BEDFORD, Mass.--(BUSINESS WIRE)--Rejoni, Inc., a privately held clinical-stage company, today announced the completion of enrollment of 150 patients in the Juveena Hydrogel pivotal clinical study. This announcement marks a significant achievement in the field of women's health, particularly concerning the prevention of intrauterine adhesions (IUAs) that can result 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 the prevention of IUAs could be a significant advancement in therapy for many women who face complications following uterine surgeries.
IUAs can have serious implications for women’s reproductive health. As many as 40% of women who have had some type of surgical procedure inside the uterus develop IUAs. Currently, there is no FDA approved treatment to prevent IUAs.
According to Christina Salazar, MD., with the University of Texas at Austin, and a Principal Investigator who participated in the clinical study, - “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.”
“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.” - said Amar Sawhney, CEO of Rejoni, Inc.
About Rejoni, Inc:
Rejoni, Inc. is a privately held company based in Bedford, MA, focused on 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. The company's first product, the Juveena Hydrogel System, is designed for preventing the formation or reformation of intrauterine adhesions following transcervical gynecological procedures.
About the Juveena Hydrogel System:
The Juveena Hydrogel System, is an investigational device intended for use as a temporary implant to prevent the formation or reformation of intrauterine adhesions following 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 over 90% water and leaves the uterine cavity naturally within a few weeks.
Contacts
Nicole Shugrue
VP Market Access and Development
Nicole.shugrue@rejoni.com
Follow us on LinkedIn: https://www.linkedin.com/company/rejoni
