single-blind controlled study of BonyPid-1000 doxycycline-eluting synthetic bone substitute + standard of care (SOC) vs. SOC alone, occurring at 6 sites in Israel and 3 in Asia. The primary endpoint is radiographic-assessed bone healing at 24 weeks.
At 16 weeks, in 12 patients treated with SOC + BonyPid vs. 13 patients treated with SOC alone:
- Time from surgery to initiation of bone healing was reduced by ~33% in the BonyPid + SOC group
- Solid radiographic markers for bone healing (the primary performance endpoint) were observed at 75 days for BonyPid + SOC, vs. 110 days in SOC alone
- >30% of SOC alone patients did not achieve the primary performance endpoint, vs. 8% of BonyPid + SOC
- Pain-free weight bearing was demonstrated in 63% of BonyPid + SOC patients at 4 months post-op, vs. 0% receiving SOC alone
Enrollment is slated to complete by year-end 2017.
Sources: PolyPid; ORTHOWORLD Inc.
On the standard of care:
“The standard of care includes systemic administration [of antibiotics into the bone void], which is limited due to low penetration into the needed site. Local delivery may overcome this issue. However, the approved local solutions are characterized by short-term and non-controlled release of the entrapped drug,” she says.
“Currently, in the U.S., the only approved local delivery is based on a cement polymer that releases an effective amount of antibiotics over a short period (several days), which is also characterized by high burst release. This release profile is limited in the eradication of significant bacterial load, and can even lead to resistant strains of bacteria.”
—Dikla Czaczkes Akselbrad, PolyPid’s Chief Strategy Officer, in “New Trauma Technologies Emerge to Treat Infections,” BONEZONE July 2016
Interim results from study of BonyPid®-1000 in the treatment of open tibial fractures indicate that the bone substitute met performance and safety endpoints in first patients at 6 months.
The 64-patient trial is a randomized, single-blind controlled study of BonyPid-1000 doxycycline-eluting synthetic bone substitute + standard of care (SOC)...
Interim results from study of BonyPid®-1000 in the treatment of open tibial fractures indicate that the bone substitute met performance and safety endpoints in first patients at 6 months.
The 64-patient trial is a randomized, single-blind controlled study of BonyPid-1000 doxycycline-eluting synthetic bone substitute + standard of care (SOC) vs. SOC alone, occurring at 6 sites in Israel and 3 in Asia. The primary endpoint is radiographic-assessed bone healing at 24 weeks.
At 16 weeks, in 12 patients treated with SOC + BonyPid vs. 13 patients treated with SOC alone:
- Time from surgery to initiation of bone healing was reduced by ~33% in the BonyPid + SOC group
- Solid radiographic markers for bone healing (the primary performance endpoint) were observed at 75 days for BonyPid + SOC, vs. 110 days in SOC alone
- >30% of SOC alone patients did not achieve the primary performance endpoint, vs. 8% of BonyPid + SOC
- Pain-free weight bearing was demonstrated in 63% of BonyPid + SOC patients at 4 months post-op, vs. 0% receiving SOC alone
Enrollment is slated to complete by year-end 2017.
Sources: PolyPid; ORTHOWORLD Inc.
On the standard of care:
“The standard of care includes systemic administration [of antibiotics into the bone void], which is limited due to low penetration into the needed site. Local delivery may overcome this issue. However, the approved local solutions are characterized by short-term and non-controlled release of the entrapped drug,” she says.
“Currently, in the U.S., the only approved local delivery is based on a cement polymer that releases an effective amount of antibiotics over a short period (several days), which is also characterized by high burst release. This release profile is limited in the eradication of significant bacterial load, and can even lead to resistant strains of bacteria.”
—Dikla Czaczkes Akselbrad, PolyPid’s Chief Strategy Officer, in “New Trauma Technologies Emerge to Treat Infections,” BONEZONE July 2016
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JV
Julie Vetalice is ORTHOWORLD's Editorial Assistant. She has covered the orthopedic industry for over 20 years, having joined the company in 1999.
