STARTUP HEALTH | NEXT Life Sciences Moves Plan A™ Toward the Clinic

ORIGINALLY POSTED ON: STARTUP HEALTH

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.

READ MORE ON: STARTUP HEALTH

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FAMILY WEALTH REPORT | Pushing Innovation In Male Health After Decades Of Stagnation

ORIGINALLY POSTED ON: FAMILY WEALTH REPORT

Investment in medical/health issues is a long-term proposition. We talk to those making a health treatment focused on male contraception.

Dr Darlene Walley, CEO of NEXT Life Sciences, the maker of the male contraceptive product Plan A™ is on something of a mission. The firm is developing a “hydrogel” called Vasalgel®

This filters sperm from the vas deferens while allowing fluids to pass. The product, according to the Plan A™ website, is designed to provide contraception for more than 10 years and can be administered in a medical office setting with the option for reversal on demand.

There’s a lot at stake. 

“More than 20 per cent of women cannot deal with oral contraceptives,” Dr. Darlene Walley said. “People want something that is safe and reliable.”

“There literally has not been an innovation in male contraception in decades, in some people’s lifetimes,” Dr Walley told Family Wealth Report. “This area is vastly overdue for innovation and we look forward to a world where there are non-hormonal, easily reversible options available for men so they can more actively participate in family planning and reproductive autonomy.”

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HLTH | Former FDA Chief Counsel Joins Plan A™ to Launch Male Birth Control

ORIGINALLY POSTED ON: HLTH

Peter Barton Hutt, former Chief Counsel at the FDA and pioneer of medical device regulatory policy, joins as Plan A™ concludes successful clinical trials.

NEXT Life Sciences, the modern reproductive healthcare company pioneering Plan A™, a first-of-its-kind, long-lasting, and on-demand-reversible male contraceptive, announced today the addition of renowned FDA regulatory expert Peter Barton Hutt to its advisory board. Known as the “Father of Modern Drug Law,” Hutt served as Chief Counsel during the most influential years at the U.S. Food & Drug Administration where he helped shape many of the policies that still govern medical devices today. Hutt’s appointment strengthens an advisory board already composed of groundbreaking experts in male contraception.

During his time at the FDA, Hutt is credited for creating the foundational structures of our modern healthcare, such as the medical device legislative policy, the Over-the-Counter (OTC) drug review, and the food nutrition label. He helped establish the use of FDA Guidance to create informal FDA policy and key safety requirements for medical devices, such as Plan A. Hutt remains the only lawyer elected from private practice to the National Academy of Medicine and is a partner at the legendary legal firm Covington & Burling LLP. He is now bringing this experience to Plan A™ as NEXT Life Science continues along its clinical pathway, following two 100% successful trials in Canada and Australia earlier this year, and heading toward potential FDA approval.

“I am indebted to have had the distinct pleasure and privilege of Peter’s guidance throughout my career bringing lifesaving products to market. We are elated to have him join our advisory board,” said Darlene Walley, PhD, chief executive officer of NEXT Life Sciences. “As we continue to work to revolutionize male contraceptives, Peter’s experience is helping to establish a course of action for Plan ATM coming to market as soon as 2027.”

Plan A™ uses a proprietary hydrogel called Vasalgel®, which is designed to filter out sperm from the vas deferens while still allowing fluids to pass. Plan A™ is intended to last for more than 10 years and can be delivered quickly in a medical office and reversed on demand, equally as easily, with a simple solution to dissolve the hydrogel.

“I have learned throughout my career that you bet on people and Darlene is one of those,” Hutt said. “I’ve worked with Darlene every place that she’s ever gone and know that’s always a brilliant decision. Her dedication and intelligence are unmatched.” Hutt added, “Many groups have tried for literally decades to create viable male birth control options and yet have not succeeded for various reasons. Plan A’s progress, including recent very promising clinical trials and patent approval, is quite encouraging. A male contraceptive will make a sizable impact on humankind.”

Currently, half of all pregnancies worldwide are unplanned, and over 17 million American men are actively seeking new contraceptive options that better align with their relationships, values, and lifestyles.

In addition to his legal work, Hutt is also a long-time lecturer on food and drug law at Harvard Law School and has written numerous scholarly articles as well as contributing to draft legislation.

To learn more or inquire about investment opportunities, contact info@planaformen.com.

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About NEXT Life Sciences 

NEXT Life Sciences, Inc. (NEXT) is modernizing reproductive healthcare with its flagship product, Plan A™, a non-hormonal, long-lasting, and reversible male contraceptive. NEXT’s executive management team and board members have proven track records of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status.

For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/.

Disclaimer

All forward-looking statements are not guarantees of future performance, and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.

