BERKELEY, Calif.--(ExThera Medical:)--
“Seraph’s affinity apheresis platform may become an effective treatment for Staph aureus bacteremia, including MRSA, to prevent metastatic infectious complications and sepsis”
“When blood samples were spiked with Staphylococcus aureus and passed through the Seraph device, as much as 80% of this deadly organism was removed from the blood, suggesting that the duration of bacteremia could be shortened with adjunctive use of Seraph.”
Steven P. LaRosa, M.D.
Division of Infectious Disease
Beverly Hospital, Beverly, Mass.
ExThera Medical announced today that its Seraph™ (Selective Removal by Apheresis) Microbind™ Affinity Blood Filter continues to receive enthusiastic scientific scrutiny for its potential to thwart sepsis-induced systemic inflammation and organ dysfunction.
The Seraph™ device is highlighted in “Immune Aspects of Sepsis and Hope for New Therapeutics” published in the recent edition of Current Infectious Disease Reports, which provides in-depth review articles contributed by international experts about the most significant developments in the field of infectious disease. The authors of the scientific article are: Steven P. LaRosa, M.D., Division of Infectious Disease, Beverly Hospital, Beverly, Mass., and acting Chief Medical Officer of ExThera Medical; and, Steven M. Opal, M.D., Infectious Disease Division, The Alpert Medical School of Brown University, Providence, R.I.
“Seraph’s affinity apheresis platform may become an effective treatment for Staph aureus bacteremia, including MRSA, to prevent metastatic infectious complications and sepsis,” said Bob Ward, President and CEO of ExThera Medical, the developer of Seraph™. “We expect to commence clinical trials for this first indication of Seraph™ in the near future.”
While other medical treatments of bacteremia caused by S. aureus or MRSA (Methicillin-Resistant S. Aureus) rely on increasingly ineffective antibiotics, the Seraph™ apheresis device capitalizes on the affinity of the bacteria in an infected patient’s blood to attach to immobilized heparin—a natural anticoagulant, with many other biological attributes. Seraph™ is designed to be an adjunct to antibiotic therapy that reduces bacterial load while also lowering levels of pro-inflammatory cytokines in a patient’s blood, to potentially prevent complications such as endocarditis, osteomyelitis, and sepsis.
Three studies—at Karolinska Institute Hospital (Stockholm, Sweden), the University of California-Berkeley, and the University of Minnesota—have demonstrated that the Seraph™ affinity therapy device binds tumor necrosis factor (TNF-α) in high yield. TNF-α, an important pro-inflammatory cytokine released during sepsis, is believed to trigger the inflammatory and coagulant cascade leading to sepsis-induced organ dysfunction.
One critically important clinical application of Seraph™ is expected to be the treatment of sepsis within intensive care units (ICU). Seraph™ consists of a specially designed cartridge packed with a novel bioactive polymer substrate that acts as a hemofilter. By incorporating immobilized heparin, the cartridge’s high-surface-area may safely and selectively reduce cytokine levels and remove certain toxins and pathogens such as S. aureus and MRSA from a patient’s blood before the blood is (re)infused.
Sepsis is a condition that results from the immune system’s response to severe infection leading to cardiovascular collapse and multiple organ failure. It is one of the top-ten causes of death in the U.S., killing over 225,000 Americans each year, more than lung and breast cancer combined. Severe sepsis has reported mortality rates ranging from 30 to 60 percent, and an average cost of $22,100 per case. Over three quarters of a million new cases of sepsis are identified in the U.S. annually, with an equally large case population in Europe and Asia. Patients with severe sepsis require intensive care and account for a large proportion of ICU resource allocation. However, reducing the duration of bacteremia through the use of Seraph™ is expected to reduce the patients’ chances of developing serious metastatic infections and severe sepsis.
About ExThera Medical
Privately held ExThera Medical, based in Berkeley, Calif., is targeting the clinical treatment of blood-borne diseases including bacteremia and sepsis, as well as the removal of harmful substances present in banked human blood and/or caused by contact with man-made materials during cardiopulmonary bypass, dialysis and other extracorporeal procedures.
CAUTION: ExThera Medical’s products are for investigational use only.