Sequel, a startup focused on advancing women’s wellness experiences, has successfully gained FDA approval for its Spiral Tampon as a medical device. This achievement not only signals a paradigm shift in tampon design but also addresses an industry characterized by a lack of distinct product offerings.
Greta Meyer and Amanda Calabrese, former high-level athletes and Stanford engineers, founded Sequel with a vision to redefine women’s products through innovative design and advanced technology. The Sequel Spiral Tampon, their inaugural creation, boasts a distinctive helical design meticulously engineered to optimize fluid mechanical efficiency. This innovative design guarantees more uniform absorption and significantly reduces the risk of leakage prior to the tampon reaching full capacity. Sequel holds 11 patents globally and within the United States, with 7 additional pending patents. The startup’s proprietary manufacturing process facilitated a smooth transition from manual proof-of-concept production to streamlined automated manufacturing.
“From the beginning, I’ve been impressed with Sequel’s mission to raise the standard of women’s health and wellness, and with this first product, they’ve brought meaningful innovation to a category ready for change,” said Claudia Kotchka, longtime Sequel Advisor and former Vice President of Design, Innovation and Strategy at Procter & Gamble.
The journey towards FDA clearance involved rigorous testing and meticulous documentation to ensure the product’s safety and effectiveness. This comprehensive process reinforced the company’s unwavering confidence in the product’s design and performance.
“FDA clearance has been a long process for us, and we know that this is one of the largest barriers to entry for new products in this category,” said Greta Meyer, co-founder and CEO of Sequel. “However, we understand the importance of these devices being held to the highest standards of safety and quality. We are proud of the work our team has done to reach this milestone for Sequel.”
The next phase in Sequel’s journey involves comprehensive consumer trials of the Sequel Spiral Tampon, with a widespread release anticipated in Q1 of 2024.