She Invented A Smarter Tampon. Then Came Three Walls To Climb

Daye's at-home diagnostic tampon kit screens for HPV, STIs, and vaginal infections—bringing cervical crab prevention retired of the session and into a patient's ain bathroom.

Daye Daye is simply a London-based gynecological wellness institution that develops patented medical-grade tampons for play symptom alleviation and at-home testing.

The tampon successful mobility detects high-risk HPV strains that origin 99.8% of cervical crab cases, has been peer-reviewed successful the Journal of Clinical Microbiology, and was named a TIME Best Invention of 2024. Yet, Google has classified Daye's diagnostic tampon not arsenic a aesculapian device, not arsenic a diagnostic tool, but arsenic a contraceptive.

No one, successful the history of medicine, has utilized a self-sampling instrumentality arsenic a contraceptive. Google’s categorization is ridiculous.

Most femtech founders deed a backing gap, a information gap, aliases an invention gap.

The Gap Nobody Funds

180 Pitches For The Seed and 400 For The Series A

You’d deliberation that a diagnostic tampon tin of helping eliminate cervical crab deserves the aforesaid seriousness arsenic everything other task superior already funds. You’d beryllium wrong.

Milanova founded Daye successful London successful 2017 aft discovering that existing tampon manufacturers had nary liking successful raising their ain standards. Tampons utilized internally required little regulatory archiving than astir over-the-counter medications. No continuous value management. No batch testing for dense metals aliases microbiological content. One-time biocompatibility data, and that’s enough.

So she built her ain manufacturing installation successful Bulgaria, designed her ain accumulation standards, and applied for ISO 13485, GMP, and EU MDR certification—the aforesaid standards utilized for surgical instruments. She received FDA 510(k) clearance for her menstrual tampon and went connected to create a second-generation diagnostic tampon tin of at-home HPV and STI detection. The institution has raised astir $28 million, positive astir $4 cardinal successful grants, according to Milanova.

Getting location required pitching 180 investors for the seed information and much than 400 for the Series A. Milanova is nonstop astir why.

Annie Theriault, founding partner astatine CBIV and a Daye committee personnel for 4 years, frames the aforesaid reality from the different side. "Daye does the unglamorous, capital-intensive activity astir of the class avoids—clinical trials, in-house medical-device manufacturing, existent regulatory clearances,” she noted. “That operation is uncommon successful femtech, and it's what builds a durable business alternatively than a momentary one."

Tatum Getty, a partner astatine Thena Capital, an investor successful Daye, wrote that the company’s attack addresses a basal obstruction to adoption. "Valentina didn't inquire women to adopt an wholly caller behaviour; she took a merchandise millions already cognize and spot and expanded what it could do,” she said. “That's the benignant of healthcare invention that has the top chance of changing outcomes because it removes clash alternatively of creating it. Daye has paired that simplicity pinch rigorous objective evidence, which is simply a operation we seldom spot pinch an tremendous marketplace opportunity."

What Investors Never Hear

What Milanova has learned complete astir a decade is which parts of her ain institution to conceal successful a pitch. CPT codification eligibility, which Daye received past twelvemonth and which opens a way to security reimbursement, really frightened investors who instantly thought astir a 14 to 90 time billing cycles depending connected the payor. The tampon's ongoing usage successful objective tests to observe ovarian and endometrial crab successful the US and UK prompted the mobility "why aren't you focused?" The aesculapian database Daye has built from vaginal, menstrual, and hormonal wellness outcomes, shared pro bono pinch world institutions, generated nary liking astatine all.

The world femtech market was estimated astatine $39.29 cardinal successful 2024 and is projected to scope $97.25 cardinal by 2030. None of that projected maturation changes what an investor said to Milanova earlier 1 caller transportation meeting, a remark that encapsulates the problem. He opened by telling her she looked prettier successful personification than successful her LinkedIn photo. She has made a deliberate determination to extremity being angry astir moments for illustration that and put the power location productive. It is not a mini decision.

The Machine Nobody Makes

One Company Controls Global Tampon Manufacturing

One structural truth reframes everything other successful Daye's story. Surprisingly only 1 institution manufactures each world tampon manufacturing instrumentality lines. Milanova discovered this erstwhile she went looking for a accumulation partner and recovered nary 1 consenting aliases tin of gathering her standards.

So Daye designed its ain machines, built its ain cleanable rooms, implemented gamma ray radiation for sterility, and developed batch testing protocols for PFAs, dense metals, and microbiological content—none of which existing manufacturers required. The FDA 510(k) clearance Daye received was for a tampon dissimilar immoderate antecedently approved: water-soluble wrapper, afloat sterilized, produced to aesculapian instrumentality standards. "We brought tampon manufacturing successful house," Milanova recounts, "and we decided we were going to inquire notifying bodies and regulators to dainty america arsenic a aesculapian device."

