What are the indications for use?
This product has been approved in Israel for the treatment of chronic wounds. It has been used in Israel for a variety of wound types such as pressure ulcers, diabetic foot ulcers, and post-operative wounds (deep sternal wound infection, post cesarean operation, post orthopedic surgery, and post abdominal surgeries).
What is the safety profile?
More than 5,000 patients with various wounds have been treated with CureXcell™ with an excellent safety profile.
What is the clinical efficacy?
In a non-randomized controlled Phase IV trial comparing CureXcell™ to standard of care for chronic, severe full thickness (stage III/IV) hard to heal ulcers, there was a five-fold increase in the percentage of complete closure of the wounds vs. standard of care (N=38, p<0.001). In another study, the effect of CureXcell™ treatment was studied in deep sternal wound infections (DSWI) prospectively and compared to a four year historical control standard of care cohort. Mortality was 3% (2/66) in the CureXcell™ group vs 29.7% (19/64) in the control group. No side effects related to the treatment were reported.
What is the method of administration?
The suspension should be injected superficially throughout the wound using a 25 gauge needle.