Rejoni, Inc., a commercial-stage women's health company focused on uterine health, today announced that the U.S. Food and Drug Administration (FDA) has granted Premarket Approval (PMA P250051) for the Juveena Hydrogel System. The Juveena Hydrogel System is indicated for use in adult women to reduce the incidence and severity of intrauterine adhesion formation following hysteroscopic adhesiolysis for symptomatic moderate to severe intrauterine adhesions.

A seasoned executive with more than two decades of leadership experience in women’s health and medical devices, Mr. Nealon brings a distinguished record of building high-performing teams, driving commercial growth, and delivering patient-centered solutions to market.

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.

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