GLR Female Fluid Collection Device

Every year, between 3 million and 10 million women in the United States suffer from rare disease-related bladder incontinence. Bladder incontinence is often an inconvenient and often life-altering symptom of rare diseases impacting the nervous system, such as Multiple Sclerosis, Parkinson’s disease, and cystic fibrosis, and rare autoimmune diseases, such as Lupus, Scleroderma and Sjogren’s syndrome. Diseases like Multiple Sclerosis, which disproportionately impacts women of color, damage the nerves that send and receive signals messages from the bladder indicating when it is full or empty.

Women with rare disease-related bladder incontinence suffer severe rashes, increased risk of bacterial and fungal infections, significant decrease in physical activity, higher risk of falls and fractures, as well as a 40-80% chance of experiencing depression and anxiety depending on the severity of incontinence. The financial burden of bladder incontinence from all causes is exorbitant, costing tens of billions of dollars every year. In addition to time off work due to incontinence, the expenses of incontinence care include absorbent products, medications, doctor visits, and laundry. These costs increase as the patient ages.

The impact on the environment is similarly debilitating, as hundreds of billions of adult diapers and pads fill our landfills annually, resulting in deforestation and soil and water contamination. Adult diapers are single-use products, comprised of plastic and other non-biodegradable products. It is estimated that female adult diapers comprise 5% of our landfills and are the most common source of non-biodegradable waste.

The GLR Female Fluid Collection Device frees women from the physical, mental, and financial impacts of rare disease-related bladder incontinence. This small, simple, yet innovative device, diverts and collects urine and menstrual fluid, virtually eliminating the need for adult diapers and pads for those suffering from these rare diseases.

The Female Fluid Collection Device is a reusable device that extends over the urethra with an intravaginal anchor. The unique design creates a secure seal, eliminating embarrassing leaks or accidents that negatively impact the quality of life for women living with rare diseases impacting the nervous system and rare autoimmune diseases. Besides collecting waste urine, the device also collects waste menstrual flow. It can also be used to collect non-waste fluid samples.

Composed of medical-grade, antibacterial silicone, the Female Fluid Collection Device is resistant to bacteria and will significantly reduce the risk of bacterial and fungal infections. As a bacterial resistant device, it also can eliminate toxic shock syndrome associated with tampons and pads.

When used for patient hospitalization as an alternative to insertion catheters, our product is also expected to significantly reduce the incidence of CAUTIs (Catheter Acquired Urinary Tract Infections) which is one of the leading causes of hospital acquired infections.

This reusable device can dramatically reduce the medical waste and environmental impact of incontinence products. This reusable device will eliminate the need for hundreds of millions of adult diapers each year, thus reducing the carbon footprint from the fuel and electricity used for manufacturing adult diapers and pads and additional laundry.

GLR Medical’s Female Fluid Collection Device directly and meaningfully improves the quality of life for women living with rare disease-related incontinence, including serves women with several rare diseases that cause incontinence, including Multiple Sclerosis, Parkinson’s disease, cystic fibrosis, Lupus, Scleroderma and Sjogren’s syndrome. In the case of Multiple Sclerosis, Lupus and Sjogren’s syndrome, these rare diseases are most common in women and are often diagnosed between the ages of 25 and 50. Those with these rare diseases experience a range of debilitating symptoms that are not easily treatable. Bladder incontinence is one symptom that is easily treatable with our device and can significantly increase their quality of life.

Inspired by the unique incontinence treatment needs of women, Dr. Elizabeth Hatz co-developed this simple, yet innovative solution for specifically for women. Dr. Hatz has tested the device herself to test both its comfort and efficacy. In the pilot stage, we will engage women of all ages, backgrounds, and activity levels, including women suffering from rare disease-related incontinence issues, to test the comfort and efficacy of our device.

This device has broader applications outside of rare disease-related incontinence treatment. Specifically, our product can be used in place of insertion catheters in hospital settings, and is expected to significantly reduce the incidence of CAUTIs (Catheter Acquired Urinary Tract Infections) which is one of the leading causes of hospital acquired infections. This device also has special applications for pre-surgical transgender men. 

Our cofounder Dr. Elizabeth Hatz is a rural medical general practicing physician that also has experience with the medical needs of emerging countries.

As a woman and physician, she saw the need, co-invented and designed a solution, filed its patents and tested the device.

Our team also includes a specialist engineer, a manufacturing expert and an Executive Chairman who manages channels, supply chains and our advisory group of medical professionals.

