ViaCyte Achieves Significant Milestone with ISO 13485:2003 Certification for its Encaptra Drug Delivery System
San Diego, CA — July 8, 2014 — ViaCyte, Inc. (“ViaCyte”), a privately held regenerative medicine company developing a cell therapy for treatment of type I diabetes, today announced it has received International Standards Organization (ISO) 13485:2003 certification, an internationally recognized quality standard for medical devices. ViaCyte’s certification was awarded by the British Standards Institution (BSI), one of the world’s leading certification bodies.
“Achieving this certification is a significant milestone for ViaCyte which takes us closer to initiating clinical trials of our first product, VC-01, a combination product candidate composed of human stem cell derived pancreatic progenitor cells encapsulated in an immune-protective device,” said Michael Scott, Vice President Device Research & Development and Chief Development Officer of ViaCyte, Inc. “ISO 13485:2003 certification represents ViaCyte’s commitment to designing, testing and manufacturing the highest quality product possible”
ISO 13485:2003 (the “Standard”) specifies requirements for a comprehensive quality management system for the design and manufacture of medical devices. ViaCyte was assessed and deemed to comply with the ISO’s requirements with respect to the design and manufacture of medical devices for encapsulation and delivery of cells with its Encaptra® drug delivery system. The Standard focuses on controlled systems to produce medical devices that consistently meet customer and regulatory requirements.
ViaCyte is a private regenerative medicine company currently focused on developing a novel cell therapy for the treatment of diabetes. The Company’s lead product candidate, VC-01, is based on the production of pancreatic progenitors derived from human pluripotent stem cells. These cells are implanted in a durable and retrievable encapsulation device called the Encaptra® drug delivery system. Once implanted and matured, these cells are designed to secrete insulin and other regulatory factors in response to blood glucose levels. The Company is funded in part by the California Institute for Regenerative Medicine (CIRM) and JDRF. For more information please visit www.viacyte.com.
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