Materna Medical is securing a $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 private equity firm, InnovaHealth Partners, LP (InnovaHealth), which joins major existing investors including Wavemaker 360 Health and Kimera Ltd. Enabling Materna to provide pelvic health solutions to women and healthcare professionals across the US, the increase is one of the largest in women’s medical devices.

The round was raised by Materna’s President and CEO, Tracy McNeil, and led by InnovaHealth Co-Founder and Managing Director, Dr. Ariela Golomb. As part of the investment, Materna is expanding its board of directors to welcome Dr. Golomb, as well as Eileen Stockburger, former vice president, global business development and strategic planning at Johnson & Johnson, and Lisa Granik, partner at Fletcher Spaght, Inc. .

While only 2.3% of venture capital has gone to companies with a female founder, according to Crunchbase, Materna is proud to join 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 is misunderstood, underdiagnosed, understudied and neglected, 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 discomfort during desired penetration, including intercourse, tampons and pelvic exams. The most common reason patients end up with vaginismus is if they have an underlying condition that causes pelvic pain that becomes chronic. For example, menopause, cancer treatment, sexual abuse, and birth injuries are common conditions that can cause secondary vaginismus, a chronic contraction of the pelvic floor muscles. Patients often do not realize that these symptoms are common and point to a treatable condition called vaginismus.

“And the confusion is not just in the patient. There is a tremendous amount of misunderstanding and misinformation about the condition in the medical profession. Unfortunately, vaginismus is not taught much in medical school. This lack of information means that patients often suffer from the disease 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 by thereby improving their care and well-being,” explains Materna Medical President and CEO, Tracy McNeil.

Materna believes that women’s pelvic health disorders represent a significant unmet need that creates a huge opportunity for innovation, social impact and ROI, and disrupts the $6 billion market in the most common pelvic conditions women face.

Basic research in obstetrics

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

“Our second product, Materna Prep, is currently in the EASE pivotal clinical trial to see if it can help first-time mothers achieve less pelvic muscle injury, a shorter second stage of labor and -small chance of cesarean section. Following the EASE trial and FDA approval, Materna plans to launch Prep in the US,” added MacNeal.

Regarding Materna Prep, Materna is excited to introduce a new, innovative product in a pivotal study in obstetrics. Conducting clinical research in childbirth is fundamentally challenging because of the unpredictable nature of childbirth. Introducing new technology to 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 fast-paced environment of labor and delivery.

The Prep technology comes from the Stanford Biodesign program, focusing on a clinically unmet need for perineal lacerations (tearing) and pelvic floor injury. Up to 9 in 10 new mothers suffer perineal tears during childbirth – sometimes minor injuries, sometimes life-changing, causing permanent disfigurement, sexual dysfunction and long-term urinary and faecal incontinence. In addition, damage to the pelvic floor muscles themselves is common, 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 injury by 60%, so we knew we were on to something important. That’s why we’re conducting this large, pivotal study at 15 of the best hospitals in the US,” McNeil shared.

Without a doubt, McNeil and her team are excited to partner with some of the best pelvic floor researchers in the world. Of note, they won a $2.2 million grant from the NIH to support their EASE study and a partnership with the University of Michigan 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 help improve the standard of care at birth.

Women leading the company

Traditionally, in women’s healthcare companies, management, board composition and decision-making bodies have been predominantly male. With this new round, women will continue to lead Materna Medical and will now be represented in five of seven board seats by women who are at the top of the field, according to MacNeal. Existing board members (including company CEO Tracy McNeil and Michaela Griggs, CEO of Southern California Reproductive Centerwill) remain.

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

“Materna’s goal is to challenge the status quo in childbirth. For the first time, clinicians may be able to proactively offer their patients the option of mitigating pelvic floor injury during childbirth. The company makes pelvic floor health a priority and develops advanced solutions to treat common problems that women face throughout their lives. We couldn’t be more excited to partner with Tracy and the Materna team to make this happen. Our investment demonstrates a commitment to women’s healthcare and an investment in women leaders. Materna will join an exclusive group of companies with a majority female board, a female CEO and a majority female management team,” said InnovaHealth Co-Founder and Managing Director, Dr. Ariela Golomb.

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

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