FDA Approves Tampon With Helical Design

Sequel, a startup company, has received U.S. Food and Drug Administration (FDA) approval as a medical device for its spiral tampon, which is designed to be more comfortable and less prone to leakage.
 
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 seven additional patents pending internationally. The firm has developed a proprietary manufacturing method that enabled it 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,” Sequel Co-Founder/CEO Greta Meyer stated. “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 of the Sequel Spiral Tampon follows the infusion of $5 million in seed funding from Pear VC and MaC Venture Capital. The company also has rapidly grown its team, opened a new San Francisco headquarters, and solidified a manufacturing partnership with Albaad, one of the world’s largest manufacturers of feminine hygiene products and wet wipes.
 
Sequel will now begin a series of consumer trials of the Sequel Spiral Tampon, with broad availability expected in the first quarter of next year. 
 
Sequel is engineering better health and wellness experiences for women.