(H.E.L.P.)Apheresis Therapy to Compare the Reduction of LDL (Low Density Lipoprotein) Cholesterol

The primary study endpoint is the change in percent measurements of the pre-to-post apheresis
LDL measurements between the approved H.E.L.P. system and the modified H.E.L.P. system. The
secondary study endpoints are clinical lab profiles and device parameters analyzed at
specific time points throughout the study.

Inclusion Criteria:

- Subject is between 25 and 70 years of age (inclusive) at the time of randomization.

- Subject is an appropriate candidate for H.E.L.P. apheresis treatment for
hypercholesterolemia according to current Plasmat® Secura approval criteria.

- Subject has received a minimum of two consecutive bi-monthly* H.E.L.P. apheresis
treatments using the Plasmat® Secura apheresis system >30 days prior to the screening
visit.

- Subject is willing to maintain cholesterol lowering dietary and drug therapies as
prescribed through the course of the study.

- Subject is willing and able to provide written informed consent and Health Insurance
Portability and Accountability Act (HIPAA) Waiver.

- Sterile, post-menopausal, or using acceptable birth control for the duration of the
study. Acceptable birth control is defined as having a vasectomized, postmenopausal,
or sterile partner; the ongoing use of approved hormonal contraceptives, barrier
method, or an intrauterine device; or abstinence.

- Every 14 days (±2 days)

Exclusion Criteria:

- A History of a known sensitivity to heparin or ethylene oxide.

- A history of hemorrhagic diathesis, bleeding/clotting disorder, thrombocytopenia
(defined as platelet count < 150 x109/L), or for whom the use of heparin would cause
excessive or uncontrolled anticoagulation or for whom adequate anticoagulation cannot
be safely achieved (ie., hemophilia, recent surgery, acute internal bleeding,
gastrointestinal ulcers).

- Females who are pregnant or lactating.

- Subjects< 106 lbs. or <48.2 kg in body weight; or whose weight is >1.5 times their
ideal weight.

- Certain cardiac impairments such as congestive heart failure, major arrhythmia, or
diastolic blood pressure greater than 100 mm/Hg on two separate occasions at least 24
hours apart.

- Renal insufficiency defined as creatinine greater >2.0 mg/dlL or is dependent upon
renal dialysis.

- Untreated hypothyroidism; uncontrolled diabetes mellitus; or fasting triglycerides
>500 mg/dL.

- Serious systemic disease (e.g., advanced neoplasms, and acute hepatitis) including
Immune system suppression or compromise, that could preclude survival to study
completion.

- History of stroke within 6 months of the screening visit.

- Received thrombolytic treatment < 7 days of screening.visit.

- Taken or requires a prohibited treatment < 30 days prior to the Screening Visit, or
requires a prohibited treatment at anytime during the course of the study.

- Neutropenia (neutrophil count < 0.5 x109/L).

- History of liver disease or serum ALT and/or AST > 2X upper limit of normal range.

- History of dementia.

- History of anemia (value outside the lower normal range).

- acetyl salicylic acid (ASA) > 325 mg/day.

- Subject currently enrolled in another investigational study (does not apply to PMS for
Secura device).

- Subject with any other medical condition that in the opinion of the investigator might
put the subject at risk or interfere with his/her participation.

- Subject is unwilling or unable to comply with the protocol or to cooperate fully with
the investigator or site personnel.