January 04, 2024
Contraline's ADAM breaks new ground as a non-hormonal male contraceptive to release in-human clinical data, paving the way to reproductive equality. This marks the first major development in male contraception since the vasectomy.
January 4, 2024, Charlottesville, VA and Melbourne, Australia
Contraline, a venture-backed, medical device company pioneering the field of male contraception, is pleased to announce positive interim results from its First-in-Human trial. The trial is for the company’s flagship product, ADAM, a male contraceptive that is long-lasting, non-hormonal, and non-permanent.
ADAM is a patented, biocompatible, and injectable hydrogel that is implanted into the vas deferens via a minimally-invasive procedure, where it blocks sperm transport. While there have been over 50 years of research into the development of vas-occlusive contraceptives, no product has achieved regulatory approval or commercial launch to date. ADAM is the first vas-occlusive product designed to be inert, non-permanent, and reversible. These results mark a significant leap forward in the development of a non-hormonal male contraceptive to enter human clinical trials, demonstrating both safety and efficacy of ADAM.
Conducted across three centers in Melbourne, Brisbane, and Wollongong, Australia, the trial has successfully implanted 23 patients. All procedures were conducted by one of the study’s investigators and had a 100% successful implantation rate, measured by the surgeon’s ability to exteriorize and cannulate the vas deferens, and implant the ADAM hydrogel into the vasal lumen using Contraline’s proprietary injector. ADAM procedures, lasting 20 minutes on average, were able to be performed under local or general anesthesia.
Healthy males 25-65 years old with normal semen parameters, suitable for a vasectomy, were enrolled into the trial. The trial has generated substantial interest, with over 1,500 men signing up to participate in the study. The enrolled patients ranged from 28-52 years old, most are in relationships, and about 50% have children. Participants were placed into two cohorts, each receiving varying amounts of hydrogel to gather comprehensive safety and efficacy data across several injection volumes.
Within 30 days of implantation, ADAM™ showcased a 99.8-100.0% reduction in the number of motile sperm, demonstrating that ADAM™ is able to lower sperm concentration and motility to levels comparable to vasectomy, the most effective contraceptive, in a short amount of time.
There have been no reports of serious or severe adverse events. All adverse events reported have been anticipated and predominantly mild. Contraline’s Data Safety Monitoring Board, chaired by Dr. Larry Lipshultz, Professor of Urology at Baylor College of Medicine, concluded that the safety of ADAM is excellent and the study should continue in its current form without modification.
"I am pleased with the early results we are seeing from the trial; it is exciting to see the preliminary outcomes showing ADAM is safe and effective. The level of participant interest we are seeing shows that there is a major need for this type of contraception, and I am excited to continue working with Contraline in the development of the device." said Dr. Peter Chin, Urologist and Associate Professor at the University of Wollongong, and an investigator in the Study.
"We are thrilled to share these positive results which we believe take us one step closer to transforming the contraceptive landscape. This trial and the data presented are a clear indication that ADAM is safe, effective, easy to use, and in-demand. The fact that we are seeing such dramatic reduction in sperm counts and motility, without compromising on safety, suggests that it is possible to achieve similar levels of efficacy as long-acting female contraceptives like IUDs. Ultimately, I’d like to make ADAM become a “no brainer” for men when it comes to considering their options for contraception,” said Kevin Eisenfrats, Co-Founder and CEO of Contraline.
Patients enrolled in the First-in-Human trial will continue to be monitored with regular follow-ups with the physician and semen analyses, contributing to valuable insights into the long-term effects of the implant. Contraline is currently preparing for an IDE (Investigational Device Exemption) submission in 2024, with subsequent plans for initiation of a US registration trial.
Eisenfrats concluded, “This milestone would not have been possible without our courageous patients and study investigators. Because of their contributions, we are one step closer to providing men with an appealing way to control their reproduction.”