NEXT Life Sciences Is Making Effective, Reversible Male Contraceptive a Reality
Challenge
Globally, nearly half of all pregnancies are unplanned. Yes, half. One of the most important decisions of someone’s life–whether or not to have a child–is often the result of chance. There are big picture health equity issues that contribute to unplanned pregnancies: things like education levels, access to birth control and healthcare, and gender inequality. Then there’s the human error side of it: old condoms, forgotten pills, miscalculated fertility cycles.
Historically, women have shouldered the burden of pregnancy prevention, often turning to hormonal birth control methods to ensure they don’t have a child. For most of their adult life, women using these methods endure side effects that can range from annoying (weight gain, unusual hair growth, breast tenderness) to concerning (nausea, mood changes, blood pressure risks) to harmful (migraines, cardiovascular disease and blood clots, and breast cancer).
As reproductive health issues play out in the headlines, there’s been growing press around the idea of better male birth control, something that would help couples share the onus of responsibility for unplanned pregnancies. The two current main options for men–condoms and vasectomies–don’t get the job done. Condoms have a 18% failure rate and a 57% dissatisfaction rate, making compliance difficult to achieve across the population. The pain and discomfort associated with vasectomy make it less popular with men. But more significantly, vasectomy is considered permanent contraception since the ability to reverse the vasectomy by reattachment of the vas deferens requires expensive microsurgery and restabilizing patency of the vas deferens is unpredictable, making it an unappealing option for younger men who might want to have a child sometime down the road.
In recent years, researchers have worked on cracking the code for hormone-based birth control for men. The news of the trial phases of “the male pill” produced a fair bit of understandable glee and ribbing from the half of the population who have suffered the side effects of hormonal birth control for years. While they are still under development, the fact of the matter is that hormonal contraception for men comes with the same laundry list of problems as hormonal contraception for women–physical and emotional side effects, difficulty adhering to a schedule, issues of access and supply.
There needs to be a better way. No one, whether they have testes or ovaries, should have to suffer the side effects of hormonal birth control. No one should have to choose between having an unplanned pregnancy or increasing their risk of certain cancers. The decision to have a child shouldn’t be a game of chance. Whether someone works in tech in downtown Seattle or raises cattle in the Paraguayan Chaco, they need a long-lasting, safe, and practical solution to preventing pregnancy.
Origin Story
Growing up in the foster care system of California, L.R. Fox saw firsthand the consequences of unintended pregnancies. He remembers a particular moment as a teenager when he looked around his group home and saw the chaos around him–things like abuse, poverty, domestic violence–and thought so much of it could have been prevented if people got to choose when they had a child.
“It’s a systemic problem that affects every class of society. People should be able to effectively choose when to bring a child into the world.”
Fox is not the type to ignore a problem. At age 19, he launched WhiteFox Defense Technologies, when he recognized the security and safety issues the booming drone industry created. He worked with Congress to pass legislation that guided safe integration of drone usage into society and grew the company into one of the most influential thought leaders in the counter-drone and airspace management arena, earning him a spot on the Forbes list of 30 under 30 in 2019 at the age of 23.
Moving from aerospace to male birth control might seem like a leap, but as Fox explains, he’s drawn to “solving big problems that everyone recognizes and yet no one is doing anything about.” As he worked with Congress to solve airspace issues around future potentialities like flying taxis, it struck him as ridiculous to be thinking about flying taxis as a nation when we haven’t even cracked the code on how to reliably prevent unplanned pregnancies, particularly when it comes to the man’s role.
Fox started exploring solutions for effective male birth control and came across the work of Parsemus Foundation and its founder Elaine Lissner, known as the “Mother of Male Birth Control.” After decades of experimentation with various potential methods, Lissner and her team discovered a safe and effective method of non-hormonal male contraception known as RISUG (Reversible Inhibition of Sperm Under Guidance). Developed in India and initiated in 1979, RISUG involves injecting a polymer gel into the vas deferens which allow fluids, but not sperm, to pass through the channel. After successful use in around 1,000 patients, RISUG was shown to be a safe and effective solution. Parsemus expanded on those learnings and optimized the formula and procedure to increase accessibility, naming the new product Vasalgel.
