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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
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 ReGenica, Histogen's proprietary liquid formula.
Histogen Hair Regrowth Clinical Trial Results to be Presented at AAD Annual Meeting
SAN FRANCISCO, March 7, 2009 - Attendees of the American Academy of Dermatology Annual Meeting, taking place March 6-10, 2009 in San Francisco, will receive a peek of Histogen's preliminary hair regrowth clinical trial results in two presentations during the event. Data will be shared within an electronic poster from Histogen throughout the event, as well as within a podium presentation being given by Dr. Kenneth Washenik on advances in the treatment of hair loss on Sunday, March 8th.
Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, has recently released data from the 12 week timepoint of the Company's first human clinical evaluation of ReGenicaTM for hair regrowth. This clinical trial is the first time that a single application of a treatment has shown an increase in new follicles, thickness of existing hairs, and number of hairs in pre-existing follicles, in a human study.
ReGenica, a proprietary liquid containing naturally secreted embryonic proteins and growth factors, is the first naturally stabilized and bioactive formulation of Wnt proteins and natural cofactors, which have been implicated in the formation of new hair follicles.
"It is definitely exciting to see the laboratory promise of Wnt's effect on hair growth successfully translated into a clinical study," said Dr. Washenik, who is the Medical Director of Bosley, the nation's largest hair restoration group, and a faculty member in the Department of Dermatology at NYU's School of Medicine.
Histogen scientists reported on the upregulation of several Wnt genes in response to the embryonic conditions in the Company's proprietary bioreactors. In addition, the data has confirmed the activity of these Wnt proteins, through the nuclear translocation of beta catenin in human keratinocytes, the downstream signaling of Wnt-responsive TCF/ Lef promoter, and the presence of secreted Wnt 7a through western blot analysis.
Histogen began its outside-U.S. clinical trial of ReGenica for hair regrowth in November, with the goal of more rapidly obtaining human safety data which will allow the Company to progress with product development. Dr. Craig Ziering, the principal investigator on the trial, is a leading hair transplant specialist and the founder of Ziering Medical.
"For the millions of men and women who grapple every day with their hair loss, the results of our early testing indicate the potential for a phenomenal treatment option, particularly for women and men presenting with diffuse hair loss who are not good candidates for hair transplant surgery," said Dr. Ziering. "In addition to growing new hair, it increases the diameter of existing hair, creating more volume and coverage, which are the primary goals of those seeking help for their thinning or balding hair."
The trial is currently in progress, with the final scheduled 5 month timepoint upcoming. The Company expects to release full results from this first clinical trial in the first half of 2009.
Histogens' 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 ReGenica, Histogen's proprietary liquid formula.
Histogen to Present Preliminary Hair Regrowth Clinical Results at Stem Cell Summit
Company will Share Sneak Peek at Safety and Efficacy Results from In Progress Clinical Trial
NEW YORK, February 16, 2009 - Dr. Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts grown under embryonic conditions, will address attendees tomorrow at the 4th Annual Stem Cell Summit in New York. Dr. Naughton will be presenting preliminary mid-trial results from Histogen's first human clinical evaluation of ReGenicaTM for hair regrowth.
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The primary objective of this double-blind, placebo-controlled, randomized study is to evaluate safety in the clinical application of the ReGenica product for hair regrowth. Histogen is also examining product efficacy as a secondary objective, specifically looking at the same end-points the Company has seen in the animal model - new hair growth, and the thickness of new and existing hair. The study is in progress, but the Company has reviewed data from the scheduled 12 week time point and is pleased with the results to date.
"Histogen's clinical trial was designed to assess the safety of its product over a five month period," commented Dr. Craig Ziering, principal investigator of the study and founder of Ziering Medical. "In addition to seeing no adverse reactions, we were delighted to see more hair, thicker hair shafts, and what appears to be the growth of completely new hair follicles in the areas that received the ReGenica treatment."
ReGenica is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment, and then harvesting the naturally secreted embryonic wnt proteins, growth factors, and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors, which are thought to act in the formation of new hair follicles.
"Wnt signaling has been shown to be responsible for initiating epidermal stem cells to form new hair follicles in mice, and is also important in maintaining the hair inducing activity from existing follicles," said Frank Zeigler, General Manager at Histogen. "We are excited to be the first group to show these effects in a clinical setting using human WNT proteins."
Histogen began this outside-U.S. study of ReGenica for hair regrowth in November, with the goal of more rapidly obtaining human safety data which will allow the Company to progress with product development. The trial is currently ongoing, and Histogen expects to release full results from this first clinical study in the first half of 2009.
Dr. Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. Dr. Naughton founded Histogen in 2007, and currently serves as Chief Executive Officer and Chairman of the Board for the Company, in addition to her position as Dean of the College of Business at San Diego State University.
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 ReGenica, Histogen's proprietary liquid formula.
Histogen Welcomes Dr. Hyma Gollamudi as Chief Business Officer
Regenerative Medicine Company Poised for Business Growth
SAN DIEGO, December 03, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, announced today that Dr. Hyma Gollamudi has joined the Company as Chief Business Officer. Gollamudi's business and product development expertise will be invaluable as Histogen begins seeking strategic alliances nationally and internationally.
"With our early-stage product launches underway, and exciting projects coming quickly down the pipeline, Histogen is increasingly examining relationships with companies, physicians and investors," said Dr. Gail Naughton, Histogen CEO and Chairman of the Board. "I am excited to welcome Hyma Gollamudi to Histogen, and look forward to seeing the Company's business development and strategic planning efforts flourish through her oversight and experience."
Dr. Gollamudi brings more than 10 years of experience from the healthcare and financial industries to Histogen. Most recently, she served as a Product Director in the healthcare division of Fair Isaac Corporation, a leading provider of analytics and decision management technology. In this position, Dr. Gollamudi oversaw alliances and partnerships and grew the Company's government (Medicare and Medicaid) and commercial business through dedicated attention to client relationships and client managements.
