Along with the breakthrough BME needle, BioMedical Enterprises has developed:

• The arterial blood line, which is a tube that transports blood from the patient to the dialysis filter
• The venous blood line, which is similar to the arterial blood lines but transports blood from the dialysis filter to the patient
• Double lumen dialysis catheter (The catheter consists on two thinner plastic tubes attached to each other; one that withdraws blood from the patient (like an arterial needle) and another one that returns blood to the patient (like a venous needle)
• The Blood pump that propels the blood during dialysis
• A Kit including the BME needle and the BME blood lines
• Plastic Needles to replace the standard metal dialysis needles

Features and benefits

• The blood lines and dialysis blood pump drastically reduce the velocity and turbulence of the blood inside the tubing of the dialysis circuit.
• The BME’s double lumen catheter, similarly to the BME’s needle, decreases the velocity and turbulence of the blood inside the dialysis vascular access, after the blood leaves the catheter and this decreases the damage to circulating blood cells and to the vascular access.
• The BME plastic needles which will replace the metal needles are safer (less risk of accidental puncture to health care personnel, less risk of damage to the dialysis vascular access) and of lower price. The venous plastic needle will have three jets like the BME metal venous dialysis needle.

Validation

The proof of concept for all the future BME products has been obtained in the BME needle studies. A few additional studies will be required to obtain a 510K from the FDA to commercialize these products. These studies will include collaborators from Georgetown University, Children Hospital (DC), U. of Maryland and John Hopkins University.

These products can be brought to the market within 18 months.