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.

READ MORE ON: AXIOS

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.

READ MORE ON NY POST

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.

READ MORE ON FORTUNE

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.

READ MORE ON FORTUNE

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.

READ MORE ON THE SEATTLE TIMES

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.

READ MORE ON MD+DI

SHAMELESS | The Future of Male Birth Control with L.R. Fox

ORIGINALLY POSTED ON SHAMELESS

AUGUST 2024

How Plan A is changing the game when it comes to reversible, set-it-and-forget-it male contraceptives

When I began writing my last article, The Gentleman’s Guide to Birth Control, I knew I wanted to talk to Plan A. I’ve been following them for years, reading the results of all their trials, and feeling confident I was watching the creation of something amazing for men and families. Could this be the first highly effective, long-acting, reversible male contraceptive?

I reached out to Plan A for an interview so my readers could learn more about this option, how it works, how effective it is, and how likely we are to see this on the market in the near future.

While my interviews are typically shared only with paid subscribers, I wanted to ensure all my readers could share my excitement about Plan A™ and Vasalgel®. Without further ado, please enjoy my email interview with L.R. Fox.

READ MORE ON SHAMELESS

SUBSTACK | The Gentleman's Guide to Birth Control

ORIGINALLY POSTED ON SHAMELESS

AUGUST 2024

The future of male contraceptives and how knowing more about birth control makes you a better partner

Several years ago, I taught an Our Whole Lives sexuality education course for 7th-9th graders. During one of the classes, we discussed options for navigating unplanned pregnancies. After we taught the basics of abortion, one of the boys raised his hand. “I just don’t think it’s fair that if a girl is pregnant and wants an abortion, she can do that, even if the boy wants the baby.”

I considered his question before replying, “You’re right to observe that after a pregnancy begins, the girl can make decisions the boy can’t. But she’s also the one who takes on more risk and stigma. Pregnancy and birth can be physically difficult and dangerous, not to mention the challenge of teen motherhood.”

I added, “It’s important for boys to understand that their power comes in decision-making before pregnancy begins. This is why we discuss birth control with all genders in this class. Boys who are attracted to girls need to understand how effective these options are (or aren’t) so they can do their part to prevent pregnancy before it happens.”

While family planning is a topic that concerns people of all genders, birth control is socially assumed to be a woman’s issue. Men don’t always know much about the birth control their female partners take, how it works, or what kinds of questions are appropriate to ask. This, combined with the general discomfort many people have around sexual communication in general, can lead to assumptions, misunderstandings - and unplanned pregnancies.

READ MORE ON SHAMELESS

THE BREAKTHROUGH | Trials of a revolutionary ‘switch-on/off’ contraceptive could begin in the UK, Australia, and New Zealand

ORIGINALLY POSTED ON THE BREAKTHROUGH

JULY 2024

TRIALS of a revolutionary ‘switch-on/off’ contraceptive could begin in the UK, Australia, and New Zealand as early as next year and the company is looking for men aged 25-65 to take part.

It aims to significantly reduce the rate of unintended pregnancies in the UK, which currently stands at nearly half of all pregnancies, with 36% resulting in abortion.

Globally, there are 121 million unintended pregnancies each year, with 61% ending in abortion.

READ MORE ON THE BREAKTHROUGH

NY1 | New Male Birth Control Options Are In The Works

ORIGINALLY POSTED ON NY1 SPECTRUM NEWS

JULY 2024

This interview has been edited for length and clarity. Full interview can be found on NY1 Spectrum News

BY ERIN BILLUPS - NATIONAL HEALTH REPORTER NATIONWIDE

Abortion remains a top issue this election cycle. The uncertainty surrounding reproductive rights since the Supreme Court overturned Roe v Wade has led to a sharp increase in vasectomies and tubal ligations, and has also added fuel to the push to create male contraceptives. National Health Reporter Erin Billups looks at where things stand and at the timeline for getting these options to market. 

READ MORE ON NY1 SPECTRUM NEWS

NPR Morning Edition | Arizona startup is working on making birth control for men a reality

ORIGINALLY POSTED ON NPR MORNING EDITION

APRIL 2024

A research lab in Flagstaff, Ariz., is trying to leverage a 1970s discovery into a safe and desirable alternative for men who want to prevent pregnancy.

READ MORE ON NPR MORNING EDITION

CBS | Flagstaff Lab Working on Male Birth Control That Can Take Effect and Be Reversed in Minutes

ORIGINALLY POSTED ON ARIZONA FAMILY CBS AND MSN

APRIL 2024

The Arizona Supreme Court ruled this week the state can enforce an 1864 law that bans almost all abortions.

Now, eyes are on contraceptives, and some are in the works that would allow men to take control of birth control.

For decades, birth control has become mainly a woman’s responsibility; however, honey-like liquid in vials from a small Flagstaff lab could hold the key to reversible and nonhormonal male birth control.

Dr Rob Kellar is the chief science officer for NEXT Life Sciences’ Flagstaff lab. He and his team are developing and testing Plan A, male birth control. “Having the ability to develop new technology that gives not just men but partners, couples, some other options to consider in family planning is a really big deal,” Kellar said

Plan A would be a shot aiming to provide up to ten years of male birth control. It takes effect and can be reversed in just minutes. “We were looking to deliver an option that can be reliable but also reversible, and it’s on-demand reversible,” Kellar said.

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NBC | Flagstaff Startup is Working on a Medical Male Birth Control Method

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APRIL 2024

The product, and ones like it, has been eagerly awaited for years. Discussion around it has become more prominent in the last few days since Wednesday’s Arizona Supreme Court decision that created a mostly-no-abortion environment in the state.

“Just like in the kitchen you use a strainer to strain your spaghetti noodles, allow the water to flow through and leave behind the spaghetti noodles,” chief science officer Dr. Rob Kellar said. “That’s kind of the same analogy here.”

Kellar and his team have spent the last several years testing and developing Plan A, which, he says, is built upon decades of lab and clinical testing around the world.

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POLITICO | A ‘Plan A’ for Men

ORIGINALLY POSTED ON POLITICO

APRIL 2024

For decades, the responsibility for birth control has disproportionately fallen on women. Now, several companies are working on male birth control.

Male contraception is in demand. Between 2014 and 2021, the rate of vasectomies among men 18-64 grew 26 percent, according to one study. Vasectomies jumped again after the Supreme Court overturned the constitutional right to an abortion in 2022.

In the U.K., an oral contraceptive has entered safety trials. But two companies, NEXT Life Sciences and Contraline, are each exploring the possibility of using hydrogel to block sperm. Both have clinical trials underway.

Ruth sat down with NEXT Life Sciences CEO Luke R. Fox to talk about his company’s male contraceptive, Plan A, and the future of male birth control.

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