OVERVIEW

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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
 


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BONYPID-1000

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FORMULATION

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)

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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

simple-use-Bonypid1000

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

Study design

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™

Results-Standard-of-Care

(1)  Compared to historical control at the same hospital 
(2)  Compared to known literature
(3)  In Gustilo III A,B –  compared to historical control at the same hospital
(4)  At least 2 surgeries – compared to historical control at the same hospita

Technology

The PLEX™ (Polymer-Lipid Encapsulation matriX) platform is a matrix made of alternating layers of polymers and lipids that allows controlled, local release of unmodified drugs over extended periods of time.

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D-PLEX™

Provides safe and effective local antibiotic protection against SSI (surgical Site Infection) at the needed tissues or organs by administration during surgical procedures.

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BonyPid-1000™

Comprised of antibiotic eluting ß tri-calcium phosphate (ßTCP) granules, designed for bone related infections applications.

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