Biomedical Enterprises Inc.
Biomedical Enterprises Inc. is a leader in designing innovative medical devices. The company has designed devices to treat life threatening systemic infections with heat and ultraviolet light, induce hypothermia, and identify cancer cells with artificial intelligence. In addition to this, the company created a dialysis needle that has been recognized and supported by the National Institute of Health through its commercialization assistance program.
The BME Needle
The BME needle is a breakthrough invention based in BME discoveries. It is the first needle designed specifically for hemodialysis, and it has proven to be safe, effective and superior to the standard needle in fluid dynamic studies and in dialysis studies in sheep and humans. In fact, with respect to needles, there has been little innovation in the past 40 years until now. The standard needle which has been used since hemodialysis was started in the late 1960s was patented by Huber in 1955 to give hypodermic shots, and it does not fulfill current needs. Most of the needle innovations over the last 50 years have focused on devices to prevent accidental punctures to health care personnel, sharpening the distal end of the needle and lubrication of the shaft to facilitate tissue penetration.
Benefits of the BME Needle
The BME needle ejects the blood into the dialysis vascular access as three jets with drastically slower velocity and turbulence than the single jet of the standard venous needle. The lower velocity and turbulence give the following advantages:
Less damage to the vascular access which is a major contributor to clotting of the vascular access. This leads to less clotting of the vascular access, less hospitalization, surgery, infection and death.
Less damage to white cells, less inflammation, oxidative stress, malnutrition, cardiovascular disease, accelerated atherosclerosis, hypertension, anemia and mortality, and likely the fatigue (“wash out” feeling) and poor appetite after dialysis.
Less destruction of red cells and thereby less anemia.
Less damage to platelets, release of pro-coagulants and formation of clots inside the micro capillaries of the dialysis filter, improved removal of toxins from the blood and less anemia.
Less hospitalization increases revenue of providers of dialysis because they receive payment for each dialysis given and patients receive more outpatient dialysis treatment because they have less complications, hospitalizations and in-hospital dialysis.
Insurance companies and Medicare benefit from the decrease in the cost of care because of lower occurrence of medical complications, surgery, hospitalizations, and vascular access complications. Vascular access complications are a major cause of morbidity and even mortality, they consume >10% of the total cost of care of all the dialysis patients, and the occurrence of access complications is reaching epidemic proportions.
Validation
The BME needle has been fully tested and validated in research laboratories and in studies in animals and patients. Fluid dynamic studies were performed at the fluid dynamic laboratories of the Department of Biomedical Engineering at the Georgia Institute of Technology and at the University of Alabama at Birmingham. Testing during in vitro dialysis was performed at the George Washington University. Testing during dialysis in sheep was performed at the MedStar Research Institute, Washington DC. Finally, the BME needle was tested during hemodialysis on patients with permanent kidney failure. The BME needle has been found to be safe and effective and superior to the standard needle, and all the necessary requirements to obtain a 510K from the Federal Drug Administration (FDA) for commercialization have been fulfilled. The BME needle can be brought to the market within six months.
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