Somewhere between a step counter and a prescription sits a wristband that can tell a woman about her fertility at any given moment. WHOOP’s integration with Natural Cycles is a compelling product story in its own right: continuous sensing from a wristband feeding the first digital method of contraception to receive FDA De Novo authorization, putting clinical-grade guidance on hardware people already wear to bed. For purposes of this article, though, the focus is the deal that made it possible. Millions of people who already own the hardware gained an FDA-authorized clinical tool without buying a new device, and a women’s health company expanded its reach without surrendering the hard-won credential it spent years earning. Natural Cycles kept its authorization. WHOOP supplied the sensor and the membership base. Neither company had to buy the other, and each kept the asset that made it worth partnering with. That is the part founders should study. The same clearance, dataset, and distribution channel can build a lasting business or leave a company dependent on its partner, and the difference comes down to how the agreement handles clearance, data rights, exclusivity, and what happens at exit. For founders and investors, this deal is a template, but it is not the first of its kind.
The pattern goes back further. Natural Cycles integrated with Oura in 2022 and with Apple Watch temperature sensing after that, running one cleared algorithm across new sensors and new user bases and reaching more women each time. Some hardware companies pursued FDA authorization themselves. Apple secured clearance for its ECG and atrial fibrillation features, Fitbit cleared an algorithm for irregular rhythm detection, and Samsung followed with its own cardiac clearances. Taken together, these deals show consumer wearables acquiring regulated clinical claims, some by building and some by licensing. Women’s health companies stand to gain, because the signals wearables already capture – temperature, heart rate variability, and sleep – map directly onto cycle, fertility, and hormonal health. Physiology that went understudied for decades is finally being measured every night, at scale. The clearance is what turns those measurements into medicine, and the agreement that licenses it determines how far they reach.
Where the Money Is Going, and Why Now
Roughly $2 billion went into women’s health and femtech in 2025, a category barely visible to institutional investors a decade ago. Femtech here means technology-enabled products and services built around health conditions and physiology specific to women, or that affect women disproportionately or differently, spanning software, wearables, diagnostics, devices, and care delivery. Two billion dollars is still a small share of health and tech funding, but the shortfall is the opportunity, since women are half the population and make most household health decisions. What has changed is what the money buys. Fewer undifferentiated seed-stage tracking apps are getting funded, and more goes to companies with clinical validation, regulatory clearance, or a diagnostics business, especially in four long-underserved markets: fertility and cycle tracking, menopause, maternal health, and hormone and lab testing. The field is widening. Conditions such as cardiovascular disease, autoimmune conditions, and cancer, can look different in women and respond differently to treatment, which makes sex-differentiated research a frontier where funding has not kept pace. Deal count held steady in 2025 while the median round grew. That tells you more than the headline total, because bigger checks into fewer companies suggest investors are backing businesses, not experiments. Look at what those businesses are made of and the WHOOP structure comes back into view. Clearance, proprietary data, and distribution are drawing the larger checks, and each one is created, shared, or given away in a partnership agreement. The money is there for companies that can show they own what they say they own.
Capital is not just more selective. It is paying a clear premium for one thing. Companies with a credible AI or data layer have drawn valuations approaching triple those of comparable peers without one. What many investors want is the proprietary data, not the model, which gets cheaper by the month, and because female physiology has been so little studied, the data itself is new science. Every additional cycle logged widens the lead, and that lead is difficult to shortcut. The timing helps too. 2026 looks better than 2025, with capital waiting on the sidelines, a healthier exit window, and strategic buyers showing interest in women’s health again. That premium rewards what the WHOOP structure produced, continuous physiological data at scale. An app captures what users remember to log; a wearable captures what happens while they sleep. Partnership is often the fastest route to that data without five years and a hardware budget, but the premium only accrues if the agreement says it does. Whether the data, the models trained on it, and the clinical claim it supports end up on your balance sheet or your partner’s comes down to drafting. That is why structure in this sector is frequently where value is made, not only where risk is managed.
Classification Is a Choice, Clearance Is an Asset
If structure determines value, the first structural decision is regulatory. The FDA regulates what a product claims to do, not necessarily the sensors inside it. A wristband that reports skin temperature is generally treated as general wellness. The same wristband telling a user she can skip birth control tonight is a medical device. That can make marketing copy a regulatory document, from the landing page and app store description to a CEO’s podcast appearance. Align your claims and your regulatory strategy from the start, and classification becomes a line you draw on purpose instead of one you stumble across.
Crossing that line is expensive, which is exactly what makes FDA clearance worth having. Natural Cycles earned De Novo authorization with clinical data and years of regulatory work. A company starting today would likely face a multiyear research and development process before it can make a comparable claim. What an FDA cleared partner really sells is time, and its spending on regulatory compliance can become an asset it licenses again and again, to a wearable, a retail health platform, or an insurer. So, the money spent getting cleared need not be a sunk cost. Handled well, it is a product you can sell to more than one buyer.
