RenovaCare, Inc. is a biotechnology company focused on developing first-of-their-kind autologous (self-donated) stem cell therapies for the regeneration of human organs.
RenovaCare products are currently in development. They are not available for sale in the United States. There is no assurance that the company’s planned or filed submissions to the U.S. Food and Drug Administration, if any, will be accepted or cleared by the FDA.
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The company’s pipeline products under development target the body’s largest organ, the skin. The RenovaCare CellMist™ System will use the patented SkinGun™ to spray a liquid suspension of a patient’s stem cells – the CellMist™ Solution – onto wounds. RenovaCare is developing its CellMist™ System as a promising new alternative for patients suffering from burns, chronic and acute wounds, and scars.
In addition to the SkinGun™, the company is developing a medical-grade sprayer that uses a liquid-into-air stream system to disperse a gentle spray of wound care and/or irrigation fluids over a wound area.
Flagship CellMist™ System makes use of a patient’s own stem cells, which are sprayed onto wounds using our novel SkinGun™ device. For patients suffering severe burns and other wounds, the prospect of a quick-healing, gentle spray containing their own stem cells will be a promising alternative to conventional skin graft surgery, which can be painful, prone to complications, and slow-to-heal. Based on preliminary case studies, CellMist™
System patients can be treated within 90 minutes of arriving in an emergency room; a patient’s stem cells are isolated, processed, and sprayed on to wound sites for rapid healing. RenovaCare products are under development and not approved for sale in the United States. Preliminary investigational use in Europe and the United States indicate the potential efficacy and safety of RenovaCare’s technologies. Clinical observations point to the potential for regeneration of new skin in as little as four days, rather than the many weeks of painful and risky recovery required by traditional skin graft techniques..
These technologies are the result of nearly a decade of ongoing research and development dedicated to finding the most effective way to access the regenerative properties of a patient’s own skin stem cells, and the most efficient way to deliver these potent cells to heal moderate to severe skin wounds. We believe that RenovaCare’s CellMist™ System and SkinGun™ spray device are the world’s most advanced technologies of their kind. This device system requires further clinical evaluation and data collection prior to submission of a premarketing application to the US FDA. At this time it is an investigational system and is not available for general use or sales in the United States.