BERKELEY, Calif.--(BUSINESS WIRE)--ExThera Medical Corporation, a pioneer in the development of broad-spectrum, biomimetic devices for treating life-threatening bloodstream infections, disclosed today that its Seraph® Microbind® Affinity Blood Filter (Seraph) quickly removed Cytomegalovirus from CMV-spiked whole blood. Study results were presented at the 2015 44th Critical Care Congress of the Society for Critical Care Medicine.
Over a million new cases of sepsis are identified in the U.S. annually, with an equally large case population in Europe and Asia. 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, at an average treatment cost of $22,000 per case, representing 40% of all ICU costs.
In addition to early treatment of bloodstream infections to prevent sepsis, Seraph, a dialysis-like therapy, is potentially useful in treating cytomegalovirus reactivation during severe sepsis, and in patients with compromised immune systems from other causes. In late-stage sepsis, 24% percent of the patients test positive for CMV viremia. Also:
- Approximately 60% of all adults are seropositive from previous (often mild) CMV infection;
- CMV reactivation in sepsis is associated with increased fungal infections, expensive ICU stays and a doubling of the 90-day mortality compared to patients without CMV reactivation;
- Reactivation of CMV is a source of significant morbidity in immunocompromised patients, including organ transplant recipients, HIV-infected patients, and cancer patients;
- Cytomegalovirus (CMV), like many pathogenic bacteria, fungi, and other viruses, utilizes heparan sulfate to bind to cell surfaces in the body;
- Seraph uses immobilized heparin (an analogue of heparan sulfate) in a flow-through cartridge that binds and removes CMV from blood.
CMV disease can lead to very serious complications, including pneumonia, hepatitis, encephalitis, myelitis, colitis, retinitis and neuropathy. In HIV patients, CMV disease often leads to death. With drug therapy, there is an average six-day lag before a sustained drop (e.g., a one log reduction) is seen in CMV viral blood levels, but only 58% respond after 21 days. In addition, there are over 30,000 solid organ transplants conducted in the U.S. every year with recipients requiring immune-suppressing drugs. Bloodstream infections and CMV disease in this patient group occur more often than in the general population.
Seraph is the only device reported to remove both bacteria and viruses directly from whole blood without adding anything to the blood being treated. It therefore has the potential to treat so-called ‘polymicrobial’ infections seen in critically ill and immuno-compromised patients.
According to Dr. Keith McCrea, CTO of ExThera, “After only about 30 seconds of total contact with our Seraph ‘adsorption media,’ 82% of CMV was removed from blood samples spiked with the virus. A typical 4-hour clinical treatment involves 300 seconds of contact, so we believe that a 99+% reduction is possible in that time. In addition, we measured the CMV binding capacity of our Seraph device and found it to be very high, exceeding the entire bloodstream virus load in viremic patients.”
Since 2008, privately funded ExThera (short for Extracorporeal Therapy) has been developing new tools to treat a wide range of bloodstream infections caused by both bacteria and viruses. ExThera’s Seraph® Microbind® Affinity Blood Filter (Seraph), now fully developed and about to enter clinical trials, is a broad-spectrum ‘hemoperfusion’ device with demonstrated ability to bind and remove a long list of disease-causing agents, including toxins, fungi and inflammatory cytokines.
“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. We are pleased to report these encouraging in vitro results against a virus that affects patients whose immune systems are compromised by disease or cancer treatment, or chronically suppressed because of organ transplantation,” said Bob Ward, CEO of ExThera.
In addition to the potential to treat many viral and bacterial bloodstream infections for the prevention of septic shock, Seraph is a flexible platform that may be reconfigured with optional "supplemental adsorbents" to deal with future "weaponized," or naturally-evolved, pathogens.
About ExThera Medical
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 human blood. While medical treatments of e.g., bacteremia caused by S. aureus or MRSA (Methicillin-Resistant S. aureus) usually rely on antibiotics, ExThera Medical’s Seraph® device capitalizes on the pathogen’s affinity to attach to immobilized heparin, a natural anticoagulant which 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 a runaway systemic inflammatory response. The Company introduced its Seraph device concept to clinicians last year at the 2014 annual congress of the Society for Critical Care Medicine.
CAUTION: ExThera Medical’s Seraph® device is not cleared by the FDA for distribution in the United States.
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