Bedford, Mass. — Rejoni, Inc., a women’s health company focused on uterine health, announced that the U.S. Food and Drug Administration has granted Premarket Approval for its Juveena Hydrogel System.
The system is approved for use in adult women to reduce the incidence and severity of intrauterine adhesions following hysteroscopic adhesiolysis for symptomatic moderate to severe intrauterine adhesions.
Intrauterine adhesions can form inside the uterus following trauma to the endometrium and may lead to menstrual disruption, infertility, recurrent pregnancy loss and serious obstetric complications. Recurrence after surgical removal is common, particularly among women with severe disease.
Juveena is designed to protect the uterine cavity during healing following adhesiolysis. The hydrogel is delivered through a proprietary transcervical catheter at the end of the hysteroscopic procedure. Once placed, it forms inside the uterus, conforms to the uterine cavity and separates the uterine walls.
The hydrogel softens and liquefies within approximately 14 to 21 days before being naturally discharged through the cervix and vagina.
FDA approval was supported by the Juveena Pivotal Study, a multicenter, randomized, subject- and evaluator-blinded controlled study conducted at 15 U.S. centers.
Participants were randomized 2-to-1 to receive Juveena or surgery alone and underwent a second-look hysteroscopy approximately eight weeks after surgery. The study met its primary endpoint of the percentage of patients who were free of adhesions at week eight in the overall study population.
Among women treated following hysteroscopic adhesiolysis for symptomatic moderate to severe intrauterine adhesions, 61.5% of Juveena-treated patients were free of adhesions at week eight, compared with 38.2% of patients in the control group.
The company said adhesion severity at week eight was also significantly lower among patients treated with Juveena. Severe adhesions were observed in 6.1% of Juveena patients compared with 28.6% of controls.
In the overall safety population, device-related adverse events occurred in 8% of Juveena patients and included uterine spasm, pelvic discomfort, pelvic pain, dysmenorrhea and one device expulsion. Rejoni said all of the events were non-serious and resolved either without intervention or with conservative medical management.
“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. We are excited to bring this innovation to physicians and their patients very soon.”
Pietro Bortoletto, M.D., reproductive endocrinologist and co-founder of Terra Fertility in Dedham, Mass., who served as an investigator in the pivotal study, said protecting the uterine cavity after surgery is particularly important for women with moderate to severe adhesions.
“For women with moderate to severe intrauterine adhesions, protecting the uterine cavity after surgery is critical,” Bortoletto said. “As an investigator in the Juveena pivotal study, I saw its impact on my patients firsthand, and I’m excited to now offer it as part of my standard of care.”
Rejoni said it plans to begin a limited market release of Juveena at select U.S. centers specializing in hysteroscopic surgery and reproductive medicine, followed by a broader commercial rollout.
The company has also established a patient access program to support coverage and reimbursement. Juveena procedures may be reported using CPT Category III code 0990T.
