Increasing blood flow with ultrasound to improve women’s health - Holly Rockweiler : 24

The National Institutes of Health spends about $42 billion on medical research each year, but less than one-eighth of that money is spent specifically on women’s health. That may come as a bit of a shock, given that women make up a majority – about 51% – of the population. This underserved market is a huge economic opportunity for med tech companies.

That’s what Holly Rockweiler discovered as a Fellow at the Stanford Byers Center for Bio Design. So she put her background in biomedical engineering to work and started Madorra Medical, developing solutions to improve the vaginal atrophy and dryness that women experience after menopause or breast cancer. Madorra’s flagship product is a handheld home-use device that uses ultrasound to rekindle the body’s natural moisture-producing capability. The FDA has granted it breakthrough device designation 

The first randomized trial has been published, and a second one is on the way, and the company is now working toward the next set of data. Here in Episode #24, Madorra CEO Holly Rockweiler and Andy Rodgers talk about how that data is helping to blaze new trails in women’s health. 

Need to know:

• There was a commercial about menopause in this year’s Super Bowl (Astellas Pharma). That simple fact signals a new era in women’s health. 
• Fundraising can be the most difficult part of bringing a new product to market, and it never goes away. Investors want to know what data has been collected, what payer requirements are, and to see a clear path to market.
• Piggyback on existing data when you can. For Madorra, there was substantial literature and technology using ultrasound in other therapies, data on vaginal blood flow from sexual arousal studies, and existing ultrasound devices that could be modified to show proof of concept.

The nitty-gritty:

Vaginal dryness resulting from vulvovaginal atrophy (VVA) affects over half of post-menopausal women and is also common among breast cancer survivors due to treatments that cause estrogen levels to drop. Symptoms include soreness, irritation, pain, increased urinary tract and yeast infection rates, and pain with sexual intercourse. 

Today, the standard treatment for menopausal symptoms is estrogen therapy. But that comes with risks: breast cancer, heart attack, and stroke. The quandary for doctors and patients alike is whether the benefits of pharmaceutical treatment outweigh the risks. For some patients, the risks are too significant and estrogen therapy is not recommended.   

By putting data to work, Madorra created an ultrasound solution that stimulates natural moisture production and eliminates these risks. Madorra’s hand-held external device, used on regular basis for 8 minutes, has been producing significant results in 1 to 3 weeks.  The device is shaped to be intuitive as possible to fit naturally and is used with disposable proprietary hydrogel. Safety is always a key issue, and the wide variety of literature on ultrasound therapies – including the fact that it’s used on pregnant women – has instilled confidence in patients and clinicians alike. 

Data that made the difference:

Market data from the Stanford BioDesign program helped Rockweiler learn to do an analysis of unmet needs, stakeholders, and market dynamics before taking the big leap.

An Institutional Review Board (IRB) feasibility study helped in initial development.

Pre-existing data on ultrasound showed that ultrasound therapy in other uses improved blood flow to treated areas. This key finding indicated that it might work on thin friable vaginal tissue as well.

Patient data revealed how the condition feels to patients and