THE BIO REPORT | The Search for a New Approach to Male Contraception

ORIGINALLY POSTED ON: THE BIO REPORT

There’s been a stunning lack of innovation around male contraceptives when it comes to the area of male contraceptives. Men have the choice between a vasectomy, a procedure innovated in the 19th century, or condoms, which date back to at least King Minos in Crete in 3000 BCE. Next Life Sciences is hoping to change that with its Plan A, an experimental hydrogel that is injected into the vas deferens and provides a barrier that prevents sperm from passing. Plan A, which is regulated as a medical device, is expected to be easily reversible.

We spoke to Darlene Walley, CEO of Next Life Sciences, about Plan A, the need it is addressing, and why she expects men and women to see it as a welcome alternative to current choices.

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IHEART RADIO | Dr. Darlene Walley and Male Birth Control

ORIGINALLY POSTED ON: IHEART RADIO

Dr. Darlene Walley has over 20 years of life science business experience, having served as an executive at Procter & Gamble, Gillette, and Arm & Hammer and CEO of early-stage Pharma/Biotech companies.

She has raised over $100 million with over $1 billion in successful exits. Darlene is very skilled in the launch of products/companies, raising capital and improving performance. Darlene works with startups, investment firms and serves on the board of directors of several companies. She holds 12 patents, largely dealing with consumer health products and over 15 publications. Take a listen to her take on male birth control.

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MenAlive | Revolutionizing Male Birth Control: Dr. Darlene Walley Offers Plan A For Men

ORIGINALLY POSTED ON: MENALIVE

Like most males, I have been concerned with birth control most of my life. When I was a teenager there were admonitions from my parents to “be careful.” Though rarely put into words, I knew what they meant was: “Don’t get a girl pregnant.” I still remember overhearing a high school girl telling her friends that she was pregnant and her feelings of excitement at the prospect of being a mother and her recognition that this would mean the end of many of her dreams for the future.

As a young guy in college my soon-to-be wife and I had sex for the first time when she announced that she was “on the pill” and so sex was now safe. But it was years before we realized that taking the pill had unexpected problems for her. We discussed a vasectomy for me, which scared me. The thought of having anything sharp touching my genitals was enough to make me run the other way.

After hearing about the procedure, I was still not reassured. I understood that the little tubes carrying the sperm would be cut, but exactly where the sperm would go was confusing. Although they told me the surgery could be reversed in the future if needed, it was clear that it would be expensive, with no guarantee that it would be successful. I went ahead and got a vasectomy, but it seemed there should be a better choice for men. Now there is.

Meet Dr. Darlene Walley, Chief Executive Officer of NEXT Life Sciences

My own interest in helping men and women has evolved through the years. I graduated from college in 1965 and went to medical school, with the hope of becoming a doctor so I could help others. But medicine at the time was so narrowly focused I knew it wouldn’t help me to solve the problems that concerned me the most. I transferred to U.C. Berkeley and earned a master’s degree in social work where I received a broader education that included addressing social and environmental issues as well as physical and psychological ones. After working as a clinician for many years I went back to school and completed the requirements for a PhD in International Health and later helped develop the emerging field of Gender-Specific Medicine for men.  

As a leader in this emerging field, I often get announcements of breakthrough technologies. A recent email grabbed my attention: “Male Contraceptive Plan A Completes First North American Clinical Trial with 100% Success.” The announcement went on to say,

“Easily reversible, long-lasting male contraceptive Plan A continues to make its way toward FDA submission as it recently successfully completed its second clinical trial; this time in Canada.”

READ MORE ON: MENALIVE

American Tech Today | Plan A™ Completes 100% Successful North American Clinical Trial

Physicians from Canada and Australia have tested the Plan A™ male birth control delivery system with 100% success in 50 men.

NEXT Life Sciences, the modern reproductive healthcare company pioneering Plan A™, a first-of-its-kind male contraceptive that is long-lasting and on-demand reversible, has completed its second clinical trial with a 100 percent success rate. This latest clinical trial, conducted in Canada, had the same 100% success rate as its Australian predecessor.

Plan A™’s innovative approach to male contraception uses a proprietary hydrogel that is designed to filter out sperm for more than 10 years and can be delivered quickly in a medical office. In the Canadian clinical trial, 20 men participated, who all performed well with the procedure. 

“The Vasectomie Quebec medical and nursing team is very proud to collaborate with NEXT Life Sciences toward the development of Plan A,” said Dr. Michel Labrecque, one of the five participating physicians in the Canadian clinical trial who has performed 40,000 vasectomies throughout his career. “We look forward to when this option becomes commercially available so we can offer it to our patients.”

