OSCAR I STUDY - The ONCObind CTC Removal Study

"The ONCObind (Onco-Seraph) 100 Microbind® Affinity Blood Filter (Onco-Seraph 100) manufactured by ExThera Medical Corporation in Martinez, CA. The Onco-Seraph 100 filter has been designed and manufactured to reduce residual risks as much as possible to ensure safe usage. Literature search results concluded that heparin coated medical devices are safe and decrease platelet adhesion without affecting the adsorption of major adhesive proteins.~Literature search yielded over 45 publications and 370 treated patients with Seraph platform technology for pathogen removals without significant safety concern. The achieved results from the above-mentioned testing and studies support the performance and safety of Onco-Seraph 100 consistent with the intended use. ExThera Medical concludes that the known and potential benefits of Onco-Seraph 100, when used to treat patients with PDAC, outweigh the known and potential risks when used according to the intended use."