Madorra this week said it has received FDA breakthrough device designation for its noninvasive, home-use device for moderate to severe vulvovaginal atrophy.
Through the breakthrough device program, Madorra will have priority review and communication regarding the development of the device until the product goes on the market.
Madorra’s handheld device is designed as a prescription, noninvasive home-use device that applies ultrasound waves along the vaginal canal to stimulate local heat and blood flow and produce natural vaginal lubrication to alleviate symptoms of vulvovaginal atrophy (VVA).
“VVA is a silent condition under-discussed by society but for postmenopausal women it’s very real and impacts their lives,” Dr. Rodney Baber, a doctor at Royal North Shore Hospital in Sydney, said in a news release. “A majority of women in this trial who used the Madorra device experienced symptom relief and wanted to continue using the device after the trial completed, leading to cautious optimism for the product.”
Data submitted with the application showed that in a small, randomized, controlled study, participants who used the Madorra therapy system for 12 weeks had improvements in the physician-assess vaginal health index (VHI) and a reduction in self-assessed symptoms compared to those who used a sham device. The device was also able to raise the vaginal temperature in the treatment arm compared to the sham.
“We are pleased to see FDA recognize and prioritize the potential for VVA to be debilitating for specific patient populations,” cofounder and CEO Holly Rockweiler said. “Further, our preliminary research supports that the device has the potential to produce significant reductions in VVA symptoms. For participants who completed the treatment portion of the study, their satisfaction with the device was high and they overwhelmingly wanted to continue using the device after the trial ended—a confirming sign for our development program.”