Dr. Gollamudi has authored a number of papers, presented at various healthcare conferences and working groups, and is the co-inventor on two patents. She holds a doctorate in Agricultural Economics from the Ohio State University.
"Histogen's broad range of product applications from a single technology platform is intriguing, and offers almost limitless opportunities in markets from research tools to cosmetics," said Gollamudi. "I am excited to work toward forming alliances, navigating products through reimbursement hurdles, and contributing to the Company's success in various markets."
Through the Company's proprietary bioreactor technology, Histogen is uniquely capable of simulating the embryonic environment, creating products that are embryonic in nature without containing embryonic stem cells or animal components. From two product families - ExCeltrixTM, Histogen's insoluble human Extracellular Matrix (ECM), and ReGenicaTM, Histogen's proprietary liquid complex - the Company has created a product portfolio which includes applications from stem cell culturing to skin care, tissue regeneration to hair regrowth.
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 recently launched its first product - BioNuesisTM Human Stem Cell Culturing Kits - and announced the creation of its cosmeceutical venture - Histogen Aesthetics.
Histogen Announces Start of Hair Regrowth Clinical Evaluation
SAN DIEGO, November 20, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced the start of the Company's first human clinical evaluation of ReGenica for hair regrowth. The primary objective of the study is to evaluate safety in the clinical application of the ReGenica product.
ReGenica is a proprietary liquid formula created by the culturing of newborn fibroblasts in an embryonic-like environment, and then harvesting the naturally secreted growth factors, anitoxidants and other synergistic bioproducts that are produced. It is the first naturally stabilized and bioactive formulation of wnt proteins and natural cofactors, which are thought to act in the formation of new hair follicles.
Histogen's in-vitro and preclinical research to date has shown ReGenica to be safe, and has indicated the complex's ability to increase hair growth and new follicle formation. Based on the results of preliminary research, and the potential of ReGenica as a hair regrowth treatment, Histogen has moved forward with this outside-U.S. study to more rapidly obtain human safety data which will allow the Company to progress with product development.
We are excited to be on schedule with the initiation of our first human clinical evaluation of ReGenica for hair growth," said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. "We look forward to the results of this preliminary safety evaluation, which we can parlay into further studies."
The ReGenica study, which began today, will be a double-blind, placebo-controlled, randomized single site study. Dr. Craig Ziering, renowned hair transplant surgeon and founder of Ziering Medical, is serving as Principal Investigator on the study with Dr. David Perez-Meza as Sub-Investigator. Results of this first human hair regrowth product clinical evaluation will be released by Histogen in the first half of 2009.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.
Dr. Gail Naughton Speaks on Histogen's Business Plan and the Rise of Bioaesthetic Medicine during Commercial Translation of Regenerative Medicine
ExCeltrix Preliminary Oncology Data Presented for the First Time
SAN DIEGO, November 17, 2008 - Dr. Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today addressed attendees at the 6th Annual Commercial Translation of Regenerative Medicine conference, taking place November 17-18, 2008 in London. Dr. Naughton examined the growing bioaesthetic medicine industry, as well as shared Histogen's business plan for near-term regenerative medicine products focused on anti-aging and post-resurfacing treatments, at the event.
"Due to long timelines in the development of medical devices and pharmaceuticals, Histogen is taking advantage of the unique opportunity to enter the growing $4.5 billion global aesthetic medicine market, to help generate early revenues and allow the Company to continue to fund the development and clinical evaluation of future products," said Dr. Lawrence Rheins, President of Histogen Aesthetics LLC. "The newly formed Histogen Aesthetics division addresses this market, offering scientific and clinically-proven products based on Histogen's proprietary technology, for skin hair and nail products dispensed by physicians."
Histogen Aesthetics' initial product line will be focused on ReGenica, the Company's unique complex made up of the naturally secreted growth factors, antioxidants and other synergistic bio-products that are produced by newborn fibroblasts. Product launches in the areas of anti-aging and post-resurfacing are scheduled for early 2009.
In addition to ReGenica, Dr. Naughton spoke to Histogen's plan to bring their human embryonic-like extracellular matrix product, ExCeltrix, into clinical trials as an injectable for wrinkles and deep furrows.
"ExCeltrix, Histogen's unique human extracellular matrix which is grown in a simulated embryonic environment, is currently being evaluated for a variety of applications, from dermal fillers to implant coatings," said Dr. Robert Kellar, VP of Research and Development at Histogen. "Intriguing preliminary results from ongoing ExCeltrix research shows promise of in the field of oncology."
Dr. Naughton presented data for the first time supporting the ability of ExCeltrix to diminish or eliminate tumor load in preclinical trials. Studies were performed with three rapidly growing human tumor cell lines: melanoma, adenocarcinoma, and glioma. Cancer cells were either mixed with ExCeltrix or delivered alone in two preclinical models. In the CAM model (chollioallantoic membrane) tumor mass was significantly reduced by the presence of ExCeltrix. In the nude mouse model, cells with ExCeltrix showed little to no tumor growth, in comparison to the control which did form palpable tumors.
Dr. Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. Dr. Naughton founded Histogen in 2007, and currently serves as Chief Executive Officer and Chairman of the Board for the Company, in addition to her position as Dean of the College of Business at San Diego State University.
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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.
Recognized Dermatology Expert Dr. Zoe Draelos Joins Histogen Scientific Advisory Board
SAN DIEGO, November 13, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Zoe Diane Draelos, M.D., clinical and research dermatologist and President of Dermatology Consulting Services, has joined the Company's Scientific Advisory Board.
