AVIcure HemaSterilizer™ System

Incidents of tainted blood are increasing in lockstep with the global economy.

AVIcure anticipates marketing the HemaSterilizerTM worldwide as the first chemical-free UVBI device with a 99.99% success rate in the inactivation of pathogens.

It’s widely acknowledged that the United States has the world’s highest standards and the most effective oversight of the collection of human blood supplies intended for transfusions. Three separate federal agencies—the U.S. Food and Drug Administration (USDA), the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC) are entrusted with keeping the nation’s blood supply safe for more than 9.5 million donors and 5 million patients who receive transfusions every year.

According to the CDC, “Although the U.S. blood supply is safer than ever before, some bacteria, viruses, prions, and parasites can be transmitted by blood transfusions…Each donor is screened for risk of transmissible disease by questionnaire, and each unit of blood donated in the U.S. is routinely screened for various infectious disease pathogens, including five transfusion–transmitted viruses, using nine laboratory tests.” In the U.S., deferrals of donations from individuals involved in at-risk activities have contributed substantially to the protection of national blood supplies.

Sadly, however, developing nations and even certain regions of the world with well-developed economies and healthcare systems have not been able to attain the level of quality assurance that patients in the USA often take for granted. Incidents of tainted blood are increasing in lockstep with the global economy. Viruses, bacteria, parasites and other contaminants are growing and dangerous threats from Canada to China and every rich and poor nation in between.

We believe the AVIcure HemaSterilizer™ can be a valuable and significant part of the solution, and in doing so help prevent the spread of viruses—including Ebola, West Nile, and human herpes virus and several small DNA virus strains (TTV-SEN-V).

The fact is that there is no completely reliable pathogen inactivation system available for donated blood components and whole blood— not even in the U.S. Currently, systems used to minimize blood pathogens are often complicated to use and sometimes utilize potentially toxic chemicals such as dimethylmethylene blue, psoralen, S-303 and others. And some medical devices currently in use lack efficacy when used to inactivate PEN110, TTV and SEN-V, dangerous pathogens.

Only AVIcure’s HemaSterilizer™ system has, in its first phase of clinical trials, demonstrated the capacity for—without the use of potentially harmful chemicals—99.999% (>5log10) phage inactivation with < 1% hemolysis, 3 log10.

The benchtop device is simple to operate and maintain, and in keeping with AVIcure’s commitment to UVBI devices that are innovative, effective and affordable, will be marketed at a price accessible to blood banks and drawing centers worldwide. Its core technology—our patented ultraviolet lamp designed, engineered and built in the USA by Superior Quartz Products—irradiates blood in the C band to inactivate viral and bacterial organisms that might be present in donated blood. A disposable kit exposes donated blood from donor bags through the HemaSterilizer™ and back into a new donor bag.

Once through the required series of advanced clinical trials, AVIcure anticipates marketing the HemaSterilizer™ worldwide as the first chemical-free UVBI device with a 99.99% success rate in the inactivation of pathogens.

DISCLAIMER: The AVIcure HemaSterilizer is an investigational device and has not been approved by the FDA for commercial distribution in the United States.