Significant Investment Will Help Materna Medical Advance Impressive Plans

by | Sep 29, 2022 | Companies, Women's Health

Materna Medical, a Fogarty Innovation company focused on transforming women’s pelvic health, recently raised an impressive $20 million in Series B funding led by investment firm InnovaHealth Partners. This comes on the heels of a $10 million Series A2 funding in 2021, which was followed by the FDA clearance for the startup’s first product, Milli, a consumer wellness device that helps the millions of women who suffer from chronic pelvic pain. Those funds also allowed Materna to expand the clinical trials of its second product, Prep, a first-of-its-kind technology aimed at preventing pelvic floor injuries during childbirth, to 15 sites.

“We are very proud of the progress we have made with products targeting an area that has seen such little innovation and medical technology advancement,” said Tracy MacNeal, president and CEO of Materna Medical. “In labor and delivery, there’s rightfully a lot of attention on the safety of the delivery of the baby, but not as much attention paid to the mom, her symptoms and longer-term wellbeing.” 

Making inroads despite challenges

Materna’s clinical research for Prep is set to be completed by next year. However, gathering the data has not been as straightforward as usual because most women are not comfortable having a Materna clinical expert at their birthing experience. Accordingly, the startup needs to rely on training the principal investigators (PI) to record accurate data. Despite the device’s ease of use, that can sometimes be tricky due to the unpredictable nature of labor and delivery. 

“There are so many variables in birthing experiences, from duration of labor to whether the mom had a C-section or had the stress of an abnormal fetal heart rate. It’s like we are trying to take a boat through the whitewater rapids,” said Tracy. 

This hasn’t deterred Materna, which has recruited top leadership at some of the most prestigious hospitals in the country, including the Mayo Clinic, Rochester; the University of Pennsylvania; Columbia University and Rutgers, among many others, to trial the device.  

Taking a step toward preventing future issues

Another unique aspect of the Prep clinical trials is that they are bringing together physicians who don’t traditionally work together, including urogynecologists, hospitalists and obstetricians, in order to educate women about pelvic health during delivery.

It’s an interesting challenge because while the team is working with obstetricians to gather data, the need that Prep addresses—pelvic injury—is typically treated by urogynecologists. 

“Urogynecologists are very aware of this condition,” says Tracy, noting that these practitioners see the many patients impacted by Incontinence or prolapse caused by childbirth.  These conditions are experienced by nearly half of women by the time they’re 55. “Now we are working to educate obstetricians about their role in potentially reducing it.”  

This makes Prep a very exciting innovation, as many PIs who are working on the clinical trials didn’t previously have a solution to offer. “Until now, the only standard of care has been hope: hope that mom’s pelvic floor doesn’t suffer long-term damage,” said Tracy. 

Success on all fronts

The recent round of funding is being used to finalize the FDA De Novo Classification Request for Prep, with the aim of obtaining marketing authorization in the U.S.

The funding will also be used to accelerate the over the counter (OTC) commercialization of Milli. The company received Rx clearance in December 2021 and filed for OTC clearance early in 2022. “Once this is approved, we will be the only product in our category with this type of clearance, which is very exciting as it will give women a lot more control over their own personal health,” said Tracy.

All this positive news and funding has necessitated additional hiring at Materna, including doubling the number of clinical affairs members. “We are beginning to build our commercial infrastructure for Milli, which we can then leverage for Prep when we are ready,” said Tracy. 

Pursuing the optimal funding options

Materna was determined to find a like-minded partner for this second round of funding. The company had received considerable interest, thanks to the credibility they had built with Milli, and the fact that they already had a commercial product and revenue. “But we were still looking for a partner to take the lead on the funding who shared our mission for radically changing women’s healthcare with a meaningful technology,” said Tracy. 

Materna’s patience and focus was rewarded when they found InnovaHealth, which had been trying to get involved in the women’s health space for several years.

With the funding came the addition of Materna’s first board chair—InnovaHealth’s co-founder and managing director, Dr. Ariella Golomb, an OB/GYN with extensive experience in medical devices. “Ariella is bringing so much to the table with her experience, vision and leadership. We are thrilled to have her as our board chair as we prepare Materna to fully commercialize,” concluded Tracy. 

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