Key Highlights

• Immuron Limited (ASX:IMC, NASDAQ:IMRN) has executed an exclusive distribution agreement for PROIBS® in the United States with Swedish developer Calmino Group AB, extending a commercial relationship that began with the product's Australian launch during FY26.

• PROIBS® is a European-certified medical device, not a supplement, targeting abdominal pain, bloating, and unsettled bowel movements; the US digestive and gut health supplement market is valued at US$4.16 billion (Mordor Intelligence), with Immuron targeting a specific segment of this market.

• A usability study of 1,003 users conducted by Calmino Group found PROIBS® was helpful for 94% of participants, with 91% reporting improvement in daily life and 98% stating they would recommend it to others.

• PROIBS® has been available on the Swedish pharmacy market for more than a decade and is currently distributed internationally, providing an established commercial track record ahead of the US market entry.

Immuron Limited (ASX:IMC, NASDAQ:IMRN), the Australian biopharmaceutical company best known for its Travelan® product, has announced the execution of an exclusive distribution agreement for PROIBS® in the United States with Calmino Group AB, the Swedish life science company that developed the product. The agreement extends a commercial Partnership that commenced when Immuron launched PROIBS® in Australia during the financial year ending June 2026, now broadening its geographic scope to the world's largest consumer healthcare market.

What is PROIBS® and Its Target Condition

PROIBS® is classified as a medical device rather than a pharmaceutical drug or supplement — a distinction that has regulatory and Marketing implications in the US market. The product is indicated for abdominal pain, bloating, and unsettled bowel movements, encompassing both diarrhoea and constipation. Its active component is AVH200®, derived from the plant Aloe barbadensis Mill (commonly known as aloe vera). AVH200® contains gel-forming components that are described as supporting the intestinal mucosal barrier — the protective lining of the gut.

The product is noted for its suitability for long-term use, with no known interactions with other medications reported. This safety profile, if it holds in the US market context, could be a meaningful differentiator in a segment where consumer concerns about drug interactions are common, particularly among polypharmacy patients and older demographics who represent a disproportionate share of digestive health product consumers.

US Market Opportunity and Competitive Context

The overall US digestive and gut health supplement market is valued at US$4.16 billion according to Mordor Intelligence. Immuron has indicated it is targeting a specific subset of this broader market with PROIBS® rather than the entire category — a framing that reflects the more targeted nature of the product's indication. The scale of the broader market provides a meaningful addressable base, but the achievable share for a newly launched medical device in a competitive and fragmented category will depend heavily on physician and dietitian engagement, product awareness, and distribution execution.

PROIBS® has been commercially available in European markets, particularly in Sweden, for more than a decade, providing an established real-world usage history. The Calmino usability study of 1,003 users reported that the product was helpful for 94% of participants, with 91% experiencing improvement in daily life and 98% indicating they would recommend it. While usability studies of this kind are not Clinical Trials and their design and methodology should be reviewed carefully before drawing clinical conclusions, the results indicate a degree of consumer satisfaction that could support word-of-mouth and physician recommendation channels.

Immuron's Commercial Growth Strategy and Calmino Partnership

Immuron's Chief Commercial Officer, Flavio Palumbo, described the US launch of PROIBS® as part of a deliberate strategy to build a portfolio of innovative digestive health products following what the Company characterises as rapid growth of Travelan® sales in the US. Travelan® is Immuron's existing product targeting travellers' diarrhoea, and a PROIBS® launch would represent a second commercial pillar in the US digestive health category for the company.

For Calmino Group AB — a company founded in 2003 and based at Sahlgrenska Science Park in Gothenburg, Sweden — the agreement represents the expansion of a two-continent commercial partnership with Immuron. CEO and founder Tobias Kisker noted that what "started with PROIBS® in Australia is now developing into a partnership across two continents." Calmino characterises the product as science-driven and physician and dietitian-recommended, attributes that Immuron has stated allow it to "promote PROIBS® with absolute confidence." The product's European certification and decade-long commercial track record in Sweden are likely to be central to its positioning in the US market.

Key Risks and Execution Considerations

The US consumer healthcare market is highly competitive and requires meaningful Investment in sales infrastructure, physician outreach, and marketing to gain traction. As a medical device rather than a drug, PROIBS® does not require FDA pre-market approval in the same way as a pharmaceutical, but it will need to comply with applicable US regulatory requirements for medical devices. The conversion from European and Australian commercial success to US market penetration is not assured, and the rate of uptake will be a key variable for Immuron's Revenue trajectory from this product line.

Conclusion

Immuron's (ASX:IMC) execution of the exclusive US distribution agreement for PROIBS® marks a logical geographic extension of its growing digestive health commercial portfolio. The product enters a large and established US market with a decade of European commercial history and clinically characterised user satisfaction data. The key variable will be the effectiveness of Immuron's US commercial execution and its ability to establish PROIBS® as a distinct and recognisable option for physicians, dietitians, and consumers managing IBS-related conditions. The speed and scale of uptake in the US market will be important near-term metrics for market observers to assess the commercial potential of this partnership.