ExThera Medical Corporation

PURIFY Investigators Announce First Patient Enrolled in a US Randomized Controlled IDE Trial Evaluating Seraph 100 for the Treatment of Septic Shock

Retrieved on: 
Wednesday, March 2, 2022
Health, Medical Devices, Infectious Diseases, Surgery, Clinical Trials, Research, Science, Infection, Family, Patient, Hospital, Virus, Heparin, Treatment, Uniformed Services University of the Health Sciences, Safety, News, Jean-Louis Vincent, Knowledge, Department of Defense Serum Repository, Bacteria, FDA, Pandemic, DARPA, COVID-19, Communication, EUA, Karger Publishers, Clinical trial, Sepsis, Good Samaritan Hospital, Person, Henry M. Jackson Foundation for the Advancement of Military Medicine, CE, MD, Department, Outline of health sciences, IDE, Fungus, Randomized controlled trial, Pharmaceutical industry, EU, Seraph, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

Investigators today announced the first patient enrollment in the Blood Purification for the Treatment of Pathogen Associated Shock ( PURIFY-RCT ) trial.

Key Points: 
  • Investigators today announced the first patient enrollment in the Blood Purification for the Treatment of Pathogen Associated Shock ( PURIFY-RCT ) trial.
  • With this study, we are determining if this therapy improves clinically relevant outcomes while showing no evidence of harm in a randomized controlled trial design.
  • Now we are rigorously testing whether Seraph plus cutting-edge sepsis care will save lives in the hospital.
  • The study is expected to randomize approximately 60 patients over a 12-month timeframe, with preliminary results expected in early 2023.

Patient Enrollment is Complete in the DOD-Funded Study of Extracorporeal Hemopurification of Critically Ill COVID-19 Patients

Retrieved on: 
Tuesday, January 18, 2022
Medical Devices, Health, Infectious Diseases, Research, Science, Biotechnology, Seraph, RCT, Survival, COVID 19, Sepsis, Patient, Heparin, News, Jean-Louis Vincent, DOD, Union, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Person, COVID-19, Observational study, Virus, ICU, Safety, EUA, Pandemic, Bacteria, Infection, DARPA, CE, Physician, Food, Communication, FDA, Hospital, Fungus, COVID, Pharmaceutical industry, EU, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

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.

Key Points: 
  • 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.
  • Observations included dramatic improvement in survival and reduction in median ICU length of stay for patients treated with the Seraph 100 vs controls.
  • We expect the first peer-reviewed PURIFY-OBS clinical trial publication soon, now that the study has concluded.
  • ExThera Medicals extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis and other severe infections.

Treatment for Critically Ill COVID Patients Results in Significant Improvement in Survival Rate According to New Study

Retrieved on: 
Tuesday, January 11, 2022
Science, Biotechnology, Research, Pharmaceutical, General Health, Health, Medical Devices, Infectious Diseases, Seraph, Heparin, Survival, Sepsis, Patient, News, Jean-Louis Vincent, Survival rate, Intubation, Person, COVID-19, Virus, EUA, Transplant, Â, Pandemic, Bacteria, Infection, DARPA, CE, Nephrology Dialysis Transplantation, Communication, COSA, Treatment, FDA, Subclinical infection, Hospital, Omicron, COVID, Fungus, ICU, Pharmaceutical industry, EU, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

Few treatments are available for critically ill COVID patients in the ICU.

Key Points: 
  • Few treatments are available for critically ill COVID patients in the ICU.
  • In addition, patients treated earlier in their ICU with the Seraph 100 may avoid intubation and mechanical ventilation.
  • The new findings, published in Nephrology Dialysis Transplantation , found:
    There is still a need for therapeutic treatment options, especially in critically ill patients, as COVID variants such as Omicron continue to emerge.
  • ExThera Medicals extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from sepsis and other severe infections.