Dr. Labrecque and his fellow physician participants noted that utilizing the Plan A™ delivery system was less tissue invasive than vasectomies. The physicians who participated in Plan A™’s North American clinical trial were a mix of urologists and family medicine physicians with expertise ranging from performing 40,000 vasectomies to doing less than 1,000 of these procedures across their careers. A key goal of both Plan A™’s Canadian and Australian clinical trials was demonstrating the ease and simplicity of the delivery system for practitioners of all skill levels, making the product highly accessible. 

“As we work to revolutionize the male contraceptive market, we are very encouraged by the positive results of our many clinical trials to date, both from the patient standpoint as well as the physicians,” said L.R. Fox, chairman of NEXT Life Sciences. “Plan A was designed to give men a hormone-free, long-term, and on-demand reversible option for contraception so they and their partners can have more options to determine the best family planning method. Our goal in developing Plan A is to create an option that is seamless and easy to use for physicians to ensure global access.” 

By conducting all clinical trials under FDA guidelines, both the North American and Australian Plan A™ clinical trials advance the company’s regulatory submission efforts in the United States and the respective countries. 

“Knowing that many women do not tolerate hormone-based pills or contraception devices, the addition of Plan A to the market gives everyone a wider array of contraception options. Plan A allows men to participate in family planning by allowing them to basically ‘set and forget’ their contraceptive option,” said Dr. Darlene Walley, Chief Executive Officer of NEXT Life Sciences.

In addition to its successful clinical trials, NEXT Life Sciences is raising $20M for its Series A to fund final clinical trials and other developments. 

For more information or to become an investor, you can contact the team behind Plan A™ at: info@planaformen.com.

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About NEXT Life Sciences 

NEXT Life Sciences, Inc. (NEXT) is modernizing reproductive healthcare with its flagship product Plan A™, a non-hormonal, long-lasting, and reversible contraceptive solution for men. NEXT’s executive management team and board members have proven track records of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status. For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/. 

Disclaimer 

All forward-looking statements are not guarantees of future performance and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.

XRAISED | Revolutionizing Birth Control: The Future of Male Contraception with Plan A™

ORIGINALLY POSTED ON: XRAISED

In this groundbreaking interview, Dr. Darlene Walley—biotech leader and CEO of NEXT Life Sciences—shares the bold vision behind Plan A™, the world’s first long-lasting, non-hormonal, and reversible male contraceptive in development.

With decades of success in healthcare innovation and over $1B in company exits, Dr. Walley discusses why reproductive equity is long overdue and how Plan A™ is poised to spark a cultural shift.

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THE AUSTRALIAN SUN | NEXT Life Sciences Announces Successful Plan A™ Delivery Device Clinical Trial in Australia

ORIGINALLY POSTED ON: THE AUSTRALIAN SUN

Results Demonstrate the Effectiveness of a Revolutionary Male Contraceptive Delivery System

NEXT Life Sciences, the modern reproductive healthcare company pioneering Plan A™, a first-of-its-kind, long-lasting, and on-demand reversible male contraceptive in development, announces the successful completion of its clinical trial in Australia with a 100% success rate. This milestone follows a previous clinical evaluation in Canada in 2024 and further solidifies Plan A™ as a breakthrough in male contraception that is on track to be a viable option for men within a couple of years.

Plan A™ is designed to offer men the first non-hormonal, long-acting, and on-demand reversible birth control. This innovative contraceptive uses a proprietary hydrogel, Vasalgel®, designed to filter out sperm for up to 10 years, and can be quickly administered by a medical professional in a variety of settings—not just clinics or hospitals. The proprietary access method tested in this Australian trial would allow for a confirmation that the hydrogel can be held in place, while also being less invasive than traditional methods, such as syringes or needles. Doctors have now successfully used the new delivery method introduced by Plan A™ in procedures involving 27 men.

“Contraception has been lacking innovation for decades; we at NEXT Life Sciences are excited to continue to bring Plan A™ closer to fruition so men and couples can select from a variety of birth control options that best suit their lifestyles,” said Dr. Darlene R. Walley, Chief Executive Officer of NEXT Life Sciences. “Our clinical trials in Canada and Australia validate our approach while bringing us closer to further clinical trials and market launch.”

NEXT Life Sciences has also announced it is in the process of its Series A raise to complete clinical trials. This follows prior oversubscribed funding of $10 million and the Male Contraceptive Initiative’s reaffirmation of its commitment to Plan A™ with a renewed grant.

“Plan A™ has the potential to be a game-changer for men and couples as they traverse their lives and careers, giving them an on-demand reversible contraception option,” said Founder and Executive Chairman L.R. Fox. “This is one of the reproductive health innovations NEXT Life Sciences plans to bring to market to revolutionize a critical area of health.”

For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/.

