ExThera Medicals’ Seraph™ Microbind™ Affinity Blood Filter demonstrates potential for reducing high death rate from sepsis, a top-10 cause of death in the U.S.

ExThera Medicals’ demonstrates potential for reducing high death rate from , a top-10 cause of death in the U.S.

<0> Ronald Trahan Associates Inc.Ronald C. Trahan, APR, +1-508-359-4005, x108President </0>

announced today that its (lective emoval by eresis) Microbind™ Affinity Blood Filter continues to receive enthusiastic scientific scrutiny for its potential to thwart sepsis-induced systemic inflammation and organ dysfunction.

The device is highlighted in published in the recent edition of , 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: , Division of Infectious Disease, Beverly Hospital, Beverly, Mass., and acting Chief Medical Officer of ExThera Medical; and, , 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 , President and CEO of ExThera Medical, the developer of . “We expect to commence clinical trials for this first indication of ™ in the near future.”

While other medical treatments of bacteremia caused by or MRSA () rely on increasingly ineffective antibiotics, the 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. is designed to be an adjunct to antibiotic therapy that 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 (Stockholm, Sweden), the , and the —have demonstrated that the 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 is expected to be the treatment of within intensive care units (ICU). 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 remove certain toxins and pathogens such as 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 is expected to reduce the patients’ chances of developing serious metastatic infections and severe sepsis.

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.