Pipeline Overview
Pipeline Overview
Osteal Therapeutics' lead candidate, NEXCHANGE™ KIT (formerly known as VT-X7), is a drug-device combination product designed to more effectively treat PJI over a dramatically shorter period of time compared to two-stage exchange arthroplasty by using purpose-built drug-delivery technology and the cyclic, local, expedited, antibiotic-irrigation regimen (CLEAR™) protocol over 7 days before reimplantation of a permanent prosthesis.
NEXCHANGE™ KIT has not been approved by the FDA. It is limited by United States law to investigational use only.
How
NEXCHANGE™ KIT
Works
After removing the infected joint prosthesis, bone and soft tissue, the surgeon places a NEXCHANGE Spacer and fluid management dressing, connecting them to an irrigation pump.
1
Place NEXCHANGE Spacer
2
Over the course of one week in the hospital, a continuous cycle of high-concentration antibiotics formulated for local administration – tobramycin and vancomycin – are cycled into the joint space through the NEXCHANGE Spacer and allowed to soak the infected area for a period of time. Fluid is then removed through the wound dressing, and the next cycle begins.
CLEAR™ Protocol
3
After 7 days of treatment, the NEXCHANGE Spacer is removed and replaced with a permanent joint prosthesis, and the patient proceeds to post-surgical physical therapy.
Days of treatment
For more information on clinical trials, click here.
NEXCHANGE KIT is designed to treat PJI in 7 days. The APEX clinical program studied treatment for 7 days with an allowance up to 10 days for surgical scheduling purposes.