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About NEXT Life Sciences 

NEXT Life Sciences, Inc. (NEXT) is modernizing reproductive healthcare with its flagship product Plan A™, a non-hormonal, long-lasting, and reversible contraceptive solution for men. NEXT’s executive management team and board members have proven track records of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status. For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/. 

Disclaimer 

All forward-looking statements are not guarantees of future performance and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.

AXIOS | NEXT Life Sciences Eyes $20M for Male Birth Control

ORIGINALLY POSTED ON: AXIOS

NEXT Life Sciences is raising $20 million to develop male contraceptive product Plan A, CEO Darlene Walley tells Axios exclusively.

Why it matters: Male birth control options such as condoms and vasectomies haven't changed since the age of disco.

The latest: Calif.-based NEXT is courting investors for the Series A.

• The launch follows a $2.5 million raise last January and includes a $200,000 renewed grant from the Male Contraceptive Initiative (MCI), bringing MCI's total contribution to $400,000.

• Next has so far closed a total of six seeds, per Walley, bringing it to $10 million in total capital raised to-date (none of which will go towards the Series A).

• Walley expects the Series A to close by the end of June.

What's next: Series A money will go toward early feasibility trials in Australia and Canada, as well as preparing for a 2027 U.S. FDA submission.

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AP NEWS | NEXT Life Sciences Launches Plan A™ Male Contraceptive’s Clinical Trials

ORIGINALLY POSTED ON: AP NEWS

Australian Trials Begin in March 2025

NEXT Life Sciences, the modern reproductive healthcare company pioneering Plan A™, a first-of-its-kind, long-lasting, and on-demand reversible male contraceptive in development, announces the beginning of its clinical trials, the first set of which will begin in Australia on March 24, 2025.

With a growing global demand for more viable male contraceptive options, which to date have only included condoms and vasectomies, Plan A™ is designed to offer a hormone-free, long-term, and on-demand reversible solution so men can “set it and forget it,” meaning men can get Plan A™ and then not have to think about contraception for years until they choose to reverse it. The innovative approach uses a proprietary hydrogel, which is designed to filter out sperm for up to 10 years and is delivered in an outpatient clinic quickly. Plan A™, a Long-Acting Reversible Contraceptive (LARC), is classified as a medical device rather than a drug, which means it is positioned to navigate regulatory pathways more efficiently than traditional pharmaceuticals.

This launch of Plan A’s clinical trials in Australia takes NEXT Life Science’s male contraception solution from the pre-clinical trial phase into the clinical trial process. After both early feasibility and feasibility studies are completed this year, NEXT Life Sciences anticipates Plan A will be ready for pivotal trials followed by FDA submission as the first long-acting, reversible, on-demand male contraception, as soon as 2027.

“Male contraception has remained virtually unchanged for decades, leaving the burden of family planning primarily on women,” said Dr. Darlene R. Walley, CEO of NEXT Life Sciences. “With Plan A™, we’re excited to offer a real solution—one that is designed to be safe, reversible, and fit seamlessly into men’s lives.”

These trials build upon NEXT’s continued momentum, including additional funding from the Male Contraceptive Initiative (MCI), the world’s leading nonprofit dedicated to advancing male contraceptive solutions. MCI reaffirmed its commitment to Plan A™ with a renewed grant of $200,000, bringing its total support to $400,000. NEXT Life Sciences had successful, oversubscribed seed rounds of $10 million.

This announcement also follows the recent appointment of Dr. Walley as CEO of NEXT Life Sciences. With over 30 years of leadership in life sciences and helping medical tech companies achieve $1 billion in exits, Dr. Walley is guiding the company’s expansion alongside Founder and Executive Chairman L.R. Fox to bring Plan A™ and other reproductive health innovations to market.

To volunteer for NEXT’s Australian clinical trials, learn more at https://nextlifesciences.org/clinical-trials-australia

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About NEXT Life Sciences 

NEXT Life Sciences, Inc. (NEXT) is modernizing reproductive healthcare with its flagship product Plan A™, a non-hormonal, long-lasting, and reversible contraceptive solution for men. NEXT’s executive management team and board members have proven track records of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status. For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/. 

Disclaimer 

All forward-looking statements are not guarantees of future performance and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.

HEALTHCARE STRATEGIES | Advancing Reproductive Choices for Men

ORIGINALLY POSTED ON TECH TARGET

For more than half a century, the burden of contraception has largely fallen on women. Since the first oral contraceptive pill received FDA approval in 1960, the field of female birth control has expanded significantly, with options ranging from hormonal intrauterine devices and implants to injections and vaginal rings. In contrast, men have had only two choices: condoms, which have a relatively high failure rate, and vasectomies, which are surgically invasive and difficult to reverse.

