WALTHAM, Mass., Oct. 23 /PRNewswire-FirstCall/ -- Arbios Systems, Inc. (OTC: ABOS) today announced that it has entered into an exclusive manufacturing agreement with NxStage Medical, Inc., whereby NxStage will manufacture the SEPET(TM) Liver Assist Device developed by Arbios for use in treating liver failure. Arbios is currently seeking permission from the US Food and Drug Administration to begin a controlled pivotal clinical trial for SEPET(TM).
Under the terms of the agreement, NxStage, a marketer of innovative systems for the treatment of end-stage renal disease and acute kidney failure, will manufacture the devices for the pivotal trial and subsequent product commercialization, upon receipt of FDA approval. The SEPET(TM) device will be comprised of commercially used NxStage components and will include a proprietary synthetic microporous fiber, supplied by Membrana, GmbH. Arbios, a developer of medical devices and cell-based therapies, recently announced an exclusive supply relationship with Membrana, which is the world's largest independent membrane producer.
"We are pleased to announce this exclusive arrangement with NxStage, as it signals another step in bringing SEPET(TM) to the marketplace," commented Shawn Cain, Interim President and Chief Executive Officer of Arbios. "This joint effort with NxStage, similar to the agreement recently entered into with Membrana, signifies another important alliance with an established and well- respected manufacturer of medical products."
"We are pleased to help bring innovative solutions to clinically challenging patients that need them," said Jeffrey H. Burbank, President and Chief Executive Officer of NxStage Medical. "We believe that our technology and capabilities will enhance Arbios' opportunity and look forward to being a part of making them a success."
The exclusive manufacturing agreement stipulates that Arbios will
purchase from NxStage all commercial requirements of the SEPET(TM) dev
|SOURCE Arbios Systems, Inc.|
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