Sebela Women's Health Celebrates MIUDELLA's Award for Groundbreaking Research in Family Planning
In a remarkable recognition, the MIUDELLA® Hormone-Free Copper Intrauterine System (IUS) has received the prestigious Daniel Mishell, Jr. MD Outstanding Article Award at the Society of Family Planning Annual Meeting, held in Pittsburgh. This award was bestowed upon the publication detailing the Phase 3 data of MIUDELLA in the esteemed journal, Contraception. Sebela Women's Health Inc., part of Sebela Pharmaceuticals, announced this achievement with pride, affirming the significance of their contributions to the field of contraceptive research.
Dr. David K. Turok, one of the study's principal investigators and a prominent figure in reproductive health, represented the team at the meeting. His insights were critical to bringing the first hormone-free IUD to the U.S. market in over four decades. The innovative design of MIUDELLA includes a flexible nitinol frame, providing women with a reliable long-term birth control option, maintaining effectiveness while minimizing issues related to expulsion and side effects, such as bleeding and pain.
The impact of this recognition is profound, as it emphasizes the importance of peer-reviewed research in advancing family planning services. According to the editors and editorial board of Contraception, the award celebrates research that has a unique and significant influence on family planning practices globally. Dr. Turok expressed his delight in contributing to a groundbreaking development that promises to enhance contraceptive options available to women.
The MIUDELLA publication was deemed an important contribution to contraceptive literature, leading to accolades not just for the research team, but also for the women who participated in the Phase 3 studies. Sebela Women's Health's Kelly Culwell, MD, Head of Research and Development, voiced her gratitude towards the entire team involved in this significant project.
In addition to winning the Outstanding Article Award, MIUDELLA has also been recognized by TIME magazine as one of the Best Inventions of 2025, cementing its status as a pivotal advancement in women's healthcare. This dual recognition highlights the growing demand for effective, hormone-free contraceptive options, especially in a landscape where unplanned pregnancies remain a significant concern, accounting for approximately 41.6 percent of pregnancies in the United States.
Notably, the FDA approved MIUDELLA® on February 24, 2025, allowing its use for up to three years as an effective means of pregnancy prevention in women with reproductive potential. Anticipated to be available through healthcare providers by mid-2026, this IUD is designed to address the needs of women seeking a long-acting and reversible contraceptive method.
The American College of Obstetrics and Gynecology recognizes long-acting reversible contraceptive methods, such as IUDs, as among the most effective and appropriate contraceptive options for nearly all patients. Complications previously associated with IUD insertion underscore the necessity for proper training among healthcare providers to minimize risks, a procedure assured under the MIUDELLA® Risk Evaluation and Mitigation Strategy (REMS).
As Sebela Women's Health continues to innovate within women’s healthcare, the implications of MIUDELLA extend beyond mere recognition. By setting new standards in contraceptive safety and availability, the company reaffirms its commitment to enhancing women’s health through advanced research and product development. Bridging the gap in effective contraceptive options is essential in fostering women's autonomy and health, making MIUDELLA not just a product, but a promise for a better future in reproductive health.
The collective efforts of distinguished professionals, including Dr. Turok and lead article author Dr. Mitchell Creinin, who was also honored with the Lifetime Achievement Award during the conference, reflect a dedication to advancing contraceptive science. This momentum signals a progressive shift toward embracing innovative solutions that meet the evolving needs of women's health worldwide.
Dr. David K. Turok, one of the study's principal investigators and a prominent figure in reproductive health, represented the team at the meeting. His insights were critical to bringing the first hormone-free IUD to the U.S. market in over four decades. The innovative design of MIUDELLA includes a flexible nitinol frame, providing women with a reliable long-term birth control option, maintaining effectiveness while minimizing issues related to expulsion and side effects, such as bleeding and pain.
The impact of this recognition is profound, as it emphasizes the importance of peer-reviewed research in advancing family planning services. According to the editors and editorial board of Contraception, the award celebrates research that has a unique and significant influence on family planning practices globally. Dr. Turok expressed his delight in contributing to a groundbreaking development that promises to enhance contraceptive options available to women.
The MIUDELLA publication was deemed an important contribution to contraceptive literature, leading to accolades not just for the research team, but also for the women who participated in the Phase 3 studies. Sebela Women's Health's Kelly Culwell, MD, Head of Research and Development, voiced her gratitude towards the entire team involved in this significant project.
In addition to winning the Outstanding Article Award, MIUDELLA has also been recognized by TIME magazine as one of the Best Inventions of 2025, cementing its status as a pivotal advancement in women's healthcare. This dual recognition highlights the growing demand for effective, hormone-free contraceptive options, especially in a landscape where unplanned pregnancies remain a significant concern, accounting for approximately 41.6 percent of pregnancies in the United States.
Notably, the FDA approved MIUDELLA® on February 24, 2025, allowing its use for up to three years as an effective means of pregnancy prevention in women with reproductive potential. Anticipated to be available through healthcare providers by mid-2026, this IUD is designed to address the needs of women seeking a long-acting and reversible contraceptive method.
The American College of Obstetrics and Gynecology recognizes long-acting reversible contraceptive methods, such as IUDs, as among the most effective and appropriate contraceptive options for nearly all patients. Complications previously associated with IUD insertion underscore the necessity for proper training among healthcare providers to minimize risks, a procedure assured under the MIUDELLA® Risk Evaluation and Mitigation Strategy (REMS).
As Sebela Women's Health continues to innovate within women’s healthcare, the implications of MIUDELLA extend beyond mere recognition. By setting new standards in contraceptive safety and availability, the company reaffirms its commitment to enhancing women’s health through advanced research and product development. Bridging the gap in effective contraceptive options is essential in fostering women's autonomy and health, making MIUDELLA not just a product, but a promise for a better future in reproductive health.
The collective efforts of distinguished professionals, including Dr. Turok and lead article author Dr. Mitchell Creinin, who was also honored with the Lifetime Achievement Award during the conference, reflect a dedication to advancing contraceptive science. This momentum signals a progressive shift toward embracing innovative solutions that meet the evolving needs of women's health worldwide.
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