RenovaCare Inc. (OTCQB:RCAR) is a New York City-based biotechnology company developing its patented CellMist and SkinGun stem cell technologies for treating burns in weeks or less as well as treating chronic and acute wounds, acne scarring, and skin defects and diseases. In December, it received a U.S. patent for its SkinGun device.

Before joining RenovaCare, CEO Thomas Bold was CEO of StemCell Systems. He has more than 15 years of experience in medical biotechnology device manufacturing and stem cell platform development.

Harlan Levy: How does your CellMist technology specifically work?

Thomas Bold: Doctors isolate a high concentration of the most desirable stem cell population from a very small donor sample of the patient's own skin and suspended in the liquid CellMist Solution. It's then gently sprayed onto wound sites using our SkinGun, which looks like Captain Kirk's particle-beam gun, the "Phaser" in the Star Trek TV series.

The isolated cells include cells that proliferate rapidly in order to achieve quick re-epithelialization. This is the stage at which a burn is technically considered "healed" and patients are often discharged. The average person would recognize this healing phase as the point at which the wound develops a thin, shiny, pink-colored protective layer.

H.L.: What are existing burn treatments, and how do they compare with the SkinGun treatment?

T.B.: Traditional skin grafting has been the treatment for burns and wounds for centuries. More recently, mesh grafting has become the latest standard of care. This process surgically removes large sheets of healthy skin from the patient. Following this painful donor procedure, the sheet is punctured in a grid-like pattern to form an expandable mesh. Surgeons pull this mesh as wide as feasible and surgically stitch this skin to the patient's wound. The procedure is extremely painful, creates an additional wound at each donor site and results in poor cosmetic outcomes, often with scarred and deformed skin.

This transplanted skin can result in restricted joint movement and is unable to grow with the patient. Consequently, mesh graft patients require months and sometimes up to a year of physical therapy and can face psychological problems from the permanent disfigurement of scarring. In addition, long-term pain management with painkillers is very often necessary.

With the RenovaCare treatment technology, by spraying the patient's stem cells, the SkinGun overcomes the need for removing large sheets of donor skin, and the resultant healing does not require prolonged physical therapy. The spray procedure is gentle, and the skin that regrows looks, feels, and functions as the original skin that it replaces. Most often the healing process takes only a week.

It's very important to note here that a sheet of meshed skin covers only up to six times its original donor area. The RenovaCare system covers up to 100 times its donor skin sample. This is why the donor skin sample can be so small compared to the injured treatment area.

H.L.: What about scars and infection potential compared with conventional treatments?

T.B.: A wound heals from the edges towards the middle. The bigger the wound, the longer this process takes. And the longer this process takes, the higher the risk of infection and scarring.

Imagine a large burn of 20, 30, 40 percent of your total body surface. With our CellMist System, the doctor sprays the patient's own stem cells with a highly regenerative capacity onto the wound and, by doing so, creates tens of thousands of little regenerative islands across the wound. These islands grow outwards, ultimately connecting to each other to create a protective epithelial skin layer that covers the wound.

Experts believe the formation of this pink-colored layer marks the moment of re-epithelization where the risk of infection is reduced and the patient's wound is effectively healed. Beyond this stage, the cosmetic healing process also happens entirely natural to produce a scar-free result where, finally, skin color, tone and pigmentation are restored.

Since the RenovaCare spray procedure uses the patient's own stem cells, there isn't the risk of tissue rejection, infection, or ongoing immuno suppression therapy.

H.L.: What results have you found for patients using the SkinGun?

T.B.: We have many examples of patients recovering from severe burns within a week or two, scar-free, and walking away with unlimited joint restrictions.

In the case of one patient with severe electrical burns to over a third of his body, we were able to spray his wounds with 23 million stem cells isolated from a tiny two-inch-by two-inch sample of his own skin. Within five days of treatment, his chest and arms were already healed. Four days later, the patient was discharged from the hospital.

It's also important to note that reconstructive surgery for burn patients is especially challenging when tackling joints in the body. To this end, the authors of a case study in the reputable journal "Burns," said, "Cell-spray grafting is also especially suitable for hands and joint areas, where prolonged times to re-epithelization may significantly impact functionality and esthetic outcome."

