The Mission. Global Monitors, Inc. is developing diagnostic and treatment devices for use by hemodialysis patients and clinics. The mission of GMI is to improve hemodialysis care so that less complications are generated during and after hemodialysis treatment.
The Problem. End stage renal disease (ESRD) is a condition that occurs when kidneys are no longer able to work at a level needed for day-to-day life. Patients with ESRD require life-supporting treatments such as maintenance dialysis or kidney transplantation. Currently there are 340,000 ESRD patients taking hemodialysis (HD) treatment of 3 to 5 hour long thrice a week Overall these patients take about 50~60 million treatments a year.
As 3 to 5 liters of fluid is ultrafiltrated out of the patient over the course of HD, many patients develop hypotensive symptoms such as fainting, vomiting and cramping. This is known as intradialytic hypotension (IDH). (Hypotension means low blood pressure.) In the few hours after the HD, post-dialytic orthostatic hypotension (PDOH) can develop, making the patient hard to stand up, get onto a wheelchair, or fall to cause syncope. Due to the food and fluid intake in between treatments, the patients develop post-dialytic hypertension (PDH) which causes congestive heart failure. Induced by these three cardiovascular problems, IDH, PDOH and PDH, the resulting poor quality of life of the patients and high mortality rate (one death out of six) are unacceptable to the public and the patients.
To deal with public concerns on HD care and to reduce an expenditure of $20 billion to care for the Medicare HD patients, the Centers for Medicare and Medicaid Services (CMS) set up a Quality Incentive Program (QIP) for dialysis clinics to improve their HD care. The FDA also established an Innovation Challenge program to assist companies in getting FDA approval on innovative devices that address ESRD. Our devices are being developed under these premises.
The Company and Its Products. Global Monitors Inc. (GMI) is a US based specialist medical device company with the mission to commercializing technology that can alleviate or prevent the development of IDH, PDOH and PDH. The GMI’s way to reduce mortality and to improve HD care is to alert the health care personnel with timely diagnosis and the use of appropriate measure to reduce the complications induced by IDH, PDOH and PDH. Our product in diagnosis is the VOLEME monitor which can be an early warning detector on the development of IDH and assess the status of blood volume and fluid removal from the body so that IDH can be prevented, the HD process optimized, and the severity of PDH reduced. Our second product, the abdominal compression elastic support (ACES), is a patented treatment device that can prevent the development of IDH and PDOH.
Dr. Jen S. Lee is the CEO and Lian P. Lee the President of GMI. They have worked on cardiovascular research many years as professor and scientist at the University of Virginia. Their experience in engineering, medicine and entrepreneurship move the GMI to the stage of getting the products tested and to the stage of clinical trial. We expect that the trial will generate data to show the GMI’s product can lead to quality HD care and reduce the complications that often developed as the patients undergoing the hemodialysis treatment.
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