Materna Medical is at work on a device to help protect the more than 80 percent of women who suffer damage or tearing during childbirth.
“The clinical need we’re trying to address is that there’s a tremendous amount of damage that women suffer during childbirth,” Mark Juravic, founder and CEO of the California-based startup, said. That damage can lead to incontinence, pain, sexual dysfunction and vaginal prolapse, and much of the damage done is to the pelvic muscle because the baby stretches too much too quickly. First-time mothers are particularly susceptible to tearing.
If the device is brought to market, Juravic said there are many value propositions: it could prevent vaginal tearing for the mother, prevent pelvic muscle damage to the mother, and, perhaps most interestingly, could potentially also offer shorter delivery times using less instruments. Juravic said some evidence points to predilated tissues leading to shorter delivery times. With shorter, easier deliveries, for instance, it’s likely forceps would be less necessary, further reducing the chance of tearing and damage to the mother and stress on the baby.
“This can be if it works and provides all these benefits, it could become the standard of care for childbirth,” Juravic said. In theory, it would make the job of childbirth easier on the mother and the physician or midwife.
The device itself is surprisingly simple: a mechanical dilator that would penetrate the first third of the vaginal canal and basically pre-stretch it to full dilation. It would be used for an hour or two during the first stage of labor, and is equipped with sensitive load and location sensors, plus a semi-automatic force-controlled actuation system, so the device can be removed quickly.
The idea translates from sports medicine: slower stretching is more effective and less stressful to the body than a quick stretch. Materna is banking on this kind of slow stretch to prepare the pelvic floor for delivery.
So far, Materna has completed its first in-woman trial for the device in Sydney, Australia. Why Australia? To work with Dr. Hans Peter Dietz, a thought leader in the effects of childbirth on the pelvic floor. With his expertise, the device was used on eight women.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Earlier this year, Materna moved into the Fogarty Institute for Innovation, a non-profit that works as an incubator for the medtech startups it selects. In the company’s time there, Juravic said he will focus on gaining more clinical data. Because Fogarty is based on the El Camino Hospital campus, Juravic gets regular direct feedback from physicians on the device. Mike Stewart, the product designer and former product development engineer on projects for Boston Scientific (BSX), takes that into account for device design and testing. It’s this feedback that leads him to believe the dilator could be a platform technology for Materna.
“A number of obstetricians and gynecologists have taken a look at our device and said, ‘If you could just change this one little thing on it, I would really like to use it on X patient population or Y patient population. . . . ‘ There are a number of devices we could launch close to our core tech.”
Juravic spent his pre-startup life at Guidant, and took the Stanford BioDesign course while working there. The BioDesign course presented a number of issues to the participants, and Juravic was drawn to tears incurred during childbirth because it seemed to him there was a vast clinical need. It was biomechanical, so he thought from his previous work he could offer a unique perspective. Since the course, he began to work part-time on nights and weekends on Materna, eventually quitting his day job in 2010 when the startup secured its first round of funding for the device, $1 million from angel investors.
Now, the company has a $1.2 million target in its sights for this round, which will include some costs associated with regulatory filing. Juravic said more than half of that amount will come from existing investors.
As Materna continues onward and upward, Juravic looks forward to innovation in the obstetrics field. He said because women’s health has been “ignored” for so long, innovators “are recognizing that there are lots of unmet needs.”
