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
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.
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