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/

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

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