Vasalgel solves the major problems of other male birth control options. It takes 10 minutes to implement; it does not involve removing, cutting, cauterizing, or crimping tissue; it lasts for 10 years; and it is designed to be completely reversible at any time by another simple injection which dissolves the gel. There’s no need to remember to take a pill every day or have a condom on hand, making it a more practical option for rural communities or those lacking access to regular medical care. It is easily reversible, unlike a vasectomy, so when a person wants to start a family they can. It can be reinstated at any time after removal, and it is non-hormonal, making it safe to use without fearing the side effects.
As a non-profit, the Parsemus Foundation focused its efforts on proving Vasalgel safe and effective through trials and studies, as well as proving the demand and need for it. They were looking for a commercialization partner, someone to create the market for such a product and dispel some of the cartoonish misconceptions about male birth control, someone with experience shaping a nascent industry through legislation and messaging. In short, they were looking for someone exactly like Fox at the very same time Fox was looking for an answer to the global issue of family planning.
Under the Hood
NEXT Life Sciences exists to develop and distribute Vasalgel technology, a non-hormonal, long-lasting, reversible form of male birth control that empowers its users to choose if and when they bring a child into this world. In short, NEXT Life is creating a scalable and accessible global solution to the 85 million unintended pregnancies that occur each year.
Through preclinical studies, NEXT Life zeroed in on the optimized formula of Vasalgel that combines maximum efficacy for both contraception and reversal. They’re conducting one final study of this formula before moving into clinical trials in 2023. Currently over 50,000 people across the world are on the interest list for the product.
“We have the proof of concept. Now we are working to make this the standard of care,” says Fox.
To that end, NEXT Life is about to announce its medical advisory team, composed of some of the world’s foremost vasectomists. Fox says the physicians have greeted the news of Vasalgel technology with enthusiasm. “They love it because it is faster, easier, and in review of its use in India, has been demonstrated to be safe. It also has pragmatic value to a doctor because of the vastly bigger market size it offers.” Most vasectomies are performed on men over the age of 45; Vasalgel has the potential to work for nearly every sexually active man.
A large part of the task ahead for NEXT Life is changing some of the norms and expectations regarding contraception. It’s a messaging challenge, one the company’s Chief Marketing Officer, Dan Connolly, is meeting head on.
“It really is a cultural opportunity, the starting point of a revolution,” Connolly explains. “We want to shift the narrative to the idea of freedom–Vasalgel is about the freedom of deciding when to have a child. It’s about setting people and families up for success.”
NEXT Life is fundraising to build out its research and development and communications teams as they head towards FDA approval. They plan to implement a phased launch in 2024, rolling out different delivery methods that capitalize on their current demand before growing to private and public insurance funding and government grants.
“The question is how to introduce a brand new technology into the lives of people some would say are adverse,” says Fox. “We plan to show them the value of getting to exercise the right to not have a child if you don’t want to have a child. Men should have a choice, and it should be a shared opportunity to make that choice.”
Why We’re Proud to Invest
Sometimes a company comes along that dares to disrupt not only the method in which healthcare is delivered but a society’s fundamental way of thinking about healthcare. NEXT Life is one of those companies. StartUpHealth is proud to invest in NEXT Life’s innovative, patented male contraceptive technology that is turning birth control on its head.
Part of our enthusiasm stems from Fox’s successful track record at creating scalable, accessible solutions in highly-regulated industries. Through his work at WhiteFox in the aerospace industry and as a Vice Chair of the Chamber of Commerce, Fox proved himself able to navigate legislative and cultural minefields to create deliverables that work on different scales in different contexts. We can’t wait to see how he does the same in the contraceptive care space.
NEXT Life is also poised to capitalize on the current cultural moment, when there’s a groundswell of interest in male contraception. It’s well positioned in the growing marketplace of solutions as something that works for most men, at any stage of life. Part of this marketplace revolution comes from the recent Supreme Court decision to limit abortion access. As Fox put it, “no matter which side of the aisle you are on, both sides can agree that the less you are putting a woman in the position of needing an abortion, the better it is for society.” Vasalgel technology does just that.
Please join us in welcoming NEXT Life Sciences to the StartUp Health team. We can’t wait to see what the next few years hold for them.
Learn more and connect with the NEXT Life Sciences team. Then join us at the StartUp Health Festival @ HLTH to meet Fox and dozens of other Health Transformers in person.