Question 1:

> What progress has been made towards the commencement of clinical trials either within the United States or outside of the United States where you suggested potential partnerships in the interview (Turkey/Mexico/Japan)? Can you divulge any information on how you plan to investigate HSC in the next planned trial? For instance, multiple dosages, repeat dosages at different time intervals, etc.


Histogen has found a license partner in Mexico, and initial meetings with the COFEPRIS have been completed to discuss conducting a definitive trial in Mexico for hair loss in men. The proposed trial would be 330 patients across 3 clinical sites, with dosing of 50 0.1cc injections at baseline, 6 weeks and 12 weeks. Primary safety and efficacy will be collected at week 24.




Histogen is also in late-stage negotiations with a potential HSC partner in China, and plans to make a formal announcement of that partnership soon. In the United States, Histogen is planning a Phase I trial in women and a Phase II trial in men as the next clinical steps. Clinical sites for both US trials have already been identified. 



> Question 2:

> Does your initial timeline of potential market release outside of the United States by 2017-18 still possible? If yes, where do you believe this treatment will be available?




At this time, we believe that HSC treatment will be on the market first in Mexico, which is an excellent aesthetic tourism market for products like HSC. Following Mexico, the US and Asia continue to be are our target regions for HSC development and introduction. If a worldwide partner for HSC was secured, we could then prioritize clinical development in Europe as well. 


> Question 3:

> Do you believe that additional dosages of HSC will increase its efficacy and improve further hair regrowth? 




Yes. In Dr. Ziering's Investigator-Initiated Trial in men and women, he saw excellent results with 4 treatment timepoints and a total of 120 injections.


> Question 4:

> It has been mentioned that your company is currently trying to raise capital for clinical trials and product development. Have these fundraising efforts been successful or are you still trying to secure adequate funds for product development and commercialization?




We are in late-stage negotiations with an HSC partner in Asia, who will also be making a sizable equity investment. This will be intrumental to the advancement of HSC over the next 1-2 years. Histogen will be seeking to close the remainder of its Series D funding as well, to prepare the Company for an IPO.



> Question 5:

> I know the employees are very busy at Histogen and press releases or presentations made available to the public are scarce. However, will future clinical trials be announced? I am positive a great deal of the public would highly appreciate that and volunteer to participate.


Yes, Histogen plans to announce the start of HSC clinical trials here in the United States. 



> Question 6:

> Is there any information you can disclose at this time regarding potential launch of your product HSC, estimated cost of the procedure when its released or new data to the public?


We are currently doing market analysis with our partners in each geographic area to determine the optimum HSC price point for Histogen, our partners and the patients. We expect it to be in line with currently available hair loss treatments. 



> Question 7:

> Lastly, is there any way you would be willing to provide any supplemental documents from your latest presentation at the Stem Cell Summit? It would be greatly appreciated.



Attached is the Stem Cell Summit presentation and an HSC overview which contains more information about the science behind HSC. 

This is all very exciting news! Lets hope and pray there are no more hiccups along the way. To Dr. Gail Naughton and Eileen Brandt, if you are reading this, thank you so much again for your time, patience, and generosity for even providing me with any answers regarding your company and its pipeline. It is truly appreciated.

source:https://www.hairlosstalk.com/

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

  What is Hair Cloning & Multiplication ?

   Hair multiplication or cloning is a promising technique under development to against male pattern baldness.
     İdea of hair cloning is basically healthy hair cells (dermal papillae) can be extracted from donor site that back of head.These healthy hair cells extracted from donor site, can be cloned by some culturing methods and the produced new cells can be injected back in the recipient area(bald area) where these injected cells(dermal papillae) would act healthy so can produce back healty hairs.

    Some of university and firms (Adherence Research Institute, Technical University of Berlin, University of Pennsylvania, Durham University ) are known to research on hair cloning ,however This technique is still in research phase and isn't used in hair clinical yet.

  What is Hair Cloning & Multiplication ?

   Hair multiplication or cloning is a promising technique under development to against male pattern baldness.
     İdea of hair cloning is basically healthy hair cells (dermal papillae) can be extracted from donor site that back of head.These healthy hair cells extracted from donor site, can be cloned by some culturing methods and the produced new cells can be injected back in the recipient area(bald area) where these injected cells(dermal papillae) would act healthy so can produce back healty hairs.

    Some of university and firms (Adherence Research Institute, Technical University of Berlin, University of Pennsylvania, Durham University ) are known to research on hair cloning ,however This technique is still in research phase and isn't used in hair clinical yet.