We are entering the Pilot stage of our device. The visibility of this prize, as well as resources from winning, will help us pilot a broader, more inclusive group of women.

Dr. Elizabeth Hatz is a Family Medicine physician who also has experience with the medical needs of emerging countries. She currently sees patients in rural Nebraska as part of Indian Health Services (IHS), she has also practiced in urban communities. She does annual medical outreach to Guatamela. 

GLR’s Female Fluid Collection Device is an inexpensive, reusable, convenient solution to incontinence caused my myriad rare diseases, The device reduces large amounts of medical waste.

The same device also solves incontinence issues for less rare diseases and has innovative personal and industrial applications. These additional applications make the business model especially sustainable.

Currently more than 200 billion women’s adult diapers are disposed of each year. In five years, we expect to curtail more than 20% of these as well as the corresponding manufacturing detriment of their manufacture: deforestation, as well as soil and groundwater contamination.

In five years we expect to significantly improve quality of life for more than 30% of the women who experience incontinence from rare disease, helping more than 20 million women. We expect to improve the lives of an additional 100 million women with less rare disease that frequently suffer from incontinence.

In the first year we expect to conduct efficacy pilots across a broad range of rare disease, less rare disease, general incontinence and general hospitalization applications. As a stretch goal we also hope to pilot several personal and industrial applications that improve our economies of scale, improving the cost and reach of our products to all women.

In the next year our primary measurement tool is the efficacy of pilot participants using our product and the breadth of those participants: disease type, age, geography, application, etc.

In five years our impact goals will be actual sales and usage of product across these applications. We will be able to estimate the reduction of deforestation, soil and groundwater contamination from sales and usage data.

Our impact falls primarily with the UN categories of #3 health and well being, #6 clean water and sanitation, #12 responsible consumption and #13 climate action.

Our theory of change aligns with the incentives of those who implement the change. Patients want better quality of life. As do their physicians. Patients and insurers want more cost effective solutions. Medical distributers and suppliers are under pressure to provide solutions more cost effectively. The industry has a mechanism to validate and commercialize new solutions.

In summary, current solutions are not efficient and an existing infrastructure exists to drive efficiency in outcomes. We understand this infrastructure and use it to leverage impact.

Our solution used engineering, rapid prototyping and 3D printing to generate its current samples. Advanced manufacturing will drive cost effective pilots and production.

https://patents.google.com/patent/US10582913B2/en https://patents.google.com/patent/US20200323519A1/en

Five. GLR Medical has a full time Executive Chairman, three part time staff and one volunteer. 

We conceptualized this idea in 2012. Our first patents were issued in 2018. Our first prototypes were built last year.  

Our product is designed for women. Our team lead and cofounder is a woman who does overseas medical trips with underserved communities and who currently works within an Indian Health Services hospital.

In all countries, our product addresses women’s urinary and menstrual healthcare which contributes to gender, class and socioeconomic and racial inequality.

Our products have specific applications for transgender men and future applications for transgender women.

Our team is actively involved in local LGBTQ+ and other inclusivity initiatives.

Our business model is similar to other medical devices. Our device significantly reduces the cost of hygiene for incontinence and reduces hospital associated infections for women. Because it does so across not only several rare diseases but also less rare diseases and also affects a large part of the population, solutions for incontinence are of great interest to medical professionals, medical distribution and medical suppliers. Consequently, our business model leverages these existing channels.

Because our product specifically reduces the incidence of Catheter Acquired Unitary Tract Infection (CAUTI) which is one of the leading hospital associated infections, there is additional pressure from the Centers for Disease Control and Prevention (CDC) to solve this problem.

Our business model is to sell our product to existing businesses that provide patient care (B2B).

As a medical device that greatly reduces cost of hygiene, increases quality of care and dramatically curtails hospital infections, we can follow a traditional model for venture financing efficacy trials and early production.Then we transition to sustaining ourselves with our own sales, before transitioning to large scale distribution of our products.

We have been cautiously successful to date. Early market needs assessment, engineering and patent protection was deliberate. Throughout this time the co-founders, Liz and George self-funded the business. As the product was validated and further interest in the community grew, partner Robert Martin brought manufacturing expertise and several hundred thousand dollars in capital to broaden the patent protection and successfully validate specific medical use cases. Recently we have advanced enough to attract a Chairman with a leading venture capital and investment banking track record in the bioscience space, Ken Krull. Ken was chairman of BioMicro which he sold to Roche. Ken has been advising the founders since his last fund, Mercato Partners I, became one the world’s top performing venture funds.