Histogen Files IPO Prospectus: Regenerative Medicine Pioneer Advancing Hair Regrowth Therapy HSC660 Across Three Therapeutic Areas

Histogen is a biotechnology company headquartered in San Diego, USA. Founded in 2007, it possesses skin cell growth technologies and related regenerative medicine products. Its first U.S. patent was issued in September 2012, covering the company’s innovative methods for cultivating and growing cells under hypoxic and suspended conditions, as well as extraction processes for naturally occurring protein components.

Data shows that Histogen currently holds 8 issued U.S. patents and 40 patents in other countries, with an additional 30 patents pending. These include technologies related to extracellular matrix components cultured under hypoxic conditions; the use of basic fibroblast growth factor (bFGF) to promote the generation of pluripotent stem cells; and repair or regeneration using components derived from fibroblasts cultured under hypoxic conditions.

VCBeat (WeChat: vcbeat) will compile for you the technical principles and market prospects of HSC, a hair growth-stimulating product from the regenerative medicine company Histogen.

The company leverages biotechnology to culture skin cells, growth factors, and other related compounds under conditions simulating the embryonic environment. Its flagship product, HSC, is an injectable formulation that combines cultured skin cells, cell growth factors, specialized proteins, and other cell-secreted molecules. This injection stimulates the scalp to promote hair growth.

Histogen has an approved hair growth product for human clinical trials in the United States, previously collaborated with Allergan in the field of dermatology, and is currently actively seeking partners in the retail skincare market.

Data indicates that the company’s patented technology focuses on promoting stem cell growth and differentiation, thereby facilitating the regeneration of various human tissues.

Its flagship product is indicated for the treatment of hair loss, while other technological applications include skincare and orthopedic indications such as chondroplasty, intervertebral disc repair, wound healing, soft tissue expansion, and hyaluronic acid fillers.

To date, Histogen has raised $38 million, with the majority of funds allocated to improving the company’s manufacturing processes, filing patents in multiple countries, and refining and advancing product commercialization. The company aims to leverage existing clinical experience to conduct the first North American clinical trials of its hair growth product in 2018–2019.

Dr. Gail Naughton, the founder of Histogen, is a highly respected scientist with extensive experience in the fields of tissue engineering and regenerative medicine.

Dr. Gail Naughton discovered proteins and growth factors secreted by hypoxia-induced pluripotent stem cells, which hold potential for therapeutic and biomedical applications, and pioneered Histogen’s proprietary technology platform to develop products based on these proteins.

From concept to market launch, Histogen’s senior management team brings decades of experience in the field of cell-based regenerative products. Furthermore, the company’s Board of Directors and Scientific Advisory Board comprise leaders in regenerative medicine, global marketing, and business operations.

Regenerative Medicine Technologies: Perhaps the Next Trend in Addressing Hair Loss

In the areas of regulatory affairs, quality, and manufacturing, Histogen boasts a team of experienced advisors, including Board Chairman Stephen Zhang, Dr. Martin Ratlitz, and Mr. Stephen Hill.

Since its establishment, Histogen has completed five rounds of financing, raising a total of approximately $46.3 million. The Series A financing was conducted in two tranches in May 2008 and December 2010, raising a total of $15.4 million. The Series B financing took place in January 2013. In June 2015, during a venture capital round, Histogen secured $24.9 million from three investors: Lordship Ventures, Leonard Lavin, and Angus Mitchell.

Currently, Histogen is in its Series D financing round, with the most recent closing occurring in August 2016, when it secured $6 million from China Huapont Life Sciences Co., Ltd. Histogen plans to complete a $18 million Series D financing round, and this strategic investment constitutes a significant component of that effort.

In addition, the Company plans to collaborate with Huabang Health to manufacture and market its lead products in China. Histogen also intends to negotiate for licensing and supply agreements regarding the development and commercialization of its lead product, HSC, in China.

Data shows that Histogen’s products are primarily used for hair regeneration, skincare, and matrix regeneration.

Pluripotent Stem Cell Conditioned Medium (CCM).This culture medium is obtained through Histogen’s manufacturing process and has a complex composition, including soluble biologics containing various embryo-like proteins. These proteins are naturally incorporated into the liquid medium in a stable form, as they are produced and sequestered by cells during the secretion of the extracellular matrix.

