CHF Solutions expanding commercialization of Aquadex FlexFlow for fluid overload

CHF Solutions (NASDAQ:CHFS) has expanded its U.S. commercial team to 13 sales territories for its Aquadex FlexFlow system, an ultrafiltration treatment for patients with fluid overload who have failed diuretic therapy, along with expanded distribution in Europe and Asia.

“As we’ve been able to raise money, we’ve been able to invest in our commercial effort, which now stands at 18 people, including five field clinical specialists,” chairman and CEO, John Erb, says in an interview with BioTuesdays, noting that the company has achieved double-digit revenue growth, year-over-year, for the past five quarters.

“Congestive heart failure is the leading cause of fluid overload and is our primary disease target, representing approximately 75% of the total U.S. fluid management market,” he adds.

Aquadex therapy is 510(k) cleared by the FDA and sold internationally with a CE Mark. Historically, CHFS has had an installed base of more than 500 consoles in some 300 U.S. hospitals, with more than 60,000 successfully treated patients.

Using distributors, the Aquadex system is now available in the UK, Italy, Spain, Singapore and Hong Kong, with recently announced market entries in Germany and Thailand, he adds.

“What drew us to the international market were customers who had used the therapy before Baxter bought the business in 2012 and subsequently shut it down,” he recalls. “So when they heard that CHFS was bringing the aquapheresis therapy back to the market, we started getting many phone calls and emails, and we realized there was a segment of market demand in place.”

CHFS was a venture capital startup in 2001 and Mr. Erb was the company’s first CEO. In 2010, CHF was acquired by Gambro for $75-million. Two years later, Baxter acquired Gambro and Baxter put the CHFS business up for sale.

“I was able to acquire the business from Baxter for $4-million in 2016 and since then we’ve been reviving the business and re-engaging with cardiologists and hospitals,” he adds. CHFS also has moved manufacturing the Aquadex system from Baxter to its plant in Eden Prairie, Minn.

The therapy consists of the Aquadex console, which is about the size of a home coffee maker and has a list price of $31,000; a blood circuit set, which is a one-time use disposable and lists for $980; and a dual lumen venous catheter.

Mr. Erb explains that the dual lumen catheter is placed in a patients arm; one lumen withdraws blood, which is filtered to remove water, with the blood then returned to a patient through the second lumen. “Only about 33 cubic centimeters of blood is outside the body at any one time, which is far less than dialysis.” In addition, a blood circuit set is approved for 72 hours of use in a hospital and up to eight hours for an outpatient treatment.

According to Mr. Erb, there are 6.5 million patients with heart failure in the U.S., representing the largest driver of Medicare costs, of which more than one million are hospitalized annually. And approximately 90% of heart failure hospitalizations result from fluid overload.

Diuretic drugs are standard of care for patients with fluid overload but fail to provide optimal outcomes in many patients, he adds. “Diuretics impact the kidneys over time and patients develop resistance to these drugs, with some two-thirds of patients discharged from hospital with residual excess fluid.” In addition, diuretics increase the risk of an electrolyte imbalance in the body, lowering magnesium and potassium.

Mr. Erb points out that the majority of all 30-day readmissions to hospital result from heart failure and the Affordable Care Act carries Medicare penalties for early patient readmissions, which is driving growth of the outpatient market.

CHFS has published results of five clinical trials with its Aquadex system in peer-reviewed journals, demonstrating that the treatment can remove 40% more fluid than conventional diuretic drug therapy over the same period of time, without any clinically significant impact on electrolyte balance, blood pressure and heart rate.

Mr. Erb also says the studies found a 53% reduction in the risk of re-hospitalization with the Aquadex system, compared with patients treated solely with diuretics, after 90 days and fewer re-hospitalizations because of a cardiovascular event.

Citing a study in the Journal of American College of Cardiologists, Mr. Erb suggests another benefit of the Aquadex system is precise control of the rate and amount of fluid removal.

“Diuretic patients have to have their dose increased in steps until their kidneys pick up the rate of voiding excess body fluid. With our device, we dial in the rate of filtration and the speed, so that treatment for 300-pound patient with 100 pounds of excess fluid and a 120-pound patient with 20 pounds of excess fluid can be customized based on the clinical goals set by a physician,” he contends.

“Ultrafiltration also can restore the body’s responsiveness to diuretic drugs and can result in more effective decongestion and fewer heart failure events, compared with diuretics,” he adds.

An independent study of the Aquadex system with 67 heart failure patients conducted by Good Samaritan Hospital in Cincinnati found no readmissions for volume overload after 30 days; the length of hospital stay reduced to two days from the national average of six days; readmission rates from before aquapheresis down to 4% from 12% the year before; and an average of six liters of fluid removed per patient.

An analysis of costs savings by a health economics-consulting group found that a hospital could save about $4,000 per admission using Aquadex, compared with diuretics, over a 90-day period. “That’s significant because the average hospital in the U.S. has 600 heart failure admissions a year,” Mr. Erb contends.

The American College of Cardiology/American Heart Association, the Heart Failure Society of America, the European Society of Cardiology and Heart Failure Association, and the Canadian Cardiovascular Society have published clinical guidelines supporting the use of ultrafiltration.

Last month, CHFS announced results of an independent study presented by Britain’s National Health Service of 13 patients who underwent ultrafiltration between 2014 and 2017. Among other things, the data showed greater weight loss over a shorter treatment period with ultrafiltration, compared with IV diuretics alone, without impacting renal function.

In July, CHFS received a five-year up to $6.5-million contract from the Tampa, Florida Veterans Affairs medical center for Aquadex consoles and blood circuit sets. The Tampa VA is using the therapy in an outpatient setting instead of admitting patients into hospital.

“This is meaningful because of all the doors it will open for CHFS throughout the VA as well as a potential expansion of our outpatient market,” Mr. Erb says.

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