J3 Bioscience Receives FDA Clearance on Lead Product for Unmet Women’s Vaginal Health and Wellness Needs
PRESS RELEASE – October 27, 2021 – Salt Lake City, UT.
Patented LivRing™ is an intravaginal ring that provides long-lasting, controlled release of moisture to supplement the body’s natural lubrication and enhance the ease and comfort of sexual activity.
J3 Bioscience, Inc. today announced that its first vaginal health product, known as the “LivRing™” (aka VR101 Lubricating Intravaginal Ring), recently received 510(k) Premarket Notification clearance from the U.S. Food and Drug Administration (FDA). The LivRing is a patented, intravaginal ring (IVR) that functions as a long-term (up to 7 days) lubricating vaginal moisturizer to supplement the body’s natural lubrication and enhance the ease and comfort of intimate sexual activity. The LivRing is the longest-lasting vaginal lubricating product that will be available over-the-counter (OTC).
The LivRing™
“LivRing will solve the substantial unmet vaginal discomfort need,” said R. Tyler McCabe, PhD, President/CEO of J3 Bioscience. “The Company is thrilled to receive FDA clearance on its first and lead product as this definitely will provide a benefit to certain women and women’s health.” In addition, Dr. McCabe noted, “The LivRing is an innovative product. It contains no drugs or hormones and releases a lubricating moisturizer. Each ring is long-lasting and effective for up to 7 days. In addition, it is safe, simple, and easy to self-insert. LivRing does not interrupt intimacy or spontaneity, and is intended for continuous, repeat use when each ring is replaced weekly. Clinical study participants reported very high satisfaction and confidence levels.”
While ideal for post-menopausal women, the LivRing was clinically tested in women 21 years and older who qualified for the study. Women who will benefit include those experiencing discomfort from vaginal dryness, including potential dryness from medications and certain medical conditions. The LivRing is the only OTC product that is intended to provide long-lasting (seven days each ring) controlled-release of a natural lubricating moisturizer. The Indications for Use are: LivRing (VR101 Lubricating Intravaginal Ring) is a personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body’s natural lubrication. This product is compatible with natural rubber latex and synthetic (polyurethane and polyisoprene) male condoms and FC2 female condoms.
The LivRing is expected to be commercially available in the U.S. in the first half of 2022. Commercialization in Europe is expected later in 2022 after the product receives its CE mark.
About J3 Bioscience
J3 Bioscience, Inc., based in Salt Lake City, UT, is a commercialization-stage women’s health company focused on using its patented, proprietary technologies to create unique products addressing unmet needs for women’s vaginal health and wellness. The Company’s lead product, known as the LivRing, is a unique, clinically proven, and FDA-cleared intravaginal ring (IVR) that provides natural lubrication and moisture to women experiencing vaginal dryness. Using the same patent protected intellectual property platform, J3 Bioscience has programs in various stages of development for additional IVR products, including “light” LivRing, a pH balancing ring, and a probiotic ring.
CONTACT:
R. Tyler McCabe, PhD
Chief Executive Officer, J3 Bioscience, Inc.
[email protected]