Dr. Draelos is a board certified dermatologist in private practice, and a recognized expert in cosmetic and biologically active skin medication research. As President and Primary Investigator for Dermatology Consulting Services, a company she founded in 1988, Dr. Draelos is focused on providing education, developing formulation technology, and conducting clinical studies in association with the pharmaceutical and cosmetics industry.
Histogen recently announced the creation of Histogen Aesthetics LLC, a venture developing products for the growing medical aesthetic industries based on the Company's core technology. Dr. Draelos' addition to the Scientific Advisory Board will be invaluable as Histogen Aesthetics moves forward with product launches and further clinical evaluations in this area.
"To have Dr. Draelos, a renowned dermatologist, and skin biologist with focused expertise in cosmetic dermatology, join Histogen's SAB validates our technology and potential for treatments in the growing specialty of aesthetic medicine," stated Lawrence A. Rheins, Ph.D., President of Histogen Aesthetics LLC. "We are excited to have the opportunity to utilize her insight and clinical expertise as we prepare for product launches in post-resurfacing and anti-aging in early 2009, and continue development of additional skin, hair, and nail care products in the aesthetic medicine arena."
Dr. Draelos has served as Principal Investigator on more than 200 clinical trials, is a national and international speaker, and has been the recipient of numerous research grants. She is also a significant contributor to medical literature, with more than 200 articles and 25 book chapters to her credit. She is the author of the text Cosmetics in Dermatology, now in its third edition, and Hair Care, as well as serving as the editor for the textbook Cosmeceuticals, which has been translated into 5 languages.
Complementing her writing endeavors, Dr. Draelos serves on 8 editorial boards, including Cosmetic Dermatology, The International Journal of Cosmetic Science, Dermatologic Surgery, and Dermatology Times. She also serves as editor-in-chief of the Journal of Cosmetic Dermatology.
Dr. Draelos is a fellow and past board member of the American Academy of Dermatology and a member of the American Dermatological Association, the Society for Investigative Dermatology, the American Society of Mechanical Engineers, among others. A former Rhodes Scholar, Dr. Draelos has been the recipient of many awards and honors in recognition of her professional and academic accomplishments. She was recently given a Lifetime Achievement Award for her research from Health Beauty America, a professional skin care and cosmetics industry organization.
"The rapid development of the sub-specialty of cosmetic dermatology, with a growing focus on basic and clinical research into all aspects of cosmetic medicine, requires new technological advances to address the complexities for this growing area of medicine," commented Draelos. "Histogen scientists have developed a technology that may address many future clinical challenges of aesthetic medicine."
Histogen Aesthetics LLC, established in 2008 as a subsidiary of Histogen, Inc., focuses on the development of skin and hair care products for the plastics 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-like environment. From this process, Histogen Aesthetics extracts ReGenica, a unique complex containing naturally secreted growth factors, antioxidants and other synergistic bio-products. ReGenica is currently undergoing clinical studies as a treatment in the areas of post-resurfacing and anti-aging, with a planned product portfolio addressing a range of skin and hair care needs.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
Histogen Aesthetics is Created to Address Growing Medical Aesthetics Market
Dr. Lawrence A. Rheins Joins Histogen Aesthetics as President
SAN DIEGO/ PHOENIX, October 20, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn dermal fibroblasts, today announced the creation of Histogen Aesthetics LLC, a venture developing products for the growing medical aesthetic industries based on Histogen's core technology.
From a proprietary bioreactor process in which newborn fibroblasts are grown under proprietary embryonic-like conditions, Histogen Aesthetics extracts a unique
complex - ReGenica - made up of the naturally secreted growth factors, antioxidants and other synergistic bio - products that are produced. This complex will become the active ingredient in the Histogen Aesthetics line of products for skin, hair and nail care.
A recent clinical study of 49 patients, in which ReGenica was used as a treatment following an ablative cosmetic laser procedure, revealed improvement of overall skin condition in comparison to the vehicle control. Histogen Aesthetics is beginning follow - up studies of ReGenica for post - laser resurfacing, as well as topical skin and hair
anti - aging applications.
Dermatology, cosmetics and biotechnology industry veteran Lawrence A. Rheins, Ph.D. has joined Histogen Aesthetics, LLC as President.
"The market for next generation, novel cosmeceuticals is rapidly evolving, including the movement of physician - dispensed, non - prescription products beyond the traditional medical specialties of plastic surgery and cosmetic dermatology, and into other medical specialties," said Rheins. "There is a continuing need for adjunct palliative skin conditioning products for use following all sorts of minimally and more invasive cosmetic procedures - laser, dermabrasion - by physicians engaged in aesthetic medicine."
Based on Histogen Aesthetics' initial studies, the Company believes that the proteins and growth factors within ReGenica work synergistically with the skin and hair's own physiology to combat the effects of the normal aging process, making the complex ideal for a breadth of advanced aesthetic products.
"Of the numerous products on the market, few have robust controlled scientific data to support claims of clinical improvement," continued Rheins. "Our goal is to create a line of skin, hair and nail care products that are not only sensorially appealing to consumers, but are based on the proven results of controlled clinical studies. I am excited to announce the creation of Histogen Aesthetics, and look forward to the launch of our first skin care products for the physician - dispensed medical aesthetics arena."
Dr. Rheins joins Histogen Aesthetics from the cosmetic/ personal care industry, and brings a rich, varied background in research dermatology, tissue engineering and contract research clinical services. Most recently, he served as Vice President of Science and Technology at Floratech International, a raw material supplier of botanical - derived ingredients for the cosmetic and personal care industries. Prior to this, Dr. Rheins founded DermTech International; a biotechnology company focused on dermatologic, "point of care" diagnostics, and was co-inventor of the Company's proprietary Epidermal Genetic Information Retrieval (EGIR) technology.
