VANCOUVER, BC — February 4, 2026 — Leads & Copy — BirchBioMed Inc. announced today that its FS2 (KynA) topical cream has received regulatory approval from Health Canada as a natural health product for distribution in Canada as a treatment for scars.
The approval follows a comprehensive review of the product’s safety, quality, and efficacy by Health Canada’s Natural and Non-prescription Health Products Directorate (NNHPD). The cream can be used to treat even severe scars, such as mature keloids, without a prescription.
BirchBioMed’s scar cream contains 0.5% FS2 (KynA), providing a new option for managing keloid scarring beyond traditional prescription pathways. It also aims to reduce post-surgical treatment costs associated with scarring.
Mark Miller, Chairman & CEO of BirchBioMed Inc., stated that the NNHPD’s approval validates the company’s scientific and regulatory strategy to bring FS2 to health-care counters across Canada and represents a business milestone in improving the quality of life for patients affected by scarring.
BirchBioMed Chief Medical Officer, Dr. Carlos Camozzi, noted that the team, along with scientists, worked to develop a product that meets quality, safety, and efficacy standards, while making a difference in the physical and mental health of patients. He added that the regulatory milestone furthers BirchBioMed’s commitment to introducing therapeutic options that address unmet needs in scar management.
The Natural and Non-prescription Health Products Directorate is the Health Canada board responsible for the oversight of natural health products and non-prescription drugs. Its mandate includes the review and authorization of market authorization applications, ensuring that approved products meet established standards for safety, efficacy, and quality. The NNHPD’s regulatory framework is designed to protect public health while facilitating access to effective non-prescription therapies through evidence-based assessment and post-market compliance monitoring.
BirchBioMed Inc. is a clinical stage biopharmaceutical company focused on developing treatments for organ fibrosis, scarring, skin disorders, and autoimmune diseases, including Type 1 Diabetes. It holds exclusive, worldwide, pharmaceutical licenses from the University of British Columbia for two scientific technologies, FS2 (kynurenic acid) and AI-001 (FS2+cell therapy). BirchBioMed’s technologies have shown potential for future medical breakthrough treatments addressing multiple life threatening diseases and severe debilitating conditions, following preclinical and early/mid-stage clinical studies and trials.
Source: BirchBioMed Inc.