Despite decades of research into male hormonal contraceptives, progress has stalled due to challenges in achieving consistent sperm suppression, unwanted side effects, and lack of sustained investment. Yet, demand for non-permanent male birth control has never been stronger, particularly following shifts in U.S. reproductive policy.

In the latest episode of Healthcare Strategies, Darlene Walley, CEO of NEXT Life Sciences, explains a novel approach to a long-acting, reversible male contraceptive, Plan A. Unlike most female contraceptives, Plan A does not rely on hormonal manipulation. Instead, it employs Vasalgel, a high molecular weight polymer composed of styrene-alt-maleic acid, which is injected into the vas deferens to form a semi-solid barrier that blocks sperm while permitting the passage of seminal fluids. The polymer can be dissolved at any time within 10 years using dimethyl sulfoxide.

READ MORE ON TECH TARGET

NY POST | LA-based startup pushing male contraceptive raises $200K in new funding

ORIGINALLY POSTED ON NY POST

A Los Angeles-based startup for a male contraceptive injection that blocks the movement of sperm raised $200,000 in a fresh round of funding, the company said.

NEXT Life Sciences said the infusion of cash from the Male Contraceptive Initiative (MCI) will continue funding the development of its product, called Plan A.

MCI, the largest nonprofit dedicated to advancing male contraception, initially awarded NEXT a two-year grant in 2024.

Following a thorough review of the company’s progress, MCI unanimously approved the second year’s installment of $200,000, bringing the total grant funding for Plan A to $400,000.

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Male Contraceptive Initiative Expands Investment into Plan A™

MCI approves additional $200K grant

NEXT Life Sciences, is announcing the continuation of a grant awarded by the Male Contraceptive Initiative (MCI), the largest 501(c)(3) non-profit in the world dedicated to advancing male contraception. Awarded in 2024, this grant provided funding over two years in support of the final development of Plan A™ for upcoming clinical trials. MCI has approved ongoing funding for the second year’s $200K of this grant; reaffirming MCI's total grant funding for the development of Plan A™to $400K. This renewed support from MCI comes alongside NEXT’s preparations to begin clinical trials in Australia in Q1 of 2025 and in the US and Canada in Q2 of 2025.

“We’re incredibly grateful to MCI for their unwavering support and belief in our mission to transform male contraception,” said NEXT Life Sciences’ CEO Darlene Walley. “Our goal is to bring this revolutionary contraceptive technology to the market to provide men with a long-lasting, reversible family planning option. This further investment from MCI into Plan A™ will accelerate our ability to progress to clinical trials and move us closer to making Plan A™ a reality.”

“NEXT Life Sciences’ Plan A is an exciting option in the non-hormonal male contraceptive field,” said MCI Executive Director Heather Vahdat, MPH. “We are pleased to continue our support of NEXT Life Sciences. Plan A™ represents an exciting step toward a shared contraceptive future and provides an innovative option for men and couples seeking long-acting, reversible birth control solutions.”

This renewed support from MCI for Plan A™ also comes on the heels of the recent appointment of Dr. Darlene Walley, an industry veteran with over 30 years of experience in building life science businesses, as the new CEO of NEXT Life Sciences. Dr. Walley  is working alongside Founder and Executive Chairman of NEXT Life Sciences, L.R. Fox, to lead the company through their roadmap forward with Plan A™ and other groundbreaking reproductive health products in development.

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About NEXT Life Sciences 

NEXT Life Sciences, Inc. (NEXT) is modernizing reproductive healthcare with its flagship product Plan A™, a non-hormonal, long-lasting, and reversible contraceptive solution for men. NEXT’s executive management team and board members have proven track records of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status. For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/. 

Disclaimer 

All forward-looking statements are not guarantees of future performance and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.

AP NEWS | Revolutionizing Birth Control: NEXT Life Sciences Announces Promotion of Dr. Darlene Walley to Chief Executive Officer

Dr. Robert Dudley joins NEXT Life Sciences as the Chief Development Officer

ORIGINALLY POSTED ON AP NEWS

LOS ANGELES, CA, UNITED STATES, December 17, 2024 /EINPresswire.com/ -- NEXT Life Sciences, the maker of the male contraceptive product Plan A™ and a leader in the development of other modern reproductive healthcare solutions announced today the promotion of Dr. Darlene R. Walley as the Chief Executive Officer of NEXT, succeeding L.R. Fox, who will remain as Founder and Executive Chairman. In his continued role, Fox will support the team, ensuring they have the right resources and setting the long term vision. In addition, NEXT is announcing that Dr Robert Dudley, founder and inventor of men’s health product AndroGel® will be joining NEXT as the Chief Development Officer.

