CytoSorbents Corporation (CTSO)

[Makenlight]

Fresenius Medical Care Ventures to Support Commercialization

ExThera Medical Closes Financing Led by Fresenius Medical Care Ventures to Support Commercialization of Innovative Technology to Remove Pathogens From Whole Blood


June 02, 2016 01:00 PM Eastern Daylight Time


MARTINEZ, Calif.--(BUSINESS WIRE)--ExThera Medical Corporation, the leading developer of innovative blood filtering technology to address major global health problems, today announced that the company has closed a Series B financing round 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.


“Clinical outcomes and costs due to Staphylococcus aureus bacteremia among patients receiving long-term hemodialysis.”
Tweet this
Proceeds from the financing will be used to support European and U.S. clinical trials and regulatory approvals, and to scale manufacturing of the company’s therapeutic blood filter, aimed at reducing mortality and complications from bloodstream infections and blood-borne diseases.

ExThera’s proprietary Seraph® Microbind® Affinity 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 promises to address significant unmet needs for the immediate treatment of suspected or known bloodstream infections.

While ExThera’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 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. We are pleased to add Fresenius Medical Care Ventures as a supportive investor.”

“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 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.

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 Europe2. 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 treatment3,4,5. Because nephrologists are on the frontlines in the battle against blood infections, they are ideal partners for ExThera’s European clinical trials for Seraph in 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 important data about the device’s safety and its potential to improve patient outcomes.

http://www.businesswire.com/news/home/20160602005992/en/ExThera-Medical-Closes-Financing-Led-Fresenius-Medical