#Canada #Vancouver #FS2 #BirchBioMed #Health Canada

BirchBioMed's Milestone Approval for Scar Treatment Cream

BirchBioMed Inc., a pioneering biopharmaceutical company, has made a significant advancement in dermatological treatment with its topical cream, FS2 (KynA). On February 4, 2026, the company announced that it has received the green light from Health Canada for this innovative product, following an exhaustive review process that evaluated the product's safety, quality, and efficacy.

What is FS2 (KynA)?

FS2 is a naturally derived health product formulated to enhance the treatment of various types of scars, particularly severe ones such as mature keloid scars. The cream contains 0.5% of FS2, providing a new and promising therapeutic option for patients and healthcare providers who manage scarring beyond traditional prescription routes. This approval enables BirchBioMed to bring its valuable product to health care counters across Canada without requiring a prescription, thereby improving accessibility for those in need.

What Does This Approval Mean?

Mark Miller, CEO of BirchBioMed, emphasized the importance of this regulatory milestone, stating, "The approval from the Natural and Non-prescription Health Products Directorate (NNHPD) validates our scientific and regulatory strategy to bring FS2 to pharmacies everywhere in Canada. This accomplishment represents a significant commercial achievement in our mission to enhance the quality of life for patients struggling with scarring."

The approval allows BirchBioMed to market FS2 without a prescription, offering a more cost-effective solution for patients undergoing post-surgical healing processes, ultimately reducing the financial burden associated with scar management.

Scientific Collaboration for Results

Dr. Carlos Camozzi, the Chief Medical Officer at BirchBioMed, shared insights into the rigorous development process the product underwent. He noted, "Our team has tirelessly collaborated with world-renowned scientists to develop a product that not only meets strict standards of quality, safety, and efficacy but also makes a substantial difference in the physical and mental health of affected individuals. With this regulatory step, BirchBioMed continues its commitment to introducing clinically relevant and compelling therapeutic options that address unmet needs in scar management."

About NNHPD

The Natural and Non-prescription Health Products Directorate (NNHPD) is the Canadian authority responsible for overseeing natural health products. Its mission includes reviewing and authorizing market approval applications for health products, ensuring that they meet established safety, efficacy, and quality standards. The regulatory framework of the NNHPD is designed to protect public health while facilitating access to effective over-the-counter therapies through evidence-based evaluations and post-market compliance monitoring.

BirchBioMed's Vision

BirchBioMed Inc. is at the forefront of clinical biotechnology, focusing on developing revolutionary treatments for organ fibrosis, wound healing, skin disorders, and autoimmune diseases, including Type 1 diabetes. The company has exclusive global pharmaceutical licenses from the University of British Columbia for two cutting-edge scientific technologies: FS2 (kynurenic acid) and AI-001 (FS2 combined with cell therapy). Following preclinical and early-phase clinical studies, BirchBioMed's technologies have demonstrated the potential for groundbreaking medical treatments that could change the landscape of healthcare for life-threatening and debilitating conditions.

For more information about BirchBioMed and its innovative treatments, visit birchbiomed.com.

For inquiries, contact Susan Elliott, Director and Chief Operations Officer at BirchBioMed Inc., via telephone at (416) 726-2403 or email at [email protected].