Enrollment Ends for Study of Intrauterine Adhesion Treatment Device

Rejoni Inc. has finished enrolling 150 patients in its Juveena Hydrogel pivotal clinical study, designed to assess the company’s solution for preventing intrauterine adhesions (IUAs).

Often resulting in a condition known as “Asherman’s Syndrome,” IUAs are bands of fibrous tissue that form in the uterus, often in response to intrauterine surgical procedures. Rejoni’s efforts to develop a treatment for preventing IUAs could be a significant advancement in therapy for many women who face complications following uterine surgeries.

“Having a proven and effective solution to prevent intrauterine adhesions is greatly needed, especially for women seeking to conceive and avoid pregnancy-related complications such as pre-term birth or placenta accreta spectrum,” said Christina Salazar, M.D.., with the University of Texas at Austin, and a principal study investigator.

IUAs can have serious implications for women’s reproductive health. Industry statistics show that as many as 40% of women who have undergone a surgical procedure inside the uterus develop IUAs. There currently is no U.S. Food and Drug Administration (FDA)-approved treatment to prevent IUAs.

Rejoni’s Juveena Hydrogel System is an investigational device intended for use as a temporary implant to prevent the formation or reformation of intrauterine adhesions after transcervical gynecological procedures. The Juveena Hydrogel System consists of a proprietary transcervical catheter and two teaspoons of liquid precursors that fill the uterine cavity and to form a soft hydrogel that separates the uterine walls during the healing process. The Juveena hydrogel is comprised of more than 90% water and leaves the uterine cavity naturally within a few weeks.

“We are extremely pleased with the completion of the enrollment phase of the Juveena Pivotal Study and now are working diligently to complete follow-up and prepare for submission of the clinical results to the FDA.” Rejoni CEO Amar Sawhney stated.

Rejoni Inc. is a privately held company based in Bedford, Mass., developing and commercializing therapeutic products in gynecology using its proprietary biomaterials. The company was founded in 2020 by serial entrepreneur Amar Sawhney and Pramand LLC.