Rejoni Appoints Women’s Health MedTech Leader John Nealon as Chief Executive Officer
Rejoni, Inc., a privately held clinical-stage company based in Bedford, MA, dedicated to elevating uterine health through innovative biomaterial therapies, today announced the appointment of John Nealon as Chief Executive Officer.
FDA Files Rejoni’s Juveena® Hydrogel System PMA for the Prevention of Intrauterine Adhesions
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.
Rejoni completes patient enrollment in pivotal clinical study of a Novel Treatment for the Prevention of Intrauterine Adhesions, the Juveena® Hydrogel System.
Rejoni, Inc., a privately held clinical-stage company, today announced the completion of enrollment of 150 patients in the Juveena Hydrogel pivotal clinical study. This announcement marks a significant achievement in the field of women's health, particularly concerning the prevention of intrauterine adhesions (IUAs) that can result in a condition known as “Asherman's Syndrome”. IUAs are bands of fibrous tissue that form in the uterus, often in response to intrauterine surgical procedures. Rejoni’s efforts to develop a treatment for the prevention of IUAs could be a significant advancement in therapy for many women who face complications following uterine surgeries.