Dr. Rheins was also previously Executive Director at Advanced Tissue Sciences, a tissue engineering company focused on the growth of human skin and other tissues. He served as Director of pre - clinical/ clinical CRO services at Hill Top Research, and Divisional Toxicologist and Skin Laboratory Manager with Procter & Gamble. Prior to his industry career, Dr. Rheins served as Assistant Professor of Dermatology, at the University of Cincinnati, College of Medicine. Dr. Rheins holds several patents, and has authored more than 50 articles and book chapters on immunology, toxicology, dermatology and in vitro alternatives.
Histogen Aesthetics is currently focusing on the development of the ReGenica line of products, with launches beginning in the first quarter of 2009. These products will be distributed through Secure Medical, a technology and health care solutions provider based in Tempe, Arizona. Secure Medical already partners with Histogen to distribute its first product, the BioNuesis Human Stem Cell Culturing Kit.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high - value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula. Histogen Aesthetics can be found online at www.histogenaesthetics.com.
About Secure Medical
Secure Medical is a privately held company based in Tempe, Arizona. The company possesses ownership and interests in a variety of business models, all related to the medical industry. The following solutions are among those provided by Secure Medical: medical processing and fulfillment services/ call center capabilities;
telemedicine/ telehealth services in conjunction with the American Telemedicine Association; and patented medical kiosk manufacturing/ creation of associated software and hardware. Secure Medical is a biotech industry partner with Histogen, Inc. of San Diego, and its newest venture, Histogen Aesthetics. Histogen provides products that are naturally produced, for regenerative medicine and stem cell research.
Histogen Launches BioNuesis, the Only All-Human Stem Cell Culturing Kit
SAN DIEGO, September 22, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today launched BioNuesis, the only soluble human extracellular matrix (ECM) developed as a culturing kit for stem cell growth. The kit was launched and is being exhibited at the 2008 World Stem Cell Summit taking place in Madison, Wisconsin.
Through its proprietary bioreactors, Histogen is uniquely capable of simulating the embryonic environment, creating products that are embryonic-like in nature without the utilization of embryonic stem cells. Products are developed by extracting the proteins and growth factors produced by these fibroblasts. In working with the unique liquid formulation, Histogen researchers identified the potential for the human soluble ECM in the field of stem cell research, as compared to currently available products.
"There is a significant need for an all-human ECM product that can support pluripotent huES cell expansion in culture, without the complications inherent with mouse tumor-derived ECM extracts that are still the best replacement for feeder-layer cells," Dr. Jeanne Loring, Director of the Center for Regenerative Medicine at Scripps Research Institute. "Histogen's technology may provide the solution and help accelerate both basic science and translational research using huES cells."
BioNuesis is the first product that provides a limitless source of the natural human ECM proteins, such as laminin, collagen type 4 and fibronectin, which are required to expand human ES cells to commercial-scale.
Because current products utilize non-human sources, and can even contain mouse viruses, stem cell therapies developed using these animal products are not likely to be approved by the FDA. The technology behind the BioNuesis research kit, soluble natural human ECM, offers a solution which will eventually facilitate translation of stem cell cures to the public.
The launch of BioNuesis marks the entrance of Histogen into the marketplace as a number of products based on Histogen's proprietary technology continue down the pipeline.
"Histogen is uniquely capable of utilizing every aspect of the liquid and solid created by the Company's proprietary technology process, and developing high-value, all-human products at a commercial scale," said Dr. Gail Naughton, CEO of Histogen. "We are excited to bring our first product to the stem cell research market, and look forward to launching products in the cosmeceutical and medical fields in the near future."
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and ReGenica, Histogen's proprietary liquid formula.
About the World Stem Cell Summit
The World Stem Cell Summit, to be held Sept. 22-23, 2008 at Madison's Alliant Center, is a gathering of scientists, company leaders, ethicists, investors and others. The Summit will provide an opportunity for the exchange of important stem cell information among key players from throughout the globe. The event will coincide with the 10-year anniversary of UW-Madison scientist James Thomson becoming the first to successfully isolate and culture human embryonic stem cells. For more information about the Summit, visit www.worldstemcellsummit.com.
Stem Cell Research Expert Dr. Jeanne Loring Joins Histogen Scientific Advisory Board
SAN DIEGO, July 17, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Dr. Jeanne Loring, internationally recognized authority in the field of stem cell research, has joined Histogen's Scientific Advisory Board.
As founding Director of the Center for Regenerative Medicine at Scripps Research Institute in La Jolla, Calif., Dr. Loring focuses on supporting collaboration and strategic partnerships in human stem cell research, as well as training the next generation of stem cell scientists. She also currently serves as Professor of Developmental Neurobiology with the Institute.
"Dr. Loring's knowledge and background in the growing field of stem cell research will be an invaluable addition to Histogen's Scientific Advisory Board," said Dr. Robert Kellar, Vice President of Research & Development for Histogen. "We are excited to utilize her expertise as we move forward with research, and prepare to launch our first product, a research kit for stem cell growth."
Dr. Loring's extensive experience in the field includes research and management positions at biotechnology companies such as Hana Biologics, GenPharm International, Molecular Dynamics, and Incyte Genomics, as well as founding and serving as chief scientific officer of Arcos BioScience (now part of Novocell). Most recently, Dr. Loring acted as Co-director of the Stem Cell Center at Burnham Institute for Medical Research.
"Histogen's unique technology shows significant promise for the fields of regenerative medicine and stem cell research," said Dr. Loring. "I look forward to contributing to the Company's research initiatives and product development."
Histogen's proprietary bioreactor technology enables the Company to simulate the embryonic environment, creating products that are embryonic-like in nature with a variety of product applications from research kits to hair growth.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
CSUPERB Executive Director Dr. Susan Baxter Joins Histogen Board of Directors
SAN DIEGO, July 09, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Dr. Susan M. Baxter, Executive Director of the California State University Program for Education and Research in Biotechnology (CSUPERB), has joined Histogen's Board of Directors.
