ExThera Medical Corporation has closed a round of financing to support clinical trials and regulatory approval, and scale manufacturing of the company’s therapeutic blood filter, aimed at reducing mortality and complications from bloodstream infections and blood-borne diseases.
The Series B financing round included an equity investment 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’s proprietary Seraph Microbind Affinity Blood Filter is designed to capture and remove a broad range of sepsis-causing bacteria, viruses, toxins and pro-inflammatory cytokines from whole blood. The device has been validated in preclinical studies, and is currently under evaluation in a first-in-man clinical trial in Europe.
“As the world’s largest provider of blood purification products and services, we continually look for new technologies for the prevention and treatment of deadly infections for our chronic dialysis and acute care patients,” said Dr. Olaf Schermeier, CEO for Global Research and Development at Fresenius Medical Care.
The company said its immediate focus is on therapeutic applications in high-risk populations such as patients undergoing dialysis, but noted that 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% for certain bloodstream infections1, 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.”
“The mission of Fresenius Medical Care Ventures is to invest in early-stage companies that develop products, technologies and therapies, which could have a significant value for the patient and for health care systems. We believe that ExThera has the team and technology that fits perfectly into our investment portfolio,” stated Florian Jehle, Managing Director of Fresenius Medical Care Ventures.
ExThera is currently testing the device in Europe on dialysis patients infected with Staphylococcus aureus and methicillin-resistant Staphylococcus aureus (MRSA). 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.
About the device
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 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 anti-thrombogenic and anti-inflammatory and which has been proven to be safe in other medical devices and implants.