BELLINGHAM, Wash., Nov. 26, 2018 /PRNewswire-PRWeb/ -- Fairhaven Health has received a medical grant from a federally-funded agency for the development of Sage Gel, an isotonic biome-friendly vaginal moisturizer to relieve Genitourinary Menopausal Symptoms (GSM) for improved relief in postmenopausal women. The funding is part of the Small Business Innovation Research (SBIR) program developed to support innovative technology through the investment of federal research dollars for American priorities supporting the national economy and public health.
With the federally-backed funding, Fairhaven Health will finalize the development of Sage Gel.
There are 66 million postmenopausal women in the US, 75% of whom report routinely suffering from vaginal atrophy with a loss of natural moisture and elasticity causing increased vaginal pH and a loss of healthy bacteria. GSM's symptoms include vaginal dryness, burning and irritation, embarrassing vaginal odor, and sexual dysfunction. Sufferers report a negative impact of vaginal problems on their daily lives and sexual function and less than half seek treatment. Fewer than half are satisfied with the solutions offered by their doctor causing the syndrome to become more prevalent and inadequately treated.
Commercially available vaginal moisturizers are the usual recommended first-line therapies for GSM, despite being known causes of damage to vaginal lining and healthy bacteria required for optimal women's health. The peer-reviewed funding committee agreed with Fairhaven Health that there is an unmet need for a non-irritating, safer product that relieves symptoms of GSM and minimizes disruption to the vaginal ecosystem.
Fairhaven began developing Sage Gel in 2015 and has secured US Patent #9919018B2 with additional US and International patents pending. The product's formulation will rely heavily on naturally derived ingredients known for their moisturizing and soothing qualities, including a proprietary blend of raspberry and clary sage extracts combined with lactic acid buffers.
Sage Gel's formulation provides less mucosal irritation and less disruption to healthy lactobacillus bacteria in comparison to existing vaginal products. The federal funding will expedite development and commercialization of Sage Gel, including future development of a novel unit-dose applicator system (similar to sterile single-dose eye drops) to deliver a sterile, preservative-free product.
To lead the project, Fairhaven Health has hired Dr. Joanna Ellington, a leading sexual medicine expert and vaginal product inventor. Dr. Ellington created: BabyDance, the first FDA-cleared fertility lubricant made without parabens; IsoFresh Balancing Vaginal Gel; and BabyIt Perineal Massage and Postpartum Comfort Gel. Other project collaborators include Dr. Raina Fichorova, Professor of Obstetrics, Gynecology and Reproductive Biology at Harvard Medical School. Sage Gel will be tested for safety by Dr. Fichorova in her laboratory's bacteria-colonized vaginal system model, which screens for over 20 measurements of immune-toxicity.
"Current vaginal products used by menopausal women to treat dryness, discomfort, odor and burning can actually cause these same conditions. Many women who start using these products, stop them because of these side effects," said Dr. Ellington. "As a postmenopausal woman myself, I wanted to design a product that minimized any disruption to the vaginal ecosystem of older women. In fact, the World Health Organization (WHO) has issued an Advisory Note on chemical properties of vaginal products suggesting they be isotonic and free of ingredients found to damage vaginal cells. Despite these guidelines, leading products used by millions of women with GSM, have at least one property outside of recommended levels."
"The team working on the development of Sage Gel has combined expertise in clinical and experimental vaginal biology, vaginal product development, and commercial sales in women's vaginal products, to create a new generation of products to combat GSM and improve women's quality of life after menopause," said Fairhaven's CEO, Kelly Andrews.
ABOUT Fairhaven Health
Fairhaven Health is a specialty supplier of natural, doctor-designed products to support fertility enhancement, pregnancy and breastfeeding. We offer a broad range of products to help couples conceive, providing natural alternatives to more expensive and invasive infertility treatments. Our clinically validated fertility supplements and ovulation prediction tools are recommended by OBGYNs and fertility specialists and have helped tens of thousands of couples conceive naturally. Once pregnancy is achieved, we offer natural, doctor-designed prenatal supplements and our award-winning Milkies nursing products to help new moms meet their breastfeeding goals. And we are very excited about our newest brand, Isolove, which includes made-without-parabens and isotonic biogels designed for alleviating vaginal odor, perineal massage and postpartum comfort, as well as a fertility friendly lubricant. Learn more at fairhavenhealth.com.
SOURCE Fairhaven Health