As Executive Director of CSUPERB, Dr. Baxter works with California State University (CSU) students, faculty and administrators system-wide to provide top-tier biotechnology education, capabilities and real-world research experience. CSUPERB serves as a liaison between the CSU and industry, academia, government, and the public in biotechnology matters.
"We are excited to welcome Dr. Susan Baxter to Histogen's Board," said Dr. Gail Naughton, CEO and Chairman of the Board for Histogen. "As someone with her finger on the pulse of the industry, Dr. Baxter will be an invaluable asset to Histogen as we grow the company and our presence in the regional biotechnology sector."
Previously, Dr. Baxter served as Chief Operating Officer at the National Center for Genome Resources in Santa Fe, New Mexico, where she managed a portfolio of state - and federal-funded projects providing information technology for collaborative, interdisciplinary biotechnology research and education. Prior to this, Dr. Baxter served as Vice President of Research and Genome Analysis for GeneFormatics, later Cengent Therapeutics, a drug discovery company in San Diego. In this position, she managed programs in both target and lead discovery.
"I think Histogen's unique business model and rich product portfolio poise the Company to become a leader in the regenerative medicine field, and offer compelling opportunities for collaborations with other industry innovators" said Dr. Baxter. "I look forward to contributing to Histogen's success, and continuing to develop the region's life sciences community in this exciting, fast growing field."
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
Histogen Presents at ASAIO Annual Conference
| WHO: | Gail Naughton, Ph.D, Histogen CEO and Chairman of the Board Robert Kellar, Ph.D., Histogen Vice President of Research & Development |
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| WHAT: | Dr. Kellar to present "Tissue-Engineered Human Embryonic Extracellular Matrix for Therapeutic Device Applications"
Dr. Naughton to present "A Unique Business Model - Regenerative Medicine Redefined" |
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| WHEN: | June 19-21, 2008 | |
| WHERE: | American Society for Artificial Internal Organs Annual Conference Hilton San Francisco 333 O'Farrell Street San Francisco, CA 94102 |
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| TOPIC: | "Tissue Engineered Human Embryonic Extracellular Matrix for Therapeutic Device Applications" Thursday, June 19, 2008 at 1:30pm |
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| "A Unique Business Model - Regenerative Medicine Redefined" Friday, June 20, 2008 at 11:00am |
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About Gail Naughton, Ph.D.
In addition to serving as CEO of Histogen, Dr. Gail Naughton has been the Dean of the College of Business Administration at San Diego State University since August 2002. Prior to that, she spent more than 15 years at Advanced Tissue Sciences, where she was the company's co-founder and co-inventor of its core technology. During her tenure there, Dr. Naughton held a variety of key management positions, including president. While serving as an officer and director of the Company, Dr. Naughton oversaw the design and development of the world's first up-scaled manufacturing facility for tissue engineered products, established corporate development and marketing partnerships with companies including Smith & Nephew, Ltd., Medtronic and Inamed Corporation, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four fibroblast-based products from concept through FDA approval and market launch.
Dr. Naughton holds over 90 U.S. and foreign patents and has been extensively published in the field of tissue engineering. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering. Dr. Naughton has continued her research in cell based products for the last 5 years and in June of 2007 founded Histogen, which is focused on insoluble human extracellular matrix proteins and soluble protein products manufactured by human neonatal fibroblasts under embryonic (hypoxic) conditions.
About Robert Kellar, Ph.D.
Dr. Kellar has more than 11 years of experience in research and product development. Dr. Kellar has joined Histogen from his positions as co-owner and President of Development Engineering Sciences, a firm based in Flagstaff, Arizona. Kellar's experience in the biomedical industry includes prior positions with W.L. Gore & Associates and Advanced Tissue Sciences, where he was involved with commercial worldwide management of research, product development, business, marketing, and sales.
Kellar has authored over 7 papers and is the inventor on 5 patents and patent applications. Kellar serves on the Scientific Advisory Board for Theregen, a cell therapy company investigating the cardiovascular applications of the cell-based human tissue patch, AngineraTM. Dr. Kellar also holds an Adjunct Professor Faculty position in Mechanical Engineering at Northern Arizona University.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
Dr. Gail Naughton to Present Histogen as Part of the BIO Biotechnology Entrepreneurship Bootcamp
| WHO: | Gail Naughton, Ph.D, Histogen CEO and Chairman of the Board | |
| WHAT: | Local Company Pitch Presentation: Histogen, Inc. | |
| WHEN: | June 17, 2008 at 1:45pm | |
| WHERE: | Biotechnology Entrepreneurship Bootcamp (BIO 2008) San Diego Convention Center Room 32AB 111 West Harbor Drive San Diego, CA 92101 |
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| TOPIC: | Local Company Pitch to VCs: Histogen, Inc. | |
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About Gail Naughton, Ph.D.
In addition to serving as CEO of Histogen, Dr. Gail Naughton has been the Dean of the College of Business Administration at San Diego State University since August 2002. Prior to that, she spent more than 15 years at Advanced Tissue Sciences, where she was the company's co-founder and co-inventor of its core technology. During her tenure there, Dr. Naughton held a variety of key management positions, including president. While serving as an officer and director of the Company, Dr. Naughton oversaw the design and development of the world's first up-scaled manufacturing facility for tissue engineered products, established corporate development and marketing partnerships with companies including Smith & Nephew, Ltd., Medtronic and Inamed Corporation, was pivotal in raising over $350M from the public market and corporate partnerships, and brought four fibroblast-based products from concept through FDA approval and market launch.
