BioTime, Inc. operates as a clinical-stage biotechnology company, focuses on developing and commercializing novel therapies based on HyStem cell delivery and pluripotent stem cell technology platforms. Strategy The key elements of the company’s strategy include advancing key product development programs through clinical trials; simplifying the company structure to focus resources on the development of promising cell therapies that address large market opportunities; and unlocking value for BioTime shareholders from investments in subsidiaries. Cell-based Products & Product Candidates The company’s cell-based products and product candidates are based on one of two technologies: HyStem cell delivery technology and pluripotent stem cells. HyStem Based Products & Product Candidates Renevia The company is developing Renevia, a clinical grade HyStem hydrogel, as an injectable product. Renevia may address an immediate need in cosmetic and reconstructive surgeries and other procedures by improving the process of transplanting adipose fat derived cells or other cells. Cell types, such as adipose stem cells obtained from a patient through liposuction could be transplanted back into the same patient at another location in the body, without the risk of rejection associated with the transplant of donor tissues. The transfer of cells in Renevia might resolve this issue by localizing the transplanted cells at the intended site and by providing a three-dimensional scaffold upon which cells could rebuild normal tissue. Renevia might also support other emerging cell and tissue transplant therapies, such as those derived from pluripotent stem cells, in addition to its potential application in the treatment of a number of conditions, such as osteoarthritis, brain cancer, stroke, bone fracture, and wounds. The company is conducting a multi-site pivotal clinical study in Spain to assess the efficacy of Renevia as a delivery matrix for adipose cells to restore normal skin contours in patients where the subcutaneous adipose tissue has been lost to HIV related facial lipoatrophy. Lipoatrophy is a localized loss of fat beneath the skin and is often a consequence of the normal aging process, but lipoatrophy could also be associated with trauma, surgery, and diseases. Lipoatrophy is frequently experienced by HIV patients who have been treated with certain anti-viral drugs like Stavudine and Zidovudine. The resulting facial wasting ages the individual’s appearance prematurely and, along with a thinning of the skin, allows musculature and vasculature to be seen, resulting in what is commonly known as the face of AIDS. Renevia is manufactured in the U.S. in compliance with current good manufacturing practices (cGMP) requirements. Premvia Premvia, is a HyStem hydrogel formulation of cross-linked thiol-modified hyaluronan and thiol-modified gelatin for the management of wounds, including partial and full-thickness wounds, ulcers, tunneled/undermined wounds, surgical wounds, and burns. Premvia utilizes the same cGMP components used in Renevia. Although the company received 510(k) clearance from the FDA in 2014 to market Premvi as a medical device for wound management, it is doing commercial assessment of the broader wound management area that includes breast cancer lumpectomy surgery before launching this product. HyStem Cell Delivery Technology Renevia and Premvia are based on the company’s HyStem cell delivery technology. Its HyStem hydrogel product line is one of the components in its near-term revenue strategy. HyStem is a patented biomaterial that mimics the extracellular matrix (ECM), the network of molecules surrounding cells in organs and tissues that is essential to cellular function. Many tissue engineering and regenerative cell-based therapies would require the delivery of therapeutic cells in a matrix or scaffold for proper function. HyStem is a hydrogel that has been shown to support cellular attachment and proliferation in vivo. The patented technology underlying the company’s HyStem hydrogels, such as Renevia and Premvia was developed at the University of Utah and has been licensed to it for human ther
biotime inc (BTX:NYSE Amex)
1010 Atlantic Avenue
Alameda, CA 94501
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