Materna Medical Secures $20 Million Investment Led by InnovaHealth Partners

Materna Medical (Materna), a leading innovative medical device company in the United States, announced today that it is closing $20 million in Series B funding with lead investment from a private equity firm, InnovaHealth Partners, LP (InnovaHealth), joining major existing investors including Wavemaker 360 Health and Kimera Ltd. Materna can provide pelvic health solutions to women and healthcare professionals In the US, the increase is one of the largest in the women’s medical device space.

The round was initiated by Materna’s President and CEO, Tracy MacNeal, and was supported by InnovaHealth’s co-founder and CEO, Dr. Ariella Golomb, directed. As part of the investment, Materna is expanding its board of directors to include Dr. Golomb, as well as Aileen Stockburger, former vice president of global business development and strategic planning at Johnson & Johnson, and Lisa Granick, partner at Fletcher Spaght, Inc.

While only 2.3% of venture capital went to companies with a female founder, according to Crunchbase, Materna is proud to be part of an exclusive group of companies with a majority-female board, CEO and majority-female executive team.

Women’s vaginal health is poorly understood

Vaginismus is one of those conditions that is misinterpreted, underdiagnosed, understudied and overlooked, and as such, one of the biggest challenges related to vaginismus is simply that both patients and clinicians have not heard of the condition. Millions of women suffer from the symptoms of the disease, which are pain and anxiety during forced penetration, including intercourse, tampons, and pelvic exams. The most common reason patients end up with vaginismus is when they have a primary condition that causes pelvic pain that becomes chronic. For example, menopause, cancer treatment, sexual assault, and childbirth injuries are common conditions that can trigger secondary vaginismus, a chronic contraction of the pelvic floor muscles. Patients often don’t realize that these symptoms are common and indicate a treatable condition called vaginismus.

“And the confusion isn’t just with the patient. There is a great deal of misunderstanding and misinformation about the condition within the medical profession. Unfortunately, not much is taught about vaginismus in medical school. This lack of information means that patients often suffer from this disease for five years or more and see multiple doctors who do not know how to diagnose or treat them. What we are trying to do through our work at Materna Medical is to help clinicians learn the patterns of these patients so they can quickly identify, diagnose, and then help patients recover from secondary vaginismus, thereby streamlining their care and improve their well-being,” said Materna Medical’s President and CEO, Tracy MacNeal.

Materna believes that women’s pelvic disorders represent a significant unmet need that creates an outsized opportunity for innovation, social impact and return on investment, disrupting a $6 billion market for the most common pelvic disorders affecting women.

A pivotal study in obstetrics

Although women’s pelvic health is chronically underfunded, Materna successfully launched its first commercial product, Milli, an expanding dilator indicated to relieve the symptoms of vaginismus, to the consumer wellness market in 2019 December 2021 the 510(k)- Obtain FDA approval.

“Our second product, Materna Prep, is currently in the pivotal EASE clinical trial to see if it can help primiparae achieve fewer pelvic muscle injuries, a shorter second stage of labor and a reduced risk of cesarean sections . Following the EASE study and FDA approval, Materna plans to launch Prep in the US,” adds MacNeal.

Regarding Materna Prep, Materna is pleased to bring a new, innovative product to a pivotal study in obstetrics. Conducting clinical research in labor and delivery is inherently challenging because the nature of labor is unpredictable. The introduction of new technologies in obstetrics requires time and attention from busy, 24-hour clinical staff. As such, the company is working very closely with its research partners to focus on making this technology user-friendly in the busy environment of labor and delivery.

The Prep technology originates from the Stanford Biodesign program, which focuses on the clinical unmet need of perineal injuries (tear) and pelvic floor injuries. Up to 9 in 10 new mothers suffer perineal lacerations during childbirth – sometimes these are minor injuries, and sometimes they are life-changing, causing permanent disfigurement, sexual dysfunction and long-term urinary and fecal incontinence. In addition, the pelvic floor muscles themselves are often damaged, with up to 30% of all birth injuries involving muscle damage. Women who give birth vaginally are nine times more likely to have a prolapse later in life. “In our pilot study, Prep reduced pelvic floor injuries by 60%, so we knew we were on to something important. That’s why we’re conducting this large, pivotal study in 15 of the top hospitals in the US,” MacNeal shares.

Without a doubt, MacNeal and her team are thrilled to be working with some of the best pelvic floor researchers in the world. Specifically, they received a $2.2 million grant from the NIH to support their EASE study and a partnership with the University of Michigan’s Pelvic Floor Research Group, led by Dr. John DeLancey and Dr. James Ashton-Miller where they use Materna’s Prep data to develop predictive models to improve standards of childbirth care.

Women run the company

Traditionally, in women’s health companies, leadership, board composition and decision-making authority have been predominantly male. With this new round, Materna Medical will continue to be led by women and, according to MacNeal, will now have five out of seven board seats occupied by women leading the pack. Existing board members (including Company CEO Tracy MacNeal and Michaela Griggs, CEO of Southern California Reproductive Center) remain.

Without a doubt, Materna’s lead investor in this round — InnovaHealth Partners, LP (InnovaHealth) — is excited to be working with them.

“Materna’s goal is to challenge the status quo of labor and delivery. For the first time, doctors may be able to proactively offer their patients the opportunity to mitigate pelvic floor injuries during childbirth. The company makes pelvic floor health a priority and develops advanced solutions to treat common issues women face throughout their lives. We couldn’t be more excited to be working with Tracy and the Materna team to make this a reality. Our investment demonstrates our commitment to women’s healthcare and investment in women leaders. Materna will be part of an exclusive group of companies with a majority-female Board of Directors, a female CEO and a majority-female leadership team,” shares Dr. Ariella Golomb, co-founder and chief executive officer of InnovaHealth.

Materna will use its Series B funding to accelerate the commercialization of the millivaginal dilator and complete the de novo classification application in preparation for receiving US marketing approval

“We are conducting clinical research for Milli and Prep to expand indications and claims and ultimately make these technologies available to all patients who need them. We continue our commitment to health equity so that all patients ultimately have access regardless of ability to pay – it takes years of work, but it’s important to start early,” concludes MacNeal.

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