BonyPid-1000™ is comprised of synthetic, doxycycline eluting ß tri-calcium phosphate (ßTCP) granules.
It is biocompatible and biodegradable and presented in a 10 gram vial that contains 65 mg of doxycycline hyclate.
BonyPid-1000™ is designed for filling bone voids, providing effective eradication of bone infection caused by doxycycline-sensitive microorganism around the implant by constant release of antibiotics(¹).
It is serving as an osteoconductive bone scaffold supporting bone growth while gradually resorbing and replaced with bone during the healing process(2).
Upon hydration in the body, the PLEX™ matrix gradually degrades and allows the antibiotic entrapped between the layers to be released constantly between the granules, for a pre-designed period of at least three to four weeks.
BonyPid-1000™ is safe for immediate implantation into contaminated bones. As a result it has the potential to reduce the risk of infections, minimizing additional costly procedures and long hospitalizations, while enabling accelerated bone healing process.
BonyPid-1000™ is not yet approved for sale by regulatory agencies.
(1) US claim, pending FDA review and approval
(2) EU claim
BonyPid-1000™ formulation is well organized on a molecular level as a fine, sub-structure by self-assembly into PLEX™
LOCAL VS. SYSTEMIC DRUG DELIVERY
A low dose is sufficient to achieve a significant therapeutic effect
SYSTEMIC FORMULATION OF DOXYCYCLINE
Recommended oral dose for Doxycycline (tablets) - up to 200 mg/day (total of 6,000 mg)
BONYPID-1000™ - DOXYCYCLINE
Estimated dose of Doxycycline hyclate in a single implantation - total of 65 mg
(Should be used in conjunction with systemic antibiotic)
BonyPid-1000™ is designed to release a small antibiotic dose constantly for at least three to four weeks, with the overall accumulated dose being equal to about 1% of a 30 day oral antibiotic regimen.
NO CHANGE IN THE METHOD OF USE IN SURGERY
Simple preparation and use
On top of Standard of Care
BonyPid-1000™ is to be used in conjunction with standard of care in orthopedic surgeries.
PILOT CLINICAL TRIAL RESULTS SUMMARY
16 patients with Gustilo type III A & B open tibia fractures, were immediately implanted with BonyPid-1000 during the first surgical intervention (Irrigation and Debridement), and stabilized by external fixation. Patients had periodic laboratory, bacteriology and radiology follow-ups for 6 months.
Results - Standard of Care vs. BonyPid-1000™