LISBON, PORTUGAL, October 28, 2025 /EINPresswire.com/ -- AIRO BRANDS, Inc. (“Airo”), a U.S. multi-state CPG company focused on proprietary cannabis products, in partnership with Jupiter Research LLC, has received regulatory approval for its CE-marked Class IIa medical handheld liquid inhalation device, the Airo Medical Inhalation System, across Europe and Australia. This planned launch will introduce the second EU-certified device of its kind, designed specifically for the delivery of cannabinoid-based medicines under strict medical standards.

This milestone will mark the entry of a precision-engineered device into regulated medical markets, supported by a strategic partnership with SOMAÍ, which will manufacture EU-GMP inhalation oils and serve as the exclusive global distributor for the system’s cartridge line and API’s.

The Airo medical inhalation device is built in full compliance, offering a rechargeable, CE-certified platform engineered for precision, safety, and regulatory integrity. Its ergonomically rounded design ensures comfort and ease of use—critical factors for patients managing chronic therapies. This user-friendly form factor will not only support better patient adherence but will also allow for discreet, consistent dosing with confidence.

“Airo Brands, in connection with Jupiter Research received European regulatory approval for this new medical device — a pivotal step in our global expansion,” stated Richard Yost, CEO and Founder Airo Brands. “This milestone makes Airo one of the first US cannabis companies with a truly international footprint, spanning the U.S., Europe, and additional markets such as Australia and the UK. Built on medical-grade reliability and consumer-driven innovation, Airo is now poised to deliver best-in-class products worldwide.”

“This partnership reflects what the future of medical cannabis should look like: EU-certified medical devices with EU-GMP API’s in finished dosage formats,” said Michael Sassano, CEO of SOMAÍ Pharmaceuticals. “We are proud to support Airo’s international expansion by producing stable, EU-GMP inhalation oils and delivering them across compliant medical channels.”

SOMAÍ will produce and fill the EU-GMP-certified cartridges for the medical inhalation device at its pharmaceutical manufacturing facility in Lisbon, Portugal. These extracts have been developed and validated with EU-GMP manufacturing and shelf stability of a minimum of one year, a benchmark rarely achieved in the inhalation category.

With regulatory approvals and infrastructure already in place, the system is ready for launch in key European countries like Germany, as well as other countries like the UK and Australian markets, with additional jurisdictions in the pipeline.

Airo and SOMAÍ are also preparing to collaborate with global cannabis brands to develop therapeutically differentiated cartridges, tailored for specific patient needs. These future releases will be manufactured and distributed under the same EU-GMP-certified and CE-compliant framework—setting a new benchmark for medical-grade vaporization worldwide.

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About Airo Brands
Founded in 2017, Airo Brands is a U.S.-based multi-state CPG company recognized for its award-winning vaporization technologies and precision-engineered cannabis formulations. With innovation, design, and reliability at its core, Airo has established itself as one of the top-selling cannabis brands across the United States. As of February 2025, Airo products are available in more than 2,100 licensed medical and adult-use dispensaries in 24 U.S. states and Puerto Rico. Building on this foundation, Airo is now expanding into regulated medical cannabis markets in Europe and Australia with CE-certified medical devices and GMP-compliant formulations. Through proprietary closed-system technologies and patented innovation, Airo is setting a new benchmark for medical-grade cannabis delivery worldwide.

About SOMAÍ
SOMAÍ is a leading EU-GMP vertically integrated Multi-Country Operator (MCO) company with a global footprint of distribution for the largest and most advanced EU GMP-certified cannabinoid-containing pharmaceutical extract and flower portfolio.
SOMAÍ owns a state-of-the-art manufacturing facility, SOMAÍ Pharmaceuticals, and indoor cultivation NovaSoma in Lisbon, Portugal, and has global sales teams in the largest medical cannabis markets. We are continuing to make acquisitions and global brand partnerships that make us one of the few and the first European-based vertically integrated companies in the EU able to cater to the diverse needs of fast-growing global cannabis markets.

Nataliia Garnina
SOMAÍ Pharmaceuticals LDA
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