First Patients Underwent ONCObind Procedure at Stephenson Cancer Center in Groundbreaking Pancreatic Cancer Trial

MARTINEZ, CA- ExThera Medical has announced the completion of the Phase I OSCAR I STUDY (ONCObind CTC Removal Study NCT) at OU Health Stephenson Cancer Center, the clinical partner of the University of Oklahoma. The OSCAR study is a Prospective Single-Arm Feasibility Trial to evaluate the initial safety and signals of efficacy by determining the ability of the ONCObind procedure Hemoperfusion Filter to remove Circulating Tumor Cells (CTCs) from the blood of patients with metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

A total of five patients with PDAC have completed the ONCObind Procedure with no safety concerns or signals that have been observed. Data has subsequently been submitted to the FDA for review and approval, in order to proceed to the second phase of the feasibility trial (OSCAR II), with a proposal for expanding the patient population to include Metastatic Colorectal Cancer (MCRC), in addition to metastatic PDAC.

The ONCObind Procedure Hemoperfusion Filter is the product brand name for the Onco-Seraph platform technology, an extracorporeal blood filtration procedure designed to target and filter out CTCs from the bloodstream of patients. CTCs are shed from primary tumors and contribute to metastasis, which is responsible for most cancer-related deaths. The ONCObind Procedure uses a blood filter based on ExThera’s Seraph^® 100 Microbind^® Affinity Blood Filter technology. Both the ONCObind Procedure Hemoperfusion Filter and the Seraph^® 100 Microbind^® Affinity Blood Filter are investigational medical devices in the United States and are not approved by the U.S. Food and Drug Administration for sale or distribution.

Further details on the OSCAR I study can be found here.

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About ExThera Medical Corporation

ExThera Medical Corporation develops extracorporeal blood filtration devices, including the Seraph^® 100 Microbind^® Affinity Blood Filter (Seraph 100) for removing a broad range of pathogens from the bloodstream of patients. Seraph 100 can be used in hospitals, clinics, on battlefields and in other austere environments. With a growing body of outcome and health economic evidence from independent clinical studies, success in the DARPA Dialysis-Like Therapeutics program, and from the EU, the company is well positioned to serve healthcare professionals and patients alike.

The Seraph 100 device has neither been cleared nor approved by the U.S. Food and Drug Administration (FDA) for any indication. The Seraph 100 is not available in the US.

For more information, visit the company’s website at https://extheramedical.com/.

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