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376,565 Results for "exthera medical".
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Drug Development
ExThera Announces Completion of Phase I OSCAR I Trial
September 25, 2024
·
5 min read
Business
ExThera Medical in Growth Mode after FDA Approval of Investigational Device Exemption
ExThera Medical Corporation today announces the addition of Michael DiMeo as Chief Financial Officer.
July 26, 2023
·
5 min read
Biotech Bay
ExThera Medical Receives Certification for Medical Device Single Audit Program (MDSAP) and Recertification for International Organization for Standardization for Medical Devices (ISO 13485)
ExThera Medical Corporation announces it has received simultaneous certification per Medical Device Single Audit Program (MDSAP) and International Organization for Standardization (ISO 13485) requirements.
August 15, 2023
·
5 min read
ExThera Medical Exhibits at the 2023 International Conference on Extracorporeal Organ Support in Zagreb, Croatia
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.
June 6, 2023
·
4 min read
Biotech Bay
FDA Grants ExThera Multiple Breakthrough Device Designations for its Seraph® 100 Filter
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).
October 3, 2023
·
4 min read
FDA
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
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).
July 13, 2023
·
5 min read
Business
ExThera Medical and Asahi Kasei Medical Enter into Partnership to Expand Reach of Treatment for the Critically Ill
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.
December 21, 2021
·
5 min read
Biotech Bay
ExThera Medical Successfully Completes Phase I of PURIFY RCT: US Investigational Device Exemption Trial Evaluating Seraph 100 for the Treatment of Septic Shock
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.
April 18, 2023
·
4 min read
Press Releases
Tenon Medical(R) to Host Meetings During the 2025 J.P. Morgan Healthcare Conference in San Francisco
January 9, 2025
·
2 min read
Business
Michael Porter of Harvard Business School has Joined the Board of Directors of ExThera Medical Corporation
Michael Porter, Ph.D., has joined the board of directors of ExThera Medical Corporation, a privately held medical technology company focused on the therapeutic reduction of drug-resistant pathogens and sepsis mediators in whole blood. ExThera’s Seraph ® 100 Microbind ® Affinity Blood Filter (Seraph 100) has a CE Mark in Europe for the treatment of a wide range of bloodstream infections. In the USA Seraph 100 has Em
September 29, 2020
·
6 min read
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