CCM contains a mixture of various cell signaling components, including human growth factors such as keratinocyte growth factor, soluble human extracellular matrix proteins such as collagen, and key proteins that support epidermal stem cells and facilitate skin regeneration.

Extracellular Matrix (ECM).This extracellular matrix, produced through Histogen’s proprietary process and derived from natural sources, is suitable for all individuals. It resembles early embryonic germinal tissue structures, providing the structural support and signaling cues necessary for cell and tissue growth. By consistently producing human extracellular matrix materials that mimic the primitive architecture of intraembryonic tissues, regenerative cells have demonstrated therapeutic potential.

Histogen’s lead product is the Hair Stimulating Complex (HSC660), a dissolvable formulation under development as a booster for hair regrowth.

Pluripotent stem cell-conditioned medium is the base ingredient of the Hair Stimulation Complex (HSC660). It is produced by neonatal cells under simulated embryonic conditions, specifically in a hypoxic environment (3%–5% oxygen) and a suspension culture system.

Under these conditions, cells can produce a variety of effects, among which the positive regulation of growth factors has been proven to be crucial for hair growth capacity. HSC660 is purified from CCM to enrich hair growth factors.

Key growth factors, including KGF, VEGF, and follistatin, play important roles in generating hair structures and stimulating hair follicles.

HSC660, produced through a unified specialized manufacturing process, is a unique stem cell-derived extracellular matrix that holds immense potential for regenerative therapy applications aimed at stimulating new tissue growth, including orthopedic surgery, soft tissue expansion, and wound healing.

1. Orthopedic Surgery.Histogen’s research indicates that its CCM and ECM products hold promise in the fields of sports medicine, intervertebral disc repair, orthopedics, and dentistry. Studies by external experts have demonstrated that these two products possess anti-inflammatory and angiogenic properties, and can stimulate stem cell growth in damaged areas to promote tissue regeneration.

The most extensive application in animal models has focused on the regeneration of new hyaline cartilage and bone in full-thickness knee joint injuries. This Histogen-based patented ECM product holds significant market potential, particularly in addressing joint issues such as knee cartilage loss and other conditions associated with aging, osteoarthritis, rheumatoid arthritis, or injuries resulting from sports activities or accidents.

Second, soft tissue expansion.To date, research has shown that Histogen’s ECM serves as a biological scaffold, attracting the patient’s own stem cells and fibroblasts to migrate into it, where they proliferate and differentiate to form new soft tissue.

Unlike temporary fillers, this method generates new, healthy tissue that closely resembles the patient’s own, offering a more permanent solution for treating deep wrinkles or acne scars, as well as for restoring tissue after mastectomy or augmenting breast tissue.

Third, wound healing.Histogen has received funding from the National Science Foundation (NSF) to develop its ECM materials, combined with antimicrobial peptide technology, for the treatment of chronic wounds.

The company has developed an ECM-based wafer coated with antimicrobial peptides on its surface, which can be placed on the wound bed to facilitate tissue regeneration, prevent infection, and reduce inflammation. The initial objective of this funded work is to treat chronic wounds, particularly in patients with diabetes, as well as venous and pressure ulcers.

For skin care, Histogen has developed a vector-restricted pluripotent stem cell component that harnesses the power of growth factors and other cellular signaling molecules to support epidermal regeneration.

“Histogen has developed a next-generation regenerative cell technology that harnesses the power of growth factors and stem cell signaling molecules to restore skin vitality, addressing the limitations of Allergan’s flagship growth factor technology, TNS,” said Dr. Rahul Mehta, Vice President of Research and Development at SkinMedica, a subsidiary of Allergan.

Currently, traces of media-restricted multipotent stem cells can be found in the Allergan Regenica Regenerative System, which has been validated by dermatologists, as well as in Hydrafacial spas and specialized medical institutions. Histogen is currently seeking partners for its next-generation skincare ingredients in the global retail market.

