Press Releases

June 25, 2011 - New study of ExThera Medicals’ Seraph™ affinity apheresis device demonstrates its potential for reducing the high death rate from sepsis, a top-10 cause of death in the U.S.

Study published in Journal of Microbiology and Biotechnology

“Our study demonstrates it is possible to create an apheresis technology where the number of bacteria in the blood of a patient with sepsis caused by Staphylococcus Aureus and/or Methicillin-Resistant S. Aureus (MRSA) can be reduced to levels that could be taken care of by the patient’s immune system.”

Inger Mattsby-Baltzer, Ph.D., Senior Researcher,
Department of Infectious Diseases/Clinical Bacteriology
University of Göteborg, Göteborg, Sweden

BERKELEY, Calif., June 13, 2011—ExThera Medica Corporation announced today that a new study of its breakthrough Seraph™ (Selective Removal by Apheresis) affinity therapy device demonstrates its potential as a treatment for patients suffering from Staphylococcus aureus- and/or Methicillin-Resistant S. aureus (MRSA)-induced sepsis.

The study (“Affinity Apheresis for Treatment of Bacteremia Caused by Staphylococcus aureus and/or Methicillin-Resistant S. aureus [MRSA]”) was published in a recent edition of Journal of Microbiology and Biotechnology. The principal investigator was Dr. Inger Mattsby-Baltzer, Ph.D., senior researcher at the University of Gothenburg’s Department of Infectious Diseases and Clinical Bacteriology in Gothenburg, Sweden.

“Previous studies, in combination with the present study, strongly suggest the likelihood that Seraph’s affinity apheresis platform may become an effective treatment for sepsis caused by S. aureus and/or MRSA,” said Bob Ward, President of ExThera Medical, the developer of Seraph.

“While other medical treatments of sepsis caused by S. aureus or MRSA rely on antibiotics and have proven unsuccessful, Seraph—which is based on apheresis—capitalizes on the affinity of the bacteria in an infected patient’s blood to attach to immobilized heparin—a natural anticoagulant. Seraph is designed to be an alternative therapy that reduces bacterial load, while also lowering levels of pro-inflammatory cytokines in a patient’s blood, potentially empowering the patient’s immune system to fight the infection.”

Three previous 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. The Karolinska study of Seraph™ (“Cytokines in blood from septic patients interact with surface immobilized heparin”) was published in the Journal of the American Society for Artificial Organs (Jan.-Feb. 2010).

TNF-α, an important cytokine released during sepsis, is believed to mediate a number of other pro-inflammatory cytokines as sepsis worsens. One very important clinical application of Seraph is expected to be the treatment of sepsis within intensive care units. Seraphconsists 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 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.

“ExThera’s ongoing development of the Seraph cartridge is aimed at removing blood-borne pathogens by adsorption onto its heparinized surface. ExThera is continuing to evaluate Seraph’s safety and effectiveness in treating sepsis at its onset and during advanced stages of this deadly disease,” added Mr. Ward. “We are very pleased with our results so far, as we work toward our goal of giving clinicians a new paradigm for treating sepsis.”

About Seraph™
Selective Removal by Apheresis (Seraph™) is based on the unique binding capacity of the naturally-occurring heparin molecule, when it is permanently attached to a polymer surface. Disease-causing microorganisms use cell surface glyco-conjugates such as heparan sulphate as receptor molecules for cell attachment, e.g., to facilitate their invasion and colonization of human tissue. Similar receptors can be built into a polymer surface for selective removal of these microorganisms from blood. ExThera Medical is investigating the clinical impact of immobilized heparin’s ability to bind viruses, bacteria, parasites, toxins and excess cytokines in blood, while developing both therapeutic products to treat patients in the clinic, and devices that purify blood prophylactically before (re)perfusion. Both product types treat blood in a flow-through Heparin Affinity Apheresis™ column or cartridge, using heparin that has been chemically bonded to a polymer substrate with precisely controlled surface chemistry and nano-structure.

CAUTION: Seraph™ is an investigational device and limited by federal (United States) law to investigational use only. It is not currently available outside of the United States.

About Sepsis
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 a reported mortality rate ranging from 30 to 60 percent, and an average cost of $22,000 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.

About ExThera Medical
Privately held ExThera Medical, based in Berkeley, Calif., is targeting the clinical treatment of blood-borne diseases including sepsis and autoimmune disease, 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.

Any forward-looking statements in this press release are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include all statements relating to Seraph™, including the progress of ExThera Medical’s preclinical and clinical development programs. Investors are cautioned that all forward-looking statements involve risk and uncertainties, including without limitation: risks involved in the clinical trials of Seraph™; risks in product development, regulatory approvals and market acceptance of and demand for ExThera Medical’s products; and other risks.