ExThera Medical in Growth Mode after FDA Approval of Investigational Device Exemption
July 26, 2023

Names Michael DiMeo as CFO and Announces Collaboration with Oncology Executive Team

Martinez, CA – ExThera Medical Corporation, creator of the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100), today announces the addition of Michael DiMeo as Chief Financial Officer. Michael brings a background in life science, including oncolytics and exosome diagnostics, with expertise in MedTech capital structuring. He will report to Robert Ward, Ph.D. (h)., NAE, the CEO & a founder of ExThera Medical.

“Michael’s experience in financial management and structuring of MedTech companies is exactly what ExThera needs to take us to the next level, both operationally and financially,” said Robert Ward. Additionally, “Michael brings additional sophistication necessary for large-scale transactions needed for growth and maturity of the company,” said Erin Borger, Director & ExThera Board Member.

In addition, ExThera Medical is pleased to announce a collaboration with Trusted Health Advisors for the creation of an exciting new oncology initiative to be led by three successful oncology veterans from the in vitro diagnostic and therapeutic space. The advising team for the new program within ExThera Medical includes:

Jay Wohlgemuth, M.D., former CMO of highly successful Quest Diagnostics, responsible for R&D, Medical Affairs, and Laboratory Quality.

Professor Frank Cockerill, M.D., former Chair of Department of Laboratory Medicine and Pathology Mayo Clinic, and President of Mayo Medical Laboratories. Dr. Cockerill is a global leader in diagnostic test development for infectious diseases.

Peter Kuhn, Ph.D., Professor of Biological Sciences and Professor of Medicine, Biomedical Engineering, Aerospace/Mechanical Engineering, and Urology. Dr. Kuhn has extensive experience developing cancer diagnostic products and is focused on therapeutic and diagnostic cancer care.

Earlier this month ExThera announced FDA approval of a recently submitted Investigational New Device (IDE) application for its ONCObind™ Procedure. As previously reported, two independent laboratories have confirmed the viability of efficient removal of circulating tumor cells from human blood with ExThera’s Seraph 100 pathogen binding technology.

In addition to much needed therapeutic treatment and prevention options in metastatic cancer, ExThera plans to aggressively pursue regulatory pathways for an extremely sensitive and specific diagnostic platform currently in development. To learn more and follow our ONCObindTM Procedure program, visit: http://www.extheramedical.com/oncobind.

 

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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 http://www.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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