MFB Fertility, the creator of a series of home pregnancy-related hormone tests, announced a $ 9.7 million A-Series this week. The round follows several milestones for the company, including an FDA pre-market approval for a progesterone urine test and the launch of a mobile application. It also gives the company more fodder to build for its thesis: that hormone testing at home can save both time and stress associated with “unexplained” infertility.
MFB Fertility is more commonly known as Proov – the name of the test developed by owner and CEO Amy Beckley. Proov was founded in 2018, after Beckley had her own battle with infertility and miscarriage. She classified herself as “inexplicably infertile”.
In Beckley’s case, a prescription solved her problem. But the Proov tests, she says, were created for women who also find themselves in the “unexplained” category of infertility diagnosis. Studies estimated that somewhere between 15-30% of infertility diagnoses worldwide fall into that unexplained category.
“It’s just a fight,” Beckley told TechCrunch. “For a woman to go in and get all the tests and then come out on the other side, and it’s like, oh, yeah, you know, you’re inexplicably infertile.”
This round was led by Hambrecht Ducera Growth Ventures. These include participation in SteelSky Ventures, WCC Partners, Lightship Capital, GingerBread Capital, Established Ventures and Portfolio FemTech II Fund.
Unexplained infertility can amount to any number of male or female factors. Proov’s flagship test is designed to rule out two problems: the status of ovulation – the process by which an egg matures and is released, and the readiness of the uterus.
If you go to a doctor’s office, that doctor can do a blood test for progesterone, a hormone that helps prepare the uterus for pregnancy, and spikes after an egg is released. Proov developed a home urine test to measure a progesterone metabolite, PdG.
External research has validated PdG as a marker of ovulation. A 2017 review paper note that the measurement of urine PdG levels over three days was accurate when it comes to confirming ovulation, but that no point of care tests using this method has yet been developed.
“We have developed the first and only FDA-approved way to measure it at home through urine to understand what we call ovulation quality: Is the uterus optimally prepared to have the highest chance of conception?” said Beckley. “We found out. I was literally the first person to ever have this technology. ”
Proov went through the process of having the PdG test evaluated and getting FDA approved. It received 510 (k) clearance in February 2020because its results were essentially similar to progesterone tests (not directly to consumer) that already exist.
Proov’s own clinical trials have suggested that progesterone (and PdG) may also be useful markers of other pregnancy outcomes. The data has yet to be published, but Proov has data from a trial on 54 pregnant women indicating that women who had two days or more of negative PdG tests during a critical period saw increased rates of miscarriage.
That data is reported in a change.org petition managed by the company. The petition is in response to American College of Obstetrics and Ginecology guidelines indicating that progesterone therapy is only given to women who have already had miscarriages (the company argues that certain tests can also be used as a driving force for progesterone therapy).
However, PdG tests are not the only thing Proov has been doing. The company’s latest product is a “complete” test product that will provide tests for PdG, Luteinizing Hormone (LH), follicle-stimulating hormone (FSH) and an estrogen marker. And it’s a mobile application launched to help users interpret those tests.
The application itself is an access point for more detailed information. Users can submit photos of various test strips, which then yield numerical scores that outline certain hormone levels. Those scores are produced using “machine learning and back-end algorithms,” Beckley says.
At the end of the month, the application will provide an ovulation score, Beckley says. Although, critically, the application does more than just provide a number.
Presenting a test or even a score on its own, she said, has led to frustration among users. “Literally, they wrote on our Facebook: ‘I hate it because I do not know what to do with a negative result,'” Beckley explained.
In response, the application enables patients to share their results with physicians, talk to experts and also receive certain lifestyle tips through the application (such as exercise or nutrition) that can continue to improve progesterone levels. The company is also currently building a complementary platform that will be integrated with the application.
The takeaway, according to Beckley, is that testing alone is not enough.
“You have to take that information and give it to her carefully, but at the same time give her solutions,” she said.
There are some general trends playing into Proov’s favor. First, the rise of medical tests is at home.
Large diagnostic companies have already announced the intention to expand from COVID tests at home to other arenas. Quest Labs estimates that by 2025, home consumer testing will become a $ 2 billion industry. Robert Ford, CEO of Abbott Labs, for example, also suggested that COVID tests be at home “sow” the idea of home tests across the country. If you get used to taking COVID tests at home, you may become accustomed to home tests in general.
Beckley also noted the interest of the diagnostic company in Proov.
“These are a lot of the bigger kind of diagnostic companies that are most interested in what we do,” she said. “Their market is doctors, hospital systems, payers. They do not understand consumers and what buying behavior is, so they lean in directly to consumer companies like us, that market directly to women. ”
Fertility testing also – for both men and women – has proof is an especially active area for beginners and investors since about 2019. Crunchbase’s figures have a 89% increase in funding for fertility start-ups between 2020 and 2021, indicating that the trend is still strong.
* This story has been updated to include mention of established businesses