Biotech Values

[Praveen]

Blood and Water
Matthew Herper, 07.24.06

Heart failure defies drugs aimed at it. A new device may offer a better shot.
Eric Guggemos was in danger of drowning in his own blood. The 34-year-old corporate chef, who lives in Savage, Minn., had a bad heart valve, causing his body to bloat with water and balloon up to 275 pounds from his usual 180-pound frame. Last year doctors hooked him up to a nifty machine the size of a loaf of bread; it drained 100 pounds of water from his bloodstream in nine days. That let surgeons proceed to fix his broken valve.

"I haven't felt this good since I was 17," he says.

The blood-filtering device that saved him is the Aquadex, made by CHF Solutions of Brooklyn Park, Minn., a small seven-year-old outfit that is privately held but which may go public next year. Only 160 hospitals and clinics use it thus far, but CHF's chief, John Erb, sees a huge market for the gadget, which costs $14,500 plus $900 per filter every time a patient gets one treatment.

Three million hospitalizations occur each year because of the most acute form of congestive heart failure. Existing drugs such as Lasix, a water-draining diuretic, and new entries Natrecor and dobutamine haven't been tested in major trials or are suspected of serious side effects. "We're providing a therapy that is treating these patients more effectively, improving their quality of life and keeping them out of the hospital," Erb says. (The firm has come under fire recently for making alleged donations to a not-for-profit tied to the doctors that led trials of the device. CHF insists the money was above-board, used only to fund its own trial.)

Heart failure costs Medicare more than any other malady, racking up $30 billion in direct and indirect medical costs each year. The heart becomes so weakened by age or disease that it fails to pump enough blood to drain out fluid. At worst a heart transplant may be needed. "Patients who used to die of their high blood pressure or heart attacks are now saved only to develop heart failure later on," says John Teerlink, a director at the San Francisco Veterans Administration Medical Center. "We have to treat it aggressively. We just don't have the tools to do so yet."

The Aquadex works by a decades-old process called ultrafiltration. Blood taken from the body is passed through a filter that removes excess water. This had always required tapping into big veins in the chest, risking infection, and removing a liter of the body's five liters of blood each time, straining the heart by dropping blood pressure. The Aquadex needs only two tablespoons of blood at a time, and the blood enters and exits through catheters in the arm. New York cardiologist Howard Levin invented it in 2000, and Erb joined the firm as chief executive in late 2001, raising $51 million in venture backing on top of $12 million seed capital. CHF's investors include MPM Capital, Investor Growth Capital and SV Life Sciences.

The device sailed through the Food & Drug Administration in June 2002, billed as merely a newer form of ultrafiltration. To sell it to doctors, Erb waged a trial of 200 patients. The results, unveiled in March, showed the Aquadex removed an average of 10 pounds of water from patients, 43% more than Lasix and other drugs. Patients didn't report feeling any better than those on diuretics, yet they returned to the hospital half as often.

The Aquadex still "isn't ready for prime time," argues Keith Aaronson, a heart specialist at the University of Michigan. He says the 200-patient trial didn't use drugs intensively enough for a good comparison and that a new study is needed to clinch any reduction in hospital visits. Undaunted, CHF's Erb hopes to begin selling machines to outpatient clinics, though another skeptic, Jonathan Sackner-Bernstein at CliniLabs in New York, says that rollout is "premature," preferring its use be kept at hospitals. Erb counters: "It's a shame to wait until these patients are so overloaded they go to the emergency room."