NEXT Life Sciences Moves Plan A™ Toward the Clinic
StartUp Health community member Darlene Walley, PhD, CEO of NEXT Life Sciences, shares new momentum on Plan A, a long-acting, non-hormonal, fully reversible, on-demand male contraceptive, and a roadmap that puts shared family planning at the center.
Why This Moment Matters
Reproductive health has been one of the slowest areas of medicine to evolve, with very few new contraceptive options coming to market in the last half century. The consequences of that stagnation are stark: nearly 50% of pregnancies worldwide are unplanned, according to the World Health Organization. Beyond the personal impact, unplanned pregnancies drive significant social and economic challenges, from increased maternal health risks to generational poverty.
Demand for innovation is clear. In a recent Gates Foundation survey, more than 80% of men ages 18 to 49 said they would try a new male contraceptive if one were available. “The world is ready,” says Dr. Walley. “People will look back and wonder how we allowed half of pregnancies to be unplanned, and why the only answer we offered was more hormones for women who often cannot tolerate them.”
What Plan A Is, in Plain Terms
Plan A is designed to give men a real choice for contraception. Unlike condoms or vasectomies, it is long-acting, non-hormonal, and fully reversible on-demand. The procedure is simple: a clinician inserts a small amount of polymer solution into the vas deferens. This forms a hydrogel that acts as a filter that blocks sperm while allowing fluids to pass.
When someone decides they want to be fertile again, a clinician can dissolve the hydrogel with a sodium bicarbonate solution, restoring patency and sperm flow. The entire procedure takes just a few minutes per side, making it practical for use in doctors’ offices, college health centers, public health clinics, and even mobile care settings. Importantly, it avoids invasive surgery while preserving the delicate structure of the vas deferens, ensuring reversibility when desired.
Proof of Placement
One of the most important technical hurdles for male contraception is ensuring that the gel is delivered to the exact right spot inside the vas deferens, a tube that measures just one to two millimeters in diameter. NEXT Life Sciences has developed and patented a delivery system that allows clinicians to place the hydrogel safely and reliably.
Clinical trials in Australia and Canada tested this delivery system across physicians with a wide range of experience – from early-career family practitioners to urologists who had performed tens of thousands of vasectomies. The result was striking: 100% successful placements, confirming both the reliability of the device and the feasibility of scaling provider training globally.
From Bench to Bedside
The underlying science has been validated over decades. Preclinical studies demonstrated that the hydrogel forms a stable filter and that a simple sodium bicarbonate flush can dissolve it, restoring sperm flow without damaging tissue. Early research in India even suggested that the effect can last for more than a decade. These findings laid the groundwork for Plan A.
NEXT Life Sciences holds the exclusive worldwide license for Vasalgel® from the Parsemus Foundation, which conducted much of the early foundational preclinical research. Building on that science, the company has secured a robust IP portfolio and engineered its patented delivery device. Together, these advances position Plan A to move efficiently from research labs to clinical practice.
Regulatory Path, with Dates to Watch
The company is advancing in close collaboration with the FDA, which has already reviewed and accepted its clinical plan. Device trials are underway, and feasibility studies of the occlusion system are scheduled to begin in late 2025. If milestones stay on track, pivotal occlusion and reversal trials will follow in 2026.
The target is ambitious yet achievable: complete all clinical studies by mid 2027 and file for FDA submission. Because Plan A is a medical device rather than a pharmaceutical, the clinical pathway requires fewer participants – hundreds rather than thousands – which shortens both the timeline and the cost.
Signals of Demand
Interest in Plan A is not hypothetical. More than 50,000 men have already signed up through the company’s website, many eager to join clinical trials or gain early access once available. This consumer energy is mirrored by the medical community. “When I talk to urologists or family practitioners, they cannot wait for this product,” Dr. Walley explains. “They are ready to train and start offering it to patients.”
This dual demand – patients asking for solutions and clinicians asking for tools – creates a rare alignment. NEXT Life Sciences is developing a rollout strategy that pairs direct-to-consumer education with robust provider training. That approach is designed to accelerate adoption once Plan A clears regulatory milestones.
Team at the Helm
NEXT Life Sciences is led by Dr. Darlene Walley, CEO, who brings more than three decades of experience in biotech, medical devices and commercialization. She is joined by Founder & Executive Chairman L. R. Fox, President & COO Steve Bacich, Chief Medical Officer Dr. Charles Carignan, Chief Development Officer Dr. Robert Kellar, and Chief Technology Officer Dr. Bob Dudley. Each leader has a track record of bringing innovations from concept to market.
The advisory board is equally distinguished, including key opinion leaders in men’s health such as Dr. John Amory, Dr. Mike Eisenberg, Dr. Doug Stein, and Dr. Michel Labrecque, as well as regulatory veteran Peter Hutt and Elaine Lissner, founder of the Parsemus Foundation. This depth of expertise underscores the company’s ability to navigate science, medicine, and regulatory strategy.
Building the Delivery Network
While urologists will be the first wave of providers trained to deliver Plan A, the company expects primary care physicians to play a growing role. This expansion is not just about convenience – it’s about access. Many men do not see a doctor regularly until much later in life, often only when faced with kidney stones, prostate issues, or the desire for a vasectomy.
By creating an accessible entry point for men ages 18 to 49, Plan A could reshape how men engage with preventive health. Establishing earlier relationships with providers opens opportunities for screenings and interventions that could improve outcomes across multiple conditions, from prostate health to colorectal cancer.
Funding the Next Phase
To date, NEXT Life Sciences has raised more than $15M in seed funding. The company is now raising a $20M Series A, which will support feasibility studies and pivotal clinical trials. Looking further ahead, a $100M Series B is planned to align with FDA submission and commercialization efforts.
“Investor support is the lifeblood of the work we do,” Dr. Walley says. “We are building a category-creating product, and it takes sustained commitment to reach the finish line.” With patents secured, a global license in hand, and strong regulatory momentum, the company is positioning itself to deliver on that promise.
The Road Ahead
The next two years will be pivotal. With trials progressing, providers eager to train, and tens of thousands of men expressing interest, the company is laying the foundation for a major shift in family planning. If successful, Plan A will not just give men reproductive autonomy – it will give couples a way to share responsibility in a domain where women have long borne the disproportionate burden.
NEXT Life Sciences has been part of the StartUp Health community since 2022, advancing work that cuts across multiple Health Moonshots, from Men’s Health and Women’s Health to Access to Care. As Dr. Walley puts it, “The world is ready for a modern, non-hormonal, fully reversible male contraceptive.” The next chapters in this story may change reproductive health forever.
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Published: Oct 14, 2025
Produced by Nicole Kinsey
