FDA Clears Hydrogel From BioTime

BioTime Inc. has received U.S. Food and Drug Administration (FDA) approval to market Premvia as a Class II medical device.

Premvia is the first FDA-cleared member of BioTime’s HyStem family of hydrogels, 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 is 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 expected to soon begin its clinical trial in Europe) 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 regenerative medicine.”

The clearance of Premvia in the United States will help BioTime develop more advanced bioactive and cell-matrix combination products, bigwigs said. The Revevia trial (another HyStem-based product) is expected to begin in Europe, where BioTime is seeking a CE Mark for the use of Renevia in combination with cells to treat HIV-related lipoatrophy. BioTime also is developing HyStem technology to formulate various products manufactured from pluripotent stem cells using the company’s PureStem technology. Combination products of HyStem-based hydrogels with PureStem cell lines will require future human clinical trials.

“Premvia utilizes unique patented technology that allows the crosslinking of collagen and hyaluronic acid and is compatible with cells and tissues,” noted Gregory Keller, M.D., F.A.C.S., clinical professor at the University of California-Los Angeles 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.”

BioTime’s HyStem hydrogels are biomaterials 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, currently is undergoing clinical evaluation in Europe as a delivery matrix for autologous adipose cells to treat the facial lipoatrophy associated with HIV. BioTime’s HyStem technology is covered by two issued U.S. patents with applications pending in the European Union, Canada, Japan, and Australia.

BioTime is an Alameda, Calif.-based biotechnology company developing regenerative medicine products. BioTime’s focus is on pluripotent stem cell technology based on human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”) cells. 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 as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications; in addition, the company 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 United States by Hospira Inc. and in South Korea by CJ HealthCare Corporation.