Date: Aug 12, 2014 Author: BioTime, Inc. Source: Company Data (
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BioTime Receives FDA Premarket Notification Clearance for Premvia™ 510(k)
ALAMEDA, Calif.--(BUSINESS WIRE)--Aug. 12, 2014-- BioTime, Inc. (NYSE MKT: BTX) today announced that it has received notice from the FDA's Center for Devices and Radiologic Health that Premvia™ has been cleared for marketing as a Class II medical device. Premvia™ is the first FDA-cleared member of BioTime's HyStem® family of hydrogels, which are designed to mimic the natural structures of the human body's extracellular matrix. According to the FDA clearance, the product is indicated for the management of wounds including: partial thickness, full-thickness, tunneling wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, donor skin graft sites, post-Moh's surgery, post-laser surgery, podiatric wounds, wound dehiscence, abrasions, lacerations, second degree burns, skin tears and draining wounds.
The global market for aesthetic and reconstructive surgery was estimated to exceed $6 billion annually and is composed of many distinct market segments. Premvia™ is expected to serve a subset of these segments. "We plan to rapidly complete the review and implementation of the requisite quality and manufacturing documentation in advance of introducing the product to the market. Additionally the Company will undertake selected clinical studies to further refine the target market niches, and following that, will lay our final plans for associated marketing initiatives and strategies," said William Tew, Ph.D., BioTime's Chief Commercial Officer. "HyStem®-based products such as Premvia™ and Renevia™ (the latter anticipated to begin its pivotal clinical trial in Europe later this year) are anticipated to provide the company with opportunities for significant near-term revenue, while balancing the long-term opportunities created by the Company's pluripotent stem cell technology platform, which provides the potential for the industrial-scale manufacture of all of the cellular components of the human body. Together, these matrices and cellular building blocks provide a combination of technology platforms that we believe can lead the industry in the revolution underway commonly called ‘regenerative medicine.'"
"Premvia™ utilizes unique patented technology that allows the crosslinking of collagen and hyaluronic acid and is compatible with cells and tissues," remarked Dr. Gregory Keller, MD, FACS, Clinical Professor at UCLA and co-director of the UCLA/AAFPRS facial plastic surgery fellowship. "I am excited by the prospects of using Premvia™ in treating wounds resulting from a number of the approved indications in general aesthetic and reconstructive surgery."
The clearance of Premvia™ in the United States will provide BioTime with a foundation for the development of even more advanced bioactive and cell-matrix combination products. The pivotal trial of Renevia™ (another HyStem®-based product) is expected to begin later this year in Europe, where BioTime is seeking a CE Mark for the use of Renevia™ in combination with cells for the purpose of lipotransfer in the treatment of HIV-related lipoatrophy. BioTime also is in the process of developing HyStem® technology for use in formulating a number of products manufactured from pluripotent stem cells using the Company's proprietary PureStem® technology. Combination products of HyStem®-based hydrogels with PureStem® cell lines will require future human clinical trials.
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About HyStem®
BioTime's HyStem® family of hydrogels are unique biomaterials that are designed as matrices and scaffolds in medical device, tissue engineering, and regenerative medicine applications. HyStem® hydrogels are distributed and sold worldwide by BioTime and its distributors for pre-clinical research. Renevia™, an injectable HyStem® hydrogel, is presently undergoing clinical evaluation in Europe as a delivery matrix for autologous adipose cells to treat the facial lipoatrophy associated with HIV. Clinical grade hydrogels are also available to support translational research and investigator initiated clinical studies. BioTime's HyStem® technology is covered by two issued US patents with applications pending in the EU, Canada, Japan, and Australia.
About BioTime
BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine. Regenerative medicine refers to therapies based on stem cell technology that are designed to rebuild cell and tissue function lost due to degenerative disease or injury. BioTime's focus is on pluripotent stem cell technology based on human embryonic stem ("hES") cells and induced pluripotent stem ("iPS") cells. hES and iPS cells provide a means of manufacturing every cell type in the human body and therefore show considerable promise for the development of a number of new therapeutic products. BioTime's therapeutic and research products include a wide array of proprietary PureStem® progenitors, HyStem® hydrogels, culture media, and differentiation kits. BioTime is developing Renevia™ (a HyStem® product) as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications, and is planning to initiate a pivotal clinical trial around Renevia™, in 2014. In addition, BioTime has developed Hextend®, a blood plasma volume expander for use in surgery, emergency trauma treatment and other applications. Hextend® is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ HealthCare Corporation, under exclusive licensing agreements.
