NEXT Life Sciences is a medical device company planning to deliver the first male contraceptive solution that is non-hormonal, long lasting, and reversible. Pulse 2.0 interviewed NEXT Life Sciences CEO Dr. Darlene Walley to learn more about the company.
Dr. Darlene Walley’s Background
Could you share a bit about your background and what led you to the biotech and reproductive health space? Dr. Walley said:
“I’ve spent my career at the intersection of science, innovation, and purpose. With a PhD in chemistry, I’ve led R&D and commercialization efforts at some of the most respected medical device and pharmaceutical companies. What drew me to reproductive healthcare—and to NEXT Life Sciences in particular—is the opportunity to lead change in a space that has seen far too little innovation for men. I believe strongly in scientific solutions that create real social impact, and Plan A offers that potential in a profound way.”
Company Origins
How did the idea for NEXT Life Sciences—and more specifically, Plan A—come together? Dr. Walley shared:
“Our founder, L.R. Fox, recognized that while reproductive responsibility has traditionally been placed on women, the world was overdue for a shift. He assembled a world-class team, and we began building a company with the goal of rebalancing the conversation around contraception. Men don’t necessarily want the family planning burden to fall on their partners, but with alternatives that either fail too often or aren’t reversible, it’s understandable why they don’t have a choice.” “Plan A is our flagship innovation—rooted in decades of prior science and propelled forward by our proprietary delivery system. It represents the kind of impact-driven biotech innovation that defines NEXT Life Sciences. Plan A provides men with a long-lasting, non-hormonal, and on-demand and easily reversible contraception option.”
Primary Responsibilities
What are your primary responsibilities as CEO of the company? Dr. Walley noted:
“As CEO, I guide the strategic vision and lead our day-to-day operations—from clinical development and regulatory strategy to investor engagement and team building. I also see my role as an advocate: for scientific progress, for men’s health, and for ensuring that our work reflects the values of equality and innovation that define our company.”
Memorable Moment
What has been your most meaningful or memorable moment since joining NEXT Life Sciences? Dr. Walley reflected:
“The moment we received the results from our clinical trial in Australia showing 100% success using our new delivery device was extraordinary. It validated years of hard work and confirmed that we’re not just advancing an idea—we’re delivering a real, viable solution that could change lives. It was both a scientific and deeply human milestone for Plan A.”
Core Technologies
What are the core technologies and features behind Plan A, and what makes it such a breakthrough in male contraception? Dr. Walley explained:
“Plan A is designed to be a non-hormonal, long-acting, and on-demand reversible male contraceptive that uses a proprietary hydrogel called Vasalgel, designed to block sperm for up to 10 years. What sets it apart is its combination of long-lasting, on-demand reversibility and minimal invasiveness. Our proprietary delivery system, successfully tested in both Canada and Australia, allows medical professionals to administer it quickly and safely—without the need for surgery or traditional needle-based injections.”
Challenges Faced
What are some of the most significant challenges you’ve faced in advancing male contraceptive innovation, and how have you approached overcoming them? Dr. Walley acknowledged:
“One of the biggest challenges is the historical lack of attention and funding in male contraception. We’re working to change perceptions—both in the investor community and the broader public—by demonstrating that men do want more options, and that the science is ready. Seventeen million American men are displeased with their current family planning options and are looking for alternatives. Strategic partnerships, rigorous clinical planning, and an experienced team have helped us push through the noise.”
Evolution Of The Company’s Technology
How has your technology evolved since the company’s founding and initial concept development? Dr. Walley pointed out:
“We’ve taken a proven contraceptive concept and built a smarter, safer, and more scalable delivery method. Since our founding, we’ve advanced from early-stage R&D into manufacturing and clinical validation, and we’ve optimized the procedure to be faster and less invasive—removing key barriers to adoption.”
Key Milestones
What key milestones has the company achieved so far—scientific, clinical, or otherwise? Dr. Walley cited:
“NEXT Life Sciences has now completed successful clinical evaluations of our Plan A proprietary delivery device in two countries—Canada and Australia—with a total of 27 men receiving the treatment using our new access method.”
“We’ve also secured over $10 million in early-stage funding and received renewed support from the Male Contraceptive Initiative. As of early April, we are in the midst of our $20 million Series A raise which will take us through the rest of our clinical trials and through to commercial viability.”
“Perhaps most importantly, we’ve validated that our product is both safe and effective, laying the foundation for larger-scale clinical trials and eventual FDA submission.”
Compelling Stories
Are there any compelling stories or anecdotes from your clinical trials that highlight Plan A’s potential real-world impact? Dr. Walley highlighted:
“What stands out most are the conversations we’ve had with trial participants—men who are excited about taking control of their reproductive choices in a new way. One participant said, “It’s about time we had something like this.” That level of enthusiasm tells us we’re on the right path—not just scientifically, but culturally.”
Funding Milestones
Can you share any funding milestones or insights into your financial growth trajectory? Dr. Walley revealed:
“NEXT Life Sciences has raised more than $10 million to date in oversubscribed rounds. We are currently in our Series A raise to fund the next phase of clinical trials; we’ve been fortunate to attract mission-aligned investors who understand both the scientific and societal importance of what we’re building.”
Total Addressable Market
What is the estimated total addressable market (TAM) for Plan A, and how do you view the broader opportunity in men’s reproductive health? Dr. Walley assessed:
“The global contraceptive market is projected to reach over $30 billion by 2030, and we believe a substantial portion of that will be unlocked as male options expand. Plan A taps into a huge unmet need—millions of men globally are looking for a non-hormonal, on-demand reversible solution that gives them more options.”
Differentiation From Other Solutions
What makes NEXT Life Sciences and Plan A different from other solutions (or companies) in this space? Dr. Walley affirmed:
“We’re not just creating a product—we’re building a platform for reproductive equality. What sets us apart is our singular focus on delivering real, user-centered innovation in male contraception, backed by rigorous science, a passionate team, and a clear pathway to commercialization. We’re also designing for accessibility—from procedure simplicity to global distribution. And in the process of all this, we’re redefining how men think about contraception — empowering them with options they’ve never had before — so they and their partners can make the best choices for their lives.”
Short- & Long-Terms Goals
What are your short- and long-term goals for the company, and what comes next after the success of your most recent clinical trials? Dr. Walley emphasized:
“Our immediate goal is to launch a larger-scale clinical trial as we work toward FDA submission. Long-term, we aim to bring Plan A to market in 2027 and expand our pipeline with additional products that support reproductive autonomy and innovation. This is just the beginning.”
Additional Thoughts
Is there anything else you’d like to highlight—whether it’s a call to action, an upcoming milestone, or a personal philosophy driving your work? Dr. Walley concluded:
“At NEXT Life Sciences, we believe the future of family planning is about equal responsibility. Plan A is a step toward that future—one where both men and women have meaningful choices. If you’re an investor, healthcare provider, or potential partner who shares that vision, we’d love to connect.”
