Materna Medical’s labor continues to pay off, as it welcomed a healthy infusion of new investment within its ongoing $20 million Series B2 financing round early this spring, bringing its total funding to over $45 million. The round included new funds GLIN Impact Capital, Wealthing VC Club, and Citrine Angels, and was led by InnovaHealth Partners and other key existing investors: Wavemaker Three-Sixty Health, Kimera Limited, Women’s Venture Capital Fund and Golden Seeds.
The funding underscores the value of its mission in the vastly underserved women’s health market, noted Tracy MacNeal, president and CEO of Materna Medical. “Materna empowers women to protect and restore pelvic health at every stage of life, and we are dedicated to helping women address life-altering issues that have been historically overlooked,” she said.
Materna’s newest product, Ellora™, is an investigational device intended to reduce pelvic floor muscle injury during vaginal delivery by gently pre-stretching the area to help prepare for childbirth. More than 300,000 people—approximately 10% of those who give birth vaginally every year—experience a detached pelvic floor muscle which is the primary contributor to pelvic organ prolapse.
In a study of Materna’s Ellora device published in the International Urogynecology Journal, the lead investigator cited an injury rate between 10-30% of vaginal deliveries, and noted that pelvic organ prolapse can lead to significant symptoms of sexual, urinary or fecal dysfunction.
“The lack of innovation in this space has been disappointing, leaving women to tolerate unnecessary pain and accept it as the norm, and we appreciate this financial infusion that will support our efforts to change this,” said MacNeal. “It’s unacceptable that the United States doesn’t even rank among the top 50 countries for childbirth safety.”
The market potential is immense, with Wilson Sonsini estimating a $25 billion market in unmet needs in women’s pelvic health.
Delivering its vision on a larger scale
With Ellora, Materna is well on its way to change the status quo. It just completed enrollment for its pivotal study in 20 leading hospitals around the country, including at El Camino Health. In addition it has filed as a De Novo device with the FDA, which is a marketing pathway to classify novel medical devices for which there is no legally marketed predicate device, and is currently awaiting feedback.
The data the company has collected is exceptionally promising, with three fully blinded study phases in a randomized, controlled trial consisting of over 700 patients.
Materna has also already applied for a new reimbursement procedure code (ICD-10) in labor and delivery, a rare occurrence for a medical device.
Once commercialization for Ellora is complete, which is anticipated within one to two years, Materna will join Fogarty alumna Alydia Health as one of a select few medical device companies commercializing in the labor and delivery sector. New technology can be a key draw for hospitals, which aim to attract new mothers by providing a modern and positive birthing experience and building continued patient loyalty and community trust.
Thanks to the success of its first product, the Milli Vaginal Dilator, designed to relieve symptoms of vaginal muscle tightness and painful intercourse, Materna is well-positioned for success, with established commercial manufacturing channels and a network of partners and influencers. Already, Milli boasts more than 5,000 appreciative users who have found relief from needless pain.
A champion for women’s healthcare
While companies like Alydia Health and CooperSurgical have helped bring greater attention and funding to women’s health, MacNeal knows there is still much ground to cover to ensure stronger investing and bring forward solutions that will help women thrive in all aspects of their lives.
Women-led startups accounted for 2% or less of venture capital (VC) funding, making MacNeal’s advocacy particularly meaningful. As a trailblazer in the larger medtech space, she actively mentors other CEOs, entrepreneurs and students.
Just recently, MacNeal participated in AdvaMed’s second annual Medtech Showcase and Reception, where she voiced her appreciation for the role the medtech association plays on behalf of all entrepreneurs. “We all must join together to advance the cause of women’s healthcare,” she said. “I’m committed to using my voice to help ensure that all medtech entrepreneurs, particularly those addressing women’s needs, have the visibility and resources they need.”