ExThera Medical and Asahi Kasei Medical Enter into Partnership to Expand Reach of Treatment for the Critically Ill

Retrieved on: 
Tuesday, December 21, 2021
Health, Medical Devices, Infectious Diseases, General Health, Research, Science, Biotechnology, Mortality, Blood, Bloodstream infections, Life, COSA, Ammonia, Jean-Louis Vincent, Virus, Communication, Heparin, Patient, Sepsis, CE, Fungus, News, CEO, DARPA, Infection, Bacteria, Adsorption, Therapy, Pandemic, COVID-19, European, NDT, Solution, ICU, Hospital, Treatment, Dialysis, Health care, Multimedia, Person, EUA, FDA, Partnership, Pharmaceutical industry, Mobile phone, EU, Seraph, Asahi Kasei and Asahi Kasei Medical, ExThera Medical Corporation, Seraph 100, ASAHI KASEI AND ASAHI KASEI MEDICAL, EXTHERA MEDICAL CORPORATION, SERAPH 100

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).

Key Points: 
  • 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.
  • "ExTheras partnership with Asahi Kasei Medical is an important milestone in our collaborative ongoing fight against life threatening pathogens.
  • ExThera Medicals extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from severe infections.

Treatment for Critically Ill COVID Patients Begins 1st Randomized Clinical Trial

Retrieved on: 
Tuesday, August 31, 2021
Research, Medical Devices, Medical Supplies, Infectious Diseases, Clinical Trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, Jean-Louis Vincent, Sepsis, COVID, Blood, Enrollment, Virus, Physician, Communication, Survival, Infection, Observational study, Bacteria, Fungus, Pandemic, Person, Research, Food, Uniformed Services University of the Health Sciences, Henry M. Jackson Foundation for the Advancement of Military Medicine, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Outline of health sciences, EUA, Septic shock, Hospital, ICU, USU, Mortality, Safety, Heparin, Survival rate, News, Patient, Septic, Dow University of Health Sciences, IDE, DARPA, FDA, COVID-19, Military medicine, Pharmaceutical industry, Risk management, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

The first multicenter randomized controlled trial of the Seraph 100, which has successfully treated hundreds of COVID patients, will be studying the treatments ability to reduce ICU length of stay, hospital duration and mortality in patients suffering from septic shock..

Key Points: 
  • The first multicenter randomized controlled trial of the Seraph 100, which has successfully treated hundreds of COVID patients, will be studying the treatments ability to reduce ICU length of stay, hospital duration and mortality in patients suffering from septic shock..
  • The initial findings in our observational study for COVID patients have been very promising.
  • The study will evaluate the safety and efficacy of pathogen-removing extracorporeal blood purification therapy in critically ill patients with pathogen-associated shock utilizing ExTheras Seraph 100 filter.
  • ExThera Medicals extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from severe infections.

Canadian Health Authority Grants ExThera’s Seraph 100 Blood Filter an Interim Order for Treatment of COVID-19

Retrieved on: 
Monday, August 9, 2021
Health, Infectious Diseases, Other Health, General Health, Pharmaceutical, Biotechnology, Infection, Jean-Louis Vincent, Microscopic Observation Drug Susceptibility assay, COVID-19, Bacteria, FDA, Trial of the century, Pandemic, CEO, Interim, Mortality, Emergency Use Authorization, Bloodstream infections, IDE, Sepsis, Time, EUA, Person, DARPA, Growth, News, Severe acute respiratory syndrome coronavirus 2, Patient, Heparin, Fungus, Communication, Hospital, Virus, CE, Pharmaceutical industry, Vaccine, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

As areas in Canada are seeing significant growth in Delta variant cases, surpassing that of the prior surge, ExThera Medical s Seraph 100 Microbind Affinity Blood Filter has been granted Interim Order 324822 by the Canadian Health Authority for use in relation to COVID-19.

Key Points: 
  • As areas in Canada are seeing significant growth in Delta variant cases, surpassing that of the prior surge, ExThera Medical s Seraph 100 Microbind Affinity Blood Filter has been granted Interim Order 324822 by the Canadian Health Authority for use in relation to COVID-19.
  • The Seraph 100 treatment supports the ability to save lives for critically ill patients.
  • Since 2019 the therapeutic device has been used throughout Europe under a CE Mark for the treatment of certain bloodstream infections.
  • ExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph 100 Microbind Affinity Blood Filter for removing a broad range of pathogens from the bloodstream of patients.

ExThera Expands Distribution of Blood Purification and Pathogen Reduction Treatment for Sepsis and COVID-19 in Europe

Retrieved on: 
Wednesday, July 28, 2021
Biotechnology, General Health, Medical devices, Infectious diseases, Health, Infectious diseases, Microbiology, Pathogen, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

Earlier this year ExThera Medical and Fresenius Medical Care partnered to distribute the Seraph 100 in Europe .

