The global alopecia market was valued at $2.65 billion in 2019 and is expected to reach a value of $5.25 billion in 2027. Androgenetic alopecia is growing the fastest, estimated at 11.3% CAGR between 2019-2027. (Grand View Research Report ID: 978-1-68038-856-5).
Androgenic Alopecia (“AGA”) is the most common form of hair loss in men and women. Current treatments include hair transplants, topical solutions, pharmaceuticals, and autologous Platelet Rich Plasma (“PRP”). Autologous PRP (“AA-PRP”) is considered standard routine for dermatologists and plastic surgeon experts in hair growth (“HG”). The efficacy of autologous PRP in patients who suffer AGA is clear and it has also been reported several times by authors [1–4,7–9]. A-PRP contain at least six major GFs, including basic fibroblast growth factor (“b-FGF”), epidermal growth factor (“EGF”), transforming growth factor-β (“TGF-β”), insulin-like growth factor-1 (“IGF-1”), PDGF, and VEGF, which are released after platelet activation . Each one of these major GFs is involved in a specific bio-molecular activity during Hair ReGrowth (“HRG”). In each case, the GFs serve to promote angiogenesis, follicular cell proliferation, and initiation of cell division, thus having a fundamental role in HRG [1–4,9]1.
Dr. Amelia Hausauer conducted a randomized clinical study showing PRP was successful at increasing hair volume and density at six months by 29% respectively compared to baseline. Carmell's technology, (THA) is intended to be delivered into the scalp where the material will reside for days to weeks, constantly bathing the area with GFs and other regenerative factors. Utilizing the work by Dr. Hausauer and others that have shown autologous PRP to have some benefit in regrowing hair as a proof of concept, Carmell is developing its THA that is intended to be off the shelf, ready-to-use as a substitute for the Autologous PRP. Clinical studies will be designed to show improvement versus baseline for hair volume and hair density at six months. The company’s hypothesis it seeks to prove in a clinical study, if allowed to proceed, is that the PBM technology is effective at regrowing hair at six months with greater than 30% increase in volume and density based on the PBM’s ability to reside in the scalp for days and weeks, delivering active GFs and other regenerative molecules with a very favorable benefit/risk profile.