New cosmeceutical contains multi-potent growth factor

Suneva Medical launched its latest edition to the Regenica skin care line, Regenica Rejuvenating Dual Serum on April 5. The new anti-aging cosmeceutical, which is only available through physicians’ offices, is formulated with next generation growth factor technology, according to Gail Naughton, Ph.D.

Gail Naughton, Ph.D., CEO, chairman of the board at Histogen, which is the licensor of the patent and supplies Suneva with the line’s MRCx growth factor technology.

“Growth factors are important in reversing both the intrinsic and extrinsic signs of aging. … through the course of aging, even starting in our 30s, our skin cells start making less growth factors; they start making less collagen, less elastin. The skin thins out; the dermis decreases,” Dr. Naughton says. “What we really want to do is help reverse it, by being able to provide a growth factor that’s a type of replacement therapy. We need to go and replace the growth factor composition and quantity that you had when your skin was young….”

Dr. Naughton and colleagues discovered that by growing skin cells in low oxygen and suspension culture, which mimics embryonic conditions and a fetal environment, the cells begin to exhibit stem cell properties and secrete multipotent growth factors within two days.

“This is work that has been well published and has been the subject of a number of U.S. and foreign issued patents. The cells, themselves, start secreting robust amounts of growth factors that stimulate not only keratinocytes, fibroblasts, melanocytes and endothelial cells in your skin, but also stimulate stem cells,” Dr. Naughton says.

The MRCx growth factor composition, which is part of all Regenica products, is made by hypoxia-induced multipotent growth factors. It’s a composition of more than 120 growth factors that are known to enhance skin’s natural repair and renewal and combat the key signs of aging. Competing formulations, according to Dr. Naughton, have about 110 growth factors.

“The new product, the Regenica Rejuvenating Dual Serum … is the most potent formulation of naturally-secreted growth factors possible,” Dr. Naughton says.

Regenica Rejuvenating Dual Serum has two chambers. The first has a 95% concentration of MRCx, the company’s proprietary blend of growth factors, cytokines and proteins. The second chamber includes advanced copper peptides, amino acids, antioxidants and plant-based extracts.

Users pump the airless pump and mix the two chambers with their fingers before applying the cosmeceutical once in the morning and once at night.

In an ongoing clinical study where 40 women with varying Fitzpatrick skin types are using the Dual Serum twice daily, the investigator and/or subjects have reported significant improvements in four outcomes: skin hydration, radiance, firmness and the reduction of the appearance of fine lines, according to Dr. Naughton.

“We’re going to have 60-day data soon and will be going out to 90 days. But we were happy to see that, as early as 14 days, the patients reported a 17% reduction in the appearance of fine lines and, by 30 days, the 17% went up to 22% improvement in fine lines. In 30 days, the investigator also reported 31% improvement in the firmness of the skin, as well as a 31% improvement in the skin radiance. … there was improvement in skin hydration as early as 14 days, with a 33% improvement … at day 30,” Dr. Naughton says.

More than 97% of patients were satisfied with the serum at 30 days and would also recommend the product to a friend, according to company news.

Other important points noted by Dr. Naughton are that Regenica Rejuvenating Dual Serum does not include bovine, and serum cells for the product are grown in completely closed computer operated bioreactive systems.

“Instead of having the cells fed daily with bovine serum, which results in a very sticky and unpleasant odor, and some people are allergic to bovine materials, we were able to replace that with human recombinant albumin, which is therapeutic grade material. It has a very lovely consistency and fragrance,” she says. “The second thing is we grow our cells in completely closed computer operated bioreactive systems … so we do not have any need to have any artificial coloring in the material.”

The retail price of the product to the consumer is $250.00, according to Frank Fazio, vice president, corporate development at Suneva Medical.

“As is typical, the price point to the physician is half that. This product would be priced below the Skin Medica’s TNS Essential Serum and just above the NeoCutis Merz [Bio Serum Intensive Treatment, which retails for $235],” he says.