Rejoni Showcases FDA-Approved Juveena® Hydrogel System at AAGL 2026 Global Congress in Boston Alongside Pivotal Trial Results Published in Fertility and Sterility

Pivotal trial data to be featured in an oral presentation during AAGL Scientific Sessions; results published in Fertility and Sterility with accompanying independent editorial.

BURLINGTON, Mass.--(BUSINESS WIRE)--Rejoni, Inc., a commercial-stage women’s health company focused on uterine health, today announced its participation in the AAGL 55th Global Congress on Minimally Invasive Gynecologic Surgery (MIGS), taking place Nov. 13-16, 2026, at the Hynes Convention Center in Boston. At the meeting, results from the Juveena pivotal trial will be featured in an oral presentation during the Scientific Sessions. The trial results are published in Fertility and Sterility, the peer-reviewed journal of the American Society for Reproductive Medicine (ASRM), alongside an independent editorial commentary. Rejoni will also host an Experience Theater on its FDA-approved Juveena^® Hydrogel System.

Intrauterine adhesions (IUAs) can form after intrauterine surgery and may be associated with menstrual abnormalities, pregnancy loss, and infertility. When IUAs are accompanied by clinical manifestations, the condition is often referred to as Asherman syndrome. Adhesions frequently recur following hysteroscopic adhesiolysis, and few evidence-based options exist to reduce adhesion reformation during the critical postoperative period.

The Juveena pivotal trial, conducted across 15 U.S. academic and community gynecologic surgery centers, randomized 150 participants undergoing either hysteroscopic adhesiolysis for moderate-to-severe IUAs or selected high-risk hysteroscopic myomectomy procedures in a 2:1 ratio to receive the in situ-forming hydrogel barrier (n=99) or no intrauterine barrier (n=51) following the index procedure. The primary endpoint was the proportion of participants without IUAs at second-look hysteroscopy, assessed by a blinded, independent central review committee using paired video evaluation.

Key published findings included:

In the modified intention-to-treat adhesiolysis subgroup, which included participants with confirmed eligibility and evaluable hysteroscopy videos, 60.3% of Juveena participants were adhesion-free at second-look hysteroscopy compared with 32.3% of controls (odds ratio 3.19; 95% CI 1.29 to 7.90; p=0.015). Severe IUAs at second-look hysteroscopy were observed in 6.3% of hydrogel barrier participants compared with 32.3% of controls (odds ratio 0.14; 95% CI 0.04 to 0.50; p=0.002).

Device-related adverse events occurred in 8% of Juveena patients; all were non-serious and resolved with no intervention or conservative medical management.

“Intrauterine adhesions remain one of the most challenging problems we face after hysteroscopic surgery, and recurrence following adhesiolysis is common. In this randomized, blinded trial, more patients who received the hydrogel barrier were adhesion-free at second-look hysteroscopy. These are encouraging findings for a patient population with few evidence-based options,” said Christina A. Salazar, MD, Associate Professor of Women’s Health at The University of Texas at Austin Dell Medical School, lead study author and Principal Investigator.

In an editorial accompanying the study in Fertility and Sterility, J. Preston Parry, MD, MPH, of Positive Steps Fertility & Parryscope Fertility and the Department of Obstetrics and Gynecology at Louisiana State University Health-Ochsner, and co-authors pointed to the trial’s randomized, multicenter design with participants drawn from academic medicine and private practices, blinding of subjects and evaluators, second-look hysteroscopy, and statistical analysis performed by an external organization.

The publication and accompanying editorial add to the peer-reviewed evidence on the Juveena Hydrogel System.

“Seeing these results published in a leading peer-reviewed journal, alongside an independent editorial recognizing the rigor of the study design, is an important milestone for Rejoni and our mission to advance uterine health, an area that has been underserved for far too long,” said John Nealon, Chief Executive Officer of Rejoni. “AAGL brings together the gynecologic surgeons who manage intrauterine adhesions every day. We look forward to sharing the data and the Juveena experience with them in Boston, and we remain grateful to the investigators and to the women who participated in this trial.”

The article, “Safety and Effectiveness of an In Situ-Forming Hydrogel Barrier in Preventing Intrauterine Adhesions After Adhesiogenic Hysteroscopic Procedures: A Multicenter, Randomized, Controlled Trial,” is published in Fertility and Sterility (doi: 10.1016/j.fertnstert.2026.07.015). The accompanying editorial by Parry, Drizi, and Vitale is also published in Fertility and Sterility (doi: 10.1016/j.fertnstert.2026.09.002).

About Juveena

The Juveena Hydrogel System is an FDA-approved, in situ-forming hydrogel system 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. The system uses a proprietary transcervical catheter to deliver two aqueous polymer solutions that rapidly form a soft, temporary hydrogel spacer. The hydrogel conforms to the uterine cavity and upper cervical canal, keeping the uterine walls apart while they heal. Juveena received FDA premarket approval in September 2026.

Indication and Important Safety Information

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.

The Juveena Hydrogel System should not be used in patients with hemorrhage, active pelvic infection, sexually transmitted disease, or pregnancy, or in patients with known hypersensitivity or allergy to polyethylene glycol (PEG) or FD&C Blue #1 dye. Safety and effectiveness have not been established following hysteroscopic procedures other than adhesiolysis of moderate to severe intrauterine adhesions, or in patients undergoing thermal endometrial ablation. Patients should avoid pregnancy during the first complete menstrual cycle after treatment. Potential adverse reactions include discomfort, pain/cramping, infection, local inflammatory reaction, and allergic reaction. Caution: Federal (USA) law restricts this device to sale by or on the order of a physician or licensed practitioner. For complete information, see the Instructions for Use at www.rejoni.com.

About Rejoni

Rejoni, Inc. is a privately held commercial-stage medical device company based in Burlington, Massachusetts, developing gynecologic products based on its proprietary biomaterials. Founded in June 2020, Rejoni is the latest venture from serial entrepreneur Amar Sawhney, who also founded Confluent Surgical, Ocular Therapeutix, and Augmenix.

More information about Rejoni can be found at www.rejoni.com.

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