Daye’s founder and CEO Valentina Milanova said the FDA greenlight “marks a pivotal moment in our mission to enhance the health and well-being of women and assigned female at birth individuals.” Image credit: Daye.

UK gynaecological startup Daye will be able to reach women’s and girls’ health across the pond, after the US Food and Drug Administration (FDA) cleared the company’s Nude Tampon for marketing as a medical device.

The female-led company founded in 2017, which is best known for inventing a cannabidiol (CBD) tampon, has developed its Nude Tampons with gamma ray sanitisation. A safe way of sterilising the products, Daye says its product is the only tampon on the market sanitised this way.

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Killing pathogens and ensuring cleanliness of tampons can reduce the chances of toxic shock syndrome – a rare but potentially life-threatening condition that has become associated with tampon and menstrual cup use. Though the syndrome can have other causes, Daye adds that the gamma-irradiation also reduces the risk of other vaginal infections like thrush and bacterial vaginosis.

Not only is Daye overcoming the pathogenic front, but it is also tackling eco issues in the health space. Its tampons are fully organic and made using ethically sourced materials, free of many chemicals and compounds found in mainstream products.

The company plans to launch the tampons in the US next month. The US women’s health market is expected to reach $153m by 2025, according to a report by GlobalData.

Daye’s unique approach to menstrual care has already seen it disrupt much of the status quo – its CBD tampons created an extensive media buzz from launch. The company states the tampons are used by more than 75,000 individuals, though there is still limited evidence as to how efficacious CBD is in treating period pain.

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In October 2022, the company expanded beyond tampons and launched a vaginal microbiome screening kit that can be conducted at-home. The swab can check for vaginal infections and other health complications such as fertility implications.

Around the same time, Daye closed a Series A funding, securing $11.5m. To date, it has raised more than $20m.

Daye founder and CEO Valentina Milanova said: “This milestone validates the extensive research, development, and testing that have gone into creating a product that not only meets the highest medical standards but also addresses the menstrual care needs of people with periods.”

“Next, we will introduce a water-soluble tampon applicator. Daye is also working on a Pain-Relieving Tampon for chronic pelvic pain and on a Diagnostic Tampon to help increase access to at-home vaginal health screenings. These additional tampon variants are based on the foundation that the Nude Tampon provides.”

On LinkedIn announcing the news, Milanova declared that the FDA-clearance is “more than just a regulatory milestone but the result of our long-standing collaboration with The A21 Campaign, a charity that supports human trafficking survivors.”