ExThera closes $15M Series B led by Fresenius

Martinez, CA – June 2, 2016. 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.

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.

^1. Neuner, Elizabeth A., et al. "Treatment and outcomes in carbapenem-resistant Klebsiella pneumoniae bloodstream infections." Diagnostic microbiology and infectious disease 69.4 (2011): 357-362.

^2. Goto, M., and M. N. Al‐Hasan. "Overall burden of bloodstream infection and nosocomial bloodstream infection in North America and Europe." Clinical Microbiology and Infection 19.6 (2013): 501-509.

^3. Engemann, John J., et al. "Clinical outcomes and costs due to Staphylococcus aureus bacteremia among patients receiving long-term hemodialysis." Infection Control & Hospital Epidemiology 26.06 (2005): 534-539. pg. 2 Medicine 51.9 (2012): 1015-1021.)

^4. Wang, I-Kuan, et al. "Bacteremia in hemodialysis and peritoneal dialysis patients." Internal Medicine 51.9 (2012): 1015-1021.)

^5. Powe, Neil R., et al. "Septicemia in dialysis patients: incidence, risk factors, and prognosis." Kidney international 55.3 (1999): 1081-1090.)

About ExThera Medical

Based in Martinez, Calif., ExThera Medical is a privately held medical device company developing an innovative, single-use blood filter capable of capturing and removing a broad range of bacteria, viruses, parasites, toxins or other harmful substances from whole blood. The company intends to develop therapeutic products to treat patients in the clinic or hospital, and also devices that purify donated, banked blood prophylactically, before transfusion. Led by an accomplished management team with extensive experience in blood-contacting devices and biomaterials, the company has a well-protected set of patents and a growing body of data from independent laboratory studies, in addition to its participation in the Defense Advanced Research Programs Agency (DARPA) “Dialysis-Like Therapeutics (DLT) program.” For more information, visit extheramedical.com.

About Fresenius Medical Care Ventures GmbH

Fresenius Medical Care Ventures was established in 2015 to invest in start-ups and early-stage companies in the healthcare sector. The investments are targeted to support Fresenius Medical Care’s corporate strategy to grow continuously in our core business and to expand into new business areas. Fresenius Medical Care Ventures is complementing the corporate activities in external innovation. For more information, visit www.fmcv.com.