ExThera Medical Celebrates Successful Completion of Trial
ExThera Medical Celebrates Successful Completion of Trial
ExThera Medical has proudly announced the successful conclusion of its Phase I OSCAR I Trial at OU Health Stephenson Cancer Center. This trial centers on evaluating the ONCObind Procedure Hemoperfusion Filter's effectiveness in removing Circulating Tumor Cells (CTCs) from patients battling metastatic Pancreatic Ductal Adenocarcinoma (PDAC).
Highlights of the Trial
The OSCAR study aims to assess the initial safety and effectiveness of the ONCObind Procedure. In total, five patients with PDAC have completed the procedure, reporting no safety concerns and demonstrating promising outcomes. As a result, ExThera has submitted data to the FDA for review, seeking approval to progress to the next phase of the feasibility trial (OSCAR II) and expand the study to include patients with Metastatic Colorectal Cancer (MCRC) in addition to metastatic PDAC.
Positive Patient Outcomes
Dr. Bob Ward, Chairman and President of ExThera Medical, expressed satisfaction with how well the ONCObind Procedure was tolerated among patients. Notably, patients showed a marked decrease in sedimentation rates, alongside improved appetite, indicating a positive response to the treatment.
Collaboration and Future Studies
Moreover, Sanja Ilic, Chief Regulatory Officer for ExThera, praised the collaborative efforts with the Stephenson Cancer Center team, expressing eagerness to continue partnering on future studies targeting pancreatic cancer and potentially branching into colorectal cancer as well.
Understanding the ONCObind Procedure
The ONCObind Procedure represents a significant advancement in cancer treatment technology. Utilizing ExThera’s proprietary Onco-Seraph platform, this extracorporeal blood filtration system is designed to effectively filter out CTCs from patients' bloodstreams. CTCs are known contributors to the metastasis of cancer and are paramount in cancer progression.
Mechanism and Technology
By employing the ONCObind Procedure, which utilizes the Seraph® 100 Microbind® Affinity Blood Filter, the therapy successfully captures and removes these harmful cells, potentially enhancing patient outcomes in metastatic conditions. This innovative technology’s efficacy has been validated in various studies, showing a trend towards improved clinical outcomes in critically ill patients.
ExThera’s Commitment to Healthcare Innovations
ExThera demonstrates a strong commitment to developing innovative medical solutions, particularly in the realm of serious illnesses such as sepsis and COVID-19. Their products aim to address critical needs in healthcare settings, whether they be in hospitals, clinics, or emergency situations.
About ExThera Medical Corporation
Founded to advance the field of blood filtration, ExThera Medical Corporation specializes in the development and commercialization of leading-edge medical devices. Their prominent product, the Seraph® 100 Microbind® Affinity Blood Filter, shows promise in removing a wide variety of pathogens from the bloodstream. With a growing body of evidence supporting its effectiveness, ExThera’s technology continues to make a difference in the fight against infections for patients of all backgrounds.
A Global Reach
The Seraph® 100 has achieved CE Mark certification and is widely available throughout the EU, further demonstrating ExThera’s international impact. In the U.S., the FDA has granted Emergency Use Authorization (EUA) specifically for its use in treating COVID-19 patients, augmenting the device's importance in addressing urgent health crises.
Frequently Asked Questions
What is the main aim of the OSCAR I Trial?
The OSCAR I Trial aims to evaluate the safety and efficacy of the ONCObind Procedure Hemoperfusion Filter in removing Circulating Tumor Cells from patients with metastatic PDAC.
How many patients participated in the OSCAR I Trial?
A total of five patients with metastatic PDAC completed the ONCObind Procedure during the trial.
What were the outcomes reported from the trial?
Participants reported no safety concerns, along with rapid reductions in sedimentation rates and improvements in appetite.
What is the Seraph® 100 Microbind® Affinity Blood Filter?
This is an investigational blood filter device designed to remove a range of pathogens from the bloodstream, contributing to improved patient outcomes.
Is ExThera’s technology available worldwide?
Yes, the Seraph® 100 is available in the EU under CE Mark and has received EUA from the FDA for use in the U.S. for COVID-19 treatment.
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