What You Are Actually Negotiating
That asset has to be licensed on terms, and this is often where deals are won or lost. Most negotiations spend the first few calls on revenue share, but the value usually sits in the data exhibit. Four questions tend to control it:
- What data moves, and in what form? Raw sensor streams, derived metrics, and de-identified aggregates carry different risks, so spell out each one.
- Can the partner use the data to train models, and who owns what comes out? A model trained on that data can be worth more than the data itself.
- What exactly is exclusive, by device category, geography, use case, and length of term? Vague language tends to be read literally.
- What happens when it ends? Cover deletion, certifications of return or destruction, any license grants that survive, and improvements the partner made to its models using your data.
Assume the relationship ends, because most do.
Everything above assumes the two companies partner instead of one buying the other. At this stage, partnership may be the better choice, for three reasons:
- Clearance stays where it is, so no one has to take on a regulated company’s quality system, FDA correspondence, recall history, product liability exposure, and ongoing obligations.
- Both sides find out whether the combination works before anyone sets a price. An integration reveals how many users overlap and whether engagement rises, and it answers those questions for the cost of engineering work instead of an acquisition.
- A partnership closes faster and can be undone, so founders can reach patients through a new channel without betting the company on it.
How Founders, Investors, and Buyers Read the Agreement
The agreement that opens a distribution channel is also an agreement about your exit. Exclusivity can shorten the buyer list: giving one wearable company exclusive rights in its category can take every other wearable out of the auction. Change-of-control provisions and rights of first refusal can hand leverage to your partner at the moment you need it most. Negotiate as though a sale is coming, because one hopefully is. Done well, the partnership becomes something a buyer wants to keep instead of something it wants to unwind.
When talking to investors, be prepared to answer four questions:
- Data – How hard would it be to replicate? Years of continuous readings tied to consenting, identifiable users are hard to rebuild quickly, and the consent trail is part of the asset, because diligence tests whether a buyer can lawfully use the data the way it intends.
- Revenue – Where does it come from, and does it last? Membership fees plus labs and diagnostics can produce recurring revenue with expanding margins. Clinical use cases also tend to hold users better than wellness features, especially when the product supports ongoing monitoring or treatment of a real disease, since someone managing a diagnosed condition may behave very differently from someone tracking a wellness metric.
- Extensibility – How far does one clearance carry? Regulatory experience, quality systems, and trusted data relationships can reach into menopause, metabolic health, and hormone testing, turning a fertility app into a platform that can serve the same woman for decades. Platforms tend to command higher multiples than features.
- Distribution – Who else can reach these users? Plenty of companies can build an algorithm, but few can put it in front of millions of people already wearing the hardware, and few hardware companies have a cleared clinical use case to justify charging more. That is what makes the trade work for both sides.
The message for founders is simple. Partnership agreements are diligence items now, and a good one can raise your valuation and shorten your round.
All of which returns to structure. Treat the partnership as an exit decision. That framing is freeing, not limiting. Each integration lengthens or shortens the list of plausible buyers, so weigh revenue and reach, then ask how the deal impacts your long-term options. The choice between an IPO and a sale is not unique to femtech. It is newly live for femtech because the category has only recently reached the scale, clearance, and revenue durability that make both paths real. Prepare for both and decide late, which means getting financial, legal, and regulatory documentation in order before you need them.
Optionality depends on breadth. A clinical credential and a real data asset tend to draw more buyers to the table. Wearables and consumer health companies want a regulated use case, diagnostics companies want volume and distribution, and large medtech wants the clearance and the clinical dataset. Protect that breadth to keep competitive tension on your side, and do not let a single partner hold a veto over your future. Structure early partnerships so buyers see validation instead of a mess to untangle, which in practice means limited-term exclusivity, narrow carve-outs, and clean data rights when the deal ends. Revisit those terms as the company grows, because a trade that was fair at Series A can look expensive by Series C.
Every one of those terms traces back to one idea, and the wristband shows it plainly. WHOOP and Natural Cycles did not merge, and neither had to. One company held a clearance earned over years of clinical work, the other had a sensor on millions of wrists, and an agreement did the rest. The hardware exists, the money is available, and the clearances have been granted. Much of what decides whether femtech companies build lasting platforms or end up as features inside someone else’s product is the document that joins them. Done well, the wristband becomes something closer to a medical Swiss Army knife, and the FDA designation does two things at once: it raises the barrier to entry for anyone trying to follow, and it makes the device useful for far more than it was designed to do. A clearance written into the right agreement can follow a woman from her first cycle through fertility, pregnancy, and menopause, on whatever hardware she happens to wear. That is worth getting right, and founders who treat the paperwork as strategy instead of closing mechanics are far better positioned to keep what they build.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
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