RenovaCare products are under development and not approved for sale in the United States.

RenovaCare products are under development and not approved for sale in the United States.

SkinGun™ and CellMist™ Technology Overview

RenovaCare is developing breakthrough technologies to address America’s $45 billion wound and burn treatment market. Our 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.

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.

The CellMist™ System

What is the CellMist™ Solution?

The CellMist™ Solution is a liquid suspension containing a patient’s own regenerative skin stem cells. A small sample (as little as a square inch) of the patient’s skin is quickly processed to liberate the stem cells from surrounding tissue. The resulting product is referred to as the ‘CellMist™ Solution’. The CellMist™ Solution is placed in the SkinGun™ for spray application onto the patient’s wound.

What is the SkinGun™?

The CellMist™ Solution, containing the patient’s stem cells, is transferred to the SkinGun™. The SkinGun™ sprays the cells onto wound sites to begin healing. Unlike conventional aerosol and pump systems, our next-generation fluid sprayer does not expose fragile cells to strong forces that can tear them apart. Instead our SkinGun™ gently delivers the CellMist™ Solution directly to the wound site using a positive-pressure air stream.

The CellMist™ Advantage

Skin tissue grafting is the traditional treatment for patients with severe burns and wounds. Grafting requires the removal of vast areas of a patient’s healthy skin, which is then surgically stitched onto wounds.

In contrast, our CellMist™ System requires only a small, postage-stamp sized donor skin sample from a patient. Stem cells are liberated from the donor skin and suspended in the liquid CellMist™ Solution, which is then gently sprayed onto wound sites using our SkinGun™ deposition device

Beyond conventional grafting, several skin replication biotechnologies have emerged in recent years. However, patients are still subject to weeks of pre- and post-graft hospitalization, risk of infection, and other painful complications. In some of these methods surgeons remove healthy skin, which is then shipped to a central processing unit for reproduction. After weeks of waiting – and making use of non-human cells – sheets of artificial skin are “grown” and shipped back to the surgeon for stitching to the wounded area. This can be a slow, painful, and expensive process.

RenovaCare’s CellMist™ System procedure by contrast needs only 90 minutes to liberate the patient’s highly-regenerative stem cells and gently spray them onto the wound site.

Almost immediately the cells begin to differentiate and become new skin. Some early CellMist™ patients have grown sufficient amounts of new skin to be safely discharged from hospital only a few days after treatment.

According to researchers, such rapid healing is possible because the wound itself is an ideal natural incubator for a patient’s own stem cells.