Rejoni, Inc. Announces First Patients Treated with Juveena™ Hydrogel System in US IDE Pivotal Study

Rejoni, a privately held medical technology company designing and developing hydrogels to improve the standard of care in Women’s Health, announced today that it has begun enrollment of patients in the Juveena Hydrogel System Pivotal Study. The Juveena Hydrogel System is being developed for use as a temporary intrauterine implant to prevent the intrauterine adhesions (IUA) that can form inside the uterine cavity following transcervical gynecological procedures.

Dr. David Grainger, board-certified physician in obstetrics and gynecology at Wesley Healthcare in Wichita, KS, enrolled the first patient and Dr. Kelly Roy from Arizona Gynecology Consultants in Phoenix, AZ has begun treating patients as well.  “I am honored to have been chosen to participate in the Juveena clinical trial for evaluating the use of the hydrogel to reduce adhesions in the uterus,” said Dr. Roy. “I look forward to evaluating this technology as we work to reduce intrauterine adhesions and the impactful consequences they place on our patients.”

As many as 40% of women who have had some type of surgical procedure inside the uterus develop Asherman’s Syndrome.

Commonly referred to as “Asherman’s Syndrome”, IUAs are bands of fibrous tissue that form in the uterus, often in response to a uterine procedure. As many as 40% of women who have had some type of surgical procedure inside the uterus develop Asherman’s Syndrome.  The thicker the bands of scar tissue, the more they can cause the uterine cavity to narrow, resulting in pain, skipped, sparse or absent menstrual periods as well as recurring pregnancy loss and other pregnancy complications.

The Juveena Hydrogel is instilled using a thin flexible catheter into the uterus directly after intrauterine surgery to fill the uterus, keeping the walls of the uterus apart during the healing process to prevent IUA from forming. The material is designed to remain in place for a few weeks while healing occurs and then naturally liquefy and leave the body.

“At Rejoni we aim to use our absorbable hydrogel technology to guide healing and recovery after surgical procedures.   The Juveena Hydrogel System is the first product designed for intrauterine adhesion prevention to enter clinical trials in the United States. If approved by the FDA, it will bring much needed relief to many women who suffer from adhesions and have to undergo repeated surgeries” remarked Amar Sawhney PhD, CEO of Rejoni.

Rejoni, Inc. is a privately held company based in Bedford, MA focused on the development and commercialization of products for gynecological surgery using its proprietary biomaterials.  The company, founded in June 2020, is the latest by serial entrepreneur Dr. Amar Sawhney who also founded Confluent Surgical, Ocular Therapeutix, Access Closure, and Augmenix, Inc.  More information about Rejoni can be found at http://www.rejoni.com