Rejoni, Inc., a clinical-stage company focused on uterine health, today announced that the U.S. Food and Drug Administration (FDA) has completed its filing review and formally filed the Premarket Approval (PMA) application for the Juveena Hydrogel System. In its filing notification, FDA stated that the submission contains the information needed to proceed with substantive review.

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The Juveena Hydrogel System is designed as a temporary spacer to help prevent the formation and reformation of intrauterine adhesions (IUAs). The PMA submission includes results from a pivotal clinical study in patients undergoing transcervical procedures, including adhesiolysis and fibroid removal.

IUAs often occur after trauma to the uterine lining and are a significant but underdiagnosed complication of common transcervical procedures. The presence of IUAs can impact fertility and quality of life, and recurrence after surgery is common—underscoring the need for effective prevention.

“FDA’s filing of the Juveena PMA represents an important regulatory milestone for Rejoni,” said Amarpreet Sawhney, PhD, CEO of Rejoni, Inc. “We believe Juveena has the potential to address a significant and long-standing unmet need in the prevention of intrauterine adhesions, and we look forward to working with FDA as the review progresses.”

About Rejoni, Inc.

Rejoni, Inc., based in Bedford, Massachusetts, develops and commercializes gynecologic therapies using proprietary biomaterials and associated delivery systems. Founded in 2020 by Amar Sawhney, PhD, and Pramand LLC, Rejoni is committed to protecting, preserving, and healing the uterus.

About the Juveena Hydrogel System

Juveena is an investigational device designed as a temporary spacer to help prevent intrauterine adhesions after transcervical gynecologic procedures. Juveena is not yet approved for sale or commercial distribution.

To learn more, visit www.rejoni.com.

Juveena is a registered trademark of Rejoni, Inc.

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"Juveena has the potential to address a significant and long-standing unmet need in the prevention of intrauterine adhesions."