Appointment of FDA Consultants as ReGen Factor’s Lead FDA Consulting Group

FDA Consultants to join with ReGen Factor

We are excited to announce the appointment of a leading FDA consulting group headquartered in Phoenix, Arizona as our new FDA consulting team. This FDA consulting group will be assisted by our FDA lawyer and consultant, Heather Bustos from the Bustos Group in Florida, USA.

ReGen Factor goals:

1. Regen Factor Pty Ltd plans to seek permission to execute a clinical trial under section 564 of the Federal Food, Drug, and Cosmetic Act to use ReGen Factor’s bFGF as a preventive, protective and/or therapeutic approach for COVID-19 treatment. This pathway will facilitate to fast track ReGen Factor’s PepFactor Scalp product and FDA approval for our bio-identical bFGF to treat Hydrogenous Alopecia.
2. Commence trials by 30 January 2021 for the effect of PepFactor in the treatment of Androgenetic Alopecia. These trials will follow the exact protocols as FDA trials. This study will include 30 to 50 patients and will conclude on 17 April 2021. 3. Receive FDA approval for our bio-identical bFGF as a biologic in PepFactor for treating Androgenetic Alopecia in both men and women. This form of alopecia is the most common globally. New York April 25,2019 – GLOBE NEWSWIRE publication estimated the global market size for alopecia at USD 8.64 billion in 2018 with a market growth of CARG 5.1%. The Alopecia Market is expected to reach USD 12.99 billion by 2026.