Executive Summary Overview

The HairCell therapy available to you will depend on the regulatory status in the individual country where you reside. In the USA and Canada our intent is to start with a three part therapy of (1) in clinic high fidelity bioelectric stimulation with a 510K market cleared stimulator, (2) amniotic fluid injections via DermaPen and (3) amniotic membrane application in fully bald areas of the head and out of the clinic at home we will apply the TeslaBrush electrostatic stimulation device. In other countries where permitted by regulatory authorities a more advanced therapy will be applied which includes repeat injections and applications of the HC-15 fifteen component stem cell based composition which includes exosomes, selected alkaloids, micro RNAs, nutrient hydrogel and hair scalp matrix within a hair regeneration promoting scaffolding. Also outside of the USA and Canada in selected markets we will apply a wider range of bioelectric signals to control expressions of SDF-1, HGF, EGF, IGF-1, PDGF, VEGF, HIF 1 alpha, eNOS, Activin A+B, Follistatin, Tropoelastin and perhaps also GDF-10 and GDF-11.

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Vision

The vision is to significantly improve the percentage of hair regrowth compared to the current treatments and almost completely restore hair to previous growth quality before hair loss.

Product

HairCell (patent pending) has the mission to significantly improve hair regeneration in comparison to current hair restoration methods. HairCell would use a patented bioelectric stimulator coupled with the patented tesla brush and several protein additives to achieve this goal.

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Problem

A survey done by the International Society of Hair Restoration Surgery in 2014 showed that approximately 35 million men in the United States alone would suffer hair loss in one form or another. It also showed that about 21 million women are affected by hair loss as well. By age 35, about 40% of men will suffer visible hair loss. This percentage increases significantly with age, so much so that almost half of men by their
late-forties to early-fifties show noticeable hair loss. The numbers for women however are even higher. Statistics show that by age 40, approximately 40% of women suffer some type of hair loss. Then by age 60, that percentage jumps to 80% of women to suffer noticeable hair loss.

Patents

Over 400 patent claims issued, pending, licensed or optioned for organ regeneration and recovery. Patent claims cover over 20 regenerative proteins expressions including SDF-1 + PDGF for stem cell homing, a full suite of angiogenesis (blood vessel forming) protein expressions and bioelectric signaling sequences for managing inflammation, blood pressure, muscle formation and nerve regeneration. Important regeneration promoting controlled proteins expressions include klotho, tropoelastin (for increasing elasticity), follistatin and sonic hedgehog

Pre-clinical

• Hair growth-promotion effects of different alternating current parameter settings are mediated by the activation of Wnt/-catenin and MAPK pathway. (1) Click Here to View

• In animal model, hair regrowth was observed in the entire stimulated areas under individual conditions. Expression of hair-related genes in the skin significantly increased on 6(th) week of treatment.

• Battle against baldness turns to stem cells. (2) Click here to View

• A group of researchers have found a way to regrow a type of cell crucial for the development of healthy follicles, making it possible to grow new hair without having to sacrifice tissue from another part of the body.

• When the scientists planted their epithelial cells onto mice, the stem cells transformed into cells for both human skin and hair follicles. The cells even produced structurally recognizable hair shafts.

Clinical

• Elastatropin in Scalp & Hair Conditioning. (3)
https://www.proteingenomics.com/haircare.html

• We have recently evaluated the topical application of human tropoelastin, the precursor to elastin, to the scalp of a volunteer showing the signs of male pattern baldness. If damage to the structure and matrix of elastin in the scalp contributes to the thinning and loss of hair, then providing an external source of this human protein could help reduce ongoing hair loss and stimulate new hair growth.

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Upcoming Milestones

• Completion of 12 patient pilot study South Africa summer 2019
• Completion of bioelectric + laser study in identical twins summer 2019
• Target gaol start of auction for exit December 2019.
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References

1. Ki Min Sohn, Kwan Ho Jeong, Jung Eun Kim, et al. Hair growth-promotion effects of different alternating current parameter settings are mediated by the activation of Wnt/-catenin and MAPK pathway. Experimental Dermatology. 2015 Aug: 24(12).
2. Robert Ferris. Battle Against Baldness Turns To Stem Cells. CNBC Biotech and Pharma. 2015 Jan 29: 1;1.
3. Anonymous. Elastatropin in Scalp & Hair Conditioning. Protein Genomics. 2008: 1(1)

Team

Howard Leonhardt, Executive Chairman and CEO, is an inventor and serial entrepreneur with over 21 issued U.S. patents and dozens more pending. He developed the leading endovascular stent graft system and the first percutaneous heart valve, both now a part of Medtronic. He has founded over 30 startups and has numerous successful exit.

Derek Kahn
President,
Dr. Leslie Miller
Chief Medical Officer.
Bernhard Rudert
Chief Adviser Bioelectric Hair Regeneration.
Dr. Jorge Genovese
Chief Scientist.
Alex Richardson
Vice President Engineering & Product Development
Dr. Brett Burton
Director of R&D and Product Management
Michael Angerbauer
Chief Bioengineer
Kapil Sharma
Staff Bioengineer
Paul Norman
VP Business Development