Articles from ExThera Medical Corporation

Please replace the release dated Jan. 22, 2025 with the following corrected version due to multiple revisions.

A new laboratory study has provided insights into the potential therapeutic benefits of blood purification for patients with metastatic pancreatic ductal adenocarcinoma (PDAC), one of the deadliest forms of cancer. Researchers have demonstrated that ExThera Medical’s Seraph® 100 Microbind ® Affinity Blood Filter (Seraph 100) adsorption media selectively removes specific tumor-associated microparticles from the blood of PDAC patients, offering the potential for a novel approach to disease management.

The first patient has been enrolled in ExThera Medical’s OSCAR I STUDY (ONCObind CTC Removal Study) clinical study at OU Health Stephenson Cancer Center, the clinical partner of the University of Oklahoma. The study is a Prospective Single-Arm Feasibility trial to evaluate the initial safety and signals of efficacy by determining the ability of the ONCObind procedure hemoperfusion filter to remove Circulating Tumor Cells (CTCs) from the blood of patients with Metastatic Pancreatic Ductal Adenocarcinoma (PDAC).

In a groundbreaking advancement of a novel cancer treatment, researchers have successfully deployed Seraph® 100 blood filtration media to demonstrate removal of Circulating Tumor Cells (CTCs) from the blood of patients suffering from advanced pancreatic cancer. The published results are foundational for ExThera Medical’s innovative circulating tumor cell reducing device, the ONCObind™ Procedure Hemoperfusion Filter (ONCObind™), to pave the way for improved longevity and better outcomes by reducing or eliminating cancer metastasis. ONCObind™ uses the Seraph® 100 filtration media to filter circulating tumor cells from the blood.

ExThera Medical Corporation’s PURIFY-RCT II trial to evaluate the efficacy of pathogen removal from severely ill patients suffering from pathogen shock is moving forward with the first patient enrollment at Mayo Clinic. This comes after ExThera Medical completed the first phase of the prospective interventional multicenter PURIFY-RCT trial, where pharmacokinetic/pharmacodynamic safety was demonstrated. This means the Seraph 100 blood filter treatment does not reduce bloodstream concentrations of tested anti-infective medications that are currently used as a critical frontline/standard of care treatment against bloodstream infections.

ExThera Medical, a developer of oncologic and pathogen therapies, today announced the formation of an advisory board consisting of leading experts in business, government affairs/public policy, finance, and emerging technology. The Business Advisory Board will work closely with ExThera’s executive team to advance the company’s metastatic oncology ONCOBindTM Procedure from development to commercialization.

ExThera Medical Corporation is pleased to announce Erin Borger has assumed the role of CEO of ExThera. Erin has been in finance for the last 20 years at both UBS and Morgan Stanley and brings with him a wealth of knowledge in the healthcare space. Robert Ward, Chairman, President, and Founder will continue in those roles while focusing on Research, Product Development/IP and Manufacturing Scale Up.

ExThera Medical Corporation has been awarded a 5-year U.S. Department of Veterans Affairs (VA) Federal Supply Schedule (FSS) contract, which allows ExThera to pursue contracts with federal healthcare organizations including the U.S. Department of Veteran Affairs, U.S. Federal Prison System, Indian Reservations, and the Department of Defense. The contract grants streamlined access to the company’s Seraph® 100 MicroBind® Affinity Blood Filter. Military and VA clinicians have been enthusiastic users of Seraph 100 for the treatment of COVID-19. News articles featuring Seraph 100 have been published by the Uniformed Services University and VA News.

ExThera Medical Corporation, a healthcare company developing and manufacturing extracorporeal pathogen technologies, announces that it has received multiple Breakthrough Device Designations from the U.S. Food and Drug Administration (FDA), for its Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). The Seraph 100 is a patented blood filter containing a biomimetic surface, similar to that found in the human circulatory system that removes pathogens that could otherwise overwhelm a patient; a common source of severe/critical illness.

ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements. MDSAP certification confirms comprehensive achievement of regulatory audit requirements and compliance standards for medical device manufacturers looking to sell products within the United States (FDA), Canada (HC), Japan (MHLW), Australia (TGA), and Brazil (ANVISA). MDSAP certification has the added benefit of potentially expediting the timetable to commercialization within these participating geographies. The internationally recognized ISO 13485 certification further confirms achievement of medical device manufacturer quality standards requirements necessary for global market entry.

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.

Today, ExThera announces that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for ExThera’s OncoBindTM 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.

ExThera Medical, a healthcare company that has developed and commercialized a unique extracorporeal blood filtration medical device, participated in the annual International Conference on Extracorporeal Organ Support. Throughout the conference, the Seraph® 100 MicroBind® Affinity Blood Filter was featured as a therapy with established clinical utility for broad bacterial, viral, and fungal pathogen removal, with academic faculty presentations highlighting published data and successful patient treatments therein.

Brooke Army Medical Center published positive results for critically ill patients treated with ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter. “The use of the Seraph 100 blood filter was associated with statistically and clinically significant improvements in hemodynamic parameters and decreased vasopressor requirements in patients with septic shock and SARS-CoV-2 infection.” This was the conclusion of BAMC’s multidisciplinary team after studying a diverse cohort of critically ill patients suffering from septic shock. Additionally, two of the treated patients were infected with Candida fungus. CDC has issued a recent warning considering the threat of Candida auris to public health, so emerging evidence of Seraph 100 successful treatment of Candida infections is timely.

Investigators today announced completion of patient enrollment in the pharmacokinetic/pharmacodynamic phase of the PURIFY Randomized Clinical Trial (RCT), as required by the US Food Drug Administration. Data is now being collected and analyzed to submit to the FDA toward approval, allowing continuation of this pivotal study. Upon FDA approval to expand enrollment, PURIFY RCT will proceed to the critical phase of enrollment, the final clinical study required by the FDA for clearance to treat bloodstream infections in septic patients.

ExThera Medical announces the publication of clinical study data further demonstrating safety in the treatment of critically ill COVID-19 patients with the Seraph® 100 Microbind® Affinity Blood Filter. The device was investigated under the PURIFY OBS multicenter observational study facilitated by the Henry Jackson Foundation for the Advancement of Military Medicine and the Uniformed Services University of the Department of Defense.

ExThera Medical and Fresenius Medical Care, the world’s leading provider of products and services for individuals with renal diseases, announced the expanded distribution of ExThera’s Seraph® 100 Microbind® Affinity Blood Filter in Mexico. In 2021, ExThera Medical and Fresenius Medical Care partnered to distribute the Seraph 100® in select European countries.

PURIFY OBS, an observational study of critically-ill COVID patients treated with the Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100), has recently completed enrollment.

Critically ill patients treated with ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) within 60 hours of ICU admission experienced a survival rate double that of patients treated after being in the ICU for 60 or more hours, according to a newly released study.

ExThera Medical and Asahi Kasei Medical, a core operating company of the Asahi Kasei Group, have entered into an exclusive distribution agreement in Japan for ExThera's Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100). Per the agreement structure, ExThera Medical and Asahi Kasei Medical will collaborate to obtain regulatory approval of Seraph 100 for commercialization in Japan.

Physicians across the country are using ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) under emergency use authorization from the U.S. Food and Drug Administration to treat critically ill COVID patients resulting in statistically significant improvements in survival rate among patients whose blood was filtered with the Seraph 100.

ExThera Medical’s Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100), a blood purification device with many potential applications including the treatment of sepsis, will be studied in an upcoming randomized control trial. The endpoint of the trial is to determine the Seraph’s effectiveness against a variety of bloodstream infections that can lead to sepsis. The Seraph 100 is the first blood purification device to be shown to reduce both bacterial and viral loads in the bloodstream and has been used on more than 300 US and EU patients with COVID-19 since April 2020. The device has been in use under an Emergency Use Authorization since that time and has been shown to dramatically reduce mortality in severe COVID-19 cases.