Two early proof-of-concept clinical trials on the conditioned medium of pluripotent stem cells (CCM) were conducted outside the United States, and the results revealed good therapeutic effects. Data from one of the trials showed that 84.6% of patients experienced a remarkable increase in both the number and thickness of their hair after just a single 12-week treatment course.

In the second clinical trial, patients received two treatment courses, each lasting 6 weeks, resulting in a 46.5% greater increase in total hair count compared to a single treatment course.

Histogen Treatment Trial Results: Female Participants Received 40 Injections of Hair Regrowth Product

By Week 12, total hair count, terminal hair density, and hair shaft thickness had increased significantly. Hair growth parameters remained stable over the course of one year. These two clinical trials also demonstrated the product’s efficacy in patients with traditional treatment-refractory alopecia. Furthermore, in a small investigator-initiated trial, the product was observed to promote hair growth in women with effects comparable to those seen in men.

These clinical investigations have consistently demonstrated that the use of targeted growth factors is highly effective in treating hair loss. Building on these initial studies, Histogen plans to initiate Phase I clinical trials in the United States using HSC660 (Hair Stimulating Complex).

HSC660 is a refined complex rich in KGF, VEGF, and follistatin, as well as other essential growth factors for hair regeneration, including placental growth factor, angiopoietin, and hepatocyte growth factor.

In 2017, Dr. Gail Naughton stated in an interview, “The U.S. clinical trial program is scheduled to begin in 2018. We estimate that we will first obtain approval from Mexico in 2020, followed by U.S. approval at a later date.”

In April this year, Dr. Gail Naughton stated that Histogen’s clinical trial in Mexico, which uses human chorionic somatomammotropin (HCS) to treat baldness, is progressing toward its final phase.

Histogen has initiated Phase III clinical trials in Mexico. The trial is evaluating a hair growth product for men, described as an “early version of HSC660,” which therefore differs slightly from the latest HSC660 formulation targeted at women.

In 2016, Histogen estimated that its male hair loss product would be launched in 2018. The company had originally planned to initiate clinical trials in Mexico in 2016, but this was actually delayed by one to two years.

Furthermore, Dr. Gail Naughton, CEO, expressed confidence in the success of the Phase III trials and looked forward to commercialization. “We are in advanced negotiations with several major retail partners, and results will be announced soon.” In March 2018, the U.S. FDA approved Histogen’s Investigational New Drug (IND) application for clinical trials targeting female pattern hair loss.

Histogen, now in its 11th year of operation, may soon initiate Phase I clinical trials for its female hair loss product. Despite the tight timeline, the company will accelerate the clinical trial process, as the product has already completed testing in male subjects.

In the United States alone, hair loss affects over 40 million men and 21 million women; however, currently, fewer than 7% of patients seek treatment. This is largely due to the limited efficacy of existing treatment options and many patients’ reluctance to undergo invasive surgical procedures.

The future HSC660 therapy is similar to botulinum toxin injections, being periodic, rapid, and easy to manage. This treatment modality is well-received by both patients and dermatologists.

As a supplier of hypoxia-induced biomaterials, Histogen leverages its extensive product and patent portfolio to provide patented biomaterials to partners for the co-production of a broader range of products. To achieve this goal, Histogen has made significant investments, including building a core team of scientists and engineers, developing an intellectual property portfolio, and establishing manufacturing infrastructure.

The company’s technology platform produces stem cell-conditioned media with multifaceted effects, as well as bone tissue engineering raw materials containing signaling proteins, which can stimulate human stem cells to restore tissues.

These materials hold significant potential for high-value aesthetic applications, such as hair growth, skin care, and soft tissue filling. Furthermore, they are expected to be utilized in therapeutic areas including orthopedics and wound healing. Looking ahead, Histogen will collaborate closely with industry leaders to maximize the potential of its proprietary technology platform.

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Further Reading:

With 73 Clinics, How Did Bosley Become the Largest Hair Transplant Chain in the US?

The Father of Global Hair Transplantation, William R. Rassman, and the Two Internationally Recognized Hair Transplant Techniques: FUT and FUE

Image Sources and References:

http://www.histogeninc.com/investors.htm

https://www.hairlosscure2020.com/category/histogen/