BirchBioMed

What BirchBioMed does

BirchBioMed Inc. is a clinical-stage Canadian biopharmaceutical company founded in 2015 as a spin-off from the University of British Columbia (UBC), developing therapeutics based on Kynurenic Acid (KynA/FS2), an endogenous tryptophan-pathway metabolite with antifibrotic, anti-inflammatory, and immunomodulatory properties. The company operates two exclusive worldwide licenses from UBC: FS2 (KynA), deployed as a 0.5% topical cream and as a systemic antifibrotic, and AI-001, a combination of KynA with antigen-presenting cells targeting autoimmune disorders. Its lead indications are scar and keloid management (Health Canada–approved under NPN 80147114 in February 2026), burns (Phase II/III with Hamilton Health Sciences), idiopathic pulmonary fibrosis (FDA Orphan Drug Designation December 2025), and earlier-stage programs in Type 1 Diabetes and Alopecia Areata.

Name

BirchBioMed

Legal name

BirchBioMed Inc.

Website

https://birchbiomed.ca

Company type

Private

Founded year

2015

Operating status

Operating

Headcount range

1–10 employees

Short description

BirchBioMed is a Canadian clinical-stage biopharmaceutical company developing Kynurenic Acid-based therapies for organ fibrosis, scarring, and autoimmune disorders, with Health Canada-approved FS2 topical cream and FDA Orphan Drug designation for IPF.

Ownership category

akta.pro rank

Headquarters

HQ city

King City

HQ country

Canada

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales

Revenue model

1. FS2 Topical Cream (NHP/OTC): Revenue from over-the-counter topical cream (NPN 80147114) approved by Health Canada for scar treatment including mature keloids. Distributed through OTC/cosmetic partnerships and potentially retail channels in Canada.
2. Prescription (Rx) Pharmaceutical Products: Revenue from systemic KynA administration products for organ fibrosis treatment and AI-001 for autoimmune disorders, following successful clinical trials and regulatory approvals. Will be commercialized through strategic pharmaceutical partnerships or direct sales.
3. Licensing and Royalties: Technology licensed from UBC for FS2 and AI-001 with milestone payments and royalties based on worldwide sales. Revenue from out-licensing proprietary formulations to pharmaceutical and cosmetic partners.
4. Cosmetic/Anti-aging Products: Revenue from wrinkles and rhytids treatment products leveraging KynA's properties to address intrinsic aging and environmental impacts. Targeting the global anti-aging market projected to reach approximately $88.3 billion by 2026.

Go-to-market motion3 records

Distribution channels3 records

Marketing channels6 records

Core offering

BirchBioMed is a clinical-stage biopharmaceutical company developing therapeutics based on Kynurenic Acid (KynA). Its core offerings include the FS2 topical cream for scars and keloids (approved as OTC in Canada in February 2026), a systemic KynA formulation targeting organ fibrosis including idiopathic pulmonary fibrosis (IPF), and the AI-001 combination therapy for autoimmune disorders. The company holds exclusive worldwide licenses from the University of British Columbia covering its KynA-based technology platform.

Product overview

BirchBioMed is a clinical-stage biopharmaceutical company developing treatments based on two core proprietary technologies licensed from the University of British Columbia: FS2 (Kynurenic Acid/KynA) and AI-001. The product portfolio consists of three main offerings: (1) FS2 Topical Cream - a 0.5% cream for dermatological conditions including scars, keloids, burns, and wrinkles; (2) FS2 Systemic Administration - delivered directly into the bloodstream for organ fibrosis conditions like idiopathic pulmonary fibrosis; and (3) AI-001 - a novel combination of systemic KynA with one-time antigen-presenting cell (APC) therapy for autoimmune disorders including Type 1 Diabetes and Alopecia Areata. The company is advancing eight distinct clinical programs across North America, Europe, and Southeast Asia.

Differentiator

Problem solved

Functional benefit

Brands

• FS2 (KynA): Kynurenic Acid-based therapeutic platform for topical and systemic treatment of fibrosis, scarring, and organ fibrosis. Also known by its original compound name FS2.
• AI-001

Products and services

• FS2 (KynA) Topical Cream Over-the-counter topical cream based on Kynurenic Acid (KynA) intended to reduce the appearance of scars and keloids. Approved by Health Canada in February 2026 and sold in Canada to consumers seeking clinically validated scar treatment.
• FS2 (KynA) Systemic Formulation Systemic KynA therapeutic candidate in clinical development for the treatment of organ fibrosis, including idiopathic pulmonary fibrosis. Developed for pharmaceutical licensing partners and eventual commercialization in fibrosis indications.
• AI-001 Combination Therapy Combination therapeutic based on the KynA platform in development for autoimmune disorders. Targeted at pharmaceutical partners seeking differentiated candidates in autoimmune disease.

Quantifiable outcome

• Phase II clinical trial showed significant superiority over market leader in keloid scar treatment
• +4 more outcomes

Named customers4 records

Segments4 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature4 records

Partnerships

Four partnerships are on record, tiered core and supporting.

• Hamilton Health Sciences' Centre For Burn ResearchcoreStrategic or Co-development Partner · 4 September 2025Pivotal Phase II/III clinical trial partnership for FS2 scar treatment in burns patients in Ontario. Hamilton Health Sciences' Centre leads national trial for scar treatment. This represents the first clinical trial site for burn applications and last stage of groundbreaking clinical program.
• Sensus Healthcare Inc. (Nasdaq: SRTS)supportingStrategic or Co-development Partner · 5 February 2018Collaboration to treat and prevent scarring for keloids patients around the world. Sensus Healthcare CEO Joseph C. Sardano joined BirchBioMed's Board of Directors in 2018. Focus on keloid treatment using FS2 technology combined with Sensus's radiation therapy expertise.
• University of British ColumbiacoreTechnology or IntegrationAs a UBC spin-off company, BirchBioMed holds exclusive worldwide pharmaceutical licenses for FS2 (KynA) and AI-001 technologies developed by UBC researchers including Dr. Aziz Ghahary. The company benefits from extensive funding of more than $6 million from Canada's most prestigious government and private research institutions. FS2 represents the most clinically advanced UBC therapeutic to be transferred to industry.
• Vancouver Coastal Health Research Institute (VCHRI)supportingStrategic or Co-development PartnerPartnership with BC Firefighters Burn and Wound Healing Laboratory, part of Vancouver Coastal Health Research Institute, where Dr. Aziz Ghahary serves as Director. Research conducted at Vancouver General Hospital.

Scale indicators9 records

Recent moves7 records

Expansion highlights6 records

Direct peers

• MiMedx Group: Regenerative medicine company developing wound care and scar treatment products using placental tissue allografts. Direct peer for BirchBioMed's FS2 topical scar treatment franchise targeting the same surgical scar and wound healing market.
• Vertex Pharmaceuticals: Commercial-stage biopharmaceutical company developing transformative therapies for serious diseases, including Type 1 Diabetes programs (VX-880, VX-264). Direct peer for BirchBioMed's AI-001 autoimmune therapy targeting T1D.
• Organogenesis: Commercial-stage regenerative medicine company focused on wound care, surgical, and sports medicine markets. Direct peer for BirchBioMed's topical scar treatment platform with comparable scar management and wound healing focus.
• FibroGen: Clinical-stage biopharmaceutical company developing therapies for fibrosis and serious unmet medical needs, including programs in idiopathic pulmonary fibrosis. Direct peer as BirchBioMed's systemic KynA program targets the same organ fibrosis indications.
• Galapagos NV: Clinical-stage biotechnology company focused on fibrosis and immunology indications, including IPF and autoimmune diseases. Direct peer with overlapping fibrosis target portfolio and similar clinical-stage development profile.
• Pliant Therapeutics: Clinical-stage biopharmaceutical company developing integrin-based therapies for fibrotic diseases, with lead program bexotegrast in Phase II/III for IPF. Direct peer in the organ fibrosis space with comparable clinical-stage profile.

Broad incumbents

• United Therapeutics: Commercial-stage biotechnology company with Tyvaso and other therapies for pulmonary hypertension and fibrotic lung diseases. Broad incumbent in the pulmonary fibrosis therapeutic area where BirchBioMed's IPF program is positioned.
• Roche: Global pharmaceutical company with Esbriet (pirfenidone) for IPF plus a broader autoimmune disease portfolio. Broad incumbent overlapping with BirchBioMed's systemic fibrosis and autoimmune disorder programs.
• Boehringer Ingelheim: Global pharmaceutical company and IPF market leader with Ofev (nintedanib), the leading approved therapy for organ fibrosis. Broad incumbent that BirchBioMed's systemic KynA program would compete against in the IPF market.

Emerging players

• Prometheus Biosciences: Clinical-stage biotechnology company developing precision immunology therapies for autoimmune diseases. Emerging player with comparable autoimmune disease focus to BirchBioMed's AI-001 platform targeting T1D and Alopecia Areata.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• LinkedInlinkedin.com/company/birchbiomed-inc

Compliance2 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles2 records

Funding overview

Funding rounds4 records

Investors2 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about BirchBioMed