BioTime receives ISO 13485:2003 certification for development of BioTime HyStem hydrogels

May 28 2014

BioTime, Inc. (NYSE MKT: BTX) today announced that it 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.

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. In this first clinical application, Renevia™ will be used as a delivery matrix for autologous adipose cells to treat the facial lipoatrophy associated with HIV. Restoration of normal skin contour is an important quality-of-life issue with this chronic condition and BioTime believes that this cell-based therapy will offer fewer complications and a more natural like appearance compared to products currently available. It has been estimated that worldwide over 40% of individuals receiving long-term antiretroviral therapies suffer from this disfiguring condition. According to www.avert.org in 2011 there were approximately 800,000 persons living with HIV/AIDS in Western Europe. Globally the number exceeds 30 million.

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. Once the use of Renevia™ is established in Europe, BioTime will address an even larger potential market in Asia and the United States.

William P. Tew, Ph.D., BioTime's Chief Commercial Officer stated, "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."