Once again, Rachel and Dr. Dweck are hosting a conversation that brings to light a topic little discussed but pervasive in the world of women’s health. Their guest on this episode of Busine$$ of the V, Tracy MacNeal, explains why dilators have an important role to play for a huge number of women who are suffering – usually undiagnosed – with pelvic floor-related issues. President and CEO at Materna Health, she shares the ins and outs (so to speak) of the products they have on the market and in development to treat and prevent pelvic floor issues.

Materna Medical is a novel OBGYN platform company, defining a $6B market in the most common pelvic conditions women face. Their first product, Milli, is a vaginal trainer (known as a “dilator”) with adjustable, incremental sizing for women who are trying to achieve intimate health. Their second product, Materna Prep, is currently in clinical trials and having tremendous success protecting mothers in labor from pelvic muscle injuries during childbirth. It doesn’t hurt that early indications also suggest that this device, for use in-hospital, also shortens the length of delivery and could help reduce unwanted C-sections.

A huge percentage of women suffer near-term pelvic injury during childbirth that leaves them with long-lasting consequences such as incontinence and prolapse. Tracy and her hosts also highlight the difficulty women have in getting diagnosed correctly (while more than 80% of sufferers don’t seek help at all). Education is key to helping patients self-identify often overlooked, little-known conditions like vaginismus. Their guest is a medtech dynamo who is combining her expertise as a medical device engineer with scientific rigor and marketing savvy. Materna Medical is a company you’ll want to watch!

You can subscribe or listen to previous episodes of the Busine$$ of the V podcast by clicking here.

HOT FLASH: Vaginismus. What is it? Muscles in the vagina constrict so tightly that they essentially put up a “Do Not Enter” sign to all forms of penetration.

TOPICS COVERED:

• Rachel and Dr. Dweck set up a larger conversation about women’s pelvic health and the availability of effective solutions as well as timely access to them.
• An introduction to Tracy MacNeal, who explains Materna’s platform.
• Dr. Dweck provides an overview of pelvic health issues – and dilator treatment.
• All about Milli – its technology and how it differentiates in the market. Tracy positions the product from her medtech engineering point of view.
• Do the numbers matter? More detail about diameters and how they come into play in the dilator process and in increasing blood flow.
• Does the Milli device have a role to play when trauma is a factor in pelvic discomfort? The answer is: Yes!
• What customers are saying about the Milli technique:
  • Highly effective
  • Less painful than alternatives
  • 86% of patients return to intercourse within six months (after having suffered issues for an average of five years)
  • Relief to have found a treatment option, often after multiple failed attempts
  • A key word to describe patient reaction: Relief
• How do consumers most often find out about Milli? About 80% come directly to Materna via internet research, but there is a growing affiliate network that includes 85 physicians so far.
• Menopausal women as well as those who have undergone cancer treatment make up a substantial portion of the market for the Milli.
• Rachel asks about the emotional component that frequently attends vaginismus and the anxiety that results.
• What role the FDA has to play in the development of Materna products like Milli and how Materna is adhering to strictest guidelines for medical devices.
• Materna rigorously maps to medical data in publicly available scientific journals and can make claims based on those outcomes, but the information can’t be used in marketing until the FDA signs off. This standard is important to Materna.
• “Claims” are what patients can expect to derive from a product while “Indications” are about what is going on physically with the patient. It can be challenging to find the right words to communicate easily identifiable symptoms. “Painful sex” would be one term.
• Dr. Dweck shares thoughts on the mind-body aspect of pelvic issues and Rachel touches on the average seven years it takes so many women to receive accurate diagnoses for gynecological issues.
• Tracy reveals that their patients have on average been looking for help with vaginismus for five years before finally connecting with a solution – and that excludes the many women who aren’t even stepping up to ask questions and seek help (which is believed to be as many as 80% of sufferers).
• In securing full FDA approval, Milli will go through the entire process and will be made available by prescription, but also ultimately sold over the counter (OTC).
• The role telemedicine has to play in connecting patients and specialists to accelerate education and access.
• In the pipeline: Materna will soon be offering dilators to be used in the labor and delivery room to help avert injuries during childbirth, i.e. to address the 50% of women that will suffer incontinence or prolapse subsequent to vaginal delivery.
• Materna’s new product will slowly, gently stretch the vaginal wall prior to delivery in order to protect against injury during childbirth. Studies so far indicate a 60% reduction in pelvic floor injuries as a result.

There are financial and other pressures on hospitals to reduce their rates of C-section deliveries and initial data indicate that Materna’s in-childbirth dilator can reduce pelvic floor damage by 50%. Could be a game-changer!

Quotes from the Tracy MacNeal Interview:

(08:17) – “I had no idea how common pelvic floor injuries are, due to childbirth and certain kinds of prolapse.”

(09:11) – “This program works. It just take some motivation so I generally preface that to my patients when we’re talking about dilators. And it also takes a lot of education because many, many women have absolutely no idea that this even exists.” (Dr. Dweck)

(10:20) – “I remember thinking as a medical device engineer ‘This is the best that my industry can do for women with pain and anxiety about wanted penetration?’ ”

(17:42) – “What we’re trying to find are all the millions of women who have secondary vaginismus – whatever their primary condition was. Could be trauma, endometriosis. About half the market as far as we can tell is menopausal.”

(18:33) – “Secondary vaginismus is a very common and very treatable condition. What we’re all about is just getting the conversation normalized in the popular culture so we can self-identify and get treated. There’s no reason to suffer.”

 (27:03) – “What we see in so many categories that we’ve spent woefully little time talking about as a society, is there is this overwhelming feeling of relief. To the extent that a product like (Milli) enables people to get an answer sooner – it’s so exciting.” (Rachel)

(29:120) – “(Over-counter-treatment) is a good thing. It empowers women.”

(32:03) – “There are pelvic muscles that hold your organs in place … and as the baby is going through (the birth canal) those muscles can separate from the bone and then the organs don’t have the support they need. And those are difficult injuries to fix.”

About Tracy MacNeal

Tracy is a growth-minded executive creating meaningful contributions to healthcare. Her specialties include: Women’s health, medical devices, digital health/connected health, healthcare executive, strategy, financing, fundraising, sales leadership, implementation plans, project management, market strategy, new business development, M&A, strategic partnerships in healthcare companies

FURTHER RESOURCES:

Website: www.maternamedical.com

More about Milli @Milli For Her

Tracy @LinkedIn

LINKS FOR BUSINE$$ OF THE V:

Dr. Alyssa Dweck: https://drdweck.com

Author Rachel Braun Scherl: www.sparksolutionsforgrowth.com/about-rachel-braun-scherl/