Describe your device and how it will benefit healthcare.
Vestagen's VESTEX enhanced fabric is designed to improve the safety of healthcare workers and their patients. According to the Bureau of Labor Statistics, healthcare professionals experience the highest rates of injury and illness of any occupation in the United States. Frequent exposure to body fluid splatters and spills result in bacterial colonization of apparel, a well-documented source of pathogen transmission. Pathogen transmission is linked to worker illness and high rates of healthcare-associated infections (HAIs) in patients. The cost of HAIs is high-thousands of lost lives, millions of additional hospital days, and billions of dollars annually. Vestagen currently manufactures healthcare worker uniforms and outerwear (scrubs, lab coats, etc.) with VESTEX technology. VESTEX garments are engineered to have robust liquid repellency and antimicrobial properties, along with breathability, comfort, and durability.
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?
VESTEX is the first and only apparel product to earn the exclusive endorsement of the American Hospital Association. VESTEX is proven in a clinical setting to reduce the acquisition and retention of contaminants on clothing. In a peer-reviewed published study, researchers reported a statistically significant MRSA reduction of more than 99.99% on the VESTEX scrubs compared with standard uniforms.
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?
VESTEX is currently being purchased by healthcare systems and providers. In any given month, Vestagen receives hundreds of orders from approximately 10-15 different customers. Vestagen is in late-stage negotiations with large health systems in the Mountain West, Southeast and Northeast portions of the United States.
|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?
More than $10 million
Who are your investors?
Vestagen is backed by an elite group of venture and private investors, including Advent Life Sciences, Sofinnova Healthquest Partners L.P., V-Ten Capital - VVEST LLC, Merefin Capital, and ClearWell Group.
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?
VESTEX fabric is currently registered with FDA as a Class I medical device, and the company plans to file for FDA clearance as a Class II medical device in 2016.
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.