FDA Approves IDE Use of ExThera Medical’s OncoBind Extracorporeal Procedure

ExThera has received U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) approval for its OncoBind extracorporeal blood filter procedure. OncoBind is designed to remove circulating tumor cells (CTCs) from the bloodstream of pancreatic cancer patients.  
 
CTCs are tumor cells that are cast off from a primary tumor and enter the bloodstream. They can cause metastatic cancer.   
 
“This is an important milestone for ExThera Medical and we are thrilled to be advancing the OncoBind procedure into a novel category of clinical development,” said Sanja ILIC, M.D., RAC and chief regulatory officer for ExThera. “We are eager to confirm our preclinical data in the clinic and expect to begin enrolling study patients in Fall of 2023. It is exciting to further demonstrate the potential of ExThera’s products for use in removal of CTCs.”
 
The OncoBind procedure based on ExThera’s Seraph 100 Microbind Affinity Blood Filter, has demonstrated removal of metastatic circulating tumor cells in several in-vitro models, most recently with professor Peter Kuhn, Ph.D., from the University of Southern California. According to Kuhn, “Current thinking is that CTC removal from the bloodstream is important, because it could potentially interrupt metastasis, theoretically preventing a cancer from spreading in the body.”

As a patient’s blood flows through the OncoBind Blood Filter it passes over beads with receptors that mimic the receptors on human cells that pathogens and CTCs target for attachment and colonization. CTCs are captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. OncoBind, like Seraph 100, adds nothing to the blood. OncoBind, like Seraph’s adsorption media (the beads) constitute a flexible platform that uses immobilized (chemically bonded) heparin for its well-established blood compatibility and its unique ability to bind CTCs.
 
“Seraph technology has an excellent safety record in more than 2,500 clinical treatments performed globally, of bacterial, viral, and fungal bloodstream infections. We are pleased to begin an important new clinical trial, and ecstatic that FDA has approved our recent IDE application,” ExThera Medical Founder/CEO Bob Ward, Ph.D., stated. “If ExThera’s technology captures CTCs in the clinical setting, as it has in the laboratory, the potential is enormous, adding another much-needed tool to the arsenal for treating PDAC, a lethal cancer with a low five-year survival rate.”
 
ExThera Medical Corporation is a research and manufacturing biotechnology company that develops and commercializes extracorporeal medical devices for blood purification, including the OncoBind and Seraph 100 Microbind Affinity Blood Filters for removing circulating tumor cells and a broad range of pathogens respectively from patients’ bloodstreams. Seraph can be used in hospitals, clinics, or field hospitals to address nosocomial and community-acquired infections as well as those caused by battlefield wounds and pandemics. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and other severe infections. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from successful clinical use in the United States, the European Union, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. The Seraph 100 attained CE Mark and is commercially available in the EU. The Seraph 100 has FDA Emergency Use Authorization (EUA) for treatment of COVID-19 in the United States.