Exthera Medical said today that the FDA granted its Seraph 100 blood filter an expedited access pathway designation.
The approval comes with an initial indication for use “as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is heparin- or heparin sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE and MRSE,” the company said.
“We submitted our EAP application in early June. FDA responded by requesting additional information and clarifications, and Seraph was granted EAP designation within the accelerated timeframe FDA set for itself. The support we received from FDA was very helpful,” COO Kathleen White said in a press release.
The company’s Seraph microbind affinity blood filter is designed to remove a range of sepsis-causing bacteria, viruses, toxins and pro-inflammatory cytokines from blood.
Exthera said that the Seraph varies from other blood filters as it removes a variety of different pathogens simultaneously by using a blood-contacting surface which does not injure blood.
“The EAP designation for Seraph gives us the opportunity to accelerate the approval process in the United States while still maintaining the high standards of safety, efficacy and scientific rigor required by the program. It has been said that ‘Speed is life’ in the effective treatment of blood stream infections. Seraph can potentially save thousands of lives now lost to infections for which there are no available drugs. ExThera Medical is focused on developing simple devices for the rapid treatment of bloodstream infections, especially in the face of rising incidence rates and the worldwide spread of drug-resistant pathogens. Effective treatments for potentially lethal BSIs are also needed for members of our military for whom the risk of exposure is significant,” CEO & prez Dr. Robert Ward said in a prepared statement.
Last June, Exthera said it raised a $15.3 million Series B round following positive tests of its CE-Marked Seraph blood filter in animal studies.