April 26, 2023
CHARLOTTESVILLE, Va.-- Contraline, a clinical-stage medical device company, announced the acceptance of abstracts detailing the initial results from the company’s first in human clinical trial of ADAM, a hydrogel-based, long-lasting, non-hormonal, and non-permanent male contraceptive. The abstracts were written and submitted by investigators leading the study, and were accepted for presentation at the two largest, annual international urology meetings, the European Association of Urology (EAU) and the American Urological Association (AUA).
Contraline’s first-in-human clinical trial, “The ADAM Study”, began implanting its first patients in September 2022 and is being led by principal investigator Nathan Lawrentschuk, PhD, MBBS, FRACS, Professor of Urology at The Royal Melbourne Hospital and Epworth Hospital, and co-investigator Paul Anderson, MBBS, FRACS.
The ADAM System consists of a patented hydrogel, which is implanted into the vas deferens of patients via a minimally invasive procedure, and a delivery device that automates the delivery of the hydrogel. ADAM is the first hydrogel designed to occlude sperm passage through the vas deferens for a predefined period, degrading without intervention and thus offering a non-permanent contraceptive option for men, in contrast to vasectomy, which is considered permanent.
The podium presentations by Nathan Lawrentschuk at AUA and Paul Anderson at EAU highlight the early research findings on the ADAM System. The first-in-human clinical trial is focused on defining the safety of the ADAM System, while evaluating the preliminary efficacy in inducing azoospermia in study participants.
“The early findings of The ADAM Study support an excellent safety profile for the ADAM System, with most adverse events being minor and related to the procedure, which is similar to a no-scalpel vasectomy, rather than as a result of the implant; no patients to date have experienced any serious adverse events. The preliminary efficacy data have demonstrated that azoospermia has been induced in all men implanted with ADAM. These initial data are very exciting and we are eager to continue enrolling patients into the study. This study enables us to optimize the dose of ADAM while continually improving the implantation procedure, opening to the door to conduct a pivotal trial,” said Nathan Lawrentschuk.
“Even the early data from The ADAM Study support the vas-occlusive hydrogel being a potential game changer in reproductive medicine, with men and couples being able to take even more control over family planning than ever before,” said Alexander Pastuszak, MD, PhD, Chief Medical Officer of Contraline.
Contraline is currently expanding the number of sites for its first in human study in Australia, with the eventual goal of opening a larger study in the United States.