-Sequel, a startup, dedicated to engineering better health and wellness experiences for women, today announced that its breakthrough spiral tampon has received approval from the United States Food and Drug Administration (FDA) as a medical device. Approval from the FDA marks a critical step in enabling Sequel to bring its tampon–which is designed to be more comfortable and less prone to leakage–to market and reinvigorate a space that has been flooded with private label newcomers, but little product differentiation.

Founded by two high-level athletes and Stanford engineers, Sequel’s mission is to raise the standard of women’s products with better design and superior technology. As the company’s first novel product, the Sequel Spiral™ Tampon features a proprietary spiral design that is engineered to be more fluid mechanically efficient, meaning it is designed to absorb more evenly and not leak before it’s full. The company has been granted 11 patents in the United States and globally with 7 additional patents pending internationally. They have developed a proprietary manufacturing method that enabled them to scale up quickly and transition from proof-of-concept manual manufacturing to automatic 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.

As a part of the FDA clearance process, Sequel performed extensive testing and documentation of the safety and efficacy of the product, which validates the company’s confidence in the design of the Sequel Spiral™ Tampon.

“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.”

FDA approval for the Sequel Spiral™ Tampon comes on the heels of significant momentum for the startup. Sequel’s founders, Greta Meyer and Amanda Calabrese, were named to the 2023 Forbes 30 Under 30 list; raised $5 million in seed funding from Pear VC and MaC Venture Capital; grew their team and opened a new San Francisco headquarters; and solidified a manufacturing partnership with Albaad, one of the largest manufacturers of feminine hygiene products and wet wipes in the world.