Glyciome R&D
About Glyciome®
Glyciome, LLC is a women-owned, biomedical company commercializing first-in-class personal and urogenital care devices and therapeutics to diagnose, prevent and treat common infections and inflammation-based disease (e.g. genital cancers). Glyciome has a pipeline of patent-pending products for diagnosing and managing vaginal infections and preventing the cancers these infections can lead to. Our Founders have a unique, established understanding of topical gel impact on genital physiology allowing us to develop products with unparalleled user tolerance and safety.
Our Mission
Glyciome is developing drugs and devices that will change genital care paradigms in the clinic and at home. The products launched by our biomedical startup will reduce common genital infections that more than double the risk of costly diseases, such as preterm birth and genital cancers (e.g. cervical, ovarian, and penile). Our patent portfolio uniquely leverages cutting-edge science in metabolomics and nanosensor-technology with our Founders’ established, human-centered product commercialization approach, to meet the demands of the $26B/yr global “personal” healthcare market.
Glyciome is currently developing their disruptive prebiotic intravaginal gel, “PreBioGyn”, as a cervical cancer prevention therapeutic. Our company also has existing sales of our prebiotic, direct-to-consumer (DTC) personal-care product line that shares patents pending with our PreBioGyn technology (Wild & Pure® - wildandpure.com).
Our Cervical Cancer Prevention Technology
Our PreBioGyn gel has been developed using tailored “design-thinking” for people living in low resource settings (LRS) with poor healthcare access. These people are those most at risk of developing cervical cancer, the 4th most frequent female cancer worldwide, and a demographic with a recent “staggering rise” in U.S. mortality rates.
Our $454,968 NCI Phase I STTR (“Cervical Cancer Prevention Prebiotic Device” - completed in late 2023) was one of 35 U.S. awards funded under NOT-CA-21-062 (“Cancer Prevention, Diagnosis, and Treatment Technologies for Low-Resource Settings”). Our project addressed SBA approved waiver eligible topics, allowing us to access increased Phase I funding. We are applying for NIH SEED Phase II funding to continue development of our PreBioGyn cervical cancer prevention therapeutic.
Variations of the PreBioGyn gel as an FDA-cleared medical device can quickly be scaled for use by all people at risk for cervical cancer. However, it is also an opportune time to seek funding for a drug variation of our gel for use during pregnancy. Our Founders have established expertise in reproductive physiology and pregnancy is a patient niche with little competition, at the same time that federal funding is increasing to improve obstetrical outcomes.
Glyciome’s Founders
JE Ellington, PhD - Majority Owner/Founder & CEO
Reproductive Physiologist and experienced entrepreneur. For three decades, she has invented and commercialized ground-breaking, reproductive-health related products (e.g. first FDA-cleared fertility lubricant, first paraben-free antepartum perineal massage gel). She holds over 15 issued patents. Her most successful product to date is Pre-Seed® Fertility Lubricant (licensed to Church & Dwight). Through her NIH-funded PI and CEO roles in several start-ups she has learned each step of the commercialization process. Dr. Ellington has extensive capability in messaging to federal agencies, Key Opinion Leaders, and consumers/patients. She has overseen three SBIR/STTR grants and completed the NIH ICORP training. She oversees our patent and grant development, scientific strategy, budget management, product design and marketing, and retail and wholesale sales.
Dr. Clifton, PharmD - Owner/Founder, COO & Pharmaceutical Scientist
Dr. Clifton has 20 years of experience in commercialization of reproductive healthcare products. He has played a key role in the bench to market transition of over 10 consumer products. Dr. Clifton’s experience includes pharmacy practice, clinical pharmacology research, and administration (e.g. Dept Chair & Interim Dean, WSU). He oversees our product formulation, production, biocompatibility testing, IRB & clinical study design/oversight, and regulatory & quality management. He has prepared and submitted numerous FDA 510(k) applications. His sales experience consists of successful pitch presentations and negotiations with large retail chains (e.g. CVS, Walgreens, Target).
Our corporate business professional partners include Eide Bailly and Greenburg Traurig Law.
