The Company's new natural health product promotes treatment and improves appearance of scars, including even severe ones like mature keloid scars
VANCOUVER, BC, Feb. 4, 2026 /PRNewswire/ -- BirchBioMed Inc. today announced that following a comprehensive review of the product's safety, quality, and efficacy by Health Canada's Natural and Non-prescription Health Products Directorate (NNHPD), its FS2 (KynA) topical cream has been granted regulatory approval as a natural health product (no prescription required) for distribution in Canada as a treatment for scars, even severe ones like mature keloids.
BirchBioMed's scar cream contains 0.5% FS2 (KynA), providing patients, healthcare practitioners, and caregivers with a substantive new option for managing keloid scarring beyond traditional prescription pathways, and reducing post-surgical treatment costs associated with scarring.
"The NNHPD's approval validates and confirms the value of our scientific and regulatory strategy to bring FS2 to health-care counters across Canada," said Mark Miller, Chairman & CEO of BirchBioMed Inc. "This regulatory approval is an outstanding business milestone in our quest to improve quality of life for patients affected by scarring."
BirchBioMed Chief Medical Officer, Dr. Carlos Camozzi, said: "Our team, together with world-renowned scientists, has worked relentlessly to bring forward a product that not only meets rigorous quality, safety and efficacy standards but, more importantly, makes a real difference in the physical and mental health of sufferers. With this regulatory milestone, BirchBioMed furthers its commitment to introducing clinically relevant and compelling therapeutic options that address unmet needs in scar management."
About the Natural and Non-prescription Health Products Directorate (NNHPD)
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.
About BirchBioMed Inc.
BirchBioMed Inc. is a pioneering clinical stage biopharmaceutical company focused on developing novel, breakthrough 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, novel technologies, FS2 (kynurenic acid) and AI-001 (FS2+cell therapy). Following preclinical and early/mid-stage clinical studies and trials, BirchBioMed's technologies have shown potential for future medical breakthrough treatments addressing multiple life threatening diseases and severe debilitating conditions.
birchbiomed.com
For further information, contact: Susan Elliott, Director and Chief Operating Officer, BirchBioMed Inc., Phone: (416)726-2403, susan.elliott@birchbiomed.com, BirchBioMed.com
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