On Thursday, a medical device company Counterline became the first to implant a hydrogel-based male contraceptive in humans in a clinical trial. The reversible, non-hormonal gel was implanted into the vas deferens of four men.
The Charlottesville, Virginia-based company was founded in 2015 to address the world’s lack of male contraception.
“Three-quarters of the entire world uses birth control at any one time, and the vast majority of methods are still focused on women,” Contraline CEO Kevin Eisenfrats said in an interview. “There’s a growing demand for men who want new opportunities, and we’re trying to address that.”
Using a non-invasive, scalpel-free method, doctors implanted four men with Adam, Contraline’s flagship product, in Melbourne, Australia. Adam is designed to block the flow of sperm to the vas deferens for a period of time.
“We like to call it the ‘IUD for men’ simply because there is no long-lasting, reversible method for men – something that is ‘set it and forget it.’ But somewhat, that analogy stops,” Eisenfrats said.
The analogy stops because, unlike the IUD, Adam is non-hormonal and comes in gel form. But like the IUD, Adam can be implanted during a doctor’s visit.
The office procedure can happen in less than 10 minutes and is performed under local anesthesia, according to Eisenfrats. He said the procedure is “virtually identical to a vasectomy,” but “instead of doing a pinch,” the doctor injects a hydrogel into the vas deferens. Once the sperm is blocked from traveling through the vas deferens, the man does not produce sperm in his ejaculate and is therefore unable to fertilize an egg.
Eisenfrats pointed out that the key difference between getting an Adam implant and getting a vasectomy is that the latter is considered irreversible.
“We’re not really going after the vasectomy market – right now we’re going after the younger men who don’t really have any options,” he said.
Adam’s clinical trial tested the product’s safety and efficacy while monitoring participants’ sperm parameters over three years. The study, which is being conducted in Australia, is recruiting up to 25 patients, according to Eisenfrats. He said recruitment for the trial has been “really easy and straightforward” so far because there are a lot of people who are excited about this product — something he’s seen even in the clinical trial setting.
Investors are also backing Contraline’s product. The company recently closed a $7.2 million funding round led by GVbringing it to $17.9 million in total fundraising to date.
Eisenfrats identified Vassalgel as Contraline’s only direct competitor. He said Vasalgel had been working on putting a gel into the vas deferens for more than a decade, and his gel had a completely different chemistry than Adam’s. Vasagel never entered a clinical trial because of concerns about injection safety and reversibility, Eisenfrats said.
“Even though this is like an early stage clinical trial, it’s a big deal for the entire field that this is moving forward,” he said. “And this will be the first clinical data for non-hormonal male contraceptives in more than 20 years – that’s why it’s a really big deal.”