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Hair Stimulating Complex (HSC)
Histogen’s lead product application is Hair Stimulating Complex (HSC), which is a soluble formulation developed as an injectable for hair regrowth. The cell conditioned media that comprises HSC is produced by neonatal cells grown under simulated embryonic conditions of hypoxia (3-5% oxygen) and suspension. Under these conditions, the cells become multipotent and there is a significant upregulation of growth factors which have been shown to be important in hair viability. The proteins within HSC, including KGF, VEGF, and follistatin, are involved in signaling stem cells in the body, and have been shown to be key in hair formation and the stimulation of resting hair follicles. Follistatin in particular has been linked to hair follicle stem cell proliferation.

HSC Clinical Development
Two company-sponsored clinical trials of HSC have been completed, revealing an excellent safety profile and promising efficacy results. In the Pilot trial, 84.6% of patients receiving just one HSC treatment showed a significant increase in terminal hair count and hair thickness at 12 weeks.

In the Phase I/II clinical trial of HSC, which was designed with an additional treatment timepoint, the increase in total hair count was 46.5% above that seen in the pilot HSC trial at 12 weeks. Statistical significance was noted in all efficacy endpoints which include increases in total hair count (p=0.0013), terminal hairs (p=0.0135) and hair thickness (p=0.026). At one year, hair growth parameters remain substantially above baseline, with a statistically significant increase in total hair count (p=0.028). Such an increase at the one year timepoint was also seen in the Pilot trial.

The two completed clinical trials have also revealed efficacy in traditionally difficult-to-treat hair loss populations. Subjects receiving HSC in the temporal recession, which is known to be more difficult to treat than other areas of hair loss, saw marked improvement in terminal hair count, with a mean increase of 22.6% at 12 weeks and 25.2% at the 24 week time point. In both trials men over 40, normally less responsive to non-surgical treatments, responded extremely well to HSC, including a mean increase of 39% in terminal hairs and 19.4% in total hair count in this age group in the current trial

In addition, a completed Investigator-Initiated Trial by Dr. Craig Ziering showed an excellent hair growth response in women as well as men.

HSC has shown a strong safety profile. Two years of clinical follow-up revealed no hamartomas and normal histology. Clinical chemistry has shown no indication of toxicity or blood/urine abnormalities, and adverse events were mild, transient and quickly resolved.

Market
The hair loss market is both large and underserved - hair loss affects over 40 million men and 21 million women in the United States alone, however less than 7% of sufferers currently seek treatment. This may be due to the ineffectiveness of currently available options, and the hesitation of many affected to seek surgical treatments.

Histogen sees HSC as a potential hair restoration category killer, as efficacy results far surpass those seen with topical and prescription treatments. Without the limitations of currently marketed hair loss products, HSC has the potential to expand the hair restoration market by offering a successful option to those that currently have none, and a more effective option to anyone presently using or considering Rogaine or Propecia.

Histogen's HSC is currently being developed and evaluated an injectable for hair growth. The combination of Wnt proteins and growth factors making up the formulation have been shown to both stimulate resting hair follicles and induce new follicle formation.
© Histogen Inc., CA 92121