ExThera Medical Announces FDA Approval of IDE Application for Use of the OncoBindTM Extracorporeal Procedure to Remove Circulating Tumor Cells in Patients with Pancreatic Cancer

OncoBind^TM IDE Approved to Study Metastatic Cancer

MARTINEZ, Calif.--(BUSINESS WIRE)--Today, ExThera announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for ExThera’s OncoBind^TM 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^TM 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^TM 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.

About ExThera Medical Corporation

ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the OncoBind^TM and Seraph® 100 Microbind® Affinity Blood Filters for removing circulating tumor cells and a broad range of pathogens respectively from the bloodstream of patients. 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 US, the EU, 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 USA. The FDA has approved the OncoBind^TM procedure via Investigational Device Exemption (IDE).

For more information visit the company’s website at www.extheramedical.com.

About the OncoBind^TM Extracorporeal Blood Filter

As a patient's blood flows through the OncoBind^TM 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^TM, like Seraph 100, adds nothing to the blood. OncoBind^TM, 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.

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Disclaimer

All information contained in this news release derives from plausible reliable sources, which, however, have not been independently examined. There is no warranty, confirmation or guarantee, and no responsibility or liability is taken concerning correctness or completeness. As far as it is allowed by the relevant law, no liability whatsoever is taken on for any direct or indirect loss caused by the deployment of this news release or its contents. This communication includes forward-looking statements regarding events, trends and business prospects that may affect our future operating results and financial position. Such statements are subject to risks and uncertainties that could cause our actual results and financial position to differ materially. The investment and/or the revenues that arise from it can rise or fall. A total loss is possible. Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly. 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. Results from case studies (reviews) may not be predictive of future results.

Sam Shull
sam.shull@extheramedical.com