HispanicBusiness

Overall, we continue to make significant progress in our commercialization efforts and are pleased with the initial physician response and clinical experience.

Research and Development update

We continue to advance our technologies and grow our product pipeline through investments in research and development. We have recently been awarded approximately $5M in government contracts that help to fund these efforts.

DARPA $3.8M Contract
As part of DARPA's "Dialysis-like Therapeutics" program to treat sepsis, we were awarded a $3.8M five-year contract in August to develop advanced polymers that can remove not only cytokines but also a variety of bacterial and biowarfare toxins. Our technology is ideally suited for this broad spectrum capability. In fact, we have already demonstrated the ability of CytoSorb® to remove a number of these toxins in vitro such as Staphylococcus aureus alpha toxin, a potent toxin that is responsible for cell destruction and widespread tissue damage in Staph. aureus and methicillin resistant Staph. aureus, or MRSA, infection. MRSA is one of the leading and most deadly hospital acquired infections. Outside of this DARPA contract, Dr. John Kellum at University of Pittsburgh has demonstrated in an animal model of sepsis, that a reduction of cytokines by CytoSorb® hemoadsorption appears to redirect the immune response to the area of infection, helping to control it even in the absence of antibiotics, while preventing unwanted immune-mediated injury to uninvolved, healthy organs. These new and exciting findings highlight the multi-factorial and synergistic benefit that CytoSorb® may have in these critical illnesses (i.e. reduction of cytokine storm, removal of damaging bacterial toxins, redirection of the immune response, and others) and why we believe our technology is the best-in-class solution.

United States Army $1M Phase 2 SBIR Award
We are nearing the completion of our negotiations of our $1 million Phase 2 SBIR award with the U.S. Army. Ahead of this, we have been continuing our work from the Phase I SBIR award, and should be in a good position to make rapid progress with funding. We remain excited by the prospect of continuing to work with the Army and obtaining efficacy data in animal models of both burn injury and trauma which, if positive, will help advance these applications in human treatment. We are also encouraged by interest from other branches of the military in our technologies, which may lead to other opportunities.

Business Development

One of the key goals of the Company is to establish strategic partnerships for various products in our pipeline. We cannot commercialize all of them by ourselves, so leveraging the expertise, financial resources, and infrastructure of dedicated partners remains a logical option. The majority of our products under development have achieved proof-of-concept, at a bare minimum.

One of our most advanced development candidates is our HemoDefend blood purification technology. HemoDefend is designed to remove contaminants in blood transfusion products that can cause transfusion reactions, effectively "washing blood" without the cost, time and trouble of actually doing so. We have made significant advances in our in-line blood transfusion filter, demonstrating the ability to filter standard packed red blood cells (pRBCs) that account for nearly half of the 100+ million worldwide blood transfusions each year, while removing significant amounts of contaminants such as toxic free hemoglobin, and others. We have optimized the design so that a unit of packed red blood cells passes relatively easily through this low resistance, high flow filter by gravity alone in under a half an hour. This meets the requirements of the vast number of pRBC transfusions performed each year. We are also in the process of optimizing our packaging to help drive down the unit costs of each device. We also continue to make good progress on our "Beads in a Bag" configuration, with demonstration of our neutrally buoyant bead technology, and efficient removal of contaminants such antibodies, cytokines, free hemoglobin, and bioactive lipids over 42 days. This was the subject of our scientific poster presentation at the 2012 American Association of Blood Banks (AABB) conference. We believe that HemoDefend represents a significant new innovation and capability to the blood transfusion industry.