“Dr. Walley has already had incredible success in securing a clear pathway for Plan A with the FDA and it made sense for her to lead the entire organization to get our portfolio of products to market,” said L.R. Fox, Founder and Executive Chairman of NEXT Life Sciences. “Plan A is one of many products in the pipeline as NEXT continues to revolutionize reproductive health. Dr. Walley is known for her tremendous success as an executive in both big Pharma and biotech startups where she has led companies specializing in drug development, manufacturing, and clinical research, and this rare combination puts her in an incredibly unique position to take all of our critical products to the world.”

“Since joining NEXT, I’ve had the profound opportunity to work with other people who are deeply passionate about creating solutions to some of the world’s most pressing issues. Working with Fox has been the high point of my career to witness his vision and brilliance at every level,” stated Dr. Walley. “The world needs and welcomes Plan A. Whether talking to men and women, researchers, regulators, investors and even my friends - everyone agrees the time is right for Plan A. I am excited to lead the talented team in bringing Plan A and our highly de-risked portfolio and pipeline of reproductive health products to the market which will have a wide reaching impact on society.”

Dr. Walley, who earlier this year joined NEXT as the CEO of Plan A™, has over 30 years of life science business experience, having served as an Executive at Procter & Gamble, Gillette, and Arm & Hammer and CEO of multiple early-stage pharma and biotech companies. To date, she has raised over $100M for these companies with over $1B in successful exits. In her extensive career, Dr. Walley has worked with startups, and investment firms, and served on the Board of Directors of several companies, proving her skills through leading successful product launches, capital raises, and company performance improvements. Dr. Walley currently holds 12 patents, largely dealing with health products, with 18 peer-reviewed publications.

Founder and Executive Chairman of NEXT Life Sciences, L.R. Fox, will continue his focus on developing and pioneering world-leading technologies through his family office, NEXT Global. The focus of NEXT Global has always been to invest in and incubate technologies with the potential for transformational societal impact. NEXT Global carries out this vision through direct investments, startup incubations, and early-stage buy-outs, as well as nonprofit incubation through its support of the NEXT Foundation.

Dr. Robert E. Dudley is an experienced C-level pharmaceutical executive with over 20 years as President/CEO of small to private and public pharmaceutical companies. He has a strong record of capital raises with over $150M in equity raised to fund successful product development through regulatory approvals and commercialization in the U.S. and across major foreign markets. He is the primary Inventor of AndroGel®, one of the most successful men’s health products developed and commercialized worldwide with multiple-years of annual sales exceeding $1B. He also invented the first true oral testosterone replacement product approved by the FDA, known as JATENZO®, and oversaw its development through approval to market launch. He also holds numerous patents and has published many articles in top medical journals for his work in developing innovative reproductive health products.

"I am delighted to be part of an organization committed to innovative products in reproductive health -- particularly those aimed at men that benefit the couple," stated Dr. Dudley. "For over 30 years I have been involved in developing and commercializing products to improve men's health. Being part of the leadership team at NEXT Life Sciences is a perfect fit for my experience and will enable me to use my talents to help create cutting-edge products that help men and women live better, more satisfying lives."

“I am pleased to welcome Dr. Dudley to our team. He has been credited with proving the massive market potential of the men’s health space, most notably demonstrating the large opportunity with AndroGel®. He will help us advance our mission of bringing a new generation of accessible reproductive health products to the market,” said L.R. Fox, Founder and Executive Chairman of NEXT Life Sciences.

About NEXT Life Sciences
NEXT Life Sciences, Inc. (NEXT) is revolutionizing modern reproductive healthcare and transforming lives through the development of its lead program, Plan A™, designed to provide a non-hormonal, long-lasting, and reversible contraceptive solution for men. NEXT’s executive management team and board members have a proven track record of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status. For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/.

Disclaimer
All forward-looking statements are not guarantees of future performance and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.

NEXT Life Sciences
Plan A™ Male Birth Control
press@nextlifesciences.org

FORTUNE | The Companies Betting on Male Birth Control Step Closer to Approval - and into An Uncertain Political Chapter

FORTUNE | MOST POWERFUL WOMEN DAILY BY NINA AJEMIAN

– In control. For years, advocates of reproductive freedom have been waiting for the arrival of male birth control (besides condoms and vasectomies). New options are finally getting closer to market—just as the second Trump administration enters the White House. 

This is an issue on which the Trump White House could be a bit of a wildcard. On the one hand, the conservative roadmap Project 2025 threatens access to birth control for women, from allowing employers to opt out of covering it to limiting the contraceptive methods that can be covered under the Affordable Care Act. But male birth control has the luxury of being “removed from the whole debate” about abortion, says Darlene Walley, CEO of Next Life Sciences’ Plan A, a male contraceptive in development. Most women know that treatments for men and women are often viewed differently, like how insurers have covered birth control compared to Viagra. Trump’s Health and Human Services nominee Robert F. Kennedy Jr., meanwhile, is poised to overhaul the FDA and its drug approvals process just as new treatments seek the FDA’s signoff. 

