MARTINEZ, Calif.--(BUSINESS WIRE)--ExThera Medical Corporation, the leading developer of innovative filtration devices for removing pathogens from whole blood, today announced that the U.S. Food and Drug Administration (FDA) has granted ExThera’s Seraph® 100 Blood Filter (Seraph) the agency’s Expedited Access Pathway (EAP) designation. Seraph’s initial indication for use will be ‘as an adjunctive treatment for bacteremia in addition to antibiotics for patients receiving hemodialysis when the source of the infection is a heparin- or heparan sulfate-binding bacteria, including antibiotic resistant bacteria MRSA, VRE, ESBL, CRE, and MRSE.’
As explained on the FDA web site and in a guidance document issued by FDA:
“The Expedited Access Pathway (EAP) program is a voluntary program for certain medical devices that demonstrate the potential to address unmet medical needs for life threatening or irreversibly debilitating diseases or conditions that are subject to premarket approval applications (PMA), premarket notification (510[k]) or requests for De Novo designation. The program is detailed in the FDA's guidance Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions.”
“Under EAP, the FDA works with device sponsors to try to reduce the time and cost from development to marketing decision without changing the FDA's PMA approval standard of reasonable assurance of safety and effectiveness, the standards for granting De Novo requests, or any other standards of valid scientific evidence. Components of the program include priority review, more interactive review, senior management involvement, and assignment of a case manager.”
“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,” commented Dr. Robert Ward, ExThera’s President and CEO. It has been said that ‘Speed is life’ in the effective treatment of blood stream infections (BSI). Seraph can potentially save thousands of lives now lost to infections for which there are no available drugs.”
According to Kathleen White, ExThera’s COO, “We submitted our EAP application in late 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.”
Although similar in appearance, Seraph is different from other blood filters. Seraph removes many different pathogens simultaneously using a blood-contacting surface that does not injure the blood. As such, Seraph is designed to quickly treat blood stream infections to prevent them from becoming life-threatening.
“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,” said Dr. Ward.
About the Seraph® Microbind® Affinity Blood Filter
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 quickly captured and adsorbed onto the proprietary surface and are thereby removed from the bloodstream without adding anything to the blood, which is returned to the patient with blood cells intact. The adsorption media is a flexible platform using chemically-bound, immobilized heparin for its blood compatibility, and its unique binding capacity for pathogens.
Seraph may be configured with optional supplemental adsorbents to remove other toxins and evolved pathogens. For example, ‘Seraph 200’ adds endotoxin binding to Seraph 100, which may be useful in certain bloodstream infections that progress to endotoxemia. The Seraph filters have a blood-contacting surface that is anti-thrombogenic and anti-inflammatory.
About ExThera Medical
Based in Martinez, Calif., ExThera Medical is a privately held medical device company developing innovative, single-use blood filters capable of capturing and removing a broad range of bacteria, viruses, parasites, toxins or other harmful substances from whole blood. The company develops therapeutic products to treat patients in the field or hospital, and devices that can purify transfused blood prophylactically. 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, including testing within DARPA’s Dialysis-Like Therapeutics program. For more information, visit www.extheramedical.com.
Disclaimer: This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements include any related to the FDA approval process for the company’s products, including Seraph, and any related to the actual efficacy of Seraph if it is approved. These statements are subject to risks and uncertainties that could cause events and our actual results and financial position to differ materially from those currently anticipated. Such risks and uncertainties include the possibility that FDA approval will not be forthcoming on a prompt basis, or at all, or that the actual efficacy of Seraph will not be as currently projected or indicated by testing to date. We assume no responsibility to update or revise any forward-looking statements contained in this news release to reflect events, trends, or circumstances after the date of this news release.
Caution: The Seraph® Microbind® Affinity Blood Filter is currently undergoing clinical evaluation and is not available for commercial sale.
