Rejoni has received premarket FDA approval for its Juveena Hydrogel System to support endometrial healing in the uterine cavity following intrauterine surgery.
The system delivers a hydrogel via a proprietary transcervical catheter after hysteroscopic procedures to separate the uterine walls, supporting healing and preventing common intrauterine adhesions (IUAs) – which can lead to menstrual disruption, infertility, recurrent pregnancy loss, and obstetric complications.
“Recurrence of IUAs after adhesiolysis has been a persistent problem with few good options,” said John Nealon, President and Chief Executive Officer of Rejoni, Inc. “This approval gives surgeons a tool backed by rigorous scientific evidence.”
The approval is supported by the company’s Juveena Pivotal Study, a randomized, subject- and evaluator-blinded controlled study conducted at 15 US centers. Compared with surgery alone, the study found the majority of Juveena-treated women were adhesion-free after adhesiolysis, while cases of adhesions that did occur were significantly less severe.
Rejoni, which secured $25 million earlier this year to support commercialization, plans to make Juveena available at select specialty centers across the US before rolling out nationwide.
