ExThera Medical Corp., a developer of blood filtering technology, has obtained financing to support European and U.S. clinical trials, regulatory approvals, and manufacturing of the its proprietary therapeutic SeraphMicrobindAffinity Blood Filter aimed at reducing mortality and complications from bloodstream infections and blood-borne diseases.
A Series B financing round was closed with an equity investment led by new investor Fresenius Medical Care Ventures GmbH. The round included existing investors, and the conversion of the company’s convertible note, for a total of $15.3 million. Other terms were not disclosed.
ExThera says its proprietary blood filter is the only device of its kind capable of capturing and removing a broad range of sepsis-causing bacteria, viruses, toxins and pro-inflammatory cytokines from whole blood. Validated in preclinical studies, and currently under evaluation in a first-in-man clinical trial in Europe, the device may address significant unmet needs for the immediate treatment of suspected or known bloodstream infections.
While the comapny’s immediate focus is on therapeutic applications in high-risk populations such as patients undergoing dialysis, Seraph also has the potential for other applications that could offer far-reaching global impact, such as treatment for drug-resistant “superbugs,” and the purification of blood for use by blood banks, which are increasingly vulnerable to the growing threat of emerging pathogens.
“ExThera’s vision is to make life-threatening bloodstream infections unheard of in the future by providing clinicians with a broad-spectrum therapeutic option that allows treatment to begin quickly–even before pathogen identification,” said Robert Ward, CEO of ExThera Medical. “With mortality rates as high as 50 percent for certain bloodstream infections, the continued emergence of drug-resistant pathogens, and fewer anti-infective drugs in development, we see a critical need to address this growing global health issue with safe, accessible and cost-effective solutions.”
Bacterial bloodstream infections are believed to be one of the top seven causes of death in North America and Europe, with an estimated annual incidence of up to 677,000 cases in North America and up to 1,200,000 cases in Europe. Once bacteria enter the bloodstream from a local site of infection, they can be disseminated throughout the body, leading to metastatic complications such as endocarditis, meningitis, and osteomyelitis. If not treated properly, uncontrolled infections quickly lead to a dysfunctional immune response. Disease progression may lead to sepsis and septic shock.
Dialysis patients rely on infection-prone vascular access sites, contributing to infection. The second leading cause of death, infection poses a constant threat to overall health and wellbeing of dialysis patients, especially within the first six months after beginning treatment. Because nephrologists are on the frontlines in the battle against blood infections, they are suitable partners for ExThera’s European clinical trials for Seraph in dialysis patients infected with Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA), according to the company. The results of the trial, which is currently enrolling patients in Germany, will provide data about the device’s safety and its potential to improve patient outcomes.
As a patient’s blood flows through the Seraph Microbind Affinity Blood Filter, it passes over proprietary microspheres coated with molecular receptor sites that mimic the receptors on human cells that pathogens use when they invade the body. Harmful substances are captured and adsorbed onto the proprietary surface and thereby removed from the bloodstream without adding anything to the treated blood, which is returned to the patient’s body with blood cells intact. The adsorption media is a flexible platform that uses chemically bound, immobilized heparin for its unique binding capacity, and may be configured with optional supplemental adsorbents to remove other toxins and evolved pathogens. The blood filter has a blood-contacting surface that is very anti-thrombogenic and anti-inflammatory and which has been proven to be safe in other medical devices and implants.
