ONCObind™ IDE Approved to Study Metastatic Cancer

Martinez, Calif. –  Today, 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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About ExThera Medical Corporation
ExThera Medical Corporation develops and commercializes 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 to address nosocomial and community-acquired infections as well as those caused by battlefield wounds, pandemics, and biological warfare agents. ExThera Medical’s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis, COVID-19, and many other severe bloodstream 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 U.S., the EU, and the Middle East, the company is well positioned to serve healthcare professionals and patients alike. 

The Seraph 100 Microbind Affinity Blood Filter (Seraph 100) attained CE Mark in 2019 and is commercially available in the EU for the treatment of blood stream infections. 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 has been authorized by FDA under an Emergency Use Authorization (EUA) to treat patients with COVID-19 infection. The Seraph 100 is authorized only for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of the Seraph 100 device under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

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

About Seraph 100 and the ONCObind Procedure
As a patient’s blood flows through the Seraph^® 100 Microbind^® Affinity Filter (Seraph 100), it passes through a bed of small beads with receptors that mimic the receptors on human cells that pathogens target when they invade the body. Many harmful substances are quickly captured and adsorbed onto the surface of the beads and are thereby subtracted from the bloodstream. Seraph 100 adds nothing to the bloodstream. It targets the pathogens that cause the infection, while it also binds and removes harmful substances generated by the pathogen and by the body’s response to the infection. Seraph’s proprietary 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 circulating tumor cells, bacteria, viruses, fungi, and important sepsis mediators reported to contribute to organ failure during sepsis.

ExThera Medical is currently developing the ONCObind Procedure Hemoperfusion Filter (ONCObind) to support cancer treatment. ONCObind is part of the same platform technology as Seraph 100.

For more news stories on Seraph 100 and ONCObind, click here.

Disclaimer
All information contained in this news release derives from plausible, reliable sources, however they have not been independently examined or verified. There is no representation, warranty, or guarantee provided herein. Except as otherwise required by appliable law, all liability for any direct or indirect claims, damages or losses are hereby disclaimed whether or not foreseeable. 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. Accordingly, the investment and/or the revenues that arise from it can rise or fall or fail entirely. We assume no responsibility to update or revise any statements contained in this news release, including forward-looking, to reflect events, trends, or circumstances that might arise after the date of this news release. Results from case studies (reviews) may not be predictive of future results.

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