Materna Medical Secures $20 Million Investment Led By InnovaHealth Partners

Materna Medical (Materna), a leading innovative medical device company in the US, announced today that it has closed $20 million in Series B funding with lead investment from a private equity firm, InnovaHealth Partners, LP (InnovaHealth), which joins major existing investors including Wavemaker 360 Health and Kimera Ltd. Enabling Materna to bring pelvic health solutions to women and healthcare specialists in the US, the raise is one of the largest in the women’s medical device space.

The round was raised by Materna’s president and CEO, Tracy MacNeal, and led by InnovaHealth’s cofounder and managing director, Dr. Ariella Golomb. As part of the investment, Materna is expanding its Board of Directors to welcome Dr. Golomb, as well as Aileen Stockburger, former Vice President, Worldwide Business Development & Strategic Planning at Johnson & Johnson, and Lisa Granick, Partner at Fletcher Spaght, Inc.

While according to Crunchbase, only 2.3% of venture capital went to companies with a female founder, Materna is proud to be joining an exclusive group of companies with a majority female Board of Directors, a female CEO, and a majority female leadership team.

Women’s Vaginal Health Is Poorly Understood

Vaginismus is one of those conditions that are misinterpreted, underdiagnosed, understudied, and overlooked, and as such one of the biggest challenges surrounding vaginismus is simply that both patients and clinicians have not heard of the condition. Millions of women suffer from the condition’s symptoms, which are pain and anxiety during desired penetration, including sexual intercourse, tampons, and pelvic exams. The most common reason patients end up with vaginismus is if 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 point to a treatable condition called vaginismus.

“And the confusion doesn’t just lie with the patient. There is a huge amount of misunderstanding and misinformation about the condition within the medical profession. Sadly, not much is taught about vaginismus in medical school. This lack of information means that patients often suffer from the condition for five years or more and see several clinicians who do not know how to diagnose or treat it. What we are trying to do through our work at Materna Medical is to help clinicians learn the patterns of these patients so that they can quickly identify, diagnose, and then help patients recover from secondary vaginismus, thus improving their care and well-being,” explains Materna. Medical’s President and CEO, Tracy MacNeal.

Materna believes that women’s pelvic health disorders represent a significant unmet need that creates an outsized opportunity for innovation, social impact, and returns on investment, and is disrupting a $6 billion worth market in the most common pelvic conditions women face.

A Pivotal Study in Obstetrics

Despite women’s pelvic health being chronically under-resourced, Materna successfully launched its first commercial product, Milli, an expanding dilator indicated to help relieve the symptoms of vaginismus, into the consumer wellness market in 2019. Investors saw the $10 million Series A2 funds successfully used to obtain 510(k) clearance from FDA in December 2021.

Our second product, Materna Prep, is currently in the pivotal “EASE” clinical trial to see if it can help first-time moms achieve less pelvic muscle injury, a shorter second stage of labor, and less chance of C-sections. After the EASE Trial and FDA clearance, Materna plans to launch Prep in the US,” adds MacNeal.

Regarding Materna Prep, Materna is excited to be bringing a new, innovative product to a pivotal study in Obstetrics. Conducting clinical research in labor and delivery is fundamentally challenging, as the nature of labor is unpredictable. Introducing new technology in Obstetrics requires time and attention from busy, 24/7 clinical staff, so the company has stayed very close to its research partners to focus on making this technology easy to use in the hectic environment of Labor & Delivery.

The Prep technology came from the Stanford Biodesign program, focusing on the clinical unmet need of perineal lacerations (tearing) and pelvic floor injury. Up to 9 in every 10 new mothers experience 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. Additionally, damage to the pelvic floor muscles themselves is common, up to 30% of all childbirth injuries involve muscle damage. Women who deliver vaginally are nine times more likely to have prolapse later in life. “In our pilot study, Prep reduced pelvic floor injury by 60%, so we knew we were onto something important. That’s why we’re pursuing this large, pivotal study in 15 of the top hospitals in the US,” shares MacNeal.

Without a doubt, MacNeal and her team are thrilled to be partnered with some of the top pelvic floor researchers in the world. Notably, they won a $2.2 million grant from the NIH to support their EASE trial and a partnership with the University of Michigan’s Pelvic Floor Research Group, led by Dr. John De Lancey and Dr. James Ashton-Miller, where they are using Materna’s Prep data to develop predictive models for helping improve the standard of care in childbirth.

Women Leading The Company

Traditionally in women’s health companies, the leadership, board composition, and decision-making authority are predominantly male. With this new round, women will continue to lead Materna Medical and will now be represented in five out of seven board seats by women who are at the top of the field, as per MacNeal. Existing board members (including the company’s CEO Tracy MacNeal and Michaela Griggs, CEO of Southern California Reproductive Center) will remain.

Without a doubt, Materna’s lead investor from this round – InnovaHealth Partners, LP (InnovaHealth), is thrilled to be partnering with them.

“Materna’s goal is to challenge the status quo in labor and delivery. For the first time, clinicians may be able to proactively offer their patients an opportunity to mitigate pelvic floor injury during childbirth. The company is making pelvic floor health a priority and developing advanced solutions to treat common problems that women face over their lifetimes. We couldn’t be more excited to be partnering with Tracy and the Materna team to make this happen. Our investment demonstrates a commitment to women’s healthcare and investment in women leaders. Materna will be joining an exclusive group of companies with a majority female board, a female CEO, and a majority female leadership team,” shares InnovaHealth’s cofounder and managing director, Dr. Ariella Golomb.

Materna will use its Series B financing to accelerate the commercialization of the Milli Vaginal Dilator and to finalize the De Novo Classification Request for Prep to obtain marketing authorization in the US

“We are running clinical research for both Milli and Prep to expand indications and claims and ultimately get these technologies to all patients who need them. We’re pursuing our commitment to health equity so that all patients can eventually have access regardless of their ability to pay – that’s years of work but it’s important to start early,” concludes MacNeal.

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