BERKELEY, CA, Jan. 7, 2015 / ExThera Medical Corporation has joined a team led by Battelle that is developing a Dialysis-Like Therapeutics (DLT) device to treat sepsis. ExThera plans to work with Battelle and NxStage Medical (NXTM), Inc. on a contract from the Defense Advanced Research Projects Agency, or DARPA, to develop an innovative, new medical device.
ExThera is a pioneer in the development of broad-spectrum therapeutic devices to treat life-threatening bloodstream infections. As part of the DLT Program, Battelle will perform safety and efficacy studies on ExThera’s second-generation Seraph® Microbind® Affinity Blood Filter (Seraph).
“Each year there are 1.8 million new cases of bloodstream infection in the U.S. and Europe, causing patients serious complications and imposing a major cost burden on health care systems. With fewer anti-infective drugs being developed, and the continuing emergence of new drug-resistant pathogens, ExThera’s sorbent hemoperfusion device should become an important new tool for critical care clinicians.” Bob Ward, CEO, ExThera Medical
Initiated in 2010, DARPA’s DLT program is developing a portable system that removes "dirty" blood from the body, removes harmful agents, and returns "clean" blood to the body in a manner similar to the treatment of kidney failure with dialysis. The Battelle-led team began work on the integrated device in March 2013. The DLT program seeks to develop filter technologies, integrate them into a portable system, and rigorously validate filter effectiveness. The resulting multi-component device could decrease the morbidity and mortality of bloodstream infections, e.g. by preventing sepsis-induced organ failure, thereby saving thousands of lives and billions of dollars in the United States annually.
“Battelle is excited to have ExThera join our team to develop a DLT device to treat sepsis in warfighters. ExThera’s novel Seraph technology, as well as cutting-edge, blood separation technologies from other DLT developers, are needed to meet DARPA’s aggressive program requirements. Sepsis has claimed the lives of thousands of our nation’s warfighters and the DLT system could be a major step forward in improving survival rates.” Marty Toomajian, President, Battelle Energy, Health & Environment
DARPA’s integration and validation of a DLT system focuses on submitting an Investigational Device Exemption (IDE) to the FDA before the completion of the program. From there, the DLT system would be available for transition to clinical trials required for final regulatory approval. NxStage would manufacture and commercialize the DLT system while ExThera and other DLT developers would manufacture and supply blood separation filters for use in the system.
Since 2008, privately-funded ExThera (short for Extracorporeal Therapy) has been pursuing a nearly identical goal within the very large civilian market. ExThera’s Seraph® Microbind® Affinity Blood Filter, now fully developed and about to enter EU clinical trials, is a broad-spectrum ‘hemoperfusion’ device with demonstrated ability to remove a long list of pathogens and toxins from whole blood. These include viruses, drug-resistant bacteria, fungi and inflammatory cytokines.
According to Bob Ward,
“ExThera’s mission is to offer simple, device-based therapies for rapid treatment of bloodstream infections—including those caused by agents for which there are no effective therapeutic drugs or vaccines. We are very pleased to be included in this exciting program during the important device evaluation phase. Our 40-year experience in the development of blood-contacting medical devices, and their translation to manufacturing, should also be useful to the DARPA program.”
While adding nothing to the blood, Seraph uses a biomimetic ‘adsorption media’ that includes chemically-bonded heparin and supplemental adsorbent materials in a single cartridge. The well-known anti-thrombogenic properties of heparin contribute to the safety of the device, especially in situations when the device must be used without systemic blood thinners.
Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio, since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.
For more information contact Katy Delaney at (614) 424-7208 or firstname.lastname@example.org, or T.R. Massey at (614) 424-5544 or email@example.com.
About ExThera Medical Corporation
Privately held ExThera Medical, based in Berkeley, Calif., is targeting the clinical treatment of blood-borne diseases including bacteremia and viremia, as well as the removal of harmful substances present in banked/transfused human blood. While medical treatments of bacteremia, e.g., caused by S. aureus or MRSA (Methicillin-Resistant S. aureus) usually rely on antibiotics, ExThera Medical’s Seraph device capitalizes on affinity to attach to immobilized heparin, a natural anticoagulant that has many other biological attributes. Seraph is designed to be a biomimetic adjunct or alternative to anti-infective therapy for reducing pathogen load and the duration of bloodstream infections, thereby preventing complications such as endocarditis, osteomyelitis, and systemic inflammatory response. The Company introduced its Seraph device concept to clinicians in 2014 at the annual congress of the Society for Critical Care Medicine.
Contact: Ronald Trahan, APR, Ronald Trahan Associates Inc., +1-508-359-4005, x108
CAUTION: ExThera Medical’s Seraph® device is not cleared by the FDA for distribution in the United States.
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