Describe your device and how it will benefit healthcare.
PELV-ICE is a utility patent-pending device company with the only soft braces that support all sides of the pelvis with multidirectional compression and removable ice/heat therapy just where you need it. Our devices offer::
o Pelvic floor/vulvar support
o Lower back/hip (SI) support
o Abdominal support that shrinks as you do
o Ice/heat pouches for perineum, lower back and abdominal comfort
o Machine washability
o Natural moisture-wicking and anti-microbial properties
o Increased mobility
o Reduction of narcotic use
They provide a natural way to manage pain and swelling while people heal from pelvic soft-tissue trauma.
VuVa Magnetic Vaginal Dilators are a new, nonsurgical approach to helping millions of women suffering from multiple pelvic pain conditions and sexual discomfort. With more than 6 million women suffering from vulvodynia in the United States alone, women are looking for safe and effective treatments. In a double-blind, placebo clinical trial, VuVa was shown to reduce 80% of subjects' vulvar pain with magnetic dilators. VuVa Magnetic Dilator therapy can also be incorporated into treatment plans for other conditions, such as vaginismus, vulvar vestibulitis, dyspareunia, menopause, vaginal stenosis, vaginal atrophy, and vaginal dryness. Many women suffering from these pelvic pain conditions have been placed on heavy pain medications, anti-depressants, or have been advised to have invasive surgeries with low success rates. VuVa Dilators offer a low-cost, safe, noninvasive treatment option to renew the sexual desire and comfort these women deserve. VuVa Dilators are made in the United States.
How does your product differ from the competition?
Dated and damaging attitudes that surround the postpartum period, including that women need to get their bodies back fast, need to be replaced with messages of healing, support, and wellness for new mothers. Mama Strut loves helping new mothers with our devices, but Mama Strut's bigger mission to revolutionize postpartum care and create a mindset shift in society around birth and recovery. Pregnancy and birth have lasting effects that the medical community is just starting to recognize with MRI screening. The modern, breadwinning, busy new mother of today is not getting her physical, emotional, and medical needs met with today's postpartum healthcare. Differentiating Mama Strut from belly bands and girdles that make false claims and perpetuate harmful messages to new mamas is a top priority. The amazing and attentive care that a pregnant woman gets needs to extend well into the weeks and months after delivery.
VuVa Dilators have strategically placed Neodymium magnets inside each dilator, unlike all other dilators on the market, which are simply made up of silicone or plastic. The patent-pending neodymium component consists of more than 60 neodymium magnets in a set of five graduated dilators. The negative magnetic field allows an increase in blood flow to the muscles and ligaments in the vagina, relaxing the painful areas and calming the nerves. Patients have reported that by using the VuVa Dilator twenty minutes before sex, dilators can decrease penetration and intercourse pain significantly. In addition to VuVa reducing pelvic pain, subjects suffering from vaginal dryness due to menopause have reported an additional benefit of dilators helping to create natural lubrication. It is thought that future clinical trials will prove by the increase of blood flow to the area, estrogen is created, eliminating the need for expensive and controversial estrogen treatments.
Do you have customers yet?
We launched in 2015 and have sold more than 5000 units globally. We have about 500 recommending OB/GYNs and have recently signed up 1500 more at medical conferences. We have completed a pilot clinical study at Keck/USC and are about to start a larger clinical at Keck/USC.
|Since VuVa Dilators became available on the market in late 2015, we have only used social media, Google ads, and pelvic pain forums to direct traffic to our website. After selling more than 1000 dilators and receiving positive feedback, it validated our decision to perform clinical trials. Clinical trials have provided positive results by reducing nerve pain in subjects--so much so that each subject purchased a set of VuVa dilators at the conclusion of the study. Our story and product have appeared on SELF Magazine online, Natural Awakening Magazine, Yahoo Española online, and other online publications, which is driving traffic to our site. At the current time we are shipping worldwide, and are in discussions with medical device distributors in the United States and South America.|
How much money have you raised?
Who are your investors?
Friends and family
At the present time, the total investment has been provided to the two coowners and the inventors of the product, Tara Langdale Schmidt and Robert Smithson.
What is the next milestone for your device?
Getting our own device code and completing the second clinical trial
|We are seeking to have clinical trials performed in larger cities to show efficacy of using VuVa Dilators in the treatment of other pelvic pain conditions. At the completion of these clinical trials, we are confident they will help us gain FDA approval for the magnetic component in our dilators. Vaginal dilators are an already approved Class II medical device. We are searching for reputable distributors in Europe and other countries, as pelvic pain is a worldwide silent epidemic. We are evaluating other investment opportunities to raise capital to facilitate further clinical trials and marketing.|