Sebela Women's Health's MIUDELLA® System Selected as One of TIME's Best Inventions of 2025

MIUDELLA®: A Revolutionary Approach to Contraception

Sebela Women's Health, a division of Sebela Pharmaceuticals, has announced a significant milestone with its MIUDELLA® Hormone-Free Copper Intrauterine System (IUS) being recognized in TIME's esteemed list of the Best Inventions of 2025. This accolade not only highlights the innovative design but also emphasizes the importance of advancements in women's health care.

Overview of MIUDELLA®

MIUDELLA® marks a groundbreaking development as the first hormone-free copper IUD approved in the United States in over four decades. The U.S. Food and Drug Administration (FDA) granted approval for MIUDELLA® on February 24, 2025, allowing it to be used for the prevention of pregnancy in females of reproductive age for up to three years.

MIUDELLA® aims to provide an effective contraceptive option that is free from hormonal influences, catering to women who prefer or require non-hormonal birth control. It is anticipated that this revolutionary device will be made available to patients via trained healthcare providers in the U.S. in the first half of 2026.

The Importance of Recognition

The selection of MIUDELLA® for TIME's Best Inventions list involved a rigorous evaluation process conducted by TIME editors and correspondents who assessed numerous nominations from around the globe. Each invention was evaluated based on originality, effectiveness, ambition, and potential impact, making this recognition particularly meaningful for Sebela Women’s Health. Dr. Kelly Culwell, Head of Research and Development, expressed the company’s excitement about this honor, indicating that it reinforces the belief in MIUDELLA® as a valuable contraceptive option for women across the nation.

Why MIUDELLA® Matters

In the landscape of women's contraceptive options, long-acting reversible contraceptives (LARCs) such as IUDs are regarded as some of the most effective methods available. According to guidelines from the American College of Obstetrics and Gynecology, LARCs have minimal contraindications, making them suitable for a wide range of patients. Despite this, statistics indicate that approximately 41.6% of pregnancies in the U.S. are unintended, emphasizing the need for continued advancements in contraceptive solutions.

The introduction of MIUDELLA® is particularly timely, offering an alternative that fills a gap in the market for non-hormonal birth control methods. Many women seek options that do not interfere with their hormonal balance, and MIUDELLA® aims to address this demand.

Proper Training and Safety Considerations

While MIUDELLA® presents exciting possibilities, it is important to note that improper insertion of intrauterine devices, including MIUDELLA®, can increase the risk of complications. Therefore, the MIUDELLA® REMS program has been established to ensure that healthcare providers receive adequate training for correct insertion practices. This strategy is aimed at minimizing potential risks associated with the device.

Conclusion

The recognition of MIUDELLA® by TIME as one of the Best Inventions of 2025 heralds a new dawn in the field of reproductive health. As Sebela Women's Health continues to push boundaries and innovate, MIUDELLA® serves as a significant step forward in providing women with safe, effective birth control options. For those interested, further information can be found on the company’s website and the full prescribing information details the important safety information and considerations surrounding the use of MIUDELLA®.

In summary, MIUDELLA® not only innovates within the contraception space but also contributes to the broader dialogue about women’s health, emphasizing the need for diverse and effective reproductive options.