Contraline, a company based in Charlottesville, Virginia, is working on introducing a new method for male contraception that may overcome many of the limitations of existing approaches, particularly vasectomy. Contraline’s procedure is called Vasintomy and like vasectomy it works by preventing sperm from moving down the vas deferens. Unlike vasectomy, though, it’s a non-surgical procedure that doesn’t permanently reconstruct male anatomy and should be reversible. We spoke with Kevin Eisenfrats, co-founder and CEO of Contraline, to get a better idea of the technology and what we can expect from the company in the future.
Medgadget: Let’s start with how Vasintomy from Contraline works. It’s described as “non-surgical” in your literature, and we’re curious about the details from a clinician’s point of view.
Kevin Eisenfrats, Contraline: The Vasintomy can be described medically as an ultrasound-guided, percutaneous injection. Just like in vasectomy, the urologist first identifies the vas deferens, administers local anesthesia, and secures the vas to the skin. Here’s where Vasintomy is vastly different. Instead of making an incision and pulling the vas out, he/she uses a standard ultrasound probe to visualize the lumen (the hole in the center) of the vas deferens. Once visualized, they inject Echo-V (or the polymer solution) into the lumen through the skin. No incisions, sutures, or scalpels are required. Echo-V appears on the ultrasound confirming the injection was done properly. The whole procedure is predicted to take 3-4 minutes.
Medgadget: Can you tell us what side effects you hope to overcome over existing techniques?
Kevin Eisenfrats: Firstly, the gel is non-hormonal so there will be no systemic side-effects like weight gain and acne that come with female steroidal options. In the past, there have been gels or devices implanted into the vas deferens. Some of them cause scarring of the vas tissue. Granulomas can form if the urologist misses and injects into the smooth muscle layer, and foreign body responses can occur if the gel is not biocompatible. Vasintomy allows the urologist to see the lumen so it reduces (potentially eliminates) the chance for granulomas and our gel is biocompatible.
Medgadget: What about reversing the procedure, how is that performed and do you expect healthy recovery for the vas deferens?
Kevin Eisenfrats: We cannot reveal too much about our reversal procedure yet, but what we can say is that the procedure is identical to Vasintomy in that it is non-surgical…except instead of a gel being injected, we inject a solution that dissolves the gel. The solution contains an agent which will selectively and effectively de-precipitate the gel. As long as the gel does not damage the basal membrane of the epithelial wall, there should be healthy recovery of the vas. We’re testing this in our rat study now :)
Medgadget: What is your background to have ended up working on such a project and how long has your team been developing this technology?
Kevin Eisenfrats: My personal background.. I studied nanomedicine engineering at the University of Virginia. I have been interested in the field of reproductive and contraceptive health since high school. I even wrote my admissions essay for UVA on why there is no male birth control pill yet. I worked in Dr. John Herr’s lab doing research on uterine cancer for three years and at the National Institutes of Health doing research on in vitro fertilization. The Contraline team has been “going at it” for a little over a year now.
Medgadget: Is there a clinical background that led to this technology, or perhaps it was the result of a lightbulb moment for someone?
Kevin Eisenfrats: The only knowledge we had was that gels and devices had been implanted into rabbits, monkeys, and humans before (i.e. RISUG in India) and they work really well! However, there are a lot of problems with them that have limited commercialization. When I was reading these papers, I had a light-bulb moment: “why have none of these procedures been non-surgical?” That would make the whole procedure much more appealing. One of the biggest concerns for vasectomy patients is the invasiveness of the procedure. That’s why I invented Vasintomy.
Medgadget: What challenges do you expect to encounter bringing Vasintomy to market, and where in the world do you expect it’ll be initially adopted?
Kevin Eisenfrats: The biggest challenge will be the FDA. Echo-V is a high-risk device because it’s implanted in the body and lasts for years. We have to show animal data, biocompatibility data, and do human clinical trials to get approval. But that’s why we have a great team which has been through the FDA before and we’re producing all of the required data. We’re very set on going after the United States as our first market. It has the biggest target market size and sets the precedent for regulatory approval in other countries. We have some other countries around the world we are looking at.. but can’t reveal them just yet.
Medgadget: Are you or do you expect to develop other medical products and what are the long term goals for the company?
Kevin Eisenfrats: My vision is for Contraline to become a global leader in the male reproductive health space. To start, we’re developing a suite of products that accompany Vasintomy. This includes new injection devices, needles, ultrasound technology with needle-guiding algorithms, etc. We’re also interested in novel male contraceptives apart from Vasintomy/Echo-V.