Vulvovaginal Atrophy (VVA) is a condition that results from a decrease in the body’s estrogen levels. Symptoms of VVA can include vaginal soreness, irritation, and pain. Research has indicated that the condition affects at least half of all post-menopausal women and breast cancer survivors, many of whom often report substantive reductions in quality of life. The condition may be widely underdiagnosed and undertreated. Symptoms generally do not improve without treatment, which today usually involves lubricants or hormone-based therapies, according to guidance to clinicians from the Mayo Clinic. VVA, like most conditions, ranges from mild to severe. Women with moderate to severe VVA can experience significantly debilitating symptoms such as depression, anxiety, pain with activities of daily living, recurrent urinary tract infections, and reduced quality of life.

The FDA has now granted Madorra breakthrough device designation for the company’s non-invasive, home-use device for a subset of women experiencing moderate to severe vulvovaginal atrophy (VVA), a component of genitourinary syndrome of menopause (GSM). The designation is associated with priority review status for submissions relating to Madorra’s breakthrough device.

The FDA’s Breakthrough Designation Program was created to help patients and healthcare providers receive faster access to innovative technologies that hold the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. Under the Program, FDA will provide Madorra with priority review and communication regarding device development until the product is brought to market. The Company hopes that this will accelerate marketing authorization. Pending legislation via the Medicare Coverage of Innovative Technologies (MCIT) program may also lead to Medicare reimbursement once the device is granted marketing authorization by the FDA.

Madorra is developing its first product, as a prescription, non-invasive, home-use, handheld device. The company plans to evaluate the device in an upcoming pivotal clinical trial. Used at the vaginal opening (not inserted) the device applies therapeutic ultrasound waves along the vaginal canal. Madorra’s device is intended to stimulate local heat and blood flow, producing natural vaginal lubrication, which researchers hope will alleviate symptoms of VVA.

Data submitted with Madorra’s application to the FDA showed that in a small, randomized, controlled study, participants who used the Madorra Therapy System for 12 weeks had improvements in the physician-assessed Vaginal Health Index (VHI) and a reduction in self-assessed symptoms versus those using a sham device. In addition, the device raised the vaginal temperature in the treatment arm compared to sham. Company researchers have documented that a rise in temperature caused a cascade of events that improved VVA. Further, participant adherence to the therapy regimen was high at 12 weeks (80%). The data will be submitted for publication at which time more data will be available.

The combination of clinician assessments and validated patient reported outcomes was provided to FDA in support of the breakthrough device application to demonstrate a reasonable expectation of clinical success.

“VVA is a silent condition underdiscussed by society but for postmenopausal women it’s very real and impacts their lives,” said Prof. Rodney Baber, MD of Royal North Shore Hospital in Sydney. “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.”

“We are pleased to see FDA recognize and prioritize the potential for VVA to be debilitating for specific patient populations,” said Holly Rockweiler, MS, co-founder and CEO of Madorra. “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.”

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