Sequel, a startup focused on improving health and wellness experiences for women, has announced that its innovative spiral tampon has received approval from the United States Food and Drug Administration (FDA) as a medical device. This FDA approval represents a crucial step in enabling Sequel to introduce its spiral tampon to the market, aiming to bring enhanced comfort and leak prevention to a space dominated by private label products with limited differentiation.

Founded by two Stanford engineers and high-level athletes, Sequel is dedicated to raising the bar for women's products through superior design and technology. The Sequel Spiral™ Tampon, the company's flagship product, features a proprietary spiral design engineered for improved fluid absorption efficiency, resulting in more even absorption and reduced leakage. Sequel has been granted 11 patents in the United States and globally, with an additional 7 patents pending internationally. The company has developed a proprietary manufacturing method that facilitated a swift transition from manual proof-of-concept manufacturing to automatic production.

Claudia Kotchka, a Sequel Advisor and former Vice President of Design, Innovation, and Strategy at Procter & Gamble, praised the company's innovative approach: "From the beginning, I've been impressed with Sequel's mission to enhance women's health and wellness. With this initial product, they've introduced meaningful innovation to a category that's ripe for change."

During the FDA clearance process, Sequel underwent extensive testing and documentation to ensure the safety and efficacy of their product, reaffirming their confidence in the design of the Sequel Spiral™ Tampon.

Greta Meyer, co-founder and CEO of Sequel, acknowledged the challenges of the FDA clearance process: "FDA clearance has been a significant journey for us, and we recognize that it's one of the major hurdles for new products in this category. However, we understand the importance of maintaining the highest standards of safety and quality for these devices. We're proud of our team's efforts in achieving this milestone for Sequel."

FDA approval for the Sequel Spiral™ Tampon follows a period of notable progress for the startup. Sequel's founders, Greta Meyer and Amanda Calabrese, were named to the 2023 Forbes 30 Under 30 list. The company secured $5 million in seed funding from Pear VC and MaC Venture Capital, expanded their team, established a new headquarters in San Francisco, and solidified a manufacturing partnership with Albaad, a major manufacturer of feminine hygiene products and wet wipes worldwide.

 

Source: businesswire.com

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