Dr. Naughton holds over 90 U.S. and foreign patents and has been extensively published in the field of tissue engineering. In 2000, Dr. Naughton received the 27th Annual National Inventor of the Year award by the Intellectual Property Owners Association in honor of her pioneering work in the field of tissue engineering. Dr. Naughton has continued her research in cell based products for the last 5 years and in June of 2007 founded Histogen, which is focused on insoluble human extracellular matrix proteins and soluble protein products manufactured by human neonatal fibroblasts under embryonic (hypoxic) conditions.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
Histogen to Present Human ECM for Stem Cell Culture Applications at ISSCR Annual Meeting
| WHO: | Frank Zeigler, General Manager of In Vitro Products for Histogen, Inc. | |
| WHAT: | Poster Presentation: "Production of Human Extracellular Matrix (ECM) for Stem Cell Culture Applications" | |
| WHEN: | June 11 - 14, 2008 | |
| WHERE: | International Society for Stem Cell Research (ISSCR) Annual Meeting Pennsylvania Convention Center 1101 Arch Street Philadelphia, PA 19107 |
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| TOPIC: | "Production of Human Extracellular Matrix (ECM) for Stem Cell Culture Applications" | |
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| Attendees are invited to visit Histogen's poster presentation in the exhibit area from 5:30 - 7:00pm, June 11, 12 and 13, 2008. |
About Frank Zeigler
Frank Zeigler serves as General Manager of In Vitro Products for Histogen. He has more than 18 years of experience in research and product development, previously serving as senior scientist and project manager with biotechnology companies including Genentech, Advanced Tissue Sciences, and Stem Cells Inc. Recently, Zeigler was founder and CSO of Orion Biosolutions, a start-up biotech company, where he developed and brought research kit products to market. He has 8 peer-reviewed research publications and holds 3 issued US patents in the field of cell biology and cell analysis.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
Histogen Presents Feasibility Data on Hair Growth and Laser Resurfacing
Evaluations of HGEN-001 formulation indicate capabilities for new hair follicle creation and more rapid healing post-laser resurfacing
SAN DIEGO, CA May 16, 2008 - Histogen Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today presented findings from preliminary evaluations of the Company's HGEN-001 formulation, during International Investigative Dermatology 2008, taking place May 14-17, 2008 in Kyoto, Japan.
Histogen's HGEN-001 liquid formulation is produced through a proprietary bioreactor system which simulates the embryonic environment, including hypoxic conditions of 3-5% oxygen. Under these conditions, a number of growth factors key to tissue development and regeneration are significantly elevated, specifically WNT proteins 5A, 6, 7A, 10A and 11. HGEN-001 is the first evidence of naturally-secreted, native human WNT proteins in a commercially scalable growth system.
The HGEN-001 formula was evaluated as a post-laser resurfacing treatment in 49 patients, with 26 receiving a placebo gel and 23 receiving a gel with HGEN-001. The products were applied several times per day for 8 days, after a micro-fractional ablative and non-ablative laser treatment to the face. Patients were monitored for 14 days with mexameter readings, survey data, as well as independent clinical assessment of re-epithelialization.
The preliminary results indicate that patients receiving the active HGEN-001 product experienced less dramatic post-laser symptoms, such as erythema, edema, and flaking, with a more rapid recovery when compared to the placebo group. The data suggests that topical application of a skin gel supplemented with HGEN-001 can provide overall improved visible re-epithelialization of post ablative laser facial skin, and thereby accelerate patient recovery, while keeping superficial cutaneous side effects to a minimum.
"The ability to provide a treatment that results in better patient comfort and overall healing outcomes is key to many plastic surgery treatments," said Dr. Mark Hubka, Histogen's Director of Clinical Affairs. "Histogen is dedicated to developing a product pipeline to provide multiple patient benefits post dermatological and plastic surgery procedures."
Because of the native soluble WNT proteins and growth factors contained in the formula, HGEN-001 was also evaluated as a stimulus for new hair follicle creation. In the C57 Bl mouse model, an animal model widely used for hair growth, HGEN-001 was shown to significantly increase hair growth and new follicle formation.
"HGEN-001 induced a significant increase in hair follicle growth, as compared to the control, in our preclinical model," Said Frank Zeigler, General Manager of In Vitro Products for Histogen. "Researchers have reported the importance of wnt proteins and wound healing growth factors in the induction of new hair follicles for over a decade. Our research helps to substantiate the importance of these active agents in follicular neogenesis, all of which are components in HGEN-001."
Clinical trials for HGEN-001 as an application for hair growth are planned for late 2008.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
Secure Medical CEO John Rao Joins Histogen Board of Directors
SAN DIEGO, May 9, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that John Rao, founder and CEO of Secure Medical Inc., a medical technology company, has joined Histogen's Board of Directors.
Within the medical field, Mr. Rao is an accomplished entrepreneur, innovator, and strong patient rights advocate, including his involvement with the American Telemedicine Association and his current patents relating to remote health kiosks and glyph identification. Mr. Rao founded Tempe-based Secure Medical in 1999 to bring healthcare services closer to patients through telemedicine, telehealth and telecare applications.
"John Rao's background in technology innovation, and success within the medical industry, make him a prime addition to our Board of Directors," said Dr. Gail Naughton, Histogen CEO and Chairman of the Board. "We look forward to tapping into John's expertise as Histogen moves forward with manufacturing, research and development, and product launches."
In addition to Secure Medical, Mr. Rao has owned and operated 14 technology-driven companies spanning a variety of industries including retail, wholesale, manufacturing and product development, as well as computer sciences and security driven methodologies. His passion for technology spans over 40 years, and he holds a number of patents and patent applications for innovative technologies.
