Histogen Aesthetics Launches ReGenica Rejuvenation System

Natural embryonic-like human proteins stimulate skin cells to combat aging and help support healing

SAN DIEGO, April 27, 2009 - Histogen Aesthetics, a division of Histogen focused on providing unique, clinically proven, human skin cell-derived products for aesthetics medicine, today announced the launch of the ReGenicaTM Rejuvenation System for anti-aging and post-resurfacing.

Histogen Aesthetics utilizes a proprietary manufacturing process in which newborn dermal fibroblast cells are grown on beads in controlled bioreactors that maintain an embryonic-like environment, including low oxygen and low gravity conditions. During this process, the cells secrete growth factors such as Keratinocyte Growth Factor and Vascular Endothelial Growth Factor, and soluble extracellular matrix proteins such as collagens, laminin and decorin, which are associated with skin renewal and scarless healing. In addition, factors associated with scarring, such as TGFbeta, are decreased or nonexistent.

The resulting product is ReGenica, a complex made up of the naturally produced cell signaling materials and embryonic-like proteins which support the epidermal stem cells that renew skin throughout life.

Through Histogen's unique and proprietary technology process, Histogen Aesthetics is able to produce a skincare system that differentiates itself from other growth factor-containing skin products on the market. ReGenica:

  • does not contain any plant-derived growth factors or phytoestrogens which can be subject to seasonal variability and pesticide contamination
  • does not contain genetically-engineered growth factors (recombinant proteins)
  • does not contain fetal bovine or other animal serum, so no animal hormones are present

"Our patients undergoing cosmetics procedures are very interested in minimizing their downtime as well as minimizing their risk, and I believe the Histogen formulations do both," said Dr. Garth Fisher, renowned plastic surgeon and primary investigator on the first ReGenica post-resurfacing clinical study. "In addition, they have the added benefit of minimizing the risks associated with allergic responses from using animal products."

The ReGenica products are formulated based upon the results of randomized double-blind, placebo-controlled clinical studies, in which independent dermatologists both collected and blind-reviewed the data. In addition to before and after photographs, assessment of product efficacy was determined by instrumental assessment of transepidermal water loss (TEWL), viscoelasticity measurements and three dimensional image analysis of silicon replicas.

"As a participant in a ReGenica clinical study, I was impressed to see the rigorous and controlled trial process Histogen Aesthetics' products undergo," said Stephanie Parker, a patient in the ReGenica post-resurfacing clinical study. "I feel comfortable in knowing that any products released by the Company have been tested and proven safe and effective, and am excited that the anti-aging and post-resurfacing products will now be available. ReGenica products aren't just making claims - I saw real results."

Initial product launches in the ReGenica rejuvenation system include the ReGenica Facial Rejuvenation Complex for post-resurfacing, ReGenica Advanced Rejuvenation Day Repair with sunscreen and ReGenica Advanced Rejuvenation Overnight Repair. The system is now available at special introductory pricing through dermatologists, plastic surgeons and other aesthetic medicine professionals, and can also be purchased online through www.histogenaesthetics.com.

About Histogen Aesthetics
Histogen Aesthetics LLC, established in 2008 as a subsidiary of Histogen, Inc., focuses on the development of skin, hair and nail care products for the plastic surgery, dermatology and cosmetic industries. Histogen Aesthetics products are based on Histogen's core technology, in which newborn fibroblasts are grown in a proprietary simulated embryonic environment. From this process, Histogen Aesthetics extracts ReGenica, a unique complex containing naturally secreted growth factors and other synergistic bio-products. ReGenica is currently available as a treatment in the areas of post-resurfacing and anti-aging, with a planned product portfolio addressing a range of skin, hair, and nail care needs.

Histogen Aesthetics to Present Post-Resurfacing Clinical Study Results at AAD Annual Meeting

SAN FRANCISCO, March 4, 2009 - Histogen Aesthetics, a division of Histogen focused on providing clinically proven, human skin cell-derived products for aesthetics medicine, will present the results of the Company's second clinical study of ReGenicaTM for post-resurfacing at the American Academy of Dermatology annual meeting, taking place March 6-10, 2009 in San Francisco.

In this recent double-blind, controlled clinical study of 43 patients, ReGenica was used as a treatment following an ablative cosmetic laser procedure. Patients utilized the ReGenica product on one side of the face, and the vehicle control on the other, during the two week healing period following the laser procedure. The study revealed a significant reduction in epidermal water loss, as well as reduced erythema, edema and crusing, in comparison to the vehicle control.

"The ability to provide a treatment that results in less dramatic post-laser symptoms, and improved healing outcomes is key to plastic surgeons and their patients," said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. "We are excited to introduce products that have been uniquely developed from a regenerative medicine platform technology, and have been clinically proven effective."

Histogen Aesthetics will be introducing the ReGenica line of products for post-resurfacing and anti-aging this week, with product samples and special introductory pricing to patients. An official product launch is planned for late March.

Histogen Aesthetics utilizes a proprietary bioreactor process in which newborn dermal fibroblast cells are grown under unique conditions that simulate the embryonic environment. From this process, the Company extracts ReGenica, a complex made up of the naturally secreted proteins and growth factors produced by these fibroblasts.

ReGenica is composed of human growth factors such as Keratinocyte Growth Factor, soluble human ECM proteins such as collagen, and embryonic proteins which support the epidermal stem cells that renew skin throughout life. However, the ReGenica products do not contain human cells or animal byproducts, which can be found in other cell-based topical cosmeceutical products.

The electronic poster presentation, entitled Tissue-engineered human embryonic-like conditioned media for therapeutic applications, will be available for viewing throughout the American Academy of Dermatology Annual Meeting.

About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high- value products that do not contain embryonic stem cells or animal components. Through Histogen's proprietary bioreactors that mimic the embryonic environment, newborn fibroblasts are encouraged to naturally produce the vital proteins and growth factors from which the Company has developed its rich product portfolio. Histogen has two product families - ExceltrixTM, Histogen's human Extracellular Matrix (ECM) and ReGenicaTM, Histogen's proprietary liquid formula. For more information, please visit www.histogen.com