FDA Approves Extracorporeal Procedure to Remove Circulating Tumor Cells

The OncoBind procedure based on ExThera’s Seraph 100 Microbind Affinity Blood Filter.

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ExThera announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for ExThera’s OncoBind extracorporeal blood filter procedure, intended to remove Circulating Tumor Cells (CTCs) from the bloodstream of patients suffering from Pancreatic Ductal Adenocarcinoma (PDAC), a type of pancreatic cancer that is projected to become the second leading cause of cancer-related deaths by 2030.

CTCs are tumor cells that are cast off from a primary tumor and enter the bloodstream which 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., M.S., RAC & 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. Per Dr. 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.”

According to Bob Ward, Ph.D. (h)., NAE, the CEO & a founder of ExThera Medical, “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. 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 5-year survival rate.”

ExThera Medical Corporation is a leading research and manufacturing biotechnology company that develops and commercializes unique extracorporeal medical devices for blood purification. These proprietary platforms augment the innate properties of homeostasis to create a portfolio of novel therapeutic procedures. ExThera Medical is dedicated to transparency, safety, and efficacy of all of its products, developed under FDA oversight.

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