"I am pleased to join Histogen's Board of Directors, and excited to contribute to the Company's success at this stage of tremendous growth," said Rao. "Histogen's unique technology platform, which has enabled the development of an extensive product portfolio from a single manufacturing process, gears the Company to become a leader in the industry."
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
Histogen Announces Initial Close of Series A Financing Round
SAN DIEGO, May 2, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced the initial close of Series A financing at $5.35 million. The round was completed by private and corporate investors, including Secure Medical Inc., CellCeuticals Skin Care Inc., and Leonard H. Lavin, founder and Chairman Emeritus of the Alberto-Culver Company.
Histogen will utilize the round to fund Phase 1 clinical trials for hair growth and complete 510k submissions for wound and hernia repair applications. The round will also enable the Company to upscale manufacturing for Exceltrix, Histogen's human Extracellular Matrix product, and HGEN-001, Histogen's proprietary liquid formulation.
"We are pleased that we have exceeded our original target for the Series A round, and have added highly experienced investors to our list of shareholders," said Gail K. Naughton, Ph.D., CEO of Histogen. "With the close of this financing, we look forward to bringing additional talent to our already seasoned team, and getting our first products to market within the next 12 months."
The initial close of Series A financing will allow Histogen to maintain timelines for product introductions, including the Company's first tissue engineering products, which are slated for launch in late 2008 and early 2009. From two product families, Exceltrix and HGEN-001, which are derived from a single manufacturing process, Histogen forsees a breadth of applications in a variety of markets, from research tools to cosmeceuticals.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
Hair Restoration Specialist Dr. Craig Ziering Joins Histogen Scientific Advisory Board
SAN DIEGO, April 23, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Dr. Craig Ziering, renowned hair transplant surgeon and founder of Ziering Medical, has joined Histogen's Scientific Advisory Board.
A leading authority in hair transplant surgery, Dr. Ziering has performed over 12,000 procedures in his career, and currently operates hair restoration centers in California, Utah and Nevada. He is certified by both the American Board of Hair Restoration Surgery and the American Osteopathic Board of Dermatology, serves on the advisory board for companies including Merck and Lexington International, and is Surgical Faculty for the Procedural Dermatology Fellowship at the University of California at Irvine.
Dr. Ziering is recognized as an expert in the art and science of hair transplant surgery, including his work as an Extreme Team Surgeon for television's Extreme Makeover and appearances on Dr. 90210 and the Today Show. He also remains an active participant in research, and serves as a strong advocate of hair cloning as a future treatment for hair loss.
"Dr. Ziering's expertise in the areas of hair growth and restoration will be invaluable to Histogen as the Company moves toward clinical trials for our HGEN-001 formula as an injectable for hair growth," said Dr. Robert Kellar, Histogen's Vice President of Research and Development. "His understanding of maintaining and stimulating healthy hair follicles and his clinical background make him an ideal addition to Histogen's Scientific Advisory Board."
Histogen's proprietary HGEN-001 liquid formula has potential in a variety of areas from research to cosmeceutical products, but the Company sees hair regrowth as a homerun application with real potential impact. The formula's unique combination of proteins and growth factors has been shown to both stimulate resting hair follicles and induce new follicle formation.
"I am excited to join Histogen's Scientific Advisory Board, and look forward to bringing this promising product through clinical trials," said Dr. Ziering. "Recent research findings on the capabilities of wnt proteins and growth factors to induce hair follicle formation are compelling, and show great potential for the more than 50 million Americans affected by hair loss."
Histogen's injectable for hair growth will begin clinical trials in late 2008, with product launch planned for 2015. Data will be presented at International Investigative Dermatology 2008, taking place May 14-17, 2008 in Kyoto, Japan.
About Histogen
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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 - Exceltrix, Histogen's human Extracellular Matrix (ECM) and HGEN-001, Histogen's proprietary liquid formula.
About Ziering Medical
Ziering Medical was established in April of 2003 as a private practice dedicated exclusively to the specialty of hair restoration. Founder and Medical Director Dr. Craig L. Ziering is an industry pioneer, leader and lecturer who remains in constant pursuit of seeking and developing new technology such as the Ziering Whorl and Sneak Peek Long Hair Transplant. Ziering Medical performs facial hair aesthetics and corrective procedures for scars, as well as laser therapy and medical solutions for men and women. By combining art and science to create exceptional, natural looking results, Dr. Ziering's refined eye for aesthetics perfectly complements his advanced surgical skills. Providing excellence in hair restoration to patients from around the world, Ziering Medical is headquartered in Beverly Hills with offices in Newport Beach, Encino, Rancho Mirage, California, Las Vegas, Nevada and Salt Lake City, Utah. For more information, visit www.zieringmedical.com
Alberto-Culver Founder Leonard Lavin Joins Histogen Board of Directors
SAN DIEGO, February 14, 2008 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, today announced that Leonard Lavin, founder and chairman emeritus of the Alberto-Culver Company, has joined Histogen's Board of Directors.
In addition to his distinguished career with Alberto-Culver, a Fortune 1000 consumer products company, Leonard Lavin's experience and interests cross various industries. In 1946, Lavin joined Halgar, Inc., a company specializing in toiletry products, where he was instrumental in building the company into one of the leaders in its field. Lavin also formed the Excello Sales Agency, where he gained exclusive advertising and sales rights for Stopette spray deodorant, which went on to become the number one product of its kind.
Leonard Lavin and his wife Bernice bought Alberto-Culver Company in 1955 for $400,000, and turned it into a multi-billion dollar company. By positioning his products and making innovative use of television advertisements, Lavin has supplied the world with some of the most well known hair, skin and personal care products.
"Mr. Lavin's extraordinary business acumen will be invaluable as Histogen enters a tremendous stage of growth in 2008," said Gail K. Naughton Ph.D., Histogen founder and Chairman of the Board. "Leonard has proven himself to be a marketing genius, and having someone with his expertise join the board truly validates Histogen's distinctive business model."
