Peer reviewed studies have proven efficacy in a number of models
Peer reviewed animal studies have been published for mice, rats, rabbits and cows, all demonstrating that StaphOff technology is effective in a variety of applications, like wound infections, graft associated infections, cellulitis, arthritis, sepsis, osteomyelitis, mastitis and keratitis. Numerous animal studies also show that when CEN-101 or CEN-103 are used in combination with standard antibiotics, making some obsolete antibiotics effective again.
OUR TECHNOLOGY IS ALREADY SAVING LIMBS AND LIVES
Treatment with topical gel formulation of our technology is already saving many limbs and possibly lives of thousands of patients that have exhausted all other alternatives. Under the novel therapy, up to 91% of the wounds that would have been deemed ‘unhealable’ and would have resulted in a major limb amputation, are now healed (see example below). In addition, with the use of anti-biofilm strategies, the use of conventional antibiotics has dropped by 85%. Although our molecules do not have the properties of a conventional antibiotic being neither bactericidal nor bacteriostatic in vitro, they do reduce the ability of the bacteria to survive within the host, allowing even the most meager immune responses to overcome an infection.
When comparing the healing frequency, biofilm-based wound care strategies that include our molecules significantly improved healing frequency, consistently transforming ‘nonhealable’ wounds into healable ones. Importantly, no safety concerns were ever observed.
Sample case: LIMB STAYED ON AND DEVICE STAYED IN
A 50-year-old male was working his cattle when a steer kicked him in his left lower leg. This shattered the tibia and fibula. The patient was hospitalized and underwent open reduction and internal fixation of his fracture. The site where the plate was placed dehisced, and despite extensive antibiotic therapy, the patient was left with a large nonhealing surgical wound over the metal plate about 5-7 days after his surgery. The surgeons felt like the metal plate needed to be removed, and that they have to amputate his leg above the knee. The patient decided to leave the metal plate and try to heal the wound that was cultured with S. epidermidis. The patient was treated with a topical preparation that included CEN-103. The patient was also treated orally with Doxycycline for 8 weeks. The patient showed rapid closure of the wound over the implanted medical device. It took a total of 16 weeks to heal the wound over the plate. The patient has been doing his farm and ranch activities, and x-rays show the fracture is healed. As no healing was observed prior to administering CEN-103, it seems that CEN-103 was important in suppressing the S. epidermidis biofilm to the point where the patient could heal his wound.