Swedish biotech company Emplicure AB has officially launched its next-generation nicotine pouch technology, Seratek, and is preparing to enter the U.S. market by seeking regulatory authorization through the U.S. Food and Drug Administration’s premarket tobacco product application (PMTA) process.
The company states Seratek uses a bioceramic, calcium-based carrier system to release nicotine faster and at lower strengths compared to traditional pouch formats.
According to a July 2025 pharmacokinetic study published in Discover Medicine, Seratek formulations achieved a significantly faster initial uptake than competitor products; the study concluded that “SERATEK formulations provide a faster initial release and higher nicotine uptake compared to ZYN, particularly within the first 5 min of use.”
Emplicure’s own commercial release in Europe already features its pouch brand KLAR, which it says is built on Seratek technology and “releases nicotine 50% faster” than the leading brand in its class.
CEO Mattias Josander told industry media that Emplicure’s goal is “to make it easier for nicotine users to turn away from tobacco and heated inhalation devices,” and in his words, “If vaccines were the breakthrough of the 20th century, nicotine pouches could represent the public-health breakthrough of the 21st.”
The U.S. nicotine pouch market has experienced rapid growth, with adult oral nicotine alternatives increasingly favored by adult nicotine consumers. Emplicure says the global pouch market was valued at about US$7.4 billion in 2023 and projected to reach US$25.2 billion by 2028.
For its U.S. push, Emplicure intends to submit a PMTA, demonstrating that Seratek-based pouches produce a “lower-strength delivery, faster onset” profile aimed at adult smokers and existing users seeking smokeless option
Industry observers note the timing is strategic: several major tobacco companies are ramping their nicotine-pouch portfolios in the U.S., and a novel technology claiming faster onset while using less nicotine could deliver a competitive edge.
However, regulatory risks remain; the FDA does not guarantee that a PMTA will result in a marketing granted order (MGO), and the agency continues to “evaluate the health risks and addictiveness” of nicotine pouch products.
From a manufacturing standpoint, Emplicure says it has expanded its Uppsala, Sweden facility to produce Seratek-powder at a capacity equivalent to 880 million cans annually.
The company positions itself as independent of the traditional tobacco industry, stating on its website that it has “zero links to the tobacco industry” and sees its mission as developing “humankind-friendly” nicotine alternatives.
