Sequel plots next generation of menstrual care with FDA clearance of new tampon design

It’s not often that a sequel is better than the original, but one startup developing a new approach to period products is banking on it.

San Francisco-based Sequel announced Tuesday that the FDA has cleared the company’s first product, the Sequel Spiral tampon, which is billed as the first major redesign since modern tampons were first invented nearly a century ago.

With the FDA 510(k) clearance secured, the company plans to begin several consumer trials of its tampon—building on the extensive safety and efficacy testing that was needed to back up the product’s regulatory submission—before beginning a broader launch in the first quarter of next year.

“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,” Greta Meyer, Sequel’s co-founder and CEO, said in the announcement. “However, we understand the importance of these devices being held to the highest standards of safety and quality.”

Sequel’s flagship product features grooves placed in a diagonal spiral around the tampon rather than the straight up-and-down grooves typical of most others currently on the market.

According to its makers, that makes the Sequel Spiral not only more comfortable but also less leak-prone than its competitors. For one, its spiraling flow path is longer than traditional linear grooves, giving the Sequel Spiral more time to absorb fluid. For another, placing the grooves more perpendicular than parallel to the direction of blood flow gives the tampon a better chance of catching any escaped fluid.

To date, per Sequel, the spiral design has garnered 11 patents in the U.S., plus another seven currently pending patents internationally.

Sequel said in the announcement that it has also developed its own “proprietary manufacturing method” to help it quickly scale up from manual to automatic manufacturing to prepare for the full-scale product rollout. That in-house work will be compounded by a partnership that Sequel struck with personal hygiene manufacturer Albaad earlier this year to further accelerate the Sequel Spiral launch.

The novel approach to menstrual care has so far earned Sequel $5 million in seed funding. The round closed at the end of 2021, with support from MaC VC, Pear VC, prolific angel investor Cyan Banister and more.

Additionally, for their work in revolutionizing period care, Sequel’s founders were named to Forbes’ annual 30 Under 30 list earlier this year. Both Meyer and her co-founder, Amanda Calabrese, the company’s chief marketing officer, were athletes at Stanford University and graduated with engineering degrees in 2019. In the Forbes profile, they noted that Sequel is expecting to rope in $10 million in 2023 revenues.