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. The company's business plan benefits from the lessons learned at Advanced Tissue Sciences, and focuses on near, mid and long term products that are either self-pay or reimbursable.
"I am excited to be a new director on Histogen's board, and look forward to contributing to the company's success" said Lavin." The field of regenerative medicine offers many potential therapeutic and cosmetic benefits, and Histogen's unique technology positions the company to be a global leader in the field."
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 CEO Presents Extracellular Matrix Data for the First Time at MD&M West
Embryonic extracellular matrix contains unique composition of proteins for rapid cell proliferation and healing without scars
SAN DIEGO, January 31, 2008 - Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, will present data on the company's unique embryonic extracellular matrix (ECM) today at the MD&M West Conference in Anaheim, Calif.
Through the company's proprietary bioreactor technology, Histogen is uniquely capable of simulating the embryonic environment, including hypoxic conditions of 1-5% oxygen, creating a human extracellular matrix with a wide distribution of embryonic proteins unmatched by adult ECM.
"Histogen's human extracellular matrix contains a variety of proteins found only in the embryonic environment," said Dr. Robert Kellar, VP of Research and Development at Histogen. "Our human ECM provides the benefits of a natural biologic for surface modification and tissue regeneration, without the problems of allergic responses and possible viral transmission associated with porcine and bovine derived materials."
Under these hypoxic culture conditions, over 5,000 genes are differentially expressed as compared to cells grown under traditional tissue culture conditions. These distinct genes may be responsible for encouraging increased wound healing and regeneration.
"It is well known that operations performed in the prenatal environment will not leave scars present at birth," said Dr. Gail Naughton, CEO of Histogen. "To be able to replicate this rapid, scarless healing in adult patients would mean countless benefits in the areas of plastic and general surgery. The regenerative capabilities of the embryonic-like matrix also support its use as a coating for medical devices and as patches for hernia and soft tissue repair."
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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's business plan benefits from the lessons learned at Advanced Tissue Sciences, and focuses on near, mid and long term products that are either self-pay or reimbursable.
Histogen Welcomes Robert Kellar as Vice President of Research and Development
New regenerative medicine company armed for growth in 2008
SAN DIEGO, December 20, 2007 - Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, announced today that Dr. Robert Kellar has joined the company as Vice President of Research and Development. Kellar's knowledge in the field of tissue engineering, and experience in bringing products from concept through to commercial market, will be vital in enabling Histogen to meet the company's product launch goals in the coming year.
"I am excited to welcome Robert Kellar to our new, but rapidly growing, Histogen team," said Dr. Gail Naughton, CEO of Histogen. "With Rob on board, we look forward to reaching great milestones in 2008, including bringing our first tissue engineering products to market. Rob's appointment brings our senior management's total experience in tissue engineering to more than 50 years."
Dr. Kellar joins Histogen from his positions as co-owner and President of Development Engineering Sciences, a firm based in Flagstaff, Arizona. Kellar's prior experience in the biomedical industry includes positions with both W.L. Gore & Associates and Advanced Tissue Sciences, where he was involved with commercial worldwide management of research, product development, business, marketing, and sales. Kellar has authored over 7 papers and is the inventor on 5 patents and patent applications. Kellar also serves on the Scientific Advisory Board for Theregen, a cell therapy company investigating the cardiovascular applications of the cell-based human tissue patch, Anginera.
"Histogen's technology will afford the opportunity for a variety of product possibilities," said Dr. Robert Kellar. "I'm enthusiastic about joining the Histogen team and I look forward to the role we can play in advancing the field of tissue engineering and regenerative medicine."
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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's business plan benefits from the lessons learned at Advanced Tissue Sciences, and focuses on near, mid and long term products that are either self-pay or reimbursable.
Histogen CEO Speaks on Bringing Tissue Engineered Products from Lab to Market at MD&M Conference
November 15, 2007 - Gail Naughton, CEO of Histogen, Inc., a regenerative medicine company developing solutions based on the products of newborn fibroblasts, addressed attendees at the annual Medical Design & Manufacturing (MD&M) Conference, Minneapolis this October. Naughton utilized past experiences in bringing four cell-based products from concept to market, while at Advanced Tissue Sciences, to present the challenges and best practices for the development and approval of human cell-based regenerative medicine products.
"Cell based regenerative medicine products offer great potential to address countless of patient unmet needs. The high cost of manufacturing these products, long clinical timelines, and challenges with reimbursement have tremendously hurt product development and investment in this important field," said Naughton. "Developing a robust product pipeline based on one cell type and one manufacturing system is key, and can reduce the cost of developing a new product indication by 75%. It is also critical to have products with short and midterm markets and those where reimbursement challenges do not exist. Histogen's business plan and products directly address each of these key issues."
In addition to presenting at MD&M Minneapolis, which took place on October 16-17, 2007, Naughton will revisit the topic at MD&M West in January 2008.
Gail Naughton has spent more than 15 years extensively researching the tissue engineering process, and holds more than 90 patents in the field. During her time with Advanced Tissue Sciences, Naughton raised $350 million from the public market and corporate partnerships, and oversaw the design and development of the world's first upscale manufacturing facility for tissue engineered products.
Histogen, launched in 2007, seeks to redefine regenerative medicine by developing a series of high value products without the use of embryonic stem cells or animal products. 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.
For more information about the upcoming MD&M West Conference, taking place between January 28-31, 2008 in Anaheim, visit www.devicelink.com/expo/west08
- HGEN-001's components have recently been shown to be critical for new hair follicle formation
- The field of stem cell research is rapidly expanding
- Histogen scientists have developed regenerative medical technologies without the use of stem cells or animal serum
- Histogen has a foundation of proven products