Key Points: 
  • Earlier this year ExThera Medical and Fresenius Medical Care partnered to distribute the Seraph 100 in Europe .
  • Since 2019 the therapeutic device has been used throughout the continent under a CE Mark for the treatment of certain bloodstream infections.
  • The Seraph is indicated for the reduction of pathogens during bloodstream infections, in adjunction to therapy with anti-infectives.
  • ExThera Medicals extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from severe infections.

Clinical Trial for Groundbreaking Device to Treat Septic Shock set to Begin

Retrieved on: 
Monday, June 14, 2021
FDA, General Health, Health, Medical devices, Medical specialties, Medicine, Clinical medicine, Intensive care medicine, Medical emergencies, Sepsis, Bacterial diseases, Shock, Septic shock, Bloodstream infections, Infection, Septic, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

The endpoint of the trial is to determine the Seraphs effectiveness against a variety of bloodstream infections that can lead to sepsis.

Key Points: 
  • The endpoint of the trial is to determine the Seraphs effectiveness against a variety of bloodstream infections that can lead to sepsis.
  • ExThera Medical, the manufacturer of the Seraph 100 has obtained conditional approval from the US FDA to conduct the multicenter study on the treatment of critically ill patients with potentially fatal pathogen-associated shock (PURIFY-RCT), a form of septic shock.
  • The device has previously been tested successfully in partnership with the Department of Defense and the Defense Advanced Research Projects Agency (DARPA).
  • The study will evaluate the safety and efficacy of Seraph 100 blood purification therapy in critically ill patients with pathogen-associated shock across health centers in the United States.

Blood Purification and Pathogen Reduction Treatment for Sepsis and COVID-19 Set for Pan-European Distribution Launch

Retrieved on: 
Wednesday, May 26, 2021
Research, Medical devices, Infectious diseases, Hospitals, Clinical trials, Other Health, Biotechnology, Pharmaceutical, Health, Science, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

Since 2019 the therapeutic device has been used throughout the continent under a CE Mark for the treatment of bloodstream infections.

Key Points: 
  • Since 2019 the therapeutic device has been used throughout the continent under a CE Mark for the treatment of bloodstream infections.
  • We are confident that expanded clinical use of Seraph 100 therapy will further demonstrate its life saving potential and ability to address a multitude of pathogen-related illnesses.
  • The Seraph is indicated for the reduction of pathogens during bloodstream infections, in adjunction to therapy with anti-infectives.
  • Persons who are in possession of this news release are requested to obtain information concerning possible legal limitations and to observe them accordingly.

Seraph 100 Blood Filter Shows Substantially Improved Survival Rates for COVID-19 Patients

Retrieved on: 
Tuesday, April 27, 2021
Health, Medical devices, Infectious diseases, Hospitals, Clinical trials, Research, Science, XC2, COVID-19, Extracorporeal, Health sciences, Health, Medicine, ExThera Medical Corporation, Seraph 100, EXTHERA MEDICAL CORPORATION, SERAPH 100

b"ExThera Medical announced today the release of preliminary clinical study data demonstrating significantly improved survival rates among critically ill COVID-19 patients when treated with the Seraph\xc2\xae 100 Microbind\xc2\xae Affinity Blood Filter compared to contemporaneous controls.

Key Points: 
  • b"ExThera Medical announced today the release of preliminary clinical study data demonstrating significantly improved survival rates among critically ill COVID-19 patients when treated with the Seraph\xc2\xae 100 Microbind\xc2\xae Affinity Blood Filter compared to contemporaneous controls.
  • \xe2\x80\x9cOur study team feels like the Seraph 100 holds promise as a lifesaving tool in severe COVID-19.
  • Click here for the full study.\nExThera Medical Corporation develops and commercializes extracorporeal blood filtration devices, including the Seraph\xc2\xae 100 Microbind\xc2\xae Affinity Blood Filter for removing a broad range of harmful substances from the bloodstream of patients.
  • ExThera Medical\xe2\x80\x99s extracorporeal products have demonstrated life-saving capabilities in a wide range of critically ill patients suffering from severe infections.