Genetic Engineering & Biotechnology News

APR15 2017

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Genetic Engineering & Biotechnology News | | APRIL 15, 2017 | 7 faster wound healing. With RenovaCare's CellMist and SkinGun, which together con- stitute the CellMist System, one square cen- timeter of healthy skin can be used to treat 100 square centimeters of burned skin. With traditional skin grafting techniques, that square centimeter could only treat about six square centimeters. Healing is accelerated because the stem cells are sprayed into the wound, stimulat- ing islands of regeneration throughout the wound. "Wounds normally heal from the edges toward the middle," Bold points out. RenovaCare's method triggers healing all over the wound. RenovaCare is focused on severe second- degree burns where dermal structures re- main. The CellMist System therapy also may be valuable as an adjunct therapy in dermal replacement, Bold observes. Other possibili- ties include treatments for skin pigmentation disorders (such as vitiligo) and scarring (in- cluding acne scarring) as well as cosmetic ap- plications. The company also is developing sprays for wound care as well as the delivery of irrigation fluids. This technology has the potential to re- place traditional skin grafts. If that happens, hospital stays might be reduced by many weeks. Also, the risk of infections and other complications might be reduced, along with the pain and expense of harvesting healthy skin to apply to injured sites. Origin RenovaCare was formed about four years ago and was based on work that was under- taken when Bold was CEO at StemCell Sys- tems. "We were working with a hospital in Berlin," he recalls. "Its burn center wasn't sat- isfied with available therapies, so we were sup- posed to develop a multilayer skin product." The bioreactor technology at the time al- lowed the team to develop layers of a flat film that would migrate into the wounds. That approach didn't deliver optimal results, "so we developed the idea of using the wound itself as a bioreactor," Bold explains. Eventu- ally, StemCell Systems and RenovaCare col- laborated to advance the CellMist Solution and SkinGun technologies. After receiving promising clinical results, RenovaCare is focusing on the business and regulatory aspects needed to eventually com- mercialize its product. That includes refin- ing its regulatory strategy in preparation for eventual FDA filings. "We're talking with the FDA, and we expect to begin a new study soon," Bold tells GEN. Details of that study are not yet public. The company's staff has been bolstered with the addition of Rog- er Esteban-Vives, Ph.D., a world-renowned expert on stem cell isolation, as director of cell sciences. "We're putting [the next phase of] the business model together and raising funds," Bold reports. There are no plans to out-li- cense the technology. Wound care represents a $45 billion market in the U.S. alone. Simple • Convenient • Efficient • Safe Lenti – Experience the Beauty! Focus on discovery, not DNA delivery Lenti Particles and Plasmids are Both Available Lenti-shRNA Lenti-ORF Lenti Packaging Kit © 2017 OriGene Technologies, Inc. All Rights Reserved. Corporate Profile RenovaCare Location 430 Park Avenue, Suite 702 New York, NY 10022 Phone (888) 398-0202 Website Principal Thomas Bold President and CEO Number of Employees 10 Focus RenovaCare has developed spray-on stem cells for use in wound care and other skin conditions. The technology is approved for investigational clinical use in the U.S. and Europe. Vital Signs

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