Bioxyne’s Exclusive Deal Raises Stakes in Australia’s Medical Cannabis Device Market

Exclusive Partnership with Curaleaf International

Bioxyne Limited (ASX – BXN), via its wholly owned subsidiary Breathe Life Sciences (BLS), has formalised a significant partnership with Curaleaf International to exclusively import, manufacture, and distribute the Que Medical Inhalation Device (QMID) in Australia. This agreement positions Bioxyne at the forefront of medical cannabis delivery technology in the country, leveraging Curaleaf’s established expertise in medicinal cannabis products.

The QMID is notable for being the first EU Class IIa medical device designed specifically for use with medical cannabis liquid inhalants, distinguishing it from other inhalation products currently available. This regulatory classification under the EU Medical Device Regulation underscores the device’s compliance with stringent safety and efficacy standards.

Regulatory Approvals and Market Launch

Following critical regulatory milestones, including import approval from the Therapeutic Goods Administration (TGA) on 1 October 2025 and authorization by the Office of Drug Control on 27 October, BLS is set to launch the QMID across Australia in November 2025. The device will be accessible through authorised prescribers, the Special Access Scheme-Category B, and pharmacies nationwide, ensuring broad patient access from day one.

Bioxyne’s CEO, Sam Watson, highlighted the strategic importance of this partnership, emphasizing the company’s commitment to expanding access to medically compliant inhalation technologies within Australia’s therapeutic framework. The launch not only enhances patient options but also strengthens Bioxyne’s footprint in the medical device sector.

Financial Implications and Growth Prospects

The introduction of the QMID is expected to create a new recurring revenue stream for Bioxyne, encompassing both the device and replacement cartridges. This addition is projected to contribute significantly to the company’s FY26 financial guidance, which forecasts revenues between $65 million and $75 million, alongside an EBITDA range of $11.5 million to $13.5 million.

Bioxyne’s diversified operations, spanning medicinal cannabis, MDMA, and Psilocybin manufacturing and distribution, are further bolstered by this exclusive deal. The company’s multinational presence and GMP-licensed manufacturing capabilities provide a robust platform to support the QMID’s market rollout and ongoing supply.

Strategic Positioning in a Growing Market

Curaleaf International’s CEO, Juan Martinez, expressed enthusiasm about entering the Australian market with Bioxyne, highlighting the QMID’s design as a discreet and reliable inhalation device tailored for medical use. This collaboration aligns with Curaleaf’s broader mission to innovate medical cannabis technologies and expand their global footprint.

As the medicinal cannabis sector continues to evolve, Bioxyne’s exclusive rights to the QMID position it as a key player in delivering advanced therapeutic solutions. The partnership exemplifies the growing convergence of pharmaceutical-grade manufacturing and innovative delivery systems in alternative therapeutics.