Materna, a Fogarty Institute startup that is developing devices to prevent and treat pelvic floor disorders, is preparing to launch its newest device, Milli, which is aimed at treating pelvic pain, a condition that affects hundreds of thousands of women and often goes untreated.
It is estimated that 20 percent of women experience pelvic pain at some point in their lives. Numerous studies have shown that the primary or secondary cause of pelvic pain in women is from the pelvic muscles constantly contracting, making the condition similar to lower back pain. Physical therapy plays a major role in the diagnosis and management of female pelvic pain, and Milli was developed as a tool to optimize this treatment.
The startup began its beta launch, planning to sell up to 100 devices in the first few months to clinicians and their patients in order to collect data that will help them refine and finalize their product.
The idea for Milli originated from the startup’s first device, which promises to reduce the incidence of childbirth-related injuries with a device that prepares the pelvic soft tissues for delivery. One of the physicians who was testing the device mentioned that a similar device would be useful to treat pelvic pain felt by many of his female patients due to bladder or gastrointestinal issues, or injuries suffered from childbirth. The device builds and improves upon existing devices, which currently take from six months to a year to show results.
While the startup prepares for the broader market release of Milli in late 2017, it continues to improve upon its childbirth device: the company recently completed a 30-patient clinical trial at Baylor College of Medicine in Houston, Texas. The study results showed a decrease in pelvic muscle injuries during childbirth, as well as potentially decreasing delivery time.
The company will soon engage with the FDA, a positive development since studies have shown that more than 80 percent of women who have a vaginal delivery suffer from some degree of tearing, and about 50 percent suffer permanent pelvic muscle damage that leads to serious health issues later in life.