The development of any new medical product or treatment is complex and heavily regulated process, controlled by so-called National Competent Authorities such as the FDA, the MHRA in the UK and the EMA which oversees the whole EU. These authorities ultimately issue a marketing license based on clinical safety and efficacy information supplied to them by the product developer. This license allows the producer to advertise a product and make claims for its safety and efficacy.
The strategy of HairClone is to develop the various follicle extraction, cryopreservation/banking, cell expansion, cell delivery processes in parallel. This will create a community of scientists, clinicians and patient/clients dedicated to bringing this revolutionary treatment into clinical practice.
HairClone will generate funding to carry out this research and clinical development in a number of ways. All the funds and revenues generated will be used for Research and Clinical Development:
- Clinic membership
Clinical Partnerships will be developed with leading transplant clinics around the world who will help to develop the therapy and also be the first to offer this to patients when available.
- Follicle Banking and storage
When developed, patient/clients can pay to have hair follicles extracted, cryopreserved and stored. The cost structure of such banking will be similar to other cell banking services and payment will be be one-off, annual or monthly depending upon the patient/clients preference.
- Cell treatment
When the process for expansion and re-implantation has been developed by the scientist/clinician/patient partnership, portions of the banked follicles would be dissociated and expanded in culture, transported to the treatment clinic where they would be micro-injected back into the scalp. It is expected that this process will both rejuvenate miniaturising follicles as well as inducing new follicular structures. This process could be repeated every 2-3 years as the balding process continues by taking additional portions of the patient’s banked follicles and expanding them.
- Pre-payment or reward based Crowdfunding
With this, patient/clients can support HairClone by helping to fund the development and research and in return would be able to be amongst the first people treated. Additional rewards based on the amount funded could be an offset in treatment costs
Because patients would pay incrementally for the process of follicle banking and storage, the expansion of cells and re-implantation back into the scalp, this would both spread the payments over several years as well as providing a regular customer base.
- Investing in HairClone Inc.
Patients and clinicians will be invited to invest in order to support the research and development in return for equity in HairClone.