Sexual intercourse becomes painful for a significant portion of women – as many as 17%. This discomfort, felt either before or after penetration, is identified as vaginismus.
At the forefront of addressing this issue is Tracy MacNeal, the visionary leader at the helm of Materna Medical. With a pioneering spirit, she has introduced the world to Milli, the first FDA-cleared OTC all-in-one vaginal dilator. This innovation is aimed at alleviating the challenges posed by vaginismus and other related pelvic conditions. Milli represents a noteworthy stride within the FemTech revolution, offering respite from painful intercourse and championing women’s intimate well-being.
Driven by a commitment to address the needs of his wife’s clients – who are recipients of pelvic floor physical therapy – Mark Juravic ventured into the realm of technology development. This journey found its genesis within the auspices of Stanford Biodesign, where the seeds of innovation are nurtured. This program serves as a haven for creators, fostering the conception, crafting, and application of medical technologies that cater to unmet clinical necessities.
In 2010, the fruition of Juravic’s vision materialised in the form of Materna Medical, a pioneering MedTech enterprise with a distinct mission. The company is dedicated to mitigating childbirth-related injuries, which are often intertwined with pelvic floor disorders like incontinence and prolapse that manifest later in life. A staggering 90% of vaginal deliveries are accompanied by perineal tears, while severe tears afflict around 10% of initial vaginal deliveries, potentially resulting in enduring complications.
The intricate process of medical device development encompasses multifaceted stages, including design, manufacturing, rigorous testing, and strategic marketing. This path is characterised by stringent regulatory prerequisites. The Food and Drug Administration (FDA) mandates exhaustive testing and clinical trials to validate the safety and efficacy of these devices, navigating the rigorous landscape of healthcare innovation.
In the year 2019, MacNeal became a pivotal addition to the Materna team, contributing her expertise to propel the technology into the market. “I specialise in the commercialisation of medical devices,” remarked MacNeal. “I love launching innovations and building teams.”
“What caught my attention about Materna is the market size,” The worldwide market for treating chronic pelvic pain is anticipated to expand from $5.7 billion in 2021, reaching a projected $8.0 billion by the year 2031. This growth trajectory owes its momentum to the escalating incidence of this condition and the strides made in diagnostic methodologies. A surge in awareness and patient enlightenment has notably contributed to surging demand for viable treatment solutions, as patients take an active role in seeking medical intervention.
“The last time something like this was done was in the 1940s with the epidural. Since then, there hasn’t been any innovation on a broad scale,” stated MacNeal. “There was no competition, and there is intellectual property, good clinical data, and a good regulatory path. In our pilot study at Baylor College of Medicine in Houston, we reduced the pelvic floor injury rate by 60%.”
While the childbirth product stands as the initial concept, it’s Milli that blazes the trail as the debutant. Unlike the childbirth product, Milli didn’t necessitate an intensive clinical study.
While incontinence and prolapse garner substantial attention, vaginismus remains relatively unspoken. Yet, it can stem from factors like anxiety, sexual assault, menopause, cancer treatments, and post-delivery trauma.
In 2019, Milli made its entrance, albeit with a prescription requirement. However, given the scarcity of vaginismus education in medical training, securing a diagnosis and prescription can be a formidable challenge. “We found that our patients see, on average, three or four clinicians before they find us,” noted MacNeal. “So we invested in getting over-the-counter clearance.”
Equipped with accurate information, women possess the ability to self-diagnose. Tracy MacNeal emphasised “We’ve proven with our OTC clearance that if you give patients the right information about what vaginismus is, what the symptoms are, they can decide for themselves if they have it.”
In pursuit of OTC clearance, Materna underwent an FDA-mandated self-selection study. The company enlisted participants spanning various literacy levels to establish that even those with a reading level below eighth grade could comprehend Milli’s promotional materials. Women autonomously assessed their condition, later confirming their diagnosis through medical consultation. MacNeal noted, “There was a 96% correlation,” with the process taking about three months.
Milli does not fall under insurance coverage. Tracy MacNeal pointed out that this poses a significant health equity challenge, which she acknowledged as a substantial undertaking. Establishing reimbursement through Medicare and Medicaid stands as a pivotal objective.
Conducting clinical research in labour and delivery settings presents unique challenges. Primarily, the timing of a baby’s birth is often unpredictable. Babies arrive on their own schedule. Only a handful of hospitals offer round-the-clock research coverage. MacNeal remarked, “We had to train many people to use the device. That’s expensive and time-consuming.”
Materna ensures the inclusion of patients from diverse racial, ethnic, and income backgrounds in the clinical trial through innovative approaches. These include facilitating diaper subscriptions and babysitting services, enabling patients to attend ultrasounds, and even offering Uber services for appointments.
However, the course changed with the onset of the pandemic. The clinical trial was suspended until the vaccine gained widespread adoption.
The pandemic introduced a hurdle to the advancement of the childbirth product, Materna Prep. The company halted clinical trials until the vaccine reached broad usage.
MacNeal expressed her gratitude for the substantial investments garnered, stating that she has so far secured a $2 million seed round, a $10 million Series A round, and a $20 million Series B. This financial support empowered Materna to pursue both product endeavours.
In May, the company was awarded a $2.2 million grant from the National Institutes of Health (NIH) to bolster a De Novo application. This application offers a marketing pathway, classifying a novel medical device based on analogous devices in the market, ensuring reasonable assurance of safety and effectiveness.
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