“We’re in a time of transition, and the time is right for male contraception to really move out and get onto the market,” says Heather Vahdat, executive director of advocacy group the Male Contraceptive Initiative. There have been efforts made to get products on the market before, but no male contraceptive has cleared phase three trials. A lack of funding from pharmaceutical companies and severe side effects have gotten in the way. (Men have been more reluctant to tolerate side effects and treatments have been harder to get approved because pregnancy does not pose a physical risk to men.)

One of those birth control methods is Next Life Sciences’ Plan A, a non-hormonal, reversible contraceptive for men that lasts 10 years and is inserted in an outpatient procedure. Expected to enter clinical trials in the first quarter of 2025, Plan A uses a hydrogel that acts like a filter to stop sperm from moving through the vas deferens. The company plans for its FDA submission, approval, and commercialization to go through in 2027. “We’re hoping that by giving the other half of the population the ability to participate in birth control that we can have a profound effect on pregnancies,” Walley says.

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FORTUNE | MOVERS AND SHAKERS: Dr. Darlene Walley

FORTUNE | MOST POWERFUL WOMEN DAILY | MOVERS AND SHAKERS

MPW Daily is your access to the world’s most powerful women. Every weekday, senior writer Emma Hinchliffe provides original reporting, key insights, and expert perspectives on the women leading the moment in business and beyond. 

NEXT Life Sciences, a male contraceptive developer, appointed Darlene Walley as CEO of Plan A. Most recently, she was chief business development officer at Pebble Life Science.

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AP NEWS | NEXT Life Sciences Appoints Dr. Darlene Walley as CEO of Plan A™

Peter Barton Hutt: Former FDA Chief Counsel joins the Advisory Board of NEXT Life Sciences

ORIGINALLY POSTED ON AP NEWS

LOS ANGELES, CA, UNITED STATES, October 24, 2024

NEXT Life Sciences, the maker of the male contraceptive product Plan A™, announced today the appointment of Dr. Darlene R. Walley as the Chief Executive Officer of Plan A™. Dr. Walley will spearhead Plan A™ and bring it to market and in addition, oversee the R&D efforts in other male birth control options NEXT is developing.

In addition, NEXT is announcing that Peter Barton Hutt, former Chief Counsel to the Food and Drug Administration (FDA) and former Board of Directors of Moderna Pharma is joining the NEXT advisory board. Hutt was pivotal in developing the FDA’s Medical Device Guidance and will be integral to helping Plan A™ rapidly enter the market and serve the millions of couples seeking better contraceptive options.

Both will work alongside NEXT’s CEO, L.R. Fox to lay a successful foundation for the next generation of transformative healthcare options that the company is developing. “We are thrilled to bring Dr. Darlene Walley on as the Chief Executive Officer of Plan A™ with her extensive background, expertise in biotech and pharma, and passion for bringing transformative products to market,” said L.R. Fox, CEO of NEXT Life Sciences. “Dr. Walley will be vital in leading our team to market and there is no doubt she will be a great asset to the NEXT Life Sciences family.”

Dr. Walley has over 30 years of life science business experience, having served as an Executive at Procter & Gamble, Gillette, and Arm & Hammer and CEO of multiple early-stage pharma and biotech companies.

To date, she has raised over $100M for these companies with over $1B in successful exits. In her extensive career, Dr. Walley has worked with startups, investment firms, and served on the Board of Directors of several companies, proving her skills through leading successful product launches, capital raises, and company performance improvements. Dr. Walley currently holds 12 patents, largely dealing with consumer health products, with 18 peer-reviewed publications.

“I am very excited and honored to be leading the incredible Plan A team to revolutionize contraception with a long-lasting, reversible, non-hormonal option for men,” stated Dr. Walley. “This opportunity allows me to use my over 30 years of experience in developing and launching first-in-class products worldwide. Plan A is another first-in-class product and everyone I mention it to is excited and onboard.”

Peter Barton Hutt, a distinguished attorney and expert in food and drug law, has made significant contributions to the regulatory landscape in the United States. Serving as the chief counsel for the U.S. Food and Drug Administration (FDA) in the 1970s, Hutt played a pivotal role in shaping policies that enhance food safety and regulate pharmaceuticals and biotechnology, including the development of the agency’s medical device guidance. Hutt has also shared his extensive knowledge through academia, teaching at several prestigious law schools, including Harvard Law School, and authoring numerous publications on regulatory matters. His influence continues to be felt across the industry as he advocates for effective legal frameworks that protect public health and safety.