H.L.: What different uses does the SkinGun have beside burns?

T.B.: Currently, we are focusing on severe second-degree burns, but we see the RenovaCare technology also applicable for other indications such as cosmetic procedures targeting skin pigmentation disorders, scar treatment, and other related conditions.

Our goal is to bring to market the world's most advanced technology for skin repair using a patient's own stem cells.

H.L.: Is there a record of the SkinGun use in the States and abroad?

T.B.: Having treated 72 burn patients to date, the company's early clinical target is burns with follow-on indications, including chronic wounds and cosmetic procedures.

H.L.: How much research went into creating the SkinGun and over what time period?

T.B.: The birth of RenovaCare technology goes back to the early 2000s in Berlin, Germany. Researchers, at that time, were trying to "grow" skin by seeding stem cells inside multi-dimensional bioreactors. They soon discovered that these artificial chambers were no match for the growth of the same cells when transplanted inside a human body; thus, the birth of a concept to use a patient's own wound as a natural bioreactor.

A study published in "Advances in Plastic Surgery" highlights 19 early patients with deep dermal wound burns to the face and neck, complex three-dimensional surfaces. Researchers achieved such outstanding results using our cell spray that they refused to perform further skin grafting. Instead, surgeons adopted our founding technology as their standard of care.

Let me quote from the surgeons' study, which states

"We refuse to perform a prospective randomized study with groups in which traditional skin grafting and/or wound healing are still applied for the therapy for deep dermal burns due to the excellent results in our study. The method of CEA spray application has become our standard of care for these indications. The faster wound closure, the promotion of spontaneous wound healing by keratinocyte application, as well as the preservation of donor sites are further advantages of the method."

The same paper concluded that "using a spray technique results in excellent cosmetic outcomes compared with any other method."

H.L.: How has the technology changed since then?

T.B.: Since the time of this early approach, our technology has evolved and matured significantly. Our cell isolation no longer requires complex procedures, culturing, expansion, and processing time, and our stem cell spray device no longer requires multiple hand-assembled parts. Its independent power and flow-control unit has been condensed in size from a 2-foot cube down to a 9-volt battery placed inside the handle of a single handheld spray gun.

H.L.: What is the potential market for the technology in dollars and number of patients?

T.B.: Conservatively speaking, the market for our technology exceeds $50 billion. There are nearly a million people who suffer from burns each year in the U.S. alone. According to the American Burn Association, burn injuries continue to be one of the leading causes of accidental death and injury in the U.S, and one civilian fire death occurs every two hours and forty minutes.

H.L.: How much would you estimate the treatment cost may be for each different use?

T.B.: The SkinGun technology is currently under development and not approved for clinical use in the U.S., so it's too early to talk about what the treatment will cost. We have always been mindful of reimbursement, and nearly two years ago, we commissioned an investigation into the reimbursement pathway for our CellMist System. We know that reimbursement opportunities are available by way of current coding and practices.

We have further investigated and evaluated the "bundling" approach currently advocated for by insurers and are confident that that our technology is well placed to take advantages of any shift towards such a model.

H.L: What is the schedule to get Federal Drug Administration clearance?

T.B.: In order to achieve FDA clearance for the CellMist System and the SkinGun, we will be working to show our technology is safe and prove its efficacy within applicable clinical trial formats and according to the relevant regulatory requirements. I can't speculate as to how long the FDA clearance process will take, and, therefore, it's hard to speculate when our product will be commercialized.

H.L.: What other products are you investigating and how may they work?

T.B.: We are focusing on bringing the SkinGun and our stem cell spray technology to market at this time.

H.L.: What is your background, including age, education, prior employment?

T.B.: Before joining RenovaCare I worked as the CEO of StemCell Systems GmbH, a Berlin-based biomedical company engaged in the development and commercialization of advanced cell culture bioreactors. I have more than 15 years of professional business experience in the field of medical biotechnology device manufacturing, stem cell culture technology platform development and regenerative medicine research project management and product development. I also co-founded several start-up companies in Germany.

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