Abrasion Induced Neogenesis


Immune System

Abrasion Induced Neogenesis
Androgenetic Alopecia

Immune System

Abrasion Induced Neogenesis
INDICATION(S):Androgenetic Alopecia
NAME:Follica (55.6%*)
STAGE:Phase 2
Regenerative biology platform

Our regenerative biology platform is based on seminal findings from the University of Pennsylvania that demonstrated the creation of skin organs (hair follicles) in adult mammals after abrasion. This technology is being applied to treat androgenetic alopecia. Our technology is the first, to our knowledge, designed to create new follicles and hair through disruption of the skin, followed by treatment to enhance the effect. We completed three human clinical studies of patients with androgenetic alopecia to demonstrate hair growth and new hair follicle formation. 

  • Patient Need & Market Potential
    • Androgenetic alopecia represents the most common form of hair loss in men and women, with an estimated 65 million people who warrant treatment in the U.S. alone.
    • Only two drugs, both with limited efficacy, are currently approved for the treatment of androgenetic alopecia. The most effective current approach for the treatment of hair loss is hair transplantation, comprising a range of invasive procedures.
    • As a result, we believe that there is significant unmet need for safe, effective, non-surgical treatments which grow new hair.
    • Our regenerative biology platform has applications beyond hair growth to other aging-related conditions and wound healing.
  • Our Approach to Solving the Problem
    • Our approach is based on generating an “embryonic window” in adults via a series of micro injuries, creating new follicles from epithelial stem cells, and enhancing the effects through the application of specific compounds.
  • Intellectual Property
    • Our regenerative biology program has broad worldwide intellectual property coverage, including exclusive rights to 38 issued patents and patent applications.
    • The intellectual property covers the composition of matter, methods of use and design of disruption approaches and active agents to promote hair follicle regeneration.
  • Team
    • Key advisors include Dr. R. Rox Anderson, a Professor of Dermatology, Harvard Medical School and Adjunct Professor of Health Sciences and Technology at MIT, and Inventor of CoolSculpting by Zeltiq; Dr. George Cotsarelis, Chair of Dermatology at University of Pennsylvania Medical School and Founder of Kythera; and Dr. Ken Washenik, President and Chief Medical Officer of Bosley Medical Group and Former Chief Executive Officer of Aderans Research Institute.

    • Follica is led by Jason Bhardwaj and team members Jonathan Bissett and David Chastain.
  • Milestones Achieved
    • We conducted three clinical studies of patients with androgenetic alopecia, which demonstrated hair follicle neogenesis via biopsy following skin disruption, and hair growth through target area hair count. One of these studies demonstrated that skin disruption alone was safe and generates not only new hair follicles but also terminal (visible, thick hairs). We are further developing and testing compounds that enhance these effects.
    • The product concept originated from ground-breaking science demonstrating new mammalian skin formation in adult mice following abrasion. The results were published in the top tier medical science journal, Nature.
  • Expected Milestones and Timing
    • Our RAIN pivotal study is expected to commence following the completion of an ongoing optimization study.

We have preclinical data which show the potential for next-generation proprietary compounds to further enhance the effect of new hair follicle formation. We completed our clinical-stage development of a next-generation device and drug combination product for androgenetic alopecia, which is currently in an optimization study. Further phases of pre-clinical testing are also ongoing towards the prioritization and development of next-generation, proprietary compounds based on our intellectual property. Our RAIN pivotal study is expected to commence following the completion of the optimization study.

Skin disruption to create new hair follicle