"We've been waiting for this product for years. At last, Plan A has the technology that scientists have been looking for. I’m really excited about joining other distinguished leaders on the NEXT Life Sciences Advisory Board and look forward to supporting the team and contributing to the future development of the company,” said Peter Barton Hutt.

“I am pleased to welcome Peter to our advisory Board, his exceptionally accomplished legal and policy career will help us advance our mission of bringing a new generation of accessible contraception to the market,” said L.R. Fox, CEO of NEXT Life Sciences.

NEXT is developing Plan A™ to be a non-hormonal, long-acting, and reversible on-demand, contraceptive for men. The design of Plan A™ utilizes a hydrogel that acts as a flexible filter to block the flow of sperm within the male vas deferens, preventing pregnancy. The hydrogel used within Plan A™ is commonly known as Vasalgel®, a technology that earned significant attention during its 10 years of development with the non-profit Parsemus Foundation and shows a promising track record of success from pre-clinical data. The exclusive worldwide license for Vasalgel® was acquired by NEXT in 2022, with the goal to bring this technology through FDA authorization and rapidly to market.

About NEXT Life Sciences
NEXT Life Sciences, Inc. (NEXT) is revolutionizing modern reproductive healthcare and transforming lives through the development of its lead program, Plan A™, designed to provide a non-hormonal, long-lasting, and reversible contraceptive solution for men. NEXT’s executive management team and board members have a proven track record of leadership across early-stage research, product development, and global commercialization, having served in leadership roles at successful medical device and contraceptive companies that developed and launched products that achieved iconic status. For more information, visit https://www.nextlifesciences.org/ and https://www.planaformen.com/.

Disclaimer
All forward-looking statements are not guarantees of future performance and undue reliance should not be placed on them. Statements within this document have not been evaluated by the Food and Drug Administration. Plan A™ is currently not approved by the FDA for commercial distribution.

NEXT Life Sciences
Plan A™ Male Birth Control
press@nextlifesciences.org

THE SEATTLE TIMES | With abortion rights at risk, need for a male contraceptive is urgent

ORIGINALLY POSTED ON THE SEATTLE TIMES

SEPTEMBER 2024

By John Amory

People have used birth control for thousands of years. The ancient Egyptians and Romans used condoms. The human desire to prevent pregnancy is long-standing, and scientific advancement has been playing catch-up ever since.

Most research on contraception has focused on methods for women, who now enjoy many contraceptive options. For men, only condoms and vasectomies are available.

Historically, outdated assumptions have hindered funding and research into the development of novel male contraceptives. Additionally, some believe that men don’t want the responsibility of preventing pregnancy and wouldn’t use a new male birth control method, even if it existed. However, the data on the use of condoms and vasectomies show that men currently account for a third of all contraceptive use.

As a clinician and researcher working to develop novel male contraceptives, I see men every day who want to participate in the family planning process. Trends over the last two years back up these observations, all pointing toward one conclusion: It’s high time that we develop new birth control solutions for men.

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MD+DI | A Guide to Widespread Therapy Adoption in Medtech

ORIGINALLY POSTED ON MD+DI

AUGUST 2024

Thoroughly understand your stakeholders

L.R. Fox, founder of NEXT Life Sciences, is a young and ambitious innovator with a background in engineering and a track record of successful ventures in highly regulated industries like cybersecurity, defense, and aerospace. At NEXT, his team is developing Plan A, a non-hormonal, long-lasting, reversible male contraceptive.

Fox’s algorithm for medtech starts by dismantling the stakeholders and understanding each of their needs. Potential users, healthcare providers, payers, and regulatory bodies will have different concerns. Once you identify your key stakeholders, you can start a meaningful dialogue. Think carefully about whom your product or service concerns. For example, addressing the spouses or partners of their end users was an unexpected, but good step in NEXT’s case.

By actively engaging in conversations with these various audiences, Fox and his team gained valuable insights that enabled them to tailor Plan A itself as well as its messaging.

Secondly, as an entrepreneur who likes to try his hand at different industries, Fox understands the value of experience and actively seeks out domain experts and leaders in the pertinent field. He asks himself, “If there's one person that I need to talk to to really understand this, who is that person?” This attitude opens doors to valuable partnerships, collaborations, and opportunities for further innovation. Thanks to the network he built in this fashion, Fox positioned Plan A not only as a contraceptive but as an impetus for addressing structural problems in society.

To take a page from Fox’s book, take some time to identify the different groups who have a stake in your product or service. Remember, skepticism is healthy and deserves engagement. That’s the only way to tailor your solution or message to their respective needs. While doing that, actively seek out subject matter experts in your field, offer support, and foster collaborations. Connect with others who share your goals and stand together in the niche you’re seeking to reshape.

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