A period of manufacture consolidation, zero R&D investment, and 1 instrumentality manufacturer. That is the baseline Daye is moving against, and it explains why the superior strength Theriault references is not a strategical choice. It was the only disposable path.

The Regulatory Vacuum

The FDA Has No Route For A Sterile Tampon

In December 2024, the FDA issued a informing missive to Daye, citing concerns that its CBD-infused tampon was being marketed for play symptom relief, which the agency considered an unapproved modification to the cleared device. Daye voluntarily withdrew the CBD tampon from the US market. On June 11, 2026, the FDA confirmed it had reviewed Daye's corrective actions and recovered they addressed each cited items. A follow-up inspection, the modular last measurement toward general closure, remains ahead.

Milanova describes receiving the original missive arsenic "one of the saddest events successful the institution history, because each that we person done until now is effort and modulate ourselves to a overmuch higher modular than the manufacture demands."

The deeper problem, though, is the regulatory terrain that produced it. The FDA has nary established pathway for a sterile tampon. Annual FDA registration fees tally $90,000. Regulatory attorneys who tin construe guidelines that are often unwritten complaint $750 an hour, and apical firms often springiness differing proposal connected the aforesaid question.

The FDA's 2024 effort to modulate laboratory-developed tests, which would person affected Daye's diagnostic screening business, was vacated by a national tribunal and formally rescinded successful September 2025, creating months of uncertainty mid-launch. For context, a laboratory-developed trial is simply a diagnostic trial designed and utilized wrong a azygous laboratory alternatively than sold arsenic a packaged kit. It is simply a class the FDA had agelong overlooked and past abruptly moved to modulate earlier the courts intervened.

Milanova's projected hole is simply a regulatory sandbox: a system situation wherever regulators and innovators activity together to create support pathways for devices that autumn extracurricular existing categories, sharing the costs and the evidence-building earlier either broadside commits to a general process. She puts it plainly. “If we could person the regulator meet the women's wellness innovator successful immoderate benignant of a sandbox environment, that will beryllium truthful hugely beneficial for the manufacture arsenic a whole," she says.

Without that, the costs of building genuine aesculapian invention successful women's wellness falls wholly connected the founders who already cannot entree task capital.

The Last Mile Of Cervical Cancer

We Have The Technology. We Need The System

Daye’s diagnostic tampon achieves diagnostic accuracy comparable to clinician-collected swabs: sensitivity 82.9%, specificity 91.6%, and a 99.2% valid sample complaint that outperforms some self-collected swabs and clinician samples connected the past metric. The institution is one of only six nationally approved NHS suppliers of STI and HPV screening services for the full of the UK, and the only mini institution connected that list. The National Health Service is the publically funded healthcare strategy successful the UK. In March 2026, Daye won the Digital Health Rewired Pitchfest, opening a imaginable NHS aviator astatine Chelsea and Westminster Hospital.

Mindy Simon, co-Director astatine the NHS Innovation Accelerator, notes that Daye's exemplary stands retired for precisely the reasons that make it difficult to fund. "Their attack is evidence-led, system-aware, and focused connected improving entree for patients who are excessively often overlooked.,” she says.

Only 62.7% of eligible women successful the UK are adequately screened for cervical cancer, good beneath the NHS's 80% target, and cervical crab mortality is projected to emergence 17% by 2030 if that spread persists. Milanova is unequivocal astir what the existent obstacle is. "We person the technology. We person the qPCR test, we person the vaccine. We conscionable request a strategy that will clasp the patient's manus done what is typically a very analyzable journey,” she says.

That system, arsenic Daye has built it, includes tampon-based self-sampling, a caregiver consultation for each HPV-positive patient, and vaccination booking for the diligent and their partner. Clinical tests are moving successful Tanzania and Nigeria, wherever the load of cervical crab is highest globally. Milanova designed the level to beryllium world from the start, not retrofitted later because "True femtech invention needs to beryllium for everyone, and you request to creation truthful that it tin beryllium for everyone from the beginning."

The Fourth Wall

The backing gap, the information gap, and the invention spread are problems a wished laminitis tin yet solve. Milanova spent 9 years solving them. The 4th wall is different. It is the commercialization infrastructure: the platforms that suppress women's wellness advertising, the investors who person already made their 1 women's wellness stake for the year, the regulators who person nary pathway for what you built, and the wellness systems undergoing their largest restructuring successful history astatine the nonstop infinitesimal you arrive.

None of that is Daye's fault. None of it diminishes what the institution has built. Milanova is settled connected the constituent that "Creating amended solutions for women's wellness is worthy it. That's what I often show myself. If you activity connected thing impactful pinch group that you genuinely for illustration and admire, that's enough."

Whether the 4th wall moves is not up to her. That requires the platforms, the investors, and the regulators to determine that a diagnostic tampon tin of helping eliminate cervical crab deserves the aforesaid seriousness arsenic everything other they already fund.