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ExThera Medical Receives FDA Approval for IDE Application of OncoBindTM Extracorporeal Procedure in Pancreatic Cancer Patients to Eliminate Circulating Tumor Cells

Friday, July 14, 2023

ExThera Medical is excited to share significant advancements in the clinical development of their innovative OncoBindTM procedure. Sanja ILIC, M.D., M.S., RAC, and Chief Regulatory Officer at ExThera, expressed enthusiasm about the procedure's progression into a new phase of clinical development. The company is eager to validate their preclinical data through upcoming clinical trials, with patient enrollment scheduled to begin in the fall of 2023. These developments will further demonstrate the potential of ExThera's products in effectively removing circulating tumor cells (CTCs).

The OncoBindTM procedure is based on ExThera's Seraph® 100 Microbind® Affinity Blood Filter, which has shown promising results in removing metastatic CTCs in various in vitro models. Collaborative efforts, including recent collaborations with Professor Peter Kuhn, Ph.D., from the University of Southern California, have contributed to these positive findings. The removal of CTCs from the bloodstream is believed to play a vital role in potentially interrupting metastasis and preventing the spread of cancer within the body.

Bob Ward, Ph.D. (h)., NAE, CEO and Founder of ExThera Medical, emphasized the exceptional safety record of the Seraph technology, which has been successfully utilized in over 2,500 clinical treatments worldwide for bacterial, viral, and fungal bloodstream infections. The company is delighted to commence an important new clinical trial following the FDA's approval of their Investigational Device Exemption (IDE) application. If the clinical application of ExThera's technology proves as effective as it has in laboratory settings, it could become a valuable addition to the treatment options for pancreatic ductal adenocarcinoma (PDAC), a highly aggressive cancer with a low 5-year survival rate.

ExThera Medical Corporation, a leading biotechnology company specializing in research and manufacturing, is committed to the development and commercialization of innovative extracorporeal medical devices for blood purification. Their proprietary platforms harness the intrinsic properties of homeostasis to create a portfolio of novel therapeutic procedures. ExThera Medical prioritizes transparency, safety, and efficacy in all their product developments, ensuring close adherence to FDA oversight.

https://www.businesswire.com/news/home/20230712853518/en/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

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