Microbiome health company Biome Australia (ASX: BIO) has commenced a Canada registration process, with eight Activated Probiotics products now registered with Health Canada and the remainder of the range to follow over the coming months.
Biome is preparing for an initial test market launch into North America via the Canadian non-retail health practitioner market in H2 FY25.
Similar to Australia’s Therapeutic Goods Administration (TGA), Health Canada is seen as a leading regulatory body globally, enforcing rigorous compliance parameters and high barriers to entry to achieve registration.
The registration of products with Health Canada is expected to provide significant credibility for Biome’s Activated Probiotics products beyond Canada and into the bordering United States market in the future.
Biome’s North American launch is planned for H2 FY25, with a low-risk test market launch into the Canadian practitioner channel with a skeleton sales and education team, similar to the test market strategy undertaken in the UK and Ireland markets preceding the regions’ health retail launch in January 2024.
“Through our international expansion efforts, Biome aims to replicate the trust, acceptance, and loyalty we have developed locally with both European and North American health practitioners and patients. Our goal is to position Activated Probiotics as the obvious choice when health professionals recommend a probiotic to their patients,” Managing Director and Founder, Blair Vega Norfolk, said.
Elsewhere, Biome has achieved positive early sales revenue growth in international markets since the company’s recent health retail launch in the United Kingdom and Ireland in January 2024. International sales revenue is expected to surpass $850,000 for FY24, representing 85% growth vs. the previous corresponding period (FY23 $459,000).
Biome has now completed a rigorous phase of recruitment across the UK, Ireland and New Zealand over the last 18 months, assembling expert sales teams in each region to support the next one to two years of international business development in the practitioner and health retail channels.
Beyond these markets, Western Europe has been identified as a target for strategic expansion. Biome looks forward to sharing an update on the company’s progression into mainland European markets in FY25.
