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BioTime Secures ISO 13485 Certification for Medical Devices

June 9, 2014

BioTime has received ISO 13485:2003 certification from BSI (British Standards Institution) for design, development, manufacture, and distribution of BioTime HyStem hydrogels for cell delivery applications.

According to a release, BSI is currently one of the world's largest independent certification bodies for quality management systems and ISO 13485:2003 is the world's most recognized standard for quality management systems for medical devices, and is the most commonly chosen path for companies to meet the quality system requirements in Europe, Canada, Japan, Australia, and other countries.

ISO certification is a prerequisite for CE marking of medical devices within the European Union and this certification is an important milestone in BioTime's development program for Renevia, a cell delivery matrix scheduled to begin pivotal human clinical trials in 2014 at the Stem Center in Palma de Mallorca, Spain.

If Renevia is approved for the treatment of HIV-related facial lipoatrophy, BioTime plans to seek to expand its uses into other cell-based applications in reconstructive surgeries, traumatic injuries, and age-related lipoatrophy. BioTime's plan is to bring Renevia to the medical market first in the European Union, where the regulatory pathway will allow for faster approval than in the United States.

William P. Tew, Ph.D., BioTime's Chief Commercial Officer, said, "We are very pleased with our ISO Certification and BSI's acknowledgement of our on-going commitment to quality. Our quality management systems will provide a solid foundation for our clinical, regulatory, manufacturing, and future commercial activities. While this present certification focuses on HyStem hydrogels for cell delivery applications, should BioTime decide to pursue CE marks for other applications of its hydrogel technology we will expand the scope of our ISO certification."

BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine.

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Source: Professional Services Close - Up

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