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Human Clinical Trials

Exoxemis has completed a placebo controlled, randomized, international, Pivotal, Phase III, human clinical trial with 250 human subjects in each arm, at 25 U.S. and 5 Israeli sites. This study provides direct evidence that Zempia® is safe for use in open wounds—it does not interfere with normal wound healing.

About Zempia®

While Zempia® has not been approved by the FDA for human use, Zempia® has undergone extensive in vitro, efficacy studies—laboratory and animal testing—which provides direct evidence that Zempia®…..

While Zempia® has not been approved by the FDA for human use, Zempia® has undergone extensive in vitro, efficacy studies—laboratory and animal testing—which provides direct evidence that Zempia®…..


Action of Zempia®

Has broad microbicidal activity against all wound pathogens; kills antibiotic resistant bacteria; is effective in killing gram-negative and gram-positive bacteria, viruses, spores, yeast and fungi.

  • Does not harm tissue or blood cells; selects and only binds to pathogens.
  • Does not cause local irritation or sensitization.
  • Is not systemically absorbed (thereby eliminating systemic toxicity).
  • Has microbicidal activity in wound environments with blood and/or exudate where most other antiseptics in use today (except for silver) are inactivated by miniscule amounts of blood. Silver however is a small molecule and can be absorbed—hence has potential toxic side effects although no safety or evidentiary studies on silver or any other antiseptic in use today have been conducted and are on file at FDA.
  • Inactivates endotoxin and Lipid A. Other antiseptics kill bacteria but they leave the endotoxins that cause sepsis. Zempia® could potentially be a breakthrough in preventing sepsis.

For Immediate Release

Groundbreaking Research Points Towards Zempia®
As a Proposed New Weapon in Medicine’s Armamentarium to Fight Sepsis

Myeloperoxidase and Eosinophil Peroxidase Conclusively
Shown to Inactivate Endotoxin and Lipid A.

Jackson T. “Steve” Stephens
Founder & CEO

PARTNER WITH EXOXEMIS

Today, Exoxemis, Inc. is well qualified to partner with a medical device or pharmaceutical company to conduct further testing, obtain regulatory approval and to more quickly optimize Zempia® market share. An exclusive licensing agreement is available for Zempia® for several applications in a number of potential markets:  for use in conjunction with large joint implants; urinary catheters; dental implants and oral surgeries; for use in the ER, in wound treatments, colorectal, HEENT, Plastics/Burn. . . .really in any surgery or condition involving an open wound that is susceptible to infection. This includes skin care, dermatology, even cosmetics. We believe that Zempia® could be an effective weapon to fight AMR and HAI’s infections that are now a crisis and plaguing our hospital systems.

“We’re still in the age of the telegraph with regard to topical antiseptic R&D. While further testing and approval for Zempia® is necessary, we’re very excited about it’s many commercial applications.”

Jackson T. “Steve” Stephens
Founder & CEO

In 1919, Alexander Fleming proved that carbolic acid and other antiseptics indiscriminately kill pathogens as well as healthy tissue including the white blood cells that offer the body’s own defense mechanism against infection Researchers in the field of antiseptics have made futile attempts to balance pathogenic, germ cell killing with the sparing of human cells.Adding to the problem, it was also discovered that antiseptic germ-killing properties are inactivated in small amounts of human blood but still kill human cells.

 

The unsatisfactory problem with antiseptics was ignored for decades primarily due to the effective use of antibiotics. After decades of over-prescribing antibiotics and the dilution of antiseptics, germs have built up a resistance to both topical and systemic agents meant to kill them. 

Introduction to Zempia®

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