Leipzig, December 18, 2025 – Meliodays Medical, a preclinical stage pharmaceutical company addressing the unmet need in debilitating menstrual health conditions, announced first promising results for MelioOne®, its investigational drug-device combination product being developed to alleviate menstrual pain (i.e., dysmenorrhea), including pain often associated with underlying uterine conditions such as endometriosis and adenomyosis. This investigational study explores the feasibility of local, sustained celecoxib delivery via a novel intrauterine device to minimize systemic exposure while maintaining local therapeutic levels. 

 
Initial in vitro and in vivo proof-of-concept studies highlighted positive signals for the functionality of the innovation. MelioOne® demonstrated a good absorption profile in the uterine tissue in a rodent model, comparable to that observed with oral administration. Crucially, plasma concentrations of celecoxib remained below the levels typically associated with oral administration, suggesting a potential for reduced risk of systemic side effects. 

"Our preclinical findings are a major step forward for MelioOne®," said Simone Sabbione, CEO and Co-Founder of Meliodays Medical. "This data provides a strong signal that our novel approach is viable, de-risking the scientific and technical foundation of MelioOne®, validating its mechanistic concept, and confirming feasibility for continued nonclinical development." 
 

MelioOne® is a non-hormonal drug-eluting intrauterine system designed to deliver anti-inflammatory medication directly to the uterus, offering a potentially powerful new option for those who suffer from severe menstrual pain without relying on hormones or frequent oral medication. Its design combines a biocompatible EVA polymer matrix and celecoxib, a potent selective cyclooxygenase-2 (COX-2) inhibitor with a well-established safety and efficacy profile in menstrual pain management.  

 
Following these encouraging results, Meliodays Medical is advancing in nonclinical development and preparing for a Pre-IND meeting in collaboration with Premier Research to align on the whole development program and regulatory next steps. 

About MelioOne® 
MelioOne®, Meliodays Medical’s lead product candidate, is a non-hormonal drug-eluting IUD designed to alleviate the severity of menstrual pain. Its design contains an EVA polymer-based drug reservoir and Celecoxib as active pharmaceutical ingredient (API), a potent cyclooxygenase-2 (COX-2) inhibitor, a well-established on-label oral medication in the US for menstrual pain (dysmenorrhea) management.  

About Meliodays Medical 
Meliodays Medical GmbH is a pharmaceutical company focused on developing a new product for hormone-free, local treatment of menstrual pain. Meliodays Medical is developing MelioOne®, the first hormone-free, local solution to treat menstrual pain with minimal systemic side effects, thus addressing an area of high unmet medical need. With its innovative solutions, Meliodays is paving the way to a better quality of life for menstruating people, enabling them to have pain-free periods without affecting their menstrual cycle. For further information, please visit meliodays.com and follow us on LinkedIn or Instagram. 

Forward-Looking Statements 
This release may contain forward-looking statements regarding Meliodays Medical’s research, development, regulatory strategy, and business outlook. These statements are based on current expectations and assumptions and involve risks and uncertainties that could cause actual results to differ materially. Factors include, but are not limited to, research outcomes, regulatory decisions, financing, market adoption, and external conditions. Readers are cautioned not to place undue reliance on these statements. Meliodays Medical undertakes no obligation to update any forward-looking statements, except as required by applicable law. 

Meliodays Contact
Meliodays Medical GmbH
Trudy Au (VP Brand, Marketing and Communications)
Phone: +49 (0)160 94836286
E